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CLINICAL CHEMISTRYREAGENT GUIDE Beckman Coulter, Inc., 250 S. Kraemer Blvd.,Brea, CA 92821, USA. EC REP EN Beckman Coulter Biomedical Limited, Lismeehan, O' Callaghan's Mills, Co. Clare, Ireland, Tel: ++353 65 6831100. -i– This guide is intended for use with: BECKMAN COULTER AU400 BECKMAN COULTER AU600/600IVD BECKMAN COULTER AU640 BECKMAN COULTER AU2700 BECKMAN COULTER AU5400 BECKMAN COULTER AU680 BECKMAN COULTER AU480 Version .11 Revision date: 2010-06 - ii – CONTENTS 1. OVERVIEW 2. INSTRUCTIONS 2. 1 Guide Format. 2. 2 Guide Updates. 3. 4. 5. SYMBOLS GENERAL PRECAUTIONS AND WARNINGS NOTES PRODUCT GROUPINGS TABLE OF CALIBRATORS AND CONTROLS GLOSSARY ** APPENDIX 1 APPENDIX 2 APPENDIX 3 - iii – - iv – 1. OVERVIEW This guide is designed to provide specific chemistry information for the Beckman Coulter clinical chemistry systems. Please note that the latest revision of the Instructions For Use (IFU) and Setting Sheets can be found on the Beckman Coulter website at; www.beckman coulter.com. Access to this website requires registration; therefore it is recommended that you register as soon as possible. The guide does not include all the requirements governing the safe and effective operation of the Beckman Coulter clinical chemistry systems. Refer to the analyser specific User Guide and your specific laboratory procedures governing other areas, such as corrective actions, QC policies, or hazardous waste disposal that are not addressed in this guide. Beckman Coulter logo is a trademark of Beckman Coulter, Inc. and is registered in the USPTO. 2. INSTRUCTIONS 2.1 Guide Format: This guide contains the Instructions For Use (IFU), which describe how the reagent is to be used, and Setting Sheets for the Beckman Coulter range of reagent kits, which describe the required Beckman Coulter Chemistry Analyser settings to use with the specified reagents. The outer label on the Beckman Coulter reagent kit identifies the Part No. for the reagent and the applicable revision code for the IFU and the Setting Sheet. Please refer to this each time a kit is used – see below. Additionally, please ensure the use of the appropriate Setting Sheet for application with the biological fluid under investigation. Example: REF: OSR6287 BLOSR6x87.01 BSOSR6x87.01 IFU reference and revision code. Setting sheet reference and revision code. If the indicated revision or a higher revision is not present, then please contact your local Beckman Coulter support organisation. Alternatively, you may access this document on the Beckman Coulter website as described in Section 1. Note: The ‘x’ in the reference code denotes a multiple kit format. For reference code BLOSR6x87 incorporates OSR6187, OSR6287 and OSR6587. 2.2 Guide Updates: Updates to IFUs and Setting Sheets will be delivered to you as and when these become available. These updates should be inserted into the guide and the older version removed (unless specifically required) so that the latest information is available at all times. -v– 3. SYMBOLS The following symbols are used in the labelling of Beckman Coulter System Reagents. Manufacturer In Vitro Diagnostic Medical Device Consult Instructions for Use Temperature Limitation Catalogue Number Keep Upright Batch code For IVD performance evaluation only Authorized Representative in the European Community Biological Risk Contents Protect from Light Material safety data sheet available to professional users on request. Serial Number Caution, consult accompanying documents Product conforms to the IVD directive Use by: (YYYY-MM-DD or YYYY-MM) 4. • GENERAL PRECAUTIONS AND WARNINGS The following precautions and warnings are valid for all tests. There are literature reports of very rare cases where gammopathy, especially monoclonal IgM (Waldenström’s macroglobulinemia), may cause protein precipitation when mixed with reagents giving rise to turbidity. This may occasionally lead to unreliable results when processing such samples using photometric methods. Further background information can be obtained from the following paper and its references: “Berth M, Delanghe J. Protein precipitation as a possible important pitfall in the clinical chemistry analysis of blood samples containing monoclonal immunoglobulins: 2 case reports and a review of the literature. Acta Clin Belg. 2004;59:263-73.” Due to the idiosyncratic nature of this interference it can theoretically occur with any liquid reagent. Where Beckman Coulter has received reports of this type of interference, or for those reagents considered at highest risk, a warning statement is included in the Interfering Substances section of the appropriate reagent. Please note that recovery of non-Beckman Coulter controls may vary with reagent lots of immunoassay products, due to the use of non-human materials in the controls. Reagents from different containers should not be intermixed. When using serum or plasma collection tubes, follow the tube manufacturer’s processing instructions. Sample collection devices should be assessed for suitability and regularly monitored. Contact your collection device supplier for further details. Samples containing precipitates must be centrifuged before performing the assay. Patient samples should be homogeneous. Patient samples should not contain clots or air bubbles. Biological materials of human origin contained in these products were tested for Anti-HCV, HbsAg and Anti-HIV 1/2 on a single donor basis and were found to be non-reactive. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents, these products should be handled as potentially infectious materials. Handle all patient samples as potentially infectious and follow universal precautions as dictated by local or national regulations (for further details refer to CLSI GP17-A2, ISO15190 or 29CFR1910.1030). Handle samples in closed containers to avoid contamination and evaporation. • • • • • • • 5. NOTES * Control Material with values determined by this Beckman Coulter system may be used for this application. ** This is not required for the English Reagent Guide. - vi – APPENDIX 1 Enzyme OSR6x01 OSR6x03 OSR6x04 OSR6x07 OSR6x06 OSR6x82 OSR6x09 OSR6x14 OSR6x79 OSR6x155 OSR6x20 OSR6x29 OSR6x26 OSR6x28 OSR6x30 ACP ALP ALP ALT α-Amylase α-Amylase AST Cholinesterase CK (NAC) CK-MB GGT HBDH LDH LDH Lipase Albumin Bicarbonate Direct Bilirubin Total Bilirubin Calcium oCPC Calcium Arsenazo III Cholesterol Creatinine Creatinine (Enzymatic) Glucose Glucose - STAT HDL-Cholesterol PRODUCT GROUPINGS IFU Reference Code BLOSR6x01.01 BLOSR6x03.01 BLOSR6x04.01 BLOSR6x07.01 BLOSR6x06.01 BLOSR6x82.01 BLOSR6x09.01 BLOSR6x14.01 BLOSR6x79.01 BLOSR6x155.01 BLOSR6x20.01 BLOSR6x29.01 BLOSR6x26.01 BLOSR6x28.01 BLOSR6x30.01 BLOSR6x02.01 BLOSR6x90.01 BLOSR6x11.01 BLOSR6x12.01 BLOSR6x13.01 BLOSR6x117.02 BLOSR6x16.02 BLOSR6x78.02 BLOSR6x204.01 BLOSR6x21.02 BLOSR6x40.01 BLOSR6x87.01 BLOSR6x22.01 BLOSR6x86.01 BLOSR6x93.01 BLOSR6x83.02 BLOSR6x89.01 BLOSR6x32.01 BLOSR6x118.01 BLOSR6x24.01 BLOSR6x205.01 BLOSR6x34.01 BLOSR6x41.02 BLOSR6x98.01 BLOSR6x70.01 Setting Sheet Reference Code BSOSR6x01.01 BSOSR6x03.01 BSOSR6x04.01 BSOSR6x07.02 BSOSR6x06.01 BSOSR6x82.01 BSOSR6x09.02 BSOSR6x14.01 BSOSR6x79.01 BSOSR6x155.01 BSOSR6x20.01 BSOSR6x29.01 BSOSR6x26.01 BSOSR6x28.01 BSOSR6x30.01 BSOSR6x02.01 BSOSR6x90.01 BSOSR6x11.01 BSOSR6x12.01 BSOSR6x13.01 BSOSR6x117.01 BSOSR6x16.01 BSOSR6x78.01 BSOSR6x204.02 BSOSR6x21.02 BSOSR6x40.01 BSOSR6x87.01 BSOSR6x22.01 BSOSR6x86.01 BSOSR6x93.01 BSOSR6x83.01 BSOSR6x89.01 BSOSR6x32.01 BSOSR6x118.01 BSOSR6x24.01 BSOSR6x205.01 BSOSR6x34.02 BSOSR6x41.02 BSOSR6x98.01 BSOSR6x70.01 Metabolite OSR6x02 OSR6x90 OSR6x11 OSR6x12 OSR6x13 OSR6x117 OSR6x16 OSR6x78 OSR6x204 OSR6x21 OSR6x40 OSR6x87 OSR6x22 OSR6x86 OSR6x93 OSR6x83 OSR6x89 OSR6x32 OSR6x118 OSR6x24 OSR6x205 OSR6x34 OSR6x41 OSR6x98 OSR6x70 Inorganic Phosphorous Iron Lactate LDL-Cholesterol Magnesium Total Protein Triglyceride UIBC UIBC Urea Urea - STAT Uric Acid Urinary/CSF Protein α-1 Acidglycoprotein α-1 Antitrypsin Apo A1 Apo B ASO ß-2 Microglobulin C3 C4 Ceruloplasmin CRP CRP Latex D-Dimer Ferritin Ferritin Ferritin Specific Protein OSR6x62 OSR6x63 OSR6x42 OSR6x43 OSR6x94 OSR6x51 OSR6x59 OSR6x60 OSR6x64 OSR6x47 OSR6x99 OSR6x135 OSR6x50 OSR6x138 OSR6x203 BLOSR6x62.01 BLOSR6x63.01 BLOSR6x42.01 BLOSR6x43.01 BLOSR6x94.01 BLOSR6x51.01 BLOSR6x59.01 BLOSR6x60.01 BLOSR6x64.01 BLOSR6x47.01 BLOSR6x99.01 BLOSR6x135.01 BLOSR6x50.01 BLOSR6x138.01 BLOSR6x203.02 - vii – BSOSR6x62.01 BSOSR6x63.01 BSOSR6x42.01 BSOSR6x43.01 BSOSR6x94.02 BSOSR6x51.01 BSOSR6x59.01 BSOSR6x60.01 BSOSR6x64.01 BSOSR6x47.01 BSOSR6x99.01 BSOSR6x135.01 BSOSR6x50.01 BSOSR6x138.01 BSOSR6x203.02 Specific Protein OSR6x65 OSR6x92 OSR6x177 OSR6x171 OSR6x172 OSR6x173 OSR6x67 OSR6x68 OSR6x75 OSR6x105 OSR6x52 Haptoglobin HbA1c (Hemoglobin A1c) HbA1c APT (Hemoglobin A1c, Whole Blood Application) IgA IgG IgM Microalbumin Myoglobin Prealbumin RF Latex Transferrin IFU Reference Code BLOSR6x65.01 BLOSR6x92.02 BLOSR6x177.01 BLOSR6x171.01 BLOSR6x172.02 BLOSR6x173.01 BLOSR6x67.01 BLOSR6x68.01 BLOSR6x75.01 BLOSR6x105.01 BLOSR6x52.01 Setting Sheet Reference Code BSOSR6x65.01 BSOSR6x92.02 BSOSR6x177.01 BSOSR6x171.01 BSOSR6x172.02 BSOSR6x173.01 BSOSR6x67.01 BSOSR6x68.01 BSOSR6x75.01 BSOSR6x105.01 BSOSR6x52.01 Therapeutic Drug Monitoring (TDM) OSR6414 OSR6403 OSR6404 OSR6420 OSR61202 OSR6413 OSR6411 OSR6412 OSR6415 Carbamazepine Digitoxin Digoxin Gentamycin Paracetamol Phenobarbital Phenytoin Theophylline Valproic Acid BLOSR6414.01 BLOSR6403.01 BLOSR6404.01 BLOSR6420.01 BLOSR6x202.01 BLOSR6413.01 BLOSR6411.01 BLOSR6412.01 BLOSR6415.01 BSOSR6414.01 BSOSR6403.01 BSOSR6404.01 BSOSR6420.01 BSOSR6x202.01 BSOSR6413.01 BSOSR6411.01 BSOSR6412.01 BSOSR6415.01 Drugs of Abuse in Urine (DAU) OSR6323 OSR6315 OSR6316 OSR6317 OSR6318 OSR6319 OSR6320 OSR6322 Amphetamines / Ecstasy Barbiturates Benzodiazepines Cocaine EDDP Methadone Opiates THC BLOSR6323.01 BLOSR6315.01 BLOSR6316.01 BLOSR6317.01 BLOSR6318.01 BLOSR6319.01 BLOSR6320.01 BLOSR6322.01 BSOSR6323.01 BSOSR6315.01 BSOSR6316.01 BSOSR6317.01 BSOSR6318.01 BSOSR6319.01 BSOSR6320.01 BSOSR6322.01 ISE 66320 66316 66314 66317 66315 66319 66313 66318 ISE Buffer ISE High Serum Standard ISE Internal Reference ISE Low Serum Standard ISE Low/High Urine Standard ISE Mid Standard ISE Na /K Selectivity Check ISE Reference + + BL66320.02 BL66320.02 BL66320.02 BL66320.02 BL66320.02 BL66320.02 BL66320.02 BL66320.02 Calibrator ODC6413 ODR3005 ODR3022 ODR3013 ODC0019 ODR30034 ODC6411 ODC0027 ODC0026 ODR3033 ODC6326 ODC6319 ODC6320 ODC6321 ODC6315 Antibiotic TDM Multi-Calibrator Apo A1 & B Calibrator Apo A1 & B Calibrator ASO Calibrator Bicarbonate Calibrator CK-MB Calibrator Core TDM Multi-Calibrator CRP Latex Calibrator Highly Sensitive Set CRP Latex Calibrator Normal Set D-Dimer Calibrator DAU Low Intermediate Multi-Drug Calibrator DAU Methadone Cut-off Calibrator DAU Methadone Intermediate Calibrator DAU Methadone High Calibrator DAU Primary Cut-off Multi-Drug Calibrator BLODC6413.01 BLODR3005.01 BLODR3022.01 BLODR3013.01 BLODC0019.01 BLODR30034.01 BLODC6411.01 BLODC0027.01 BLODC0026.01 BLODR3033.01 BLODC6326.01 BLODC6319.01 BLODC6319.01 BLODC6319.01 BLODC6315.01 BSODC6326.01 - viii – Calibrator ODC6316 ODC6317 ODC6318 ODC6314 ODC6322 ODC6323 ODC6324 ODC6325 ODC6403 ODC6404 ODR3032 ODC0011 ODC0012 ODR30037 ODR3024 ODR3025 ODR3029 ODC0028 ODR3021 ODR3023 66300 ODC0025 DAU Secondary Cut-off Multi-Drug Calibrator DAU Intermediate Multi-Drug Calibrator DAU High Multi-Drug Calibrator DAU Negative Calibrator DAU THC 25 Calibrator DAU THC 50 Calibrator DAU THC 75 Calibrator DAU THC 100 Calibrator Digitoxin Calibrator Digoxin Calibrator HbA1c Calibrator HDL-Cholesterol Calibrator LDL-Cholesterol Calibrator MC Cal A Microalbumin Calibrator Myoglobin Calibrator Prealbumin Calibrator RF Latex Calibrator Serum Protein Multi-Calibrator Serum Protein Multi-Calibrator 2 System Calibrator Urine Calibrator IFU Reference Code BLODC6315.01 BLODC6315.01 BLODC6315.01 BLODC6314.01 BLODC6322.01 BLODC6322.01 BLODC6322.01 BLODC6322.01 BLODC6403.01 BLODC6404.01 BLODR3032.01 BLODC0011.01 BLODC0012.01 BLODR30037.01 BLODR3024.01 BLODR3025.01 BLODR3029.01 BLODR0028.01 BLODR3021.01 BLODR3023.01 BL66300.01 BLODC0025.01 Setting Sheet Reference Code Control ODR2041 ODR30035 ODR30036 ODC0003 ODC0004 ODC0013 ODC0029 ODC0006 ODC0007 ODC0008 ODC0009 ODC0022 ODC0005 ODC0014 ODC0015 ODC0016 CK-MB Control Serum CK-MB Control Level 1 CK-MB Control Level 2 Control Serum 1 Control Serum 2 CRP (Latex) Control Serum D-Dimer Control DAU Multi-Drug Control DAU Speciality Control DAU THC 25 Control DAU THC 50 Control HbA1c Control HDL/LDL-Cholesterol Control Serum ITA Control Serum 1 ITA Control Serum 2 ITA Control Serum 3 BLODR2041.01 BLODR30035.01 BLODR30036.01 BLODC0003.01 BLODC0004.01 BLODC0013.01 BLODC0029.01 BLODC0006.01 BLODC0007.01 BLODC0008.01 BLODC0008.01 BLODC0022.01 BLODC0005.01 BLODC0014.01 BLODC0015.01 BLODC0016.01 Miscellaneous ODR20067 OE66039 OSR0004 OSR62166 OSR0001 ODR2000 Cleaning Solution Cleaning Solution Hemoglobin Denaturant LIH Wash Solution Wash Solution BLODR20067.01 BLOE66039.01 BLOSR0004.01 BLOSR6x166.01 BLOSR0001.01 BLOSR0001.01 BSOSR6x166.01 - ix – -x– APPENDIX 2 Code Enzyme OSR6x01 OSR6x03 OSR6x04 OSR6x07 OSR6x06 OSR6x82 OSR6x09 OSR6x14 OSR6x79 OSR6x155 OSR6x20 OSR6x29 OSR6x26 OSR6x28 OSR6x30 CALIBRATORS AND CONTROLS Calibrator 66300 66300 66300 66300 Serum/Plasma: 66300 Urine: ODC0025 Serum/Plasma: 66300 Urine: ODC0025 66300 66300 66300 ODR30034 66300 66300 66300 66300 OSR6x30 or 66300 Parameter name as appears on kit ACP ALP ALP ALT α-Amylase α-Amylase AST Cholinesterase CK (NAC) CK-MB GGT HBDH LDH LDH Lipase Control ODC0003, ODC0004 ODC0003, ODC0004 ODC0003, ODC0004 ODC0003, ODC0004 Serum/Plasma: ODC0003, ODC0004 Urine: Biorad Liquichek Cat. No: 397 & 398 Serum/Plasma: ODC0003, ODC0004 Urine: Biorad Liquichek Cat. No: 397 & 398 ODC0003, ODC0004 ODC0003, ODC0004 ODC0003, ODC0004 ODR30035, ODR30036 ODC0003, ODC0004 ODC0003, ODC0004 ODC0003, ODC0004 ODC0003, ODC0004 ODC0003, ODC0004 Metabolite OSR6x02 OSR6x90 OSR6x11 OSR6x12 OSR6x13 OSR6x117 OSR6x16 OSR6x78 OSR6x204 OSR6x21 OSR6x40 OSR6x87 OSR6x22 OSR6x86 OSR6x93 OSR6x83 OSR6x89 OSR6x32 OSR6x118 OSR6x24 OSR6x205 OSR6x34 OSR6x41 OSR6x98 OSR6x70 Albumin Bicarbonate Direct Bilirubin Total Bilirubin Calcium oCPC Calcium Arsenazo III Cholesterol Creatinine Creatinine (Enzymatic) Glucose Glucose-STAT HDL-Cholesterol Inorganic Phosphorous Iron Lactate LDL Cholesterol Magnesium Total Protein Triglyceride UIBC UIBC Urea Urea-STAT Uric Acid Urinary/CSF Protein 66300 ODC0019 66300 66300 Serum/Plasma: 66300 Urine: ODC0025 Serum/Plasma: 66300 Urine: ODC0025 66300 Serum/Plasma: 66300 Urine: ODC0025 Serum/Plasma: 66300 Urine: ODC0025 Serum/Plasma: 66300 Urine: ODC0025 66300 ODC0011 Serum/Plasma: 66300 Urine: ODC0025 66300 66300 ODC0012 Serum/Plasma: 66300 Urine: ODC0025 66300 66300 66300 66300 Serum/Plasma: 66300 Urine: ODC0025 66300 Serum/Plasma: 66300 Urine: ODC0025 OSR6x70 ODC0003, ODC0004 * ODC0003, ODC0004 ODC0003, ODC0004 Serum/Plasma: ODC0003, ODC0004 Urine: Biorad Liquichek Cat. No: 397 & 398 Serum/Plasma: ODC0003, ODC0004 Urine: Biorad Liquichek Cat. No: 397 & 398 ODC0003, ODC0004 Serum/Plasma: ODC0003, ODC0004 Urine: Biorad Liquichek Cat. No: 397 & 398 Serum/Plasma: ODC0003, ODC0004 Urine: Biorad Liquichek Cat. No: 397 & 398 Serum/Plasma: ODC0003, ODC0004 Urine: Biorad Liquichek Cat. No: 397 & 398 ODC0003, ODC0004 ODC0005 Serum/Plasma: ODC0003, ODC0004 Urine: Biorad Liquichek Cat. No: 397 & 398 ODC0003, ODC0004 ODC0003, ODC0004 ODC0005 Serum/Plasma: ODC0003, ODC0004 Urine: Biorad Liquichek Cat. No: 397 & 398 ODC0003, ODC0004 ODC0003, ODC0004 ODC0003, ODC0004 ODC0003, ODC0004 Serum/Plasma: ODC0003, ODC0004 Urine: Biorad Liquichek Cat. No: 397 & 398 ODC0003, ODC0004 Serum/Plasma: ODC0003, ODC0004 Urine: Biorad Liquichek Cat. No: 397 & 398 * - xi – Specific Protein OSR6x62 OSR6x63 OSR6x42 OSR6x43 OSR6x94 OSR6x51 OSR6x59 OSR6x60 OSR6x64 OSR6x47 OSR6x99 OSR6x135 OSR6x50 OSR6x138 OSR6x203 OSR6x65 OSR6x92 OSR6x177 OSR6x171 OSR6x172 OSR6x173 OSR6x67 OSR6x68 OSR6x75 OSR6x105 OSR6x52 α-1 Acidglycoprotein α-1 Antitrypsin Apo A1 Apo B ASO β-2 Microglobulin C3 C4 Ceruloplasmin CRP CRP Latex D-Dimer Ferritin Ferritin Ferritin Haptoglobin HbA1c (Hemoglobin A1c) HbA1c APT (Hemoglobin A1c, Whole Blood Application) IgA IgG IgM Microalbumin Myoglobin Prealbumin RF Latex Transferrin Carbamazepine Digitoxin Digoxin Gentamycin Paracetamol Phenobarbital Phenytoin Theophylline Valproic Acid Amphetamines/ Ecstasy Barbiturates Benzodiazepines Cocaine EDDP Methadone Opiates THC ODR3023 ODR3023 ODR3005 (3 pt) / ODR3022 (5 pt) ODR3005 (3 pt) / ODR3022 (5 pt) ODR3021 or ODR3013 / ODR30037 ODR3023 ODR3021 / ODR30037 ODR3021 / ODR30037 ODR3023 ODR3021 ODC0026 (Normal), ODC0027 (Highly sensitive) ODR3033 ODR3021 ODR3021 ODR3021 ODR3023 ODR3032 ODR3032 ODR3021 ODR3021 ODR3021 ODR3024 ODR3025 ODR3029 ODC0028 ODR3021 / ODR30037 ODC6411 ODC6403 ODC6404 ODC6413 OSR6x202 ODC6411 ODC6411 ODC6411 ODC6411 Qualitative: ODC6315 (1000 µg/L) or ODC6316 (500 µg/L). Semi Quantitative: ODC6314-ODC6318 Qualitative: ODC6315 (300 µg/L) or ODC6316 (200 µg/L). Semi Quantitative: ODC6314-ODC6318 Qualitative: ODC6315 (300 µg/L) or ODC6316 (200 µg/L). Semi Quantitative: ODC6314 ODC6318 Qualitative: ODC6315 (300 µg/L) or ODC6316 (150 µg/L). Semi Quantitative: ODC6314-ODC6318 Qualitative: ODC6315 or ODC6316 (both 100 µg/L). Semi Quantitative: ODC6314, ODC6315 or ODC6316, ODC6317, ODC6318 Qualitative: ODC6319 (300 µg/L). Semi Quantitative: ODC6314, ODC6319-ODC6321 Qualitative: ODC6316 (300 µg/L). Semi Quantitative: ODC6314, ODC6316-ODC6318 Qualitative: ODC6322 (25 µg/L) or ODC6323 (50 µg/L). Semi Quantitative: ODC6314, ODC6322-ODC6325 ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 ODC0003, ODC0004 ODC0003, ODC0004 ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 (Normal, Highly sensitive),ODC0003 (Normal) ODC0013 (Highly sensitive) ODC0029 ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 ODC0022 ODC0022 ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 * * ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 ODC0014, ODC0015, ODC0016 * * * * * * * * * 1000 µg/L Cut off: ODC0006 500 µg/L Cut-off: ODC0007 300 µg/L Cut-off: ODC0006 200 µg/L Cut-off: ODC0007 300 µg/L Cut-off: ODC0006 200 µg/L Cut-off: ODC0007 300 µg/L Cut off: ODC0006 150 µg/L Cut-off: ODC0007 ODC0006 or ODC0007 ODC0006 ODC0007 25 µg/L Cut-off: ODC0008 50 µg/L Cut-off: ODC0009 TDM OSR6414 OSR6403 OSR6404 OSR6420 OSR6x202 OSR6413 OSR6411 OSR6412 OSR6415 DAU OSR6323 OSR6315 OSR6316 OSR6317 OSR6318 OSR6319 OSR6320 OSR6322 - xii – ACP OSR6101 2 x 15 mL 2 x 15 mL 4x 1 x 10 mL R1-1 R1-2 R1-S ACP-T ACP-NP ACP-S ACP-St Intended Use Kinetic colour test for the quantitative determination of acid phosphatase, EC 3.1.3.2 (ACP), in human serum on Beckman Coulter analysers. For in vitro diagnostic use only. Summary1,2 The term acid phosphatase refers to a group of similar enzymes which cleave phosphate esters optimally at a pH below 7.0. These enzymes are present in the lysosomes of all body cells with the highest activities in the liver, spleen, bone marrow, prostate, erythrocytes and platelets. Because the activities from the prostate are inhibited by tartrate, the tartrate inhibited proportion of total ACP is also referred to as prostatic ACP. Elevations of the enzymatic activity of prostatic ACP (and thus, generally, of total ACP activity) may be found in the sera of men with metastatic prostate cancer. The frequency of such findings in a population of men with prostate cancer increases as the cancer progresses, thus prostatic ACP is useful in the staging of prostate carcinoma. Serum prostatic ACP measurement is useful in monitoring remission or relapse of a prostatic malignancy and in assessing the effectiveness of various treatment regimens. Other diseases which can be associated with elevations of tartrate inhibited ACP include leukemia, polycythemia vera, primary thrombocythemia and megaloblastic anemia.The majority of the normally low ACP activity of serum is of a tartrate-resistant type and probably originates mainly in osteoclasts. Activities of this fraction are physiologically increased in growing children and pathologically in conditions of increased osteolysis and bone remodelling such as Paget's disease, hyperparathyroidism, multiple myeloma, osteosarcoma, osteogenesis imperfecta and renal osteodystrophy. Other diseases associated with elevated tartrate resistant ACP are Gaucher's disease and Niemann-Pick disease. Test Principle3 Hillmann reaction 1-Naphthyl phosphate + H2O 1-Naphthol + FRTR salt ACP Phosphate + 1-Naphthol Azo dye Contents, Reagent Composition in the Test Final concentration of reactive ingredients: Total ACP method Citrate buffer (pH 4.8) 1-Naphthyl Phosphate Fast red TR salt Pentanediol Non-Prostatic ACP method Tartrate Citrate buffer (pH 4.8) 1-Naphthyl Phosphate Fast Red TR salt Pentanediol 140 mmol/L 11 mmol/L 0.6 mmol/L 210 mmol/L 125 mmol/L 140 mmol/L 11 mmol/L 0.6 mmol/L 210 mmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: R1-S (ACP substrate). Harmful, contains Fast Red TR salt. R68: Possible risk of irreversible effects. Safety Phrases: S36/37, S60. Wear suitable protective clothing and gloves. This material and its container must be disposed of as hazardous waste. Exercise the normal precautions required for handling all laboratory reagents. Dispose of all waste material in accordance with local guidelines. Refer to Safety Data Sheets for further information. Reagent Preparation R1-1 (Total ACP) To perform a total ACP (ACP-T) assay dissolve the contents of one R1-S vial (ACP substrate) completely with the contents of one bottle of R1-1 (Total ACP buffer). R1-2 (Non-Prostatic-ACP) To perform a non-prostatic ACP (ACP-NP) assay dissolve the contents of one R1-S vial (ACP substrate) completely with the contents of one bottle of R1-2 (Non-prostatic ACP buffer). Attach the adaptor to the buffer bottle then connect the substrate powder vial to the other end. Gently mix the linked bottles until the powder is completely dissolved. The solution can then be collected in the buffer bottle and placed on board the instrument. Storage and Stability The reagents are stable, unopened, up to the stated expiry date when stored at 2…8°C. Once prepared, reagents stored on board the instrument are stable for 14 days. Specimen Serum. Do not use plasma. Serum should be separated as soon as possible and 1 drop of stabiliser (ACP-St) added to 1mL of the sample. Separated serum, without stabiliser, is stable for 15 min when stored at 15…25°C and 3-4 hours when stored at 2…8°C. Stabilised serum can be stored 4 for 8 days when stored at 2…25°C. Lipemic, icteric and haemolysed samples should be avoided. EN.01 BLOSR6x01.01 2009-08 Enzyme 1. Expected values may vary with age.67 µkat/L) for Total ACP and 0 .42 CV% 1. Method Comparison Patient serum samples were used to compare this Total ACP OSR6101 assay on the AU600 against another commercially available Total ACP assay. Quality Control controls Cat.5 μkat/L) for Prostatic ACP.31 1. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.01 3.83 SD 0. sample type.51 U/L Patient serum samples were used to compare this Prostatic OSR6101 assay on the AU600 against another commercially available Prostatic ACP assay. To provide a robust approach to generate the analyser specific MB factor.13 0.5 Pentanediol activation U/L (0. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed.23 0.Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions.05 2. it is recommended that 5 separate calibration events should be used. Each laboratory should verify the transferability of the expected values to its own population.05 U/L for Total ACP and 0. Total ACP n = 60 Mean U/L 7.57 U/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the Total ACP method to interference were as follows: Icterus: Interference less than 10% up to 0. utilising System Calibrator Cat No.40 0.39 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 0.10 U/L for Prostatic ACP. A fresh vial of calibrator.87 0. and if necessary determine its own reference interval according to good laboratory practice. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.28 Prostatic ACP n = 60 Mean U/L 5. Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used.944x – 0.10 17.0 Pentanediol activation U/L (0. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days.55 34. The lowest detectable level represents the lowest measurable level of ACP that can be distinguished from zero. Results of linear regression analysis were as follows: y = 0.23 0.0.999 n = 116 Sample range = 0.68 7.82 1.58 – 58. The activity of prostatic ACP can be generated by the analyser when set as a calculated test: Prostatic-ACP = Total-ACP – Non-Prostatic-ACP.01 .060 r = 0.28 Within Run SD 0.46 15.6 Pentanediol activation U/L (0.30 U/L (0 . Calibration The test is run in MB-mode. laboratories must confirm baseline values for patients being serially monitored. results should always be assessed in conjunction with the patient's medical history.69 Total CV% 1. For diagnostic purposes. two analyser specific MB-factors (ACP-T & ACP-NP) are required. Before changing assays. Reagent blank measurement is recommended when changing to a new lot of reagent. sex. Reference Intervals1 Adults Male Female Adults 37°C-Total ACP ≤ 6. Data obtained in your laboratory may differ from these values. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice.915x – 0. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.19 – 3. Calculation The Beckman Coulter analysers automatically compute the ACP-T and ACP-NP activity of each sample. should be used for each of these runs. No.10 0.05 µkat/L) Values obtained with different prostatic acid phosphatase assays cannot be used interchangeably. Linearity The test is linear within an enzyme activity range of 0 . Results of linear regression analysis were as follows: y = 0.24 2.271 r = 0. review all operating parameters. If any trends or sudden shifts in values are detected. clinical examinations and other findings. For the AU2700/AU5400 this procedure needs to be performed for each ring.48 Total CV% 7.76 2.01 2009-08 EN.6 mg/dL or 10. 66300 in the AB calibration mode.17 0.11 µkat/L) ≤ 6.11 µkat/L) Tartrate-inhibited ACP (Prostatic ACP) ≤ 3. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced.100 U/L (0 .3 µmol/L bilirubin Ascorbate: Interference less than 10% up to 8 mg/dL ascorbate Haemolysis: Interference less than 10% up to 4 g/L haemoglobin ® Lipemia: Interference less than 10% up to 300 mg/dL Intralipid Enzyme BLOSR6x01.77 Within Run SD 0.01 SD 0.07 0. The calibrator value is traceable to a Beckman Coulter Master Calibrator.08 0.15 0. The results obtained by any individual laboratory may vary from the given mean value.966 n = 93 Sample range = 0. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. diet and geographical location.32 CV% 1. 9(3):273-274. Set the test as a CALCULATED TEST in the INTER TESTS menu. Young DS. 3. 2. Clinical enzymology. In:Thomas L. 5th ed. AACC Press. Ensure that the correct calibrator value is entered for ACPT and ACPNP as appropriate. To work in SI units (µkat/L) divide by 60. Tietz textbook of clinical chemistry. Young DS. In: Burtis CA.711-14. 5 Limitations Prostatic acid phosphatase results may be influenced by a number of factors other than malignancy and should always be interpreted in conjunction with the patients clinical history and other diagnostic procedures. BIBLIOGRAPHY 1.01 2009-08 Enzyme . Set this test as COMMON TEST PARAMETER TEST NAME in CALCULATED TEST.01 BLOSR6x01. Z Klin Chem u Klin Biochem 1971. Hillmann G.1 µmol/L bilirubin Ascorbate: Interference less than 10% up to 2 mg/dL ascorbate Haemolysis: Interference less than 10% up to 3 g/L haemoglobin ® Lipemia: Interference less than 10% up to 600 mg/dL Intralipid Refer to Young for further information on interfering substances. 2000. Effects of preanalytical variables on clincal laboratory tests.Results of studies conducted to evaluate the susceptibility of the Prostatic ACP method to interference were as follows: Icterus: Interference less than 10% up to 1 mg/dL or 17. where A = ACPT and B = ACPNP in Parameters Specific Test Parameters CALCULATED TEST. Philadelphia:WB Saunders Company.Washington: AACC press 1997:3-5pp. 2nd ed. 4. 1999. See leaflet. Effects of drugs on clinical laboratory tests. Set factor ranges for Total ACP 800-1200* and Non-Prostatic ACP 1000-1550 Values set for working in U/L. Thomas L. Fortlaufende photometrische messung der sauren prostataphosphatase-aktivität. Enter the formula (A-B). Ashwood ER. ed. refer to leaflet for further instruction. User defined ¤ Analyser default value For use in AB mode only. Moss DW. EN. Do not use plasma. Henderson RA. 5. 2005:118-120. Saüre Phosphatase (SP). Labor und Diagnose 6 Auflage:TH-Books Verlagsgesellschaft mbH Frankfürt/Main. eds. Setting Sheet Footnotes ‡ # § * ж For determination of Prostatic ACP the above parameters must be entered twice using test names ACPT (Total ACP) and ACPNP (Non-Prostatic ACP). . 3 0. # User defined § For use in AB mode only. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # SERUM APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name ACP‡ ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L § # Conc Factor/OD-H § ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H § # Test Name: Counts: ACP‡ ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal. ∇ ∇ ∇ Sec. To work in SI units (µkat/L) divide by 60 Enzyme BSOSR6x01.5 Operation: Yes Range Test Name: ACP‡ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 10 150 0 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. No. See leaflet. L -0. H 100* Fst Fst 12 Lst Lst First H Last H 0. Reagent 1 vol Reagent 2 vol μL μL μL Fst.1 Lst. Refer to IFU for further instruction.01 2009-08 .5 0. Set factor ranges for Total ACP 800-1200* and Non-Prostatic ACP 1000-1550* * Values set for working in U/L.1 0* B 14 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil. AU400/AU640 Serum System Reagent: OSR6101 Reagent ID: TOTAL (ACPT) 001. OD L 0 Reagent OD limit Fst.3 ∇ # Test name ACP‡ Sample type Ser Page 1/2 Application ACP. Set the test as a CALCULATED TEST in the INTER TESTS menu. None Selected 8. OD H ∇ 2. vol 0 0 0 Max. Set the test as a CALCULATED TEST in the INTER TESTS menu. # User defined ¤ Analyser default value § For use in AB mode only. # # ο ∇ 7. Refer to IFU for further instruction. § OD CONC § Factor/OD-L § 1-Point Cal. H ∇ ∇ ∇ Main 410 Sub 10 150 0 Dil. Set factor ranges for Total ACP 800-1200* and Non-Prostatic ACP 1000-1550* * Values set for working in U/L. vol Dil. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. Ensure that the correct calibrator value is entered for ACPT and ACPNP as appropriate. NON-PROSTATIC (ACPNP) 008 Specific test parameters Test No ∇ Sample vol.3 800 RATE + 27 Max OD H 2. # # ο ∇ 2. Ensure that the correct calibrator value is entered for ACPT and ACPNP as appropriate. H Lst.1 Dynamic range L 0* Correlation factor % ∇ 100* 1 0 ¤ 14 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: ACP‡ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. NON-PROSTATIC (ACPNP) 008 Specific Test Parameters General LIH ISE Serum ∇ 1 0 -0. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No § Point 1 ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ο ∇ 3. See leaflet. AU600 Serum Application System Reagent: OSR6101 Reagent ID: TOTAL (ACPT) 001. # # ο ∇ 4. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name ACP‡ Sample type Ser ∇ On-board stability period 410 RATE + First 12 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse ‡ For determination of Prostatic ACP the above parameters must be entered twice using test names ACPT (Total ACP) and ACPNP (Non-Prostatic ACP).ACP. vol Dil. L -0. # # ο ∇ 6.1 -0.3 0. # # ο ∇ 5. To work in SI units (µkat/L) divide by 60 ‡ For determination of Prostatic ACP the above parameters must be entered twice using test names ACPT (Total ACP) and ACPNP (Non-Prostatic ACP). 3 Last H 0. To work in SI units (µkat/L) divide by 60 Enzyme BSOSR6x01.01 2009-08 . NON-PROSTATIC (ACPNP) 008 Specific Test Parameters General LIH ISE Serum ∇ 1 0 -0. Refer to IFU for further instruction Ensure that the correct calibrator value is entered for ACPT and ACPNP as appropriate.1 -0. # # ο ∇ 7.3 8 120 0 μL μL μL Dilution Dilution Dilution 0 10 0 μL μL μL Pri. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 410 RATE + First 12 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Serum ∇ # Range Test Name: ACP‡ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 5. # OD CONC § Factor/OD-L § 1-Point Cal. Set factor ranges for Total ACP 800-1200* and Non-Prostatic ACP 1000-1550* * Values set for working in U/L.ACP. Set the test as a CALCULATED TEST in the INTER TESTS menu.5 0. See eaflet. § For use in AB mode only.1 0* B 14 0 H 100* ∇ Operation: Yes Range Test Name: ACP‡ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Max OD H 2. # # ο ∇ 3. # # ο ∇ 4. AU2700/AU5400 Serum Application System Reagent: OSR6101 Reagent ID: TOTAL (ACPT) 001. # # ο ∇ 2. ∇ ∇ ∇ Sec.3 First H 0. No. # # ο ∇ 6. None Selected 8. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H SERUM APPLICATION Panic Value: # # Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H § # Process: CONC ∇ Test Name: ACP‡ ∇ < > Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: ‡ For determination of Prostatic ACP the above parameters must be entered twice using test names ACPT (Total ACP) and ACPNP (Non-Prostatic ACP). # User defined. OD 2. AU680/AU480 Serum Range Application Serum ∇ ∇ System Reagent: OSR6101 Reagent ID: TOTAL (ACPT) 001. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 14 Day # ∇ +++++ ∇ + ∇ ++++ ∇ NoneΦ 410 ∇nm RATE ∇ + ∇ 12 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0* 1 1 High B B 100* 0 0 Last Last 27 15 NO % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General Range Serum ∇ Panic Value Low # High # LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: ACPж ∇ < > Type: High # High # # # # # # # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 4.OD Reagent OD Limit First Low Last Low R2(R2-1) 0 μL Dilution 0 μL Name Sec. Set factor ranges for Total ACP 800-1200* and Non-Prostatic ACP 1000-1550* * Values set for working in U/L.3 Max. ∇ # # # # ο 2. No demographics 8. ∇ # # # # ο 5. Enter the formula (A-B) . where A=ACPT and B=ACPNP in Parameters Specific Test Parameters CALCULATED TEST # User defined. ∇ 7. For No. Volume R1(R1-1) 8 1 120 0 μL OD Limit μL ∇ μL Dilution 10 μL Min. Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: ACPж ∇ < > Type Serum Y=AX+B Counts: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Low § ∇ Range High § <Point Cal. ∇ # # # # ο 6. To work in SI units (µkat/L) divide by 60 Ф AU680 Enzyme BSOSR6x01. Not within expected values Month # # # # # # Low # # # # # # # # Unit U/L* Decimal Places # SERUM APPLICATION Parameters Calibrators General ∇ # ∇ None ∇ Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation # ∇ # ∇ Interval (RB/ACAL) ο Use Serum Cal.1 High High 0.1 -0.3 0. ∇ # # # # ο 3. § For use in AB mode only. NON-PROSTATIC (ACPNP) 008 Parameters General LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: ACPж ∇ < > Type: Operation Yes Dilution 0 -0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank Day Calibration Day Hour Hour MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ж Set this test as Common Test Parameter test name in CALCULATED TEST.5 Sample Volume Pre-Dilution Rate Rgt. Refer to IFU for further instruction Ensure that the correct calibrator value is entered for ACPT and ACPNP as appropriate. 0 Hour ф Common Rgt.01 2009-08 .ACP. . 1 (ALP). May cause sensitisation by skin contact.8 Magnesium chloride p-Nitrophenyl phosphate Preservative 2+ Phosphate + p-Nitrophenol Contents. such as skeletal metastases. and in diseases such as multiple myeloma. kidney tubules. contains 2.0 mol/L 0. S26. EC 3. Bottle replacement is recommended when one of the following conditions are encountered: 14 days have elapsed on board the analyser. swallowed or absorbed through skin. bone tuberculosis and healing fractures. ectopic ossification. This effect will vary depending upon the rate of use. Reaction Principle p-Nitrophenyl phosphate + H2O ALP Mg Final concentration of reactive ingredients: Diethanolamine buffer. Risk of serious damage to eyes. Dispose of all waste material in accordance with local guidelines. R43. 4 Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.2 Alkaline phosphatase (ALP) is present in almost all body tissues. Physiological increases in ALP are found in pregnancy from the 2nd trimester onwards due to placental ALP. acromegaly. such as osteomalacia. Harmful if swallowed. R22. Approximately 25% of healthy individuals also have intestinal ALP which accounts for approximately 10% of the total ALP in a fasting sample. S60. achondroplasia. Complexing anticoagulants such as citrate. EN.Avoid contact with skin. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. In case of contact with eyes. liver and placenta.3. S37/39. 4 x 30 mL 4 x 30 mL R1 R2 Summary1. osteopenia or osteoporosis. R41. ALP activity is a good indicator of bone activity. ALP originates in approximately equal proportions from the liver and the skeletal system.01 BLOSR6x03. adynamic bone disease in dialysis patients. unopened. located at or in cell membranes. In bone diseases such as Paget’s disease. Test Principle3 Method based on the recommendations of the “German Society for Clinical Chemistry” (GSCC). hyperthyroidism. pH 9. The rate of increase in absorbance due to the formation of pNP is measured at 410/480 nm and is directly proportional to the ALP activity in the sample. hypoparathyroidism. It occurs at particularly high levels in interstitial epithelium. pituitary dwarfism.1. Alkaline phosphatase activity is determined by measuring the rate of conversion of p-Nitrophenyl phospate (pNPP) to p-Nitrophenol (pNP) in the presence of magnesium ions and diethanolamine as phosphate acceptor at pH 9. Reagent Composition in the Test 1. renal insufficiency.ALP OSR6103 Intended Use Kinetic colour test for the quantitative determination of alkaline phosphatase. ALP levels may also be elevated in primary bone diseases. Wear suitable gloves and eye/face protection. vitamin D deficiency rickets and metastatic bone disease. Safety Phrases: S24. Storage and Stability The reagents are stable. up to the stated expiry date when stored at 2…8°C. Reduced levels of ALP are found in familial hypophosphatasia. Irritating to skin. with pathological ALP levels found in approximately 60% of patients with disease of the liver or biliary tract. R2 reagent: Irritant. rinse immediately with plenty of water and seek medical advice. The paediatric application is suitable for use with small volume serum/plasma samples. vitamin D intoxication and primary bone tumours. however the enzyme is associated with intestinal lipid transport and bone calcification. Refer to Safety Data Sheets for further information. For in vitro diagnostic use only. May cause sensitisation by skin contact.5 mmol/L 10 mmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: R1 reagent: Harmful. or are caused by diseases of the liver or bone. Harmful: danger of serious damage to health by prolonged exposure if swallowed. The most common cause of elevated ALP is hepatobiliary disease. chronic radiation sickness and malnutrition. in the absence of co-existing chronic liver disease. osteogenesis imperfecta. Absorption of atmospheric CO2 by the reagent on board the analyser can impair its stability. oxalate and EDTA should be avoided. ALP levels may also be increased in secondary bone diseases. in growing children due to bone ALP and postprandially in individuals with blood groups B and O.R43.01 2009-08 Enzyme . Increases in total ALP are either due to physiological causes. R48/22. Major preventative maintenance was performed on the analyser or a critical part was replaced. Specimen Serum and heparinised plasma. Total ALP is only occasionally elevated in some metabolic bone diseases such as hyperparathyroidism. This is harmful when inhaled. Significant shift in control values (>7%) following local QC procedures.2’-iminodiethanol and a mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC No 247-500-7] and 2-methyl-4-isothiazolin3-one [EC No 220-239-6] (3:1). bone (osteoblasts). R38. This material and its container must be disposed of as hazardous waste.8. Haemolysed samples should be avoided. sarcoidosis. During the reaction p-nitrophenol is produced. The precise metabolic function of ALP has not yet been fully elucidated. who are secretors of blood group substance H (intestinal ALP). in human serum and plasma on Beckman Coulter analysers. contains a mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC No 247-500-7] and 2-methyl-4-isothiazolin-3-one [EC No 220-239-6] (3:1). 5 Stable in serum and plasma for 7 days when stored at 2…25°C. Young DS. Henderson RA.999 n = 120 Sample range = 67 – 1404 U/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 1 g/L haemoglobin ® Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances.3 – 5.60 2. 1999.7 Women Men Children up to 15 years Children 15-17 years 64 . User defined ¤ Analyser default value Values set for working in U/L.40 Total CV% 4.12 r = 0. 6. and if necessary determine its own reference interval according to good laboratory practice. Reference Intervals6.182-192. Heil W. For diagnostic purposes. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. 6th ed. Alkaline phosphatase (ALP).99(15):765-6.76 2. 7. results should always be assessed in conjunction with the patient's medical history. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. ed. A fresh vial of calibrator. n = 60 Mean U/L 38 362 1088 Within Run SD 0.62 0. Results of linear regression analysis were as follows: y = 0. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. In: Burtis CA.99 23. Fundamentals of clinical chemistry.55 0. ed. 2. Thomas L. Berlin: Springer-Verlag. 5th ed.Apr 12. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced. For use in AB mode only. 1987:387pp. Dtsch Med Wochenschr 1974.1990: 294pp.300 U/L (1. Rick W. Philadelphia:WB Saunders Company. Clinical laboratory diagnostics. eds. Töpfer G.1 Rev.0 µkat/L). refer to leaflet for further instruction.1 – 25. 5. Klinische chemie und mikroskopie.36 2. et al.01 2009-08 EN.81 CV% 1. Ashwood ER.947x . To work in SI units (µkat/L) divide by 60. it is recommended that 5 separate calibration events should be used. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. 3. Kachmar JF. Clinical Enzymology. Depends on usage pattern in the laboratory. Schmitt Y. Effects of drugs on clinical laboratory tests. Rick W. The calibrator value is traceable to a Beckman Coulter Master Calibrator Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced. Enzymes In: Tietz NW. sample type.0 µkat/L) Up to 640 U/L (10.1500 U/L (0. Knedel M. Linearity The test is linear within an enzyme activity range of 5 . 1998:36-46. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Philadelphia:WB Saunders Company. Reagent blank measurement is recommended when changing to a new lot of reagent. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Data obtained in your laboratory may differ from these values. 4. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Method Comparison Patient serum samples were used to compare this ALP OSR6103 assay on the AU600 against another commercially available ALP assay.26 5.15 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 1 U/L. The lowest detectable level represents the lowest measurable level of ALP that can be distinguished from zero. Quality Control Controls Cat. review all operating parameters. Each laboratory should verify the transferability of the expected values to its own population. BIBLIOGRAPHY Enzyme BLOSR6x03. Tietz textbook of clinical chemistry. diet and geographical location. For the AU2700/AU5400 this procedure needs to be performed for each ring. AACC Press. should be used for each of these runs. Schlebusch H. Frankfurt/Main: TH-Books Verlagsgesellschaft.2:21pp. Lang H. Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood. The results obtained by any individual laboratory may vary from the given mean value.0 µkat/L) 80 – 300 U/L (1. Plasma and Serum Samples. 66300 in the AB calibration mode. Ehret W.0 – 5. 8 Setting Sheet Footnotes # * § ‡ 1. clinical examinations and other findings. Use and assessment of clinical laboratory results. 8. Zawta B. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.68 9.53 SD 1. 676-684. Moss DW.6 µkat/L) Up to 480 U/L (8. Standards in the activities of clinically important enzymes.0 µkat/L) Expected values may vary with age. In: Thomas L. utilising System Calibrator Cat No. 2000. ed. Moss DW. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed.01 . Z Klin Chem u Klin Biochem 10 Jg 1972. Calculation The Beckman Coulter analysers automatically compute the ALP activity of each sample. If any trends or sudden shifts in values are detected. Henderson RA. WHO/DIL/LAB/99. Wisser H. No.Calibration The test is run in MB-mode. Empfehlungen der Deutschen Gesellschaft für Klinische Chemie. To provide a robust approach to generate the analyser specific MB factor. sex. 1 Dynamic range L 5* Correlation factor % ∇ A 1 On-board stability period: 1500* 1 0 ¤ 14 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: ALP03 ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2.8 0.ALP. None Selected 8. OD L -0. AU400/AU640 Serum/Plasma Reagent ID: 003 Specific test parameters Serum ∇ 1 -0. Vol 0 60 60 Max.5 Fst. # # ο ∇ 6.1 Reagent OD limit Fst. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.01 2009-08 User defined ¤ Analyser default value Values set for working in U/L.8 480 RATE + 19 Max OD H 2. To work in SI units (µkat/L) divide by 60 For use in AB mode only. AU600 Serum/Plasma Application System Reagent: OSR6103 Specific Test Parameters General LIH ISE Range Test Name: ALP03 ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 60 60 μL μL μL Dilution Dilution Dilution 0 60 60 μL μL μL Pri. # # ο ∇ 4. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period Select using Space key. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name ALP03 ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §4300* # ∇ Factor/OD-H §7000* Calibration Specific General ISE Serum ∇ Process: ∇ Factor/OD-H §7000* # SERUM/PLASMA APPLICATION Test Name: Counts: ALP03 ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ Cal. # # ο ∇ 5.1 Main ∇ ∇ ∇ 410 Sub -0. Reagent 1 vol Reagent 2 vol μL μL μL 3 60 60 Dil. Vol Dil. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name ALP03 Sample type Ser ∇ 410 RATE + First 13 First 15 NO Last Last 19 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. ∇ ∇ ∇ Sec. # # ο ∇ 3. H 1500* Fst Fst 13 Lst Lst First H Last H 0.8 ∇ # Test name ALP03 Sample type Ser Page ½ System Reagent: OSR6103 Reagent ID: 003 Application ALP.5 0. L -0.1 5* B 14 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil. refer to leaflet for further instruction Depends on usage pattern in the Laboratory Enzyme . H Lst. H Sample vol. Point MB type factor Calibrator stability period # ‡ Select the function using the Function key or the Mouse # * § ‡ BSOSR6x03. L -0. § OD CONC § Factor/OD-L §4300* 1-Point Cal.1 Lst. No. # # ο ∇ 7. refer to leaflet for further instruction Depends on usage pattern in the Laboratory # * § ‡ User defined Values set for working in U/L.8 0. OD H ∇ Operation: Yes Test No ∇ 2.1 -0. To work in SI units (µkat/L) divide by 60 For use in AB mode only. Vol Dil. # # ο ∇ 6. ∇ # # # # ο 6.5 0. ∇ ∇ ∇ 5* Sec.ALP.5 0.1 -0. No. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 410 ∇nm RATE ∇ + ∇ 16 410 RATE + First 16 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 14 Day # ∇ +++++ ∇ +++++ ∇ ++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH ALP03 ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # ALP03 ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x03. To work in SI units (µkat/L) divide by 60 For use in AB mode only. AU2700/AU5400 Serum/Plasma Reagent ID: 003 Parameters General LIH ALP03 ∇ Dilution μL -0.8 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6103 Reagent ID: 003 Application Operation Yes ALP. ∇ # # # # ο 5. § OD CONC § Factor/OD-L §4300* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. Not within expected values U/L* Decimal Places Calibration Specific ISE ALP03 ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Range Low High §4300* §7000* ∇ # ο ∇ SERUM/PLASMA APPLICATION Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H §7000* # Process: Test Name: ALP03 ∇ < > Test Name: Use Serum Cal.1 R2(R2-1) μL Name Sec.01 2009-08 .OD μL Min. ∇ # # # # ο 2.8 36 36 μL μL μL Dilution Dilution Dilution 0 36 36 μL μL μL Pri. 480 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 5* 1 1 μL High B B 0 1500* 0 0 Hour 36 Dilution 36 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.8 1500* B 14 Last Last 27 15 NO % ∇ ALP03 ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 1. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. No demographics 8.8 0. # # ο ∇ 7. Volume R1(R1-1) μL ∇ μL 1. # # ο ∇ 5. None Selected 8.OD Reagent OD Limit First Low Last Low Dilution 36 0 OD Limit 2. ∇ # # # # ο 3.1 -0. # # ο ∇ 4.1 -0. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # * § ‡ ф User defined Values set for working in U/L.1 High High Max. # # ο ∇ 2. # # ο ∇ 3. ∇ # # # # ο 4. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. AU680/AU480 Serum/Plasma Application System Reagent: OSR6103 Specific Test Parameters General LIH ISE Serum ∇ 1 -0. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. refer to leaflet for further instruction Depends on usage pattern in the Laboratory AU680 <Point Cal.1 -0. For No. ∇ 7.8 0.8 1 36 Test Name: Max OD H 2. # # ο ∇ 5. # # ο ∇ 4. AU600 Paediatric Application System Reagent: OSR6103 Specific Test Parameters General LIH ISE Range Test Name: ALP3P ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 60 60 μL μL μL Dilution Dilution Dilution 10 60 50 μL μL μL Pri. ∇ ∇ ∇ Sec.5 0.1 5* B 14 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil. vol Dil. OD L -0.5 Fst. AU400/AU640 Paediatric Reagent ID: 003 Specific test parameters Serum ∇ 1 -0. refer to leaflet for further instruction Depends on usage pattern in the Laboratory Enzyme . To work in SI units (µkat/L) divide by 60 For use in AB mode only. No.1 Reagent OD limit Fst. refer to leaflet for further instruction Depends on usage pattern in the Laboratory # * § ‡ User defined Values set for working in U/L. None Selected 8.ALP. § OD CONC § Factor/OD-L §4300* 1-Point Cal.1 Lst. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name ALP3P Sample type Ser ∇ On-board stability period 410 RATE + First 13 First 15 NO Last Last 19 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min.1 Dynamic range L 5* Correlation factor % ∇ 1500* 1 0 ¤ 14 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: ALP3P ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. vol 10 60 50 Max.8 0. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name ALP3P ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §4300* # ∇ Factor/OD-H §7000* PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: ∇ Factor/OD-H §7000* # Test Name: Counts: ALP3P ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ Cal. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. L -0. H 1500* Fst Fst 13 Lst Lst First H Last H 0.1 -0. OD H ∇ Operation: Yes Test No ∇ 2. point MB type factor Calibrator stability period # ‡ Select the function using the Function key or the Mouse # * § ‡ BSOSR6x03.8 0. To work in SI units (µkat/L) divide by 60 For use in AB mode only.8 ∇ # Test name ALP3P Sample type Ser Page 1/2 System Reagent: OSR6103 Reagent ID: 003 Application ALP. # # ο ∇ 6. # # ο ∇ 3.8 480 RATE + 19 Max OD H 2. H Lst.01 2009-08 User defined ¤ Analyser default value Values set for working in U/L.1 Main ∇ ∇ ∇ 410 Sub -0. # # ο ∇ 7. Reagent 1 vol Reagent 2 vol μL μL μL 3 60 60 Dil. vol Dil. L -0. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ο ∇ 2. H Sample vol. 1 -0.8 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6103 Reagent ID: 003 Application Operation Yes ALP. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 410 ∇nm RATE ∇ + ∇ 16 410 RATE + First 16 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 14 Day # ∇ +++++ ∇ +++++ ∇ ++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH ALP3P ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # ALP3P ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 -0. ∇ ∇ ∇ 5* Sec. # # ο ∇ 7. refer to leaflet for further instruction ‡ Depends on usage pattern in the Laboratory ф AU680 <Point Cal. ∇ # # # # ο 5. No demographics 8. # # ο ∇ 5. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. AU680/AU480 Paediatric Application System Reagent: OSR6103 Specific Test Parameters General LIH ISE Serum ∇ 1 -0. # # ο ∇ 2. No.8 0.8 0. # # ο ∇ 4.8 36 36 μL μL μL Dilution Dilution Dilution 10 36 26 μL μL μL Pri. ∇ # # # # ο 2. None Selected 8. Not within expected values U/L* Decimal Places Calibration Specific ISE ALP3P ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Range Low High §4300* §7000* ∇ # ο ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H §7000* # Process: Test Name: ALP3P ∇ < > Test Name: Use Serum Cal.8 1 36 Test Name: Max OD H 2. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. ∇ # # # # ο 4. ∇ # # # # ο 3.1 R2(R2-1) μL Name Sec.ALP.5 0.1 -0. 480 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 5* 1 1 μL High B B 0 1500* 0 0 Hour 36 Dilution 26 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.8 1500* B 14 Last Last 27 15 NO % ∇ ALP3P ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 1.1 -0. For No. § OD CONC § Factor/OD-L §4300* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal.1 High High Max. Volume R1(R1-1) μL ∇ μL 1. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal.01 2009-08 .OD μL Min. ∇ # # # # ο 6. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined * Values set for working in U/L. AU2700/AU5400 Paediatric Reagent ID: 003 Parameters General LIH ALP3P ∇ Dilution μL -0.OD Reagent OD Limit First Low Last Low Dilution 36 10 OD Limit 2. # # ο ∇ 6. ∇ 7. To work in SI units (µkat/L) divide by 60 § For use in AB mode only.5 0. # # ο ∇ 3. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x03. This effect will vary depending upon the rate of use.01 2009-08 4 Enzyme . and in diseases such as multiple myeloma. contains a mixture of 5-chloro-2-methyl-4-isothiazolin-3-one [EC No 247-500-7] and 2-methyl-4-isothiazolin-3-one [EC No 220-239-6] (3:1). bone tuberculosis and healing fractures. R36/38. vitamin D intoxication and primary bone tumours.1 (ALP).4 p-Nitrophenyl phosphate HEDTA Zinc Sulphate Magnesium Acetate Preservative 0. Safety Phrases: S24. EC 3. osteopenia or osteoporosis. Refer to Safety Data Sheets for further information. flush waste-pipes with water after the disposal of undiluted reagent. pituitary dwarfism. R43. Storage and Stability The reagents are stable.S26.4. ectopic ossification. The precise metabolic function of ALP has not yet been fully elucidated. Reduced levels of ALP are found in familial hypophosphatasia.1. To avoid the possible build-up of azide compounds. This is harmful when inhaled. kidney tubules.S60. ALP levels may also be elevated in primary bone diseases. unopened. Absorption of atmospheric CO2 by the reagent on board the analyser can impair its stability. Bottle replacement is recommended when one of the following conditions are encountered: 14 days have elapsed on board the analyser. or are caused by diseases of the liver or bone. EN. vitamin D deficiency rickets and metastatic bone disease. Major preventative maintenance was performed on the analyser or a critical part was replaced. ALP levels may also be increased in secondary bone diseases.01 BLOSR6x04. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. In case of contact with eyes. Total ALP is only occasionally elevated in some metabolic bone diseases such as hyperparathyroidism. with pathological ALP levels found in approximately 60% of patients with disease of the liver or biliary tract. osteogenesis imperfecta. Dispose of all waste material in accordance with local guidelines. who are secretors of blood group substance H (intestinal ALP). in human serum and plasma on Beckman Coulter analysers. The rate of change in absorbance due to the formation of pNP is measured bichromatically at 410/480 nm and is directly proportional to the ALP activity in the sample. For in vitro diagnostic use only. acromegaly. located at or in cell membranes. Wear suitable gloves. Approximately 25% of healthy individuals also have intestinal ALP which accounts for approximately 10% of the total ALP in a fasting sample. R2 reagent: Irritant. During the reaction p-nitrophenol is produced. up to the stated expiry date when stored at 2…8 °C. ALP originates in approximately equal proportions from the liver and the skeletal system. hypoparathyroidism. Irritating to eyes and skin. Specimen Serum and heparinised plasma.S37. The most common cause of elevated ALP is hepatobiliary disease. oxalate and EDTA should be avoided.35 mol/L 16 mmol/L 2 mmol/L 1 mmol/L 2 mmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: R1 reagent: Irritant. This material and its container must be disposed of as hazardous waste. swallowed or absorbed through skin. achondroplasia. rinse immediately with plenty of water and seek medical advice. Complexing anticoagulants such as citrate. hyperthyroidism. sarcoidosis. however the enzyme is associated with intestinal lipid transport and bone calcification. It occurs at particularly high levels in interstitial epithelium. Significant shift in control values (>7 %) following local QC procedures. 4 x 12 mL 4 x 12 mL 4 x 30 mL 4 x 30 mL 4 x 53 mL 4 x 53 mL R1 R2 R1 R2 R1 R2 Summary1. ALP activity is a good indicator of bone activity. Reaction Principle pNPP + AMP ALP Mg 2+ pNP + AMP-PO4 Contents. such as skeletal metastases. Reagent Composition in the Test Final concentration of reactive ingredients: 2-Amino-2-Methyl-1-Propanol (AMP) pH 10. Test Principle3 Method based on the recommendations of the “International Federation for Clinical Chemistry” (IFCC). renal insufficiency. 5 Stable in serum and plasma for 7 days when stored at 2…25 °C. Alkaline phosphatase activity is determined by measuring the rate of conversion of p-nitro-phenylphosphate (pNPP) to p-nitrophenol (pNP) in the presence of magnesium and zinc ions and of 2-amino-2-methyl-1-propanol (AMP) as phosphate acceptor at pH 10. adynamic bone disease in dialysis patients. Increases in total ALP are either due to physiological causes. chronic radiation sickness and malnutrition. Avoid contact with skin. In bone diseases such as Paget’s disease. May cause sensitisation by skin contact. in growing children due to bone ALP and postprandially in individuals with blood groups B and O.2 Alkaline phosphatase (ALP) is present in almost all body tissues. liver and placenta.3. Exercise the normal precautions required for handling all laboratory reagents.ALP OSR6004 OSR6104 OSR6204 Intended Use Kinetic colour test for the quantitative determination of alkaline phosphatase. such as osteomalacia. Physiological increases in ALP are found in pregnancy from the 2nd trimester onwards due to placental ALP. Strongly haemolysed samples should be avoided. in the absence of co-existing chronic liver disease. bone (osteoblasts). Each laboratory should verify the transferability of the expected values to its own population. Shaw LM. Frankfurt/Main: TH-Books Verlagsgesellschaft. 5th ed.09 Total CV% 4. Moss DW. For diagnostic purposes. Calibration The test is run in MB-mode.5 g/L haemoglobin ® Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid 6 Refer to Young for further information on interfering substances. Results of linear regression analysis were as follows: y = 0.94 0. Good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. The paediatric application is suitable for use with small volume serum/plasma samples.57 11.0 µkat/L). and if necessary determine its own reference interval according to good laboratory practice. clinical examinations and other findings. Philadelphia:WB Saunders Company. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. For use in AB mode only. Data obtained in your laboratory may differ from these values. utilising System Calibrator Cat No. Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced. AACC Press.01 2009-08 EN. Enzymes In: Tietz NW. Töpfer G.45 7. 5. Quality Control Controls Cat.01 . IFCC method for alkaline phosphatase.Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.1 Rev. In: Burtis CA. review all operating parameters.2:21pp. No. Fundamentals of clinical chemistry. refer to leaflet for further instruction. 6.93 2.99 1. User defined ¤ Analyser default value Values set for working in U/L. For the AU2700/AU5400 this procedure needs to be performed for each ring. Kachmar JF. To provide a robust approach to generate the analyser specific MB factor.40 1. Schmitt Y. Zawta B. ed. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used.999 n = 124 Sample range = 17 – 1500 U/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 28 mg/dL or 479 µmol/L bilirubin Haemolysis: Interference less than 10% up to 4. Heil W.48 0. Thomas L. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. BIBLIOGRAPHY Enzyme BLOSR6x04. The lowest detectable level represents the lowest measurable level of ALP that can be distinguished from zero.934x + 8 r = 0. Method Comparison Patient serum samples were used to compare this ALP OSR6104 assay on the AU600 against another commercially available ALP assay. Reagent blank measurement is recommended when changing to a new lot of reagent. 1987:387pp. Tietz NW.21:731-48. ed. Depends on usage pattern in the laboratory. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced. should be used for each of these runs. Clinical Enzymology. Henderson RA. Linearity The test is linear within an enzyme activity range of 5 – 1500 U/L (0. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Setting Sheet Footnotes # * § ‡ 1. IFCC methods for the measurement of catalytic concentration of enzymes Part 5.56 0. Ashwood ER. 2000. Plasma and Serum Samples. Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood. diet and geographical location. eds. Values obtained for the controls should fall within specified limits as defined by the user. 66300 in the AB calibration mode. et al. Young DS. n = 60 Mean U/L 21 260 856 Within Run SD 0.67 CV% 1. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. A fresh vial of calibrator. Ehret W. 3. sex. it is recommended that 5 separate calibration events should be used. Reference Intervals2 Adults > 17y : 30 – 120 U/L Children Male (U/L) Female (U/L) 1 – 30d 75 – 316 48 – 406 30d – 1y 82 – 383 124 – 341 1 – 3y 104 – 345 108 – 317 4 – 6y 93 – 309 96 – 297 7 – 9y 86 – 315 69 – 325 10 – 12y 42 – 362 51 – 332 13 – 15y 74 – 390 50 – 162 16 – 18y 52 – 171 47 – 119 Expected values may vary with age. Moss DW. Tietz textbook of clinical chemistry. In: Thomas L.1 – 25. 1998:36-46. Effects of drugs on clinical laboratory tests. Clinical laboratory diagnostics. Rinker D. J Clin Chem Clin Biochem 1983. Henderson RA. results should always be assessed in conjunction with the patient's medical history. Philadelphia:WB Saunders Company. To work in SI units (µkat/L) divide by 60. WHO/DIL/LAB/99. If any trends or sudden shifts in values are detected.90 SD 0. Calculation The Beckman Coulter analysers automatically compute the alkaline phosphatase activity of each sample. Wisser H. Use and assessment of clinical laboratory results. 2. The calibrator value is traceable to a Beckman Coulter Master Calibrator. Each laboratory should establish its own control frequency.30 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 1 U/L. Alkaline phosphatase (ALP). 4. 676-684. sample type. 1999. L 0. OD H 2. OSR6104. Vol Dil. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name ALP04 ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L § 4000* # Conc Factor/OD-H § 6500* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H § 6500* # SERUM/PLASMA APPLICATION Test Name: Counts: ALP04 ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration # ∇ Cal. OSR6204 Specific test parameters Reagent ID: 004 Application ALP (IFCC).0 0. # # ο ∇ 2.5 1. Reagent 1 vol Reagent 2 vol μL μL μL Fst. No. refer to IFU for further instruction Values set for working in U/L. # # ο ∇ 7. H Lst. OSR6104. refer to IFU for further instruction Values set for working in U/L. Point MB type factor Calibrator stability period # § * ‡ # ‡ Select the function using the Function key or the Mouse User defined ¤ Analyser default value For use in the AB mode only.01 2009-08 .0 Lst.ALP (IFCC).2 ∇ ∇ # Test name ALP04 Sample type Ser Page ½ System Reagent: OSR6004.0 5* B 14 Linearity Fst No lag time NO Select using Space key. OSR6204 Specific Test Parameters General LIH ISE Range Serum ∇ 1 0. OD L 0. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: On-board stability period 410 RATE + First 13 First 15 NO Last Last 19 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. # # ο ∇ 3.0 Reagent OD limit Fst. AU400/AU640 Serum/Plasma Reagent ID: 004 Test No ∇ Sample vol.2 1.2 480 RATE + 19 Max OD H 2. # # ο ∇ 6.0 Dynamic range L 5* Correlation factor % ∇ 1500* 1 0 ¤ 14 Specific Test Parameters General LIH ISE Serum ∇ # # # # # # # Age Y Y Y Y Y Y Range Test Name: ALP04 ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. None Selected 8. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. AU600 Serum/Plasma Application System Reagent: OSR6004.0 0. ∇ ∇ ∇ Sec. L 0. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # L # Test name ALP04 Sample type Ser ∇ Level L # Page 2/2 Level H # 15 % Sec % ∇ 0 Sample Pre-dil H 1500* Fst Fst 13 Lst Lst First H Last H 1. To work in SI units (µkat/L) divide by 60 Depends on usage pattern in the Laboratory Enzyme BSOSR6x04.5 Operation: Yes Test Name: ALP04 ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 60 60 μL μL μL Dilution Dilution Dilution 0 60 60 μL μL μL Pri. Vol 0 60 60 Max. H ∇ ∇ ∇ Main 410 Sub 3 60 60 Dil. Vol Dil. To work in SI units (µkat/L) divide by 60 Depends on usage pattern in the Laboratory # § * ‡ User defined For use in the AB mode only. # # ο ∇ 5. § OD CONC § Factor/OD-L § 4000* 1-Point Cal. # # ο ∇ 4.2 1. # # ο ∇ 2. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. Volume R1(R1-1) μL ∇ μL 1. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 1500* A 1 On-board stability period: Common Rgt. No demographics 8. OSR6204 Specific Test Parameters General LIH ISE Serum ∇ 1 -0.1 High High Max. For No. No. # # ο ∇ 3.OD Reagent OD Limit First Low Last Low Dilution 36 0 OD Limit 2.1 -0. # # ο ∇ 4. # # ο ∇ 7. refer to IFU for further instruction * Values set for working in U/L To work in SI units (µkat/L) divide by 60 ‡ Depends on usage pattern in the Laboratory ф AU680 <Point Cal.3 First H 1. ∇ # # # # ο 3. # # ο ∇ 6. ∇ 7.1 -0.5 1. ∇ # # # # ο 6. Not within expected values U/L* Decimal Places Calibration Specific ISE ALP04 ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Range Low High §4000* §6500* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H § 6500* # Process: CONC ∇ SERUM/PLASMA APPLICATION SERUM/PLASMA APPLICATION Test Name: ALP04 ∇ < > Test Name: Use Serum Cal. AU2700/AU5400 Serum/Plasma Reagent ID: 004 Parameters General LIH ALP04 ∇ Dilution μL -0. ∇ # # # # ο 4. OSR6104.01 2009-08 .1 -0. ∇ ∇ ∇ 5* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Sec. ∇ # # # # ο 2.1 -0.2 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6004. # # ο ∇ 5.2 H B 14 Last Last 27 15 NO % ∇ 1. ∇ # # # # ο 5.8 1 36 Range Operation: ∇ Yes Test Name: ALP04 < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Max OD H 2.5 0. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined § For use in the AB mode only.OD μL Min.2 1.2 Last H 1. OSR6104. AU680/AU480 Serum/Plasma Application System Reagent: OSR6004.8 36 36 μL μL μL Dilution Dilution Dilution 0 36 36 μL μL μL Pri.ALP (IFCC). None Selected 8. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 410 ∇nm RATE ∇ + ∇ 16 410 RATE + First 16 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 14 Day # ∇ +++++ ∇ ++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH ALP04 ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # ALP04 ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. § OD CONC § Factor/OD-L § 4000* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. OSR6204 Reagent ID: 004 Application Operation Yes ALP (IFCC). 480 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 5* 1 1 μL High B B 0 1500* 0 0 Hour 36 Dilution 36 Sample Volume Pre-Dilution Rate Rgt.1 R2(R2-1) μL Name Sec. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x04. # # ο ∇ 5.0 0. AU600 Paediatric Application System Reagent: OSR6004. ∇ ∇ ∇ Sec. OD L 0. H Lst.0 Dynamic range L 5* Correlation factor % ∇ 1500* 1 0 ¤ 14 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: ALP4P ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. vol Dil. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 Fst. OSR6104. # # ο ∇ 6.0 5* B 14 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil H 1500* Fst Fst 13 Lst Lst First H Last H 1. OSR6204 Reagent ID: 004 Application ALP (IFCC). OD H ∇ Operation: Yes Test No ∇ 2. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name ALP4P Sample type Ser ∇ On-board stability period 410 RATE + First 13 First 15 NO Last Last 19 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. H Sample vol. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name ALP4P ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L § 4000* # Conc Factor/OD-H § 6500* ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H § 6500* # Test Name: Counts: ALP4P ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ Cal. No.2 1. # # ο ∇ 2. AU400/AU640 Paediatric Reagent ID: 004 Specific test parameters Serum ∇ 1 0. point MB type factor Calibrator stability period # ‡ Select the function using the Function key or the Mouse # § * ‡ BSOSR6x04. # # ο ∇ 4. vol 10 60 50 Max. To work in SI units (µkat/L) divide by 60 Depends on usage pattern in the Laboratory Enzyme . OSR6204 Specific Test Parameters General LIH ISE Range Test Name: ALP4P ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 60 60 μL μL μL Dilution Dilution Dilution 10 60 50 μL μL μL Pri.2 1. § OD CONC § Factor/OD-L § 4000* 1-Point Cal.2 ∇ # Test name ALP4P Sample type Ser Page 1/2 System Reagent: OSR6004. L 0. To work in SI units (µkat/L) divide by 60 Depends on usage pattern in the Laboratory # § * ‡ User defined For use in the AB mode only. OSR6104.0 Main ∇ ∇ ∇ 410 Sub 0. # # ο ∇ 3. Reagent 1 vol Reagent 2 vol μL μL μL 3 60 60 Dil. L 0. None Selected 8.2 480 RATE + 19 Max OD H 2.5 1. # # ο ∇ 7.ALP (IFCC).01 2009-08 User defined ¤ Analyser default value For use in the AB mode only. refer to IFU for further instruction Values set for working in U/L. vol Dil.0 Lst. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. refer to IFU for further instruction Values set for working in U/L.0 Reagent OD limit Fst. # # ο ∇ 6.01 2009-08 . # # ο ∇ 4. § OD CONC § Factor/OD-L § 4000* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation None ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 1-Point Cal.8 1 36 Range Operation: ∇ Yes Test Name: ALP4P < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Max OD H 2. OSR6104. refer to IFU for further instruction * Values set for working in U/L.1 -0.2 H 0 1500* Noneф 410 ∇nm RATE ∇ + ∇ 16 1. ∇ 7.OD Reagent OD Limit First Low Last Low 1. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Parameters General LIH ALP4P ∇ < > ISE HbA1c Test Name: 410 RATE + First 16 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Serum ∇ # Range Test Name: ALP4P ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. For No. # # ο ∇ 5. OSR6204 Reagent ID: 004 Application Operation Yes ALP (IFCC). AU680/AU480 Paediatric Application System Reagent: OSR6004. No. To work in SI units (µkat/L) divide by 60 ‡ Depends on usage pattern in the Laboratory ф AU680 <Point Cal.1 High High Max.5 1.5 0. ∇ # # # # ο 2. ∇ # # # # ο 4. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. OSR6104.2 Last H 1. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # U/L* Month # # # # # # Month # # # # # # Panic Value Low # High # L U/L* H Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.1 -0.2 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6004. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x04.2 1. 480 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 5* 1 1 14 Day # ∇ +++++ ∇ ++++ ∇ +++++ ∇ μL High B B 0 1500* 0 0 Hour 36 Dilution 26 Sample Volume Pre-Dilution Rate Rgt.1 5* B 14 15 NO % ∇ Last Last 27 R2(R2-1) μL Name Sec. # # ο ∇ 7. None Selected 8. # # ο ∇ 2. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal.1 -0. Not within expected values Decimal Places Calibration Specific ISE ALP4P ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Range Low High §4000* §6500* ∇ # ο ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H § 6500* # Process: CONC ∇ Test Name: ALP4P ∇ < > Test Name: Use Serum Cal.OD μL Dilution 36 10 OD Limit 2. # # ο ∇ 3.ALP (IFCC). ∇ # # # # ο 3. Volume R1(R1-1) μL ∇ μL Min. ∇ # # # # ο 6. AU2700/AU5400 Paediatric Reagent ID: 004 Parameters General LIH ALP4P ∇ Dilution μL -0. ∇ # # # # ο 5. No demographics 8. ∇ ∇ ∇ Sec. Point: ο with CONC-0 Slope Check: ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined § For use in the AB mode only.8 36 36 μL μL μL Dilution Dilution Dilution 10 36 26 μL μL μL Pri.3 First H 1.1 -0. OSR6204 Specific Test Parameters General LIH ISE Serum ∇ 1 -0. Volume Pyridoxal Phosphate Liquid No. OSR60180 for use with 3-part-reagent enabled systems only. of Pyridoxal Phosphate tablets OSR6007 0.01 2009-08 Enzyme . including hepatitis. 60100) are supplied separately for pyridoxal phosphate activation. pH: 7. Elevated ALT levels may be detected in viral hepatitis and other forms of liver disease prior to development of overt clinical symptoms such as jaundice. and mix by gentle inversion. R2 is ready for use and can be placed directly on board the instrument. Increased ALT levels may also be detected in cirrhosis and extrahepatic cholestasis.20 mmol/L 0. OSR6507 for use on the AU2700 and AU5400 systems only. EN.1. This method can also be used for 3-part-reagent enabled systems.8 kU/L 0. Slight or moderate increases in ALT levels may also be observed after ingestion of alcohol.01 BLOSR6x07. Reaction Principle 2-Oxoglutarate + L-Alanine Pyruvate + NADH + H + ALT LDH L-Glutamate + Pyruvate L-lactate + NAD + Contents. Pipette Pyridoxal Phosphate Liquid 60106 into the R1 bottle according to the table below. ALT is present in the cytosol of hepatocytes. To avoid the possible build-up of azide compounds. 4 x 12 mL 4 x 6 mL 4 x 50 mL 4 x 25 mL 4 x 102 mL 4 x 52 mL 4 x 17 mL Liquid 6 x 4 mL Liquid 4 x 25 Tablets R1 R2 R1 R2 R1 R2 P-5-P R1-2 Pyridoxal Phosphate Pyridoxal Phosphate Summary1. The addition of pyridoxal phosphate to the reaction mixture ensures maximum catalytic activity of ALT. The decrease in absorbance due to the consumption of NADH is measured at 340 nm and is proportional to the ALT activity in the sample.2 (ALT). Reagent Preparation With manual pyridoxal phosphate addition Pyridoxal Phosphate Liquid (Cat. For in vitro diagnostic use only. and increased serum levels indicate deterioration in the integrity of the hepatocyte plasma membrane. ALT has greater diagnostic sensitivity for hepatobiliary disease than AST. elevated serum ALT activity is mainly regarded as an indicator of parenchymal liver disease. Levels greater than 15 times the upper reference limit are always indicative of acute hepatocellular necrosis of viral. Since the specific activity of ALT in the liver is approximately 10 times that of heart and skeletal muscle. No. Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer. Test Principle4 Method based on the recommendations of the “International Federation for Clinical Chemistry” (IFCC). The pyruvate enters a lactate dehydrogenase (LDH) catalysed reaction with NADH to produce lactate and + NAD . No. Activities >50 times the upper reference limit are mainly associated with acute viral hepatitis.Alanine 2-Oxoglutarate LDH NADH Pyridoxal Phosphate (P-5-P) Preservative 100 mmol/L 500 mmol/L 12 mmol/L ≥ 1.15 (37°C) L. Markedly elevated serum ALT levels may be found in a variety of diseases involving the liver. ALT transfers the amino group from alanine to 2-oxoglutarate to form pyruvate and glutamate. Endogenous pyruvate is removed during the incubation period. or administration of drugs including penicillin.ALT OSR6007 OSR6107 OSR6507 OSR60180 60106 60100 Intended Use Kinetic UV test for the quantitative determination of alanine aminotransferase. toxic or circulatory origin. salicylates or opiates. a group of enzymes which catalyse the reversible transformation of α-keto acids into amino acids by transfer of amino groups. 60106. Safety data sheet available for professional user on request.3 ALT is an aminotransferase. 60100 or OSR60180 is used) Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. mononucleosis and cirrhosis. Cat. acute disorders of liver perfusion and acute liver necrosis due to ingestion of toxins including paracetamol and carbon tetrachloride. flush waste-pipes with water after the disposal of undiluted reagent. by mixing gently several times. Dispose of all waste material in accordance with local guidelines.2. Alternatively.1 mmol/L (when Cat.6. in human serum and plasma on Beckman Coulter analysers. EC 2.25 mL 1 tablet OSR6107 1 mL 4 tablets OSR6507 2 mL 8 tablets Without pyridoxal phosphate activation The reagents are ready for use and can be placed directly on board the instrument. No. dissolve tablets completely in the R1 bottle according to the table below. 60106) and Pyridoxal Phosphate tablets (Cat No. 60 µkat/L) Newborn/Infant 13 − 45 U/L (0. the calibrator is traceable to a Beckman Coulter Master Calibrator. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. No 60106) Once open. sex. Reference Intervals6. Reagent blank measurement is recommended when changing to a new lot of reagent. reagents stored on board the instrument are stable for 30 days. n = 60 Within Run Total Mean U/L SD CV% SD 18 0. OSR60180) is specifically for use on board 3-part-reagent enabled systems. For the AU2700/AU5400 this procedure needs to be performed for each ring.Storage and Stability Reagents are stable.80 1. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. clinical examinations and other findings. 66300 in the AB calibration mode. Each laboratory should verify the transferability of the expected values to its own population.57 56 0.0.999 n = 117 Sample range = 3 – 264 U/L Enzyme BLOSR6x07. For diagnostic purposes.95 0. utilising System Calibrator Cat No. Results of linear regression analysis were as follows: y = 1. Pyridoxal Phosphate Liquid reagent (Cat. R1 stored on board the instrument is stable for 7 days. 3-part-reagent enabled systems with P-5-P activation Reagent Preparation P-5-P Liquid (Cat. Without pyridoxal phosphate activation. Calculation The Beckman Coulter analysers automatically compute the ALT activity of each sample. R2 stored on board the instrument is stable for 30 days.00 459 2. Quality Control Controls Cat. R1 and R2 are also ready for use and can be placed directly on board the instrument. The results obtained by any individual laboratory may vary from the given mean value. P-5-P (Cat no OSR60180) is stable on board the instrument for 60 days. diet and geographical location. unopened.53 2. The paediatric application is suitable for use with small volume serum/plasma samples.05 – 8. Data obtained in your laboratory may differ from these values. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. the calibrator value is traceable to the IFCC reference method and IRMM/IFCC-454. No.67 CV% 3. up to the stated expiry date when stored at 2…8°C.85 µkat/L) Female (Adult) < 35 U/L (0.33 µkat/L).78 0.22 − 0. Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced. A fresh vial of calibrator.7 Male (Adult) < 50 U/L (0. Specimen Serum.1 r = 0. Calibration The test is run in MB-mode. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. and EDTA or heparinised plasma. review all operating parameters. The lowest detectable level represents the lowest measurable level of ALT that can be distinguished from zero. results should always be assessed in conjunction with the patient's medical history. the cap is replaced immediately after use and the reagent is stored at 2…8°C. The reagent is ready for use and can be placed directly on board the instrument in the R1 carousel.63 3. No.01 . Method Comparison with pyridoxal phosphate activation Patient serum samples were used to compare ALT OSR6107 assay on the AU640 against the IFCC reference method. Pyridoxal Phosphate Liquid reagent is stable until the expiry date printed on the label. Linearity The test is linear within an enzyme activity range of 3 – 500 U/L (0.01 2009-08 EN. With pyridoxal phosphate activation After addition of pyridoxal phosphate.80 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 1 U/L.16 1. R1 and R2 reagent stored on board the instrument are stable for 30 days. Without pyridoxal phosphate activation Once open. Storage and stability Once open. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.43 1. and if necessary determine its own reference interval according to good laboratory practice. If any trends or sudden shifts in values are detected. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.010x .75 µkat/L) Expected values may vary with age. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. With pyridoxal phosphate activation. should be used for each of these runs. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced. provided that contamination is avoided through adherence to GLP.88 0. To provide a robust approach to generate the analyser specific MB factor it is recommended that 5 separate calibration events should be used. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. 5 Stable in serum and plasma for 7 days when stored at 2…8°C and 3 days when stored at 15…25°C. sample type. 1987:369-373. Clinical laboratory diagnostics. plasma and serum samples. 6. In:Thomas L. eds.Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 5 g/L haemoglobin ® Lipemia: Interference less than 3% up to 300 mg/dL Intralipid Pyruvate: Interference less than 5% up to 1 mmol/L pyruvate Refer to Young for further information on interfering substances. BIBLIOGRAPHY EN. 8 Limitations Highly lipemic samples may exceed the reaction absorbance and will be flagged with a “@”. Diagnosis of icteric diseases. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. Philadelphia:WB Saunders Company. Cope JY. 5th ed. In: Burtis CA. Tietz textbook of clinical chemistry. 5. refer to leaflet for further instruction Thomas L. Aspartate aminotransferase (AST).29:301-08. Kachmar JF. et al. Effects of drugs on clinical laboratory tests. Part 4. Schumann G et al. Töpfer G.2:21pp. 7. Philadelphia:WB Saunders Company. 2. J Lab Med 2005. Such samples should be diluted and re-run. 8. Setting Sheet Footnotes # * § 1. Use and assessment of clinical laboratory results. Fundamentals of clinical chemistry. Ceriotti F et al. Enzymes. Schmidt FW. Moss DW. Thomas L. Clin Chem Lab Med 2002. Henderson RA.1 Rev. Schmitt Y. For use in AB mode only. 4.01 BLOSR6x07. ed. Schumann G. Frankfurt/Main: TH-Books Verlagsgesellschaft. ed. Reference Procedure for the Measurement of Catalytic Concentration of Alanine Aminotransferase.01 2009-08 Enzyme . Reference information for the clinical laboratory. Dtsch Med Wschr 1984. Zawta B. 3. To work in SI units (µkat/L) divide by 60.40:718–24. WHO/DIL/LAB/99. Painter PC. Müller M. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37°C. 1800pp. AACC Press. Alanine aminotransferase (ALT). Young DS. Bonora R. Schmidt E. Smith JL. Ashwood ER. 2000. 109: 139-146. Wisser H. In: Tietz NW. Heil W. 1998:55-65. Ehret W. User defined ¤ Analyser default value Values set for working in U/L. 1999. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. . Vol Dil. OD L 0.5 2. refer to IFU for further instruction. Point: with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 ∇ § Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. OSR6107 Reagent ID: 007 Serum/Plasma Application System Reagent: OSR6007. H Lst.60 Reagent OD limit Fst. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name ALT ∇ MB ∇ Y=AX+B OD ∇ Conc Count Process Factor/OD-L # ∇ Factor/OD-H Calibration Specific General ISE Serum # Factor/OD-H §5470* Process: ∇ ∇ SERUM/PLASMA APPLICATION Test Name: Counts: ALT ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal. Vol 0 50 50 µL µL µL Max. # User defined * Values set for working in U/L.5 # Test name ALT ∇ Sample type Ser ∇ Page ½ System Reagent: OSR6007. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. H Sample vol.5 Fst. OD H ∇ Operation: Yes ∇ Test No 2. AU400/AU640 ALT (IFCC. # # ∇ 6. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name ALT ∇ Sample type Ser ∇ On-board stability period 340 RATE First 14 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. # # ∇ 4.5 2.5 Main 340 Sub 660 RATE 27 ∇ ∇ ∇ Max OD H 2. To work in SI units (µkat/L) divide by 60 § For use in AB mode only.60 1. BSOSR6x07.02 2010-05 Enzyme . # # ∇ 3.1 Dynamic range L 3* Correlation factor % ∇ 500* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L # Age Y Y Y Y Y Y Level H # Test Name: ALT ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. H 500* Fst Fst 14 Lst Lst First H Last H 2. L 1. # # ∇ 5.1 1.ALT (IFCC.1 Lst.1 3* B 30 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil. # # ∇ 7. without Pyridoxal phosphate activation). AU600 Serum/Plasma Application Reagent ID: 007 Specific test parameters Serum 1 0. Point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. without Pyridoxal phosphate activation). L 1. refer to IFU for further instruction. ∇ ∇ ∇ Sec. Vol Dil. Reagent 1 vol Reagent 2 vol 10 100 50 Dil. # # ∇ 2. § OD CONC § Factor/OD-L §3650* § §3650* §5470* 1-Point Cal. None Selected 8. OSR6107 Specific Test Parameters General LIH ISE Range Test Name: ALT ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 10 100 50 µL µL µL Dilution Dilution Dilution 0 50 50 µL µL µL Pri. No.5 2. refer to IFU for further instruction.5 2. OSR6507 Reagent ID: 007 Serum/Plasma Application Operation Yes ∇ System Reagent: OSR6007. No demographics 8. # # # # ∇ 7.5 500* B 30 Last Last 27 15 YES % ∇ Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) 5 1 50 µL ∇ µL Test Name: ALT ∇ Yes < > Type: ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 5 50 25 µL µL µL Dilution Dilution Dilution 0 25 25 µL µL µL Pri. Not within expected values U/L* Decimal Places Calibration Specific ISE Test Name: ALT ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum ∇ Calibration Specific General ISE Type Serum Counts: Factor/OD-H §5470* # Process: ∇ ∇ SERUM/PLASMA APPLICATION Test Name: ALT ∇ < > Use Serum Cal. OSR6107.5 2. # # ∇ 6. without Pyridoxal phosphate activation).5 2. Point: with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration <Point Cal. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. AU680 Day Day Hour Hour Enzyme BSOSR6x07.60 1. # # ∇ 4.02 2010-05 . # # # # ∇ 2.1 1. # # # # ∇ 3. # # # # ∇ 4.5 2. # # # # ∇ 6. For No. without Pyridoxal phosphate activation).OD High High Dilution 25 µL Min. # # ∇ 2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. OSR6107.1 R2(R2-1) ф 660 25 µL Dilution 25 Name Sec. None Selected 8. # # # # ∇ 5.OD Reagent OD Limit First Low Last Low 0 µL OD Limit 2. # # ∇ 3.60 1. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A µL 3* 1 1 High B B 0 500* 0 0 Hour Range ∇ Operation: Max OD H 2.ALT (IFCC. To work in SI units (µkat/L) divide by 60 For use in AB mode only. ∇ ∇ ∇ 3* Sec.1 1.1 Max. # # ∇ 5. AU2700/AU5400 ALT (IFCC. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: # 1-Point Calibration Point ∇ with Conc-0 Lot Calibration ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # * § Ф User defined Values set for working in U/L.5 ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6007. OSR6507 Specific Test Parameters General LIH ISE Serum 1 0. § OD CONC § Factor/OD-L §3650* Counts: # ∇ ∇ Range Low High Slope Check §3650* §5470* Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. No. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. AU680/AU480 Serum/Plasma Application Reagent ID: 007 Parameters General LIH ALT Dilution 0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ ∇ 14 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 340 RATE First 14 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum LIH ALT ∇ < > ISE Range ∇ Test Name: Parameters General HbA1c Test Name: # ALT ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ∇ 7. L 1. Vol 0 50 50 µL µL µL Max. H Sample vol. # # ∇ 4.5 Fst.ALT (IFCC.3 Lst. No.3 3* B 7 NO Linearity Fst No lag time 15 % Sec % ∇ 0 H 500* Fst Fst Sample Pre-dil. refer to IFU for further instruction.0 Reagent OD limit Fst.5 2. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name ALT ∇ Sample type Ser 340 RATE First 14 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: On-board stability period 500* 1 0 ¤ % ∇ 7 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range ∇ Level L # Age Y Y Y Y Y Y Page 2/2 Level H # Test Name: ALT ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. with OE60106 activation).5 Wave Method Reaction Point 1 Point 2 660 RATE 27 ∇ ∇ ∇ Max OD H 2. Enzyme .5 2. Point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L.3 1. Vol Dil. Vol Dil. refer to IFU for further instruction.5 ½ System Reagent: OSR6007. with OE60106 activation). ∇ ∇ ∇ Sec.5 2. # # ∇ 6. OD H ∇ Operation: Yes ∇ # Test name ALT ∇ Sample type Ser ∇ Page 2. § OD CONC § Factor/OD-L §3650* § §3650* §5470* 1-Point Cal. # # ∇ 5. # # ∇ 3. OSR6107 Serum/Plasma Application Reagent ID: 007 System Reagent: OSR6007. AU400/AU640 Serum/Plasma ALT (IFCC.02 2010-05 # User defined * Values set for working in U/L. L 1. Point: with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 ∇ § Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.0 Main 340 Sub 1. BSOSR6x07. AU600 Application Reagent ID: 007 Specific test parameters Test No Serum 1 1. Reagent 1 vol Reagent 2 vol 10 100 50 Dil. OD L 1. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. None Selected 8.3 Dynamic range L 3* Correlation factor H A B Rate Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. OSR6107 Specific Test Parameters General LIH ISE Range Test Name: ALT ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 10 100 50 µL µL µL Dilution Dilution Dilution 0 50 50 µL µL µL Pri. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name ALT ∇ MB ∇ Y=AX+B OD ∇ Conc Count Process Factor/OD-L # ∇ Factor/OD-H Calibration Specific General ISE Serum # Factor/OD-H §5470* Process: ∇ ∇ SERUM/PLASMA APPLICATION Test Name: Counts: ALT ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal. 14 Lst Lst First H Last H 2. H Lst. 660 ∇ Min. # # ∇ 2. # # ∇ 7. 3 3* B 7 0 H 500* First H Last H 2.02 2010-05 .5 2.ALT (IFCC. Point: with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: # User defined * Values set for working in U/L. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 340 RATE First 14 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Serum # ∇ Range Test Name: ALT ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.3 1. # # ∇ 6. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Panic Value: # # Calibration Specific General ISE Type Serum Counts: Factor/OD-H §5470* # Process: ∇ ∇ SERUM/PLASMA APPLICATION Test Name: ALT ∇ < > Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal. OSR6107.5 Max OD H 2. with OE60106 activation). None Selected 8.0 1. # # ∇ 3. # # ∇ 2. ∇ ∇ ∇ Sec. AU2700/AU5400 Reagent ID: 007 Serum/Plasma Application System Reagent: OSR6007. # # ∇ 5. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. # # ∇ 4. refer to IFU for further instruction. No. OSR6507 Specific Test Parameters General LIH ISE Serum 1 1.5 ∇ Operation: Yes ∇ Range Test Name: ALT ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 5 50 25 µL µL µL Dilution Dilution Dilution 0 25 25 µL µL µL Pri. § OD CONC § Factor/OD-L §3650* 1-Point Cal. Ф AU680 Enzyme BSOSR6x07. # # ∇ 7. 0 1. # # # # ∇ 3. Calibration Specific Calibration Parameters STAT Table Calibration ISE Calibration Parameters STAT Table Calibration Type Y=AX+B Serum Counts: ∇ # ∇ Slope Check Allowance Range Check Reagent Blank Calibration None ∇ Use Serum Cal. # # # # ∇ 6. Test Name: ALT ∇ < > Type Serum Y=AX+B None ∇ Counts: # ∇ ∇ Range Low High Slope Check §3650* §5470* Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Lot Calibration ∇ Range Low High §3650* §5470* Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Advanced Calibration Operation Interval (RB/ACAL) # ∇ # Lot Calibration ∇ Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal. AU680/AU480 Serum/Plasma Application Reagent ID: 007 System Reagent: OSR6007. No demographics 8. # # # # ∇ 5. # # # # ∇ 2. Volume R1(R1-1) 5 1 50 0 µL OD Limit µL ∇ µL Dilution 25 µL Min.5 Min.5 Dilution Dilution Dilution # 660 25 µL 10 10 µL µL 0 µL OD Limit ∇ Type: Serum < > ∇ ISE HbA1c Range Specific Test Parameters Calculated Test Application Yes ∇ Parameters General Range Serum Test Name: ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: ALT ∇ < > Type: Operation Operation Yes ∇ Dilution 1.02 2010-05 . of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Day Day Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration Hour Hour <Point Cal. with OE60106 activation). Name Sec.OD Reagent OD Limit First Low Last Low Max.0 1.OD 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: # 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration ∇ with Conc-0 Day Day Hour Hour MB Type Factor: # 1-Point Calibration Point ∇ with Conc-0 Enzyme BSOSR6x07. # # # # ∇ 6. Not within expected values Month # # # # # # Low # # # # # # # # Month # # # # # # Low # # # # # # # # # High # # # # # # # # Panic Value Low # High # Unit U/L* Decimal Places # SERUM/PLASMA APPLICATION Parameters Calibrators General Parameters Calibrators General Test Name: ∇ Use Serum Cal. 7 Last Last 27 0 Hour ф 660 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 3* 1 1 3* 1 1 High B B 500* 0 0 High B B 0 500* 0 0 Hour Common Rgt.3 R2(R2-1) 25 µL High High 2. Volume R1(R1-1) R1-2 5 1 50 5 µL ∇ µL µL Sample Volume Pre-Dilution Rate Rgt. # # # # ∇ 7. # # # # ∇ 4. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check R1-2 340 ∇nm RATE ∇ ∇ 14 15 YES % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Common Rgt. For No.OD Reagent OD Limit First Low Last Low R2(R2-1) 25 µL Dilution 25 µL Name Sec. # # # # ∇ 4. For No. No demographics 8. # # # # ∇ 2. OSR6107. OSR6507 Reagent ID: 007 System Reagent: OSR6007.3 1. OSR6107. Not within expected values Decimal Places Calibration Specific ISE ALT ∇ < > Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ ∇ 14 Last Last 27 15 YES % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Parameters General Range LIH ALT ∇ < > ISE HbA1c Test Name: Parameters General Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Test Name: ALT ∇ < > Type: High # High # # # # # # # # Unit U/L* Panic Value Low # High # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1.OD 2.5 2.3 High High 2. OSR6507 ALT (IFCC. # # # # ∇ 7. with OSR60180 activation).ALT (IFCC.3 1.5 2.5 Max. # # # # ∇ 5.5 Sample Volume Pre-Dilution Rate Rgt. # # # # ∇ 3. AU680 Serum/Plasma Parameters General LIH ALT Dilution 1. BSOSR6x07. Enzyme .60 Reagent OD limit Fst.5 Sample vol. § OD CONC § Factor/OD-L §3650* § §3650* §5470* 1-Point Cal. No. H Lst. AU600 Paediatric Application Reagent ID: 007 Specific test parameters Serum 1 0.1 3* B 30 Linearity Fst No lag time NO Select using Space key. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Age Y Y Y Y Y Y L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name ALTP ∇ MB ∇ Y=AX+B OD ∇ Conc Count Process Factor/OD-L # ∇ Factor/OD-H PAEDIATRIC APPLICATION Calibration Specific General ISE Serum # Factor/OD-H §5470* Process: ∇ ∇ Test Name: ALTP ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: # ∇ Cal. OSR6107 Reagent ID: 007 Paediatric Application System Reagent: OSR6007. # # ∇ 3. # # ∇ 4. # # ∇ 6. without Pyridoxal phosphate activation). Reagent 1 vol Reagent 2 vol 10 100 50 Dil. vol Dil. refer to IFU for further instruction.5 2. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. vol Dil. H 500* Fst Fst 14 Lst Lst First H Last H 2. H Max OD H 2.1 Lst. L 1. OD L 0.5 Main 340 Sub 660 RATE 27 ∇ ∇ ∇ Fst. None Selected 8.60 1.02 2010-05 # User defined * Values set for working in U/L. vol 10 50 40 µL µL µL Max. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period 340 RATE First 14 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. OD H 2.ALT (IFCC. # # ∇ 2. Point: With CONC-0 Slope Check: None MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 ∇ § Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. L 1.5 2.1 1. ∇ ∇ ∇ Sec.5 2. OSR6107 Specific Test Parameters General LIH ISE Range Test Name: ALTP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 10 100 50 µL µL µL Dilution Dilution Dilution 10 50 40 µL µL µL Pri. To work in SI units (µkat/L) divide by 60 § For use in AB mode only.5 ∇ Operation: Yes ∇ Test No # Test name ALTP ∇ Sample type Ser ∇ Page 1/2 System Reagent: OSR6007. # # ∇ 7.1 Dynamic range L 3* Correlation factor % ∇ A 1 On-board stability period: 500* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range Test Name: ALTP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ∇ 5. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name ALTP ∇ Sample type Ser ∇ Level L # Page 2/2 Level H # 15 % Sec % ∇ 0 Sample Pre-dil. AU400/AU640 ALT (IFCC. without Pyridoxal phosphate activation). refer to IFU for further instruction. R2(R2-1) Name Sec. AU2700/AU5400 ALT (IFCC. Volume R1(R1-1) 5 1 50 µL ∇ µL Range ∇ Operation: Yes ∇ Test Name: ALTP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 5 50 25 µL µL µL Dilution Dilution Dilution 10 25 15 µL µL µL Pri.1 High High Max. None Selected 8. # # ∇ 3. No demographics 8.5 2.OD Dilution 25 µL Min. Not within expected values U/L* Decimal Places Calibration Specific ISE ALTP ∇ Test Name: < Month # # # # # # Panic Value Low # High # L U/L* H Panic Value: # # Month # # # # # # Low # # # # # # # # # PAEDIATRIC APPLICATION High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum ∇ Calibration Specific General ISE Type Serum # Process: ∇ ∇ Test Name: ALTP ∇ < > Calibration Type: MB ∇ Formula: Factor/OD-H §5470* Y=AX+B ∇ Counts: Use Serum Cal.60 Max OD H 2.1 3* B 30 Last Last 27 Sec.1 1. # # ∇ 4.ALT (IFCC. without Pyrioxal phosphate activation). To work in SI units (µkat/L) divide by 60 § For use in AB mode only. # # ∇ 2. # # # # ∇ 5.5 ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6007.1 1.60 1. No. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 15 YES % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General LIH ALTP ∇ < > ISE HbA1c Test Name: Specific Test Parameters Calculated Test Type: High # Serum ∇ Noneф 340 ∇nm RATE ∇ ∇ 14 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 500* 0 0 Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 340 RATE First 14 First 15 YES % ∇ A 1 On-board stability period: Specific Test Parameters General LIH ISE Serum # ∇ Range Test Name: ALTP ∇ < > Type: Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. AU680/AU480 Paediatric Application Reagent ID: 007 Parameters General LIH ALTP Dilution 0. # # ∇ 6.OD Reagent OD Limit First Low Last Low 10 µL OD Limit 2. without Pyridoxal phosphate activation). For No. § OD CONC § Factor/OD-L §3650* Counts: # ∇ ∇ Range Low High Slope Check §3650* §5470* Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. Cal. # # ∇ 7.5 Sample Volume Pre-Dilution Rate Rgt.5 2. Point: with CONC-0 Slope Check: None # Interval (RB/ACAL) Lot Calibration ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined * Values set for working in U/L. OSR6507 Specific Test Parameters General LIH ISE Serum 1 0. # # ∇ 5.5 Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: High B B 0 Common Rgt. Ф AU680 <Point Cal. OSR6107. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: # 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration ∇ with Conc-0 Day Day Hour Hour Enzyme BSOSR6x07. OSR6107. # # # # ∇ 4. # # # # ∇ 2.5 2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1.02 2010-05 . 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 3* 1 1 25 µL Dilution 15 µL ∇ ∇ ∇ 1. # # # # ∇ 7. # # # # ∇ 6. OSR6507 Reagent ID: 007 Paediatric Application Operation Yes ∇ System Reagent: OSR6007. refer to IFU for further instruction. # # # # ∇ 3. 660 ∇ First H Last H H 0 500* 2. ALT (IFCC.0 Reagent OD limit Fst. # # ∇ 4. vol Dil. § OD CONC § Factor/OD-L §3650* § §3650* §5470* 1-Point Cal. OSR6107 Reagent ID: 007 Paediatric Application System Reagent: OSR6007.02 2010-05 # User defined * Values set for working in U/L.3 1.3 3* B 7 Linearity Fst No lag time NO Select using Space key. L 1.5 Main 340 Sub 660 RATE 27 ∇ ∇ ∇ Fst. point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. # # ∇ 2. # # ∇ 6. # # ∇ 3. H Max OD H 2. refer to IFU for further instruction. AU600 Paediatric Application Reagent ID: 007 Specific test parameters Serum 1 1.0 1. with OE60106 activation). H 500* Fst Fst 14 Lst Lst First H Last H 2. Point: with CONC-0 Slope Check: None MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 ∇ § Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 2. Reagent 1 vol Reagent 2 vol 10 100 50 Dil. ∇ ∇ ∇ Sec. None Selected 8.5 Sample vol. # # ∇ 5. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name ALTP ∇ Sample type Ser ∇ Level L # Page 2/2 Level H # 15 % Sec % ∇ 0 Sample Pre-dil. OD L 1.3 Dynamic range L 3* Correlation factor % ∇ A 1 On-board stability period: 500* 1 0 ¤ 7 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range Test Name: ALTP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. refer to IFU for further instruction. Enzyme . OSR6107 Specific Test Parameters General LIH ISE Range Test Name: ALTP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 10 100 50 µL µL µL Dilution Dilution Dilution 10 50 40 µL µL µL Pri. AU400/AU640 ALT (IFCC. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. with OE60106 activation). BSOSR6x07. vol Dil. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period 340 RATE First 14 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. To work in SI units (µkat/L) divide by 60 § For use in AB mode only.5 2. No.3 Lst. # # ∇ 7. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Age Y Y Y Y Y Y L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name ALTP ∇ MB ∇ Y=AX+B OD ∇ Conc Count Process Factor/OD-L # ∇ Factor/OD-H PAEDIATRIC APPLICATION Calibration Specific General ISE Serum # Factor/OD-H §5470* Process: ∇ ∇ Test Name: ALTP ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: # ∇ Cal. vol 10 50 40 µL µL µL Max.5 ∇ Operation: Yes ∇ Test No # Test name ALTP ∇ Sample type Ser ∇ Page 1/2 System Reagent: OSR6007. OD H 2. L 1. H Lst.5 2. Point: with CONC-0 Slope Check: None MB Type Factor: # Calibration Stability Period: # User defined * Values set for working in U/L.3 3* B 7 0 H 500* First H Last H 2. § OD CONC § Factor/OD-L §3650* 1-Point Cal. Ф AU680 Enzyme BSOSR6x07. ∇ ∇ ∇ Sec. None Selected 8.5 ∇ Operation: Yes ∇ Range Test Name: ALTP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 5 50 25 µL µL µL Dilution Dilution Dilution 10 25 15 µL µL µL Pri. AU2700/AU5400 Reagent ID: 007 Paediatric Application System Reagent: OSR6007.5 2. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Panic Value: # # PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum # Factor/OD-H §5470* Process: ∇ ∇ Test Name: ALTP ∇ < > Calibration Type: MB ∇ Formula: Y=AX+B ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: # ∇ Cal. # # ∇ 4. No. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. # # ∇ 6. # # ∇ 7.ALT (IFCC. # # ∇ 2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 340 RATE First 14 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ A 1 On-board stability period: Specific Test Parameters General LIH ISE Serum # ∇ Range Test Name: ALTP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 Max OD H 2. # # ∇ 5.3 1.02 2010-05 . refer to IFU for further instruction. OSR6107.0 1. with OE60106 activation). OSR6507 Specific Test Parameters General LIH ISE Serum 1 1. # # ∇ 3. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: # 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration ∇ with Conc-0 Day Day Hour Hour MB Type Factor: # 1-Point Calibration Point ∇ Enzyme BSOSR6x07. # # # # ∇ 6. Calibration Specific Calibration Parameters STAT Table Calibration ISE Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ # ∇ Slope Check Allowance Range Check Reagent Blank Calibration None ∇ Use Serum Cal. No demographics 8. # # # # ∇ 2. OSR6507 ALT (IFCC. # # # # ∇ 7. AU680/AU480 Paediatric Application Reagent ID: 007 System Reagent: OSR6007.OD Reagent OD Limit First Low Last Low Max. # # # # ∇ 6. # # # # ∇ 5. OSR6507 Reagent ID: 007 System Reagent: OSR6007. No demographics 8. For No.OD Reagent OD Limit First Low Last Low Sample Volume Pre-Dilution Rate Rgt. # # # # ∇ 2.5 2. PAEDIATRIC APPLICATION Test Name: ALTP ∇ < > Type Y=AX+B None ∇ Counts: # ∇ ∇ Range Low High Slope Check §3650* §5470* Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Lot Calibration ∇ Range Low High §3650* §5470* Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Advanced Calibration Operation Interval (RB/ACAL) # ∇ # Lot Calibration ∇ Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal.OD Dilution Dilution Dilution # 660 15 µL 10 10 µL µL 10 µL OD Limit 2.3 1.5 2. 7 Last Last 27 0 Hour ф 660 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 3* 1 1 3* 1 1 High B B 500* 0 0 High B B 0 500* 0 0 Hour Common Rgt. with OE60106 activation).3 R2(R2-1) 25 µL High High 2. # # # # ∇ 4.OD 2.02 2010-05 .ALT (IFCC. AU680 Paediatric Parameters General LIH ALTP Dilution 1. Volume R1(R1-1) 5 1 50 10 µL OD Limit µL ∇ µL Dilution 25 µL R2(R2-1) 25 µL Dilution 15 µL Name Sec.0 1. Volume R1(R1-1) R1-2 5 1 50 5 µL ∇ µL µL Sample Volume Pre-Dilution Rate Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ ∇ 14 Last Last 27 15 YES % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Parameters General Range LIH ALTP ∇ < > ISE HbA1c Test Name: Parameters General Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Test Name: ALTP ∇ < > Type: High # High # # # # # # # # Unit U/L* Panic Value Low # High # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. Name Sec.3 High High Max. # # # # ∇ 3. For No.0 1. # # # # ∇ 7.5 Min. OSR6107.5 ∇ Type: Serum < > ∇ ISE HbA1c Range Specific Test Parameters Calculated Test Application Yes ∇ Parameters General Range Serum Test Name: ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: ALTP ∇ < > Type: Operation Operation Yes ∇ Dilution 1. Not within expected values Month # # # # # # Low # # # # # # # # # High # # # # # # # # Panic Value Low # High # Unit U/L* Decimal Places # Parameters Calibrators General Parameters Calibrators General Serum ∇ Use Serum Cal.5 2. # # # # ∇ 5.5 Min.3 1. # # # # ∇ 3. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check R1-2 340 ∇nm RATE ∇ ∇ 14 15 YES % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Common Rgt. OSR6107. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Day Day with Conc-0 Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration Hour Hour <Point Cal. with OSR60180 activation). Not within expected values Decimal Places Calibration Specific ISE ALTP ∇ Test Name: < Month # # # # # # Low # # # # # # # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. # # # # ∇ 4. 66300 for serum application and Urine calibrator Cat no. in the AB calibration mode.1. Haemolysed and strongly icteric samples should be avoided.. Specimen Serum. 5 Stable in serum and plasma for 7 days when stored at 2…25°C. Reagent blank measurement is recommended when changing to a new lot of reagent. renal insufficiency and diseases such as viral hepatitis. it is recommended that 5 separate calibration events should be used. To provide a robust approach to generate the analyser specific MB factor. up to the stated expiry date when stored at 2. [1. EC 3.3 Amylases are a group of hydrolases that split complex carbohydrates composed of alpha-D-glucose units linked through carbon atoms 1 and 4 located on adjacent glucose residues. 5 Stable in urine for 10 days when stored at 2…8°C and 2 days when stored at 15…25°C. sarcoidosis and trauma to the upper abdomen. utilising System Calibrator Cat No. oxalate and citrate should be avoided. 1 6 Urine: Timed or random sample. This substrate reacts directly with α-amylase and does not require the presence of ancillary enzymes. heparinised plasma. Adjust pH to approximately 7.2. Alpha amylase is excreted by glomerular filtration and then 50% of it is reabsorbed by the tubules. For the AU2700/AU5400 this procedure needs to be performed for each ring. should be used for each of these runs. Care should be taken when handling this reagent to avoid contamination with skin and body fluids. 4 x 10 mL 4 x 40 mL R1 R1 Summary1. in the presence of diabetic ketoacidosis and acute pancreatitis as well as proteinuria resulting in an increase of alpha-amylase clearance. ODC0025 for urine application. unopened. after burns. To avoid the possible build-up of azide compounds. Safety data sheet available for professional user on request. plasma and urine on Beckman Coulter analysers. parotitis. extensive destruction of the pancreas may not cause a significant increase in the plasma concentration of pancreatic alpha-amylase.4-α-D-glucan 4-glucanohydrolase. Reaction Principle CNPG3 + H2O α-amylase CNP + Maltotriose Contents. The release of 2-chloro-4-nitrophenol (CNP) from the substrate and the resulting absorbance increase at 410 nm is directly proportional to the α-amylase activity in the sample.1].2 mmol/L Potassium thiocyanate 253 mmol/L 1. Test Principle4 The α-amylase colour test employs 2-chloro-4-nitrophenyl-α-D-maltotrioside (CNPG3) as substrate.0 before storage.60 mmol/L NaCl 37. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced.1 mmol/L Calcium acetate 3.. Reagent Composition in the Test Final concentration of reactive ingredients: MES (pH 6. EN. There is also a detectable increase in amylase after an ERCP procedure. in human serum. Dispose of all waste material in accordance with local guidelines. The calibrator values are traceable to a Beckman Coulter master calibrator. abdominal typhoid.6 Plasma using EDTA. For in vitro diagnostic use only. 1. Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced. amylase is present in a number of organs and tissues.01 BLOSR6x06. amylase increases 5-6 hours after the onset of symptoms and remains elevated for 2-5 days. separate from blood cells as soon as possible. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. A fresh vial of calibrator. where the enzyme is synthesised by the acinar cells and then secreted into the intestinal tract by way of the pancreatic duct system. Hypoamylasemia has been observed in advanced cystic fibrosis. flush waste-pipes with water after the disposal of undiluted reagent. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice.2. Once open the reagent stored on board the instrument is stable for 30 days. alcoholism. The greatest concentration is present in the pancreas. Reagent Preparation The reagent is ready for use and can be placed directly on board the instrument.01 2009-08 Enzyme .8°C. Storage and Stability The reagent is stable. severe liver disease and pancreatectomy.α-AMYLASE OSR6006 OSR6106 Intended Use Kinetic colour test for the quantitative determination of α-amylase.63 mmol/L CNPG3 Preservative Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. The salivary glands also secrete a potent amylase to initiate hydrolysis of starches while the food is still in the mouth and oesophagus. This reabsorption is significantly reduced in transient tubular damage. Also due to the decreased concentration of the salivary fraction hypoamylasemia has been found in obese subjects. Diseases resulting in elevation of plasma alpha-amylase include: acute pancreatitis. In acute pancreatitis. Calibration The test is run in MB-mode. AIDS. Discard reagents if any discolouration is observed. The increase in plasma activity does not reflect disease severity and conversely. In the body.05) 36. The measurement of alpha amylase in urine is indicated in the investigation of hyperamylasemia associated with macroamylasemia or renal insufficiency. Clinical guide to laboratory tests.Quality Control Controls Cat. Frankfurt/Main: TH-Books Verlagsgesellschaft.13 494. Gella FJ. Method Comparison Patient serum samples were used to compare this α-Amylase OSR6106 assay on the AU600 against another commercially available α-amylase assay. For diagnostic purposes. IFCC methods for measurement of catalytic concentration of enzymes.63 140 1. Kachmar JF. EC 3.84 50. Schmitt Y.999 n = 112 Sample range = 11 – 1530 U/L Patient urine samples were used to compare this α-Amylase OSR6106 assay on the AU2700 against another commercially available α-amylase assay. n = 60 Within Run Total Mean U/L SD CV% SD CV% 45 0. 2005:51-56. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. eds. plasma and serum samples.3 µkat/L) for serum and plasma. Indikation und Bewertung von Laborbefunden für die Medizinische Diagnostik. 2. Moss DW.1.4-α-D-glucan 4-glucanohydrolase.94 3.067x – 4. Tietz textbook of clinical chemistry. Clin Chim Acta 1998. 7. The lowest detectable level represents the lowest measurable level of α-amylase that can be distinguished from zero.5 g/L haemoglobin ® Lipemia: Interference less than 5% up to 1000 mg/dL Intralipid Results of urine studies conducted to evaluate the susceptibility of the method to interference were as follows: Ascorbate: Interference less than 10% up to 50 mg/dL ascorbate Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin 8 Refer to Young for further information on interfering substances.1 3207. Henderson RA. Moss DW. Ballsells D. Labor und Diagnose.1 Rev.2:22.46pp.73 1. Biorad Liquichek Urine Chemistry Controls Cat. Calculation The Beckman Coulter analysers automatically compute the α-amylase activity of each sample. sample type. sex. Philadelphia:WB Saunders Company.97 1. 3 Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Enzymes.81 14.35 µkat/L) Urine Expected values may vary with age. Values obtained for the controls should fall within specified limits as defined by the user. ed.36 – 1. clinical examinations and other findings.82 1.1 – 80 µkat/L) for urine. Linearity The test is linear within an enzyme activity range of 10 – 2000 U/L (0. AACC Press. Clin Chim Acta. et al. No. Each laboratory should verify the transferability of the expected values to its own population. Ehret W. Good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. results should always be assessed in conjunction with the patient's medical history. Tietz NW. Ashwood ER. International Federation of Clinical Chemistry. 1999. 3. The test is linear within an enzyme activity range of 5 – 4800 U/L (0.63 CV% 4. ed.97 0.85 3. To work in SI units (µkat/L) divide by 60. 5. Philadelphia: WB Saunders Company.1995:47pp. review all operating parameters. 1987:393-396.84 The following data was obtained on an AU640 using 3 urine pools analysed over 20 days. Canalias F. Reference values for α-amylase in human serum and urine using 2-chloro-4-nitrophenyl-α-D-maltotrioside as substrate.69 1. Part 9.313 r = 0. diet and geographical location.80 4.51 2.81 28. 3rd ed.99 0. Each laboratory should establish its own control frequency. 4.689-698. Results of linear regression analysis were as follows: y = 0.01 2009-08 EN. Data obtained in your laboratory may differ from these values.88 1.39 3. α-Amylase.17 2. IFCC method for alpha-amylase [1.274:213–217. Results of linear regression analysis were as follows: y = 1.62 0. 1999. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days.281(1-2):S5-39. Töpfer G. Zawta B. refer to leaflet for further instruction Lorentz K. 6. No.01 .492 r = 0. Young DS.64 2. BIBLIOGRAPHY Enzyme BLOSR6x06.879x + 6. Heil W. User defined ¤ Analyser default value Values set for working in U/L. WHO/DIL/LAB/99. Reference Intervals Serum/Plasma 22 – 80 U/L (0. and if necessary determine its own reference interval according to good laboratory practice.58 101. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used for the serum/plasma application.2 – 33. Henderson RA.995 n = 125 Sample range = 18 – 339 U/L Interfering Substances Results of serum studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 20 mg/dL or 342 µmol/L bilirubin Haemolysis: Interference less than 10% up to 2.17 Sensitivity The lowest detectable level using serum settings on an AU600 analyser was calculated as 2 U/L. Philadelphia:WB Saunders Company. Gubern G. 2000. Fundamentals of clinical chemistry. n = 80 Within Run Total Mean U/L SD CV% SD 45. hrsg.2. The lowest detectable level using urine settings on an AU2700 analyser was calculated as 2 U/L. Setting Sheet Footnotes # * § 1. 5th ed. In: Burtis CA. 397 and 398 or other control materials with values determined by this Beckman Coulter system may be used for the urine application. In: Tietz NW. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.14 1562 12. Clinical Enzymology. 8.33 µkat/L) 7 42 – 321 U/L (0.12 0.1]. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. In: Thomas L. For use in AB mode only. Effects of drugs on clinical laboratory tests. Wisser H. If any trends or sudden shifts in values are detected.7 – 5. L -0. ∇ ∇ ∇ Sec. H Sample vol.2 ∇ # Test name AMY Sample type Ser Page ½ System Reagent: OSR6006. AU400/AU640 Serum/Plasma Reagent ID: 006 Specific test parameters Serum ∇ 1 -0. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ο ∇ 5. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. No. refer to leaflet for further instruction.1 Lst.1 Main ∇ ∇ ∇ 410 Sub -0. # # ο ∇ 3. # # ο ∇ 4. OD H ∇ Operation: Yes Test No ∇ 1. OD L -0. Vol Dil. AU600 Serum/Plasma Application System Reagent: OSR6006. # # ο ∇ 2.1 10* B 30 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil.2 0. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. H Lst. Vol 0 0 0 Max.1 -0. # # ο ∇ 6.01 2009-08 # User defined * Values set for working in U/L. Enzyme . None Selected 8.2 0.1 Dynamic range L 10* Correlation factor % ∇ 2000* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: AMY ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. OSR6106 Reagent ID: 006 Application AMYLASE.5 Fst. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name AMY ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §7120* # ∇ Factor/OD-H §10680* Calibration Specific General ISE Serum ∇ Process: ∇ # SERUM/PLASMA APPLICATION Test Name: Counts: AMY ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.2 480 RATE + 10 Max OD H 1. OSR6106 Specific Test Parameters General LIH ISE Range Test Name: AMY ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 200 0 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. refer to leaflet for further instruction. # # ο ∇ 7. Vol Dil. Reagent 1 vol Reagent 2 vol μL μL μL 2 200 0 Dil.AMYLASE.1 Reagent OD limit Fst. OD CONC Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ § § Factor/OD-L §7120* Factor/OD-H §10680* 1-Point Cal. L -0. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name AMY Sample type Ser ∇ On-board stability period 410 RATE + First 5 First 15 NO Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min.5 0. H 2000* Fst Fst 5 Lst Lst First H Last H 0. Point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. BSOSR6x06. 5 0. AU680/AU480 Serum/Plasma Application System Reagent: OSR6006.1 -0.1 -0.1 R2(R2-1) μL Name Sec. No. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. To work in SI units (µkat/L) divide by 60 For use in AB mode only. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank Day Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # * § ф User defined Values set for working in U/L. refer to leaflet for further instruction. OD CONC § § Factor/OD-L §7120* Factor/OD-H §10680* ∇ Range Low High §7120* §10680* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. ∇ # # # # ο 5. For No. ∇ ∇ ∇ 10* Sec. AU2700/AU5400 Serum/Plasma Reagent ID: 006 Parameters General LIH AMY ∇ Dilution μL -0.AMYLASE.1 -0. # # ο ∇ 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x06. ∇ # # # # ο 4. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 410 ∇nm RATE ∇ + ∇ 5 410 RATE + First 5 First 15 NO Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ ++++ ∇ +++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH AMY ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # AMY ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. AU680 <Point Cal. 480 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 10* 1 1 μL High B B 0 2000* 0 0 Hour 0 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. OSR6106 Specific Test Parameters General LIH ISE Serum ∇ 1 -0. # # ο ∇ 7.OD μL Min. # # ο ∇ 3.5 0. OSR6106 Reagent ID: 006 Application Operation Yes AMYLASE. ∇ # # # # ο 2. Volume R1(R1-1) μL ∇ μL 1. No demographics 8.2 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6006. Not within expected values U/L* Decimal Places Calibration Specific ISE AMY ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ ∇ Counts: # Process: SERUM/PLASMA APPLICATION Test Name: AMY ∇ < > Test Name: Use Serum Cal. # # ο ∇ 5. # # ο ∇ 6.6 160 0 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. None Selected 8. ∇ 7.2 0.2 0. # # ο ∇ 4. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 3.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 1.6 1 160 Test Name: Max OD H 1. ∇ # # # # ο 6.1 High High Max.1 -0.01 2009-08 .2 2000* B 30 Last Last 10 15 NO % ∇ AMY ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 1. BSOSR6x06. # # ο ∇ 3.5 0.AMYLASE. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # URINE APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name AMY ∇ MB ∇ Y=AX+B OD ∇ Conc Count Process # ∇ Calibration Specific General ISE Urine ∇ Process: ∇ # Test Name: Counts: AMY ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. OSR6106 Specific Test Parameters General LIH ISE Range Test Name: AMY ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 1 150 0 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.1 -0.5 Fst. point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. OD H ∇ Operation: Yes Test No ∇ 1. # # ο ∇ 7. # # ο ∇ 5. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.1 Reagent OD limit Fst. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. refer to leaflet for further instruction.2 480 RATE + 10 Max OD H 1. vol Dil. refer to leaflet for further instruction. OD CONC Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ § § Factor/OD-L §9300* Factor/OD-H §17300* § Factor/OD-L §9300* Factor/OD-H §17300* 1-Point Cal. AU600 Urine Application System Reagent: OSR6006. vol 0 0 0 Max. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name AMY Sample type Uri ∇ On-board stability period 410 RATE + First 5 First 15 NO Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min.2 ∇ # Test name AMY Sample type Uri Page 1/2 Reagent: OSR6006. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. L -0. ∇ ∇ ∇ Sec. AU400/AU640 Urine Reagent ID: 006 Specific test parameters Urine ∇ 1 -0. None Selected 8. L -0. Reagent 1 vol Reagent 2 vol μL μL μL 1 150 0 Dil.01 2009-08 # User defined * Values set for working in U/L. OSR6106 Reagent ID: 006 Application AMYLASE. OD L -0.1 Main ∇ ∇ ∇ 410 Sub -0. # # ο ∇ 6.1 Dynamic range L 5* Correlation factor % ∇ 4800* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Urine ∇ # Range Page 2/2 Level L # Level H # Test Name: AMY ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. H Lst. H Sample vol. vol Dil. Point: ο With CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 ∇ § Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. No.2 0. # # ο ∇ 4. # # ο ∇ 2. H 4800* Fst Fst 5 Lst Lst First H Last H 0.1 Lst.1 5* B 30 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil.2 0. Enzyme . 2 0.AMYLASE.1 -0.1 -0. OD CONC § § Factor/OD-L §9300* Factor/OD-H §17300* ∇ Range Low High §9300* §17300* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. ∇ # # # # ο 2. # # ο ∇ 3. ∇ # # # # ο 6.1 -0.2 4800* B 30 15 NO % ∇ AMY ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 1. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. None Selected 8. refer to leaflet for further instruction. ∇ ∇ ∇ 5* Sec. ∇ # # # # ο 4. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # URINE APPLICATION Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.2 0. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank Day Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined * Values set for working in U/L. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. AU680/AU480 Urine Application System Reagent: OSR6006. # # ο ∇ 6. AU2700/AU5400 Urine Reagent ID: 006 Parameters General LIH AMY ∇ Dilution μL -0.0 1 150 Test Name: Max OD H 1. # # ο ∇ 2. # # ο ∇ 7. Not within expected values U/L* Decimal Places Calibration Specific ISE AMY ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ # ο ∇ Calibration Specific General ISE Type Urine ∇ ∇ Counts: # Process: Test Name: AMY ∇ < > Test Name: Use Serum Cal. 480 Onboard Stability Period Last Last 10 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 5* 1 1 30 Day μL High B B 0 4800* 0 0 Hour 0 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.5 0.0 150 0 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.01 2009-08 . ∇ # # # # ο 5. ∇ # # # # ο 3. OSR6106 Reagent ID: 006 Application Operation Yes AMYLASE.5 0. No demographics 8. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x06. # # ο ∇ 5. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 410 ∇nm RATE ∇ + ∇ 5 410 RATE + First 5 First 15 NO Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Urine ∇ LIH AMY ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # AMY ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 -0.1 High High Max.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 1. ∇ 7. Volume R1(R1-1) μL ∇ μL 1.1 R2(R2-1) μL Name Sec. No. OSR6106 Specific Test Parameters General LIH ISE Urine ∇ 1 -0. For No.2 < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6006. ф AU680 <Point Cal.OD μL Min. # # ο ∇ 4. plasma and urine on Beckman Coulter analysers. The α-amylase colour test employs 4. There is also a detectable increase in amylase after an ERCP procedure. May cause sensitisation by skin contact. This material and its container must be disposed of as hazardous waste. Refer to Safety Data Sheets for further information. Exercise the normal precautions required for handling all laboratory reagents. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. Storage and Stability The reagents are stable.1]. Also due to the decreased concentration of the salivary fraction hypoamylasemia has been found in obese subjects. In the body. The increase of absorbance at 410 nm is directly proportional to the α-amylase activity in the sample.α-AMYLASE OSR6182 Intended Use Kinetic colour test for the quantitative determination of α-amylase. amylase increases 5-6h after the onset of symptoms and remains elevated for 2-5 days. EN. The salivary glands also secrete a potent amylase to initiate hydrolysis of starches while the food is still in the mouth and oesophagus.6-ethylidene(G7)-p-nitrophenyl(G1)-α-D-maltoheptaoside (ethylidene-G7PNP) as substrate. Hypoamylasemia has been observed in advanced cystic fibrosis.3 Amylases are a group of hydrolases that split complex carbohydrates composed of alpha-D-glucose units linked through carbon atoms 1 and 4 located on adjacent glucose residues. where the enzyme is synthesised by the acinar cells and then secreted into the intestinal tract by way of the pancreatic duct system. S24.01 2009-08 Enzyme .S37. severe liver disease and pancreatectomy. parotitis. For in vitro diagnostic use only. Alpha amylase is excreted by glomerular filtration and then 50% of it is reabsorbed by the tubules.8°C. renal insufficiency and diseases such as viral hepatitis. 5 Stable in urine for 10 days when stored at 2…8°C and 2 days when stored at 15…25°C.. in the presence of diabetic ketoacidosis and acute pancreatitis as well as proteinuria resulting in an increase of alpha-amylase clearance.2.2. The measurement of alpha amylase in urine is indicated in the investigation of hyperamylasemia associated with macroamylasemia or renal insufficiency. 1. 1 6 Urine: Timed or random sample. Discard reagents if any discolouration is observed. In acute pancreatitis.1. after burns. Specimen Serum or heparinised plasma. oxalate and citrate should be avoided. Test Principle4 Method based on the recommendations of the “International Federation of Clinical Chemistry” (IFCC). Reagent Composition in the Test Final concentration of reactive ingredients: HEPES buffer (pH 7. Diseases resulting in elevation of plasma alpha-amylase include: acute pancreatitis. extensive destruction of the pancreas may not cause a significant increase in the plasma concentration of pancreatic alpha-amylase. The increase in plasma activity does not reflect disease severity and conversely. sarcoidosis and trauma to the upper abdomen. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Care should be taken when handling this reagent to avoid contamination with skin and body fluids.S60. This reabsorption is significantly reduced in transient tubular damage.01 BLOSR6x82.4-α-D-glucan 4-glucanohydrolase.0 before storage. G = Glucose) α-amylase 2 ethylidene-G5 + 2 G2PNP + 2 ethylidene-G4 + 2 G3PNP + ethylidene-G3 + G4PNP 5PNP + 14G α-glucosidase Contents.6 Plasma using EDTA. AIDS.8 kU/L Precautions and Warnings R43. Adjust pH to approximately 7. Once open reagents stored on board the instrument are stable for 90 days. unopened.15) Sodium chloride Calcium chloride 4. abdominal typhoid.6-ethylidene-G7PNP α-Glucosidase Preservatives 50 mmol/L 70 mmol/L 1 mmol/L > 1.4 mmol/L ≥ 4. This substrate reacts with α-amylase and the fragments with α-glucosidase to give a 100% release of p-Nitrophenol (PNP). Dispose of all waste material in accordance with local guidelines. 5 Stable in serum and plasma for 7 days when stored at 2…25°C. alcoholism. Avoid contact with skin. The greatest concentration is present in the pancreas. [1. amylase is present in a number of organs and tissues. Wear suitable gloves. EC 3. 4 x 40 mL 4 x 10 mL R1 R2 Summary1. Reaction Principle (Simplified)4 5 ethylidene-G7PNP + 5H20 2 G2 PNP + 2 G3PNP + G4PNP + 14 H20 (PNP = p-Nitrophenol. in human serum.. up to the stated expiry date when stored at 2. Results of linear regression analysis were as follows: y = 0. in the AB calibration mode.38 0. sex. Biorad Liquichek Urine Chemistry Controls Cat.213 r = 1.55 12.46 – 1.27 1. For the AU2700/AU5400 this procedure needs to be performed for each ring. should be used for each of these runs. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used for the serum application. n = 80 Within Run Total Mean U/L SD CV% SD 51 0. diet and geographical location.66 µkat/L) ≤ 490 U/L (8.01 2009-08 EN.985x + 0. Quality Control Controls Cat. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Each laboratory should verify the transferability of the expected values to its own population.01 8 .2 – 25.50 µkat/L) or 380 U/g creatinine Expected values may vary with age. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.73 0.59 132 0.86 7. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced. and if necessary determine its own reference interval according to good laboratory practice. utilising System Calibrator Cat No. review all operating parameters. A fresh vial of calibrator. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 20 days.100 U/L (0. Calculation The Beckman Coulter analysers automatically compute the α-amylase activity of each sample. Reagent blank measurement is recommended when changing to a new lot of reagent. Data obtained in your laboratory may differ from these values. If any trends or sudden shifts in values are detected.34 1. Reference Intervals7 Serum/Plasma Urine Male Female 28 .16 1. 66300 for serum application and Urine calibrator Cat no. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Results of linear regression analysis were as follows: y = 1. The lowest detectable level using urine settings on an AU640 analyser was calculated as 2 U/L.0 µkat/L) for urine.41 3732 21.71 0. Enzyme BLOSR6x82. For diagnostic purposes. To provide a robust approach to generate the analyser specific MB factor.98 0.000 n = 116 Sample range = 30 – 1482 U/L Patient urine samples were used to compare this α-Amylase OSR6182 assay on the AU640 against another commercially available amylase assay.35 1.003x – 5.36 0.Calibration The test is run in MB-mode. Linearity The test is linear within an enzyme activity range of 10 – 1500 U/L (0.56 1.346 r = 1. it is recommended that 5 separate calibration events should be used.0 µkat/L) for serum and plasma. sample type.99 CV% 3. 397 and 398 or other control materials with values determined by this Beckman Coulter system may be used for the urine application. Method Comparison Patient serum samples were used to compare this α-Amylase OSR6182 assay on the AU640 against another commercially available amylase assay. ODC0025 for urine application. The calibrator values are traceable to a manual IFCC reference method and IRMM/IFCC-456. No.16 µkat/L) or 280 U/g creatinine ≤ 450 U/L (7.04 0. The lowest detectable level represents the lowest measurable level of α-amylase that can be distinguished from zero.94 The following data was obtained on an AU640 using 3 urine pools analysed over 20 days n = 80 Within Run Total Mean U/L SD CV% SD 46 0. clinical examinations and other findings.000 n = 98 Sample range = 18 – 4470 U/L Interfering Substances Results of serum studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 5 g/L haemoglobin ® Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid Results of urine studies conducted to evaluate the susceptibility of the method to interference were as follows: Ascorbate: Interference less than 5% up to 50 mg/dL ascorbate Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin Refer to Young for further information on interfering substances. The results obtained by any individual laboratory may vary from the given mean value. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.20 Sensitivity The lowest detectable level using serum settings on an AU640 analyser was calculated as 1 U/L.11 0. No.62 1. Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced or as deemed necessary by the user. results should always be assessed in conjunction with the patient's medical history. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems.82 1267 6.65 CV% 1.53 585 5. The test is linear within an enzyme activity range of 10 – 4800 U/L (0 – 80.57 44. 01 2009-08 Enzyme . For use in AB mode only. International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).1 Rev. 1999. Zawta B. Weittenhiller A. Tietz NW. User defined ¤ Analyser default value Values set for working in U/L. α-Amylase. Clin Chem Lab Med 1998.34:607–615. Committee on enzymes. Wortmann W. Moss DW. refer to leaflet for further instruction Lorentz K. 1987:393-396..36(3):185-203.Setting Sheet Footnotes # * § 1. Philadelphia: WB Saunders Company. 3. Henderson RA. ed. Labor und Diagnose. Fundamentals of clinical chemistry. Tietz textbook of clinical chemistry. In: Burtis CA. et al.4-αD-glucan 4-glucanohydrolase. Development and evaluation of assays for the determination of total and pancreatic amylase at 37°C according to the principle recommended by the IFCC. Philadelphia: WB Saunders Company. 2005:51-56. 46pp. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. AACC Press.2. Junge W. Clinical Enzymology.1). BIBLIOGRAPHY EN. EC 3. Heil W. Wilke B. 5th ed. Enzymes. WHO/DIL/LAB/99. Young DS. Wisser H. 689-692. 5. ed. hrsg. Waldenstrom J.1. plasma and serum samples. Effects of drugs on clinical laboratory tests. Part 9. 8. To work in SI units (µkat/L) divide by 60. IFCC method for α-amylase (1. Philadelphia:WB Saunders Company. Finke J. Schmitt Y.01 BLOSR6x82. Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. Lorentz K. 2000. Ashwood ER.1995:47pp. 4. Henderson RA. Klein G. Kachmar JF. Frankfurt/Main: TH-Books Verlagsgellschaft. Clin Biochem 2001. 6. 2. Töpfer G. In: Tietz NW. Moss DW. 7. 3rd ed. Ehret W.2:22. Indikation und Bewertung von Laborbefunden für die Medizinische Diagnostik. In: Thomas L. eds. Clinical guide to laboratory tests. . refer to IFU for further instruction Enzyme BSOSR6x82. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.AMYLASE (EPS Liquid).2 480 RATE + 27 Max OD H 2. § OD CONC § Factor/OD-L §5570* 1-Point Cal.1 Main ∇ ∇ ∇ 410 Sub -0.2 ∇ # Test name AMY Sample type Ser Page ½ System Reagent: OSR6182 Reagent ID: 082 Application AMYLASE (EPS Liquid). Point MB type factor Calibrator stability period # 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. H Lst.2 0. H 1500* Fst Fst 20 Lst Lst First H Last H 0. No. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. To work in SI units (µkat/L) divide by 60 § For use in AB mode only.0 Fst. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name AMY Sample type Ser ∇ On-board stability period 410 RATE + First 20 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. Vol 0 0 0 Max. OD H ∇ Operation: Yes Test No ∇ 2.1 Reagent OD limit Fst. refer to IFU for further instruction # User defined * Values set for working in U/L. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. L -0. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name AMY ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §5570* # ∇ Factor/OD-H §8360* Calibration Specific General ISE Type ∇ Process: ∇ Factor/OD-H §8360* Counts: # Serum SERUM/PLASMA APPLICATION Test Name: AMY ∇ < > Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: 999 # ∇ Cal. None Selected 8. H Sample vol. L -0. Vol Dil.1 -0.2 0. # # ο ∇ 7. AU400/AU640 Serum/Plasma Reagent ID: 082 Specific test parameters Serum ∇ 1 -0.1 10* B 90 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil. # # ο ∇ 2. ∇ ∇ ∇ Sec.1 Dynamic range L 10* Correlation factor % ∇ 1500* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: AMY ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 Lst.0 0. AU600 Serum/Plasma Application System Reagent: OSR6182 Specific Test Parameters General LIH ISE Range Test Name: AMY ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 4 200 50 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. Vol Dil. # # ο ∇ 4.01 2009-08 . # # ο ∇ 6. # # ο ∇ 3. OD L -0. Reagent 1 vol Reagent 2 vol μL μL μL 4 200 50 Dil. # # ο ∇ 5. # # ο ∇ 5. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. Volume R1(R1-1) μL ∇ μL 2 1 100 Test Name: Max OD H 2.1 -0. ∇ 7. None Selected 8. ∇ # # # # ο 6. AU680/AU480 Serum/Plasma Application System Reagent: OSR6182 Specific Test Parameters General LIH ISE Serum ∇ 1 -0.01 2009-08 .2 1500* B 90 Last Last 27 15 NO % ∇ AMY ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 2 100 25 μL μL μL Dilution Dilution Dilution 0 10 10 μL μL μL Pri. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x82. ∇ ∇ ∇ 10* Sec. ∇ # # # # ο 5. # # ο ∇ 4. ∇ # # # # ο 4.1 -0.OD μL Min. ∇ # # # # ο 2. No demographics 8.1 R2(R2-1) μL Name Sec. Not within expected values U/L* Decimal Places Calibration Specific ISE AMY ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High §6450* §9680* ∇ # ο ∇ SERUM/PLASMA APPLICATION Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H §9680* # Process: Test Name: AMY ∇ < > Test Name: Use Serum Cal. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined * Values set for working in U/L. No. AU2700/AU5400 Serum/Plasma Reagent ID: 082 Parameters General LIH AMY ∇ Dilution μL -0.0 0. ∇ # # # # ο 3. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. 480 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 10* 1 1 μL High B B 0 1500* 0 0 Hour 25 Dilution 10 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. # # ο ∇ 3.1 -0.1 High High Max. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.2 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6182 Reagent ID: 082 Application Operation Yes AMYLASE (EPS liquid). Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 410 ∇nm RATE ∇ + ∇ 20 410 RATE + First 20 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH AMY ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # AMY ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 -0.0 0. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. # # ο ∇ 7.2 0.OD Reagent OD Limit First Low Last Low Dilution 10 0 OD Limit 2. refer to IFU for further instruction ф AU680 <Point Cal. # # ο ∇ 6. § OD CONC § Factor/OD-L §6450* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: 999 ∇ # None ∇ 1-Point Cal. # # ο ∇ 2.AMYLASE (EPS liquid).2 0. L -0. H 4800* Fst Fst 20 Lst Lst First H Last H 0. OD L -0. # # ο ∇ 6.2 480 RATE + 27 Max OD H 2.1 Main ∇ ∇ ∇ 410 Sub -0. H Sample vol.0 Fst.1 Lst.01 2009-08 # User defined * Values set for working in U/L.0 0. Reagent 1 vol Reagent 2 vol μL μL μL 1. # # ο ∇ 7. § OD CONC § Factor/OD-L §10500* 1-Point Cal. L -0.5 150 38 Dil.2 0. point MB type factor Calibrator stability period # 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. vol Dil.1 -0.1 Dynamic range L 10* Correlation factor % ∇ 4800* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Urine ∇ # Range Page 2/2 Level L # Level H # Test Name: AMY ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. No.1 10* B 90 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil.AMYLASE (EPS Liquid). Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # URINE APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name AMY ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §10500* # ∇ Factor/OD-H §19500* Calibration Specific General ISE Urine ∇ Process: ∇ Factor/OD-H §19500* # Test Name: Counts: AMY ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal.2 ∇ # Test name AMY Sample type Uri Page 1/2 System Reagent: OSR6182 Reagent ID: 082 Application AMYLASE (EPS Liquid). OD H ∇ Operation: Yes Test No ∇ 2. AU400/AU640 Urine Reagent ID: 082 Specific test parameters Urine ∇ 1 -0. vol Dil. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. # # ο ∇ 3. refer to IFU for further instruction Enzyme .1 Reagent OD limit Fst. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. AU600 Urine Application System Reagent: OSR6182 Specific Test Parameters General LIH ISE Range Test Name: AMY ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 1.2 0. H Lst. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name AMY Sample type Uri ∇ On-board stability period 410 RATE + First 20 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. None Selected 8.5 150 38 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. # # ο ∇ 5. # # ο ∇ 4. refer to IFU for further instruction BSOSR6x82. # # ο ∇ 2. vol 0 0 0 Max. ∇ ∇ ∇ Sec. 0 100 25 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. AU2700/AU5400 Urine Reagent ID: 082 Parameters General LIH AMY ∇ Dilution μL -0.2 0. § OD CONC § Factor/OD-L §10500* Counts: # ∇ ∇ Factor Range Low High Slope Check §10500* §19500* Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. # # # # ο ∇ # # # # ο 4.0 1 100 Test Name: Max OD H 2. # # ο ∇ 6.1 High High Max. AU680/AU480 Urine Application System Reagent: OSR6182 Specific Test Parameters General LIH ISE Urine ∇ 1 -0. No demographics 8. # # ο ∇ 3. For No. 480 Onboard Stability Period Last Last 27 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 10* 1 1 90 Day μL High B B 0 4800* 0 0 Hour 25 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. Not within expected values U/L* Decimal Places Calibration Specific ISE AMY ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine ∇ ο Calibration Specific General ISE Type Urine ∇ ∇ Counts: Factor/OD-H §19500* # Process: Test Name: AMY ∇ < > Test Name: Use Serum Cal. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x82.2 0. # # ο ∇ 2. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. No. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. # # ο ∇ 5. Point: ο with CONC-0 Slope Check # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined * Values set for working in U/L.OD μL Min.0 0.1 -0. Volume R1(R1-1) μL ∇ μL 1. ∇ # # # # ο 5. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 410 ∇nm RATE ∇ + ∇ 20 410 RATE + First 20 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Urine ∇ LIH AMY ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # AMY ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.2 4800* B 90 15 NO % ∇ AMY ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 1. None Selected 8.2 < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6182 Reagent ID: 082 Application Operation Yes AMYLASE (EPS liquid).OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.1 -0. refer to IFU for further instruction ф AU680 <Point Cal. ∇ 3. # # ο ∇ 4.1 -0. ∇ ∇ ∇ 10* Sec. # # ο ∇ 7.1 -0.01 2009-08 .1 R2(R2-1) μL Name Sec. ∇ 7. ∇ # # # # ο 2.AMYLASE (EPS liquid).0 0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # URINE APPLICATION Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 6. AST levels may be increased in viral hepatitis and liver disease associated with hepatic necrosis.65 (37°C) L-aspartate 2-Oxoglutarate LDH MDH NADH Pyridoxal phosphate (P-5-P) Preservative 80 mmol/L 240 mmol/L 12 mmol/L ≥ 0.01 BLOSR6x09. 60106). kidneys. crushed muscle injuries and pulmonary emboli. progressive muscular dystrophy.9 kU/L ≥ 0. AST may be useful in monitoring the course of myocardial infarction. by mixing gently several times.AST OSR6009 OSR6109 OSR6209 OSR6509 OSR60180 60106 60100 Intended Use Kinetic UV test for the quantitative determination of aspartate aminotransferase. pancreas. with highest activities found in liver and skeletal muscle. No. lungs. OSR60180 for use with 3-part-reagent enabled systems only.01 2009-08 Enzyme . aspartate aminotransferase (AST) catalyses the transamination of aspartate and 2-oxoglutarate. of tablets OSR6009 0. Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer.1 (AST). usually involving necrosis.0 are indicative of severe liver disease.3 AST occurs in a wide variety of tissues including liver.20 mmol/L 0. and Pyridoxal Phosphate tablets (Cat. haemolytic disease. Alternatively. In some cases. Ratios >1. Measurement of AST is indicated in the diagnosis. salicylates or opiates. EC 2. Reaction Principle 2-Oxoglutarate + L-Aspartate Oxalacetate + NADH + H + AST MDH L-Glutamate + Oxalacetate L-Malate + NAD + Contents. In this method. myocardial infarction and skeletal muscle damage.1. Volume Pyridoxal Phosphate Liquid No. Endogenous pyruvate is removed by the LDH-reaction during the incubation period. and are particularly associated with diseases of an inflammatory nature. brain. Where recent myocardial infarction is suspected. flush waste-pipes with water after the disposal of undiluted reagent. Reagent Preparation With manual pyridoxal phosphate addition Pyridoxal Phosphate Liquid (Cat. Pipette Pyridoxal Phosphate Liquid 60106 into the R1 bottle according to the table below.6 kU/L 0.0 are indicative of mild liver damage. Increased AST levels may be detected in cirrhosis. pH 7. in human serum and plasma on Beckman Coulter analysers.25 mL 1 tablet OSR6109 1 mL 4 tablets OSR6209 2 mL 8 tablets OSR6509 4 mL 17 tablets EN. 4x 4x 4x 4x 4x 4x 4x 4x 4x 6x 4x 6 mL 6 mL 25 mL 25 mL 50 mL 50 mL 104 mL 104 mL 17 mL Liquid 4 mL Liquid 25 Tablets R1 R2 R1 R2 R1 R2 R1 R2 P-5-P R1-2 Pyridoxal Phosphate Pyridoxal Phosphate Summary1. acute pancreatitis. and mix by gentle inversion. Dispose of all waste material in accordance with local guidelines. Safety data sheet available for professional user on request. dermatomyositis. No. AST/ALT) is a useful indicator of liver damage. AST measurement may also be performed as part of medical screening examinations.6. The oxalacetate is reduced to L-malate by malate dehydrogenase (MDH). To avoid the possible build-up of azide compounds. with a diagnostic sensitivity of 86% at 12 hours after onset of chest pain. For in vitro diagnostic use only. Slight or moderate increases in AST levels may also be observed after ingestion of alcohol. while NADH is simultaneously converted to NAD+. extrahepatic cholestasis. Test Principle4 Method based on the recommendations of the “International Federation for Clinical Chemistry” (IFCC). forming L-glutamate and oxalacetate. The addition of pyridoxal phosphate to the reaction mixture ensures maximum catalytic activity of AST. Cat No.1 mmol/L (when Cat. AST has a diagnostic sensitivity of 96%. OSR6509 for the use on the AU2700 and AU5400 systems only. No. cardiac muscle. R2 is ready for use and can be placed directly on board the instrument. differentiation and monitoring of hepatobiliary disease. gangrene. The decrease in absorbance due to the consumption of NADH is measured at 340 nm and is proportional to the AST activity in the sample. or administration of drugs including penicillin. dissolve tablets completely in the R1 bottle according to the table below.2. erythrocytes and leucocytes. skeletal muscle. with 20 to 50 fold elevations frequently encountered. 60100) are supplied separately for pyridoxal phosphate activation. 60100 or OSR60180 is used) Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. This method can also be used for 3-part-reagent enabled systems. Ratios <1. The evaluation of AST activity in relation to ALT (De Ritis ratio. 60106. Storage and stability Once open. The results obtained by any individual laboratory may vary from the given mean value. Linearity The test is linear within an enzyme activity range of 3 – 1000 U/L (0.the calibrator value is traceable to a Beckman Coulter Master Calibrator. Reference Intervals6. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. should be used for each of these runs.42 0. sample type.01 2009-08 EN. Data obtained in your laboratory may differ from these values. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced. If any trends or sudden shifts in values are detected..25 µkat/L) Infant 15 − 60 U/L (0.05 – 16. Without pyridoxal phosphate activation Once open.01 .85 µkat/L) Female (Adult) < 35 U/L (0. n = 60 Within Run Total Mean U/L SD CV% SD 27 0. Enzyme BLOSR6x09. A fresh vial of calibrator. With pyridoxal phosphate activation After addition of pyridoxal phosphate. No.58 5.59 0.22 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 1 U/L.60 µkat/L) Newborn 25 − 75 U/L (0. To provide a robust approach to generate the analyser specific MB factor it is recommended that 5 separate calibration events should be used. up to the stated expiry date when stored at 2…8°C.. Pyridoxal Phosphate Liquid reagent is stable until the expiry date printed on the label.93 1. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. reagents stored on board the instrument are stable for 30 days. R1 stored on board the instrument is stable for 7 days. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Calculation The Beckman Coulter analysers automatically compute the AST activity of each sample. diet and geographical location. unopened. the cap is replaced immediately after use and the reagent is stored at 2…8°C. provided that contamination is avoided through adherence to GLP. Each laboratory should verify the transferability of the expected values to its own population. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. utilising System Calibrator Cat No.25 − 1 µkat/L) Expected values may vary with age.53 1. sex. R1 and R2 reagent stored on board the instrument are stable for 30 days. The lowest detectable level represents the lowest measurable level of AST that can be distinguished from zero. The reagent is ready for use and can be placed directly on board the instrument in the R1 carousel.23 1. With pyridoxal phosphate activation the calibrator value is traceable to the IFCC reference method.7 µkat/L). No. Storage and Stability Reagents are stable. Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.16 71 0. review all operating parameters. 5 Calibration The test is run in MB-mode. Haemolysed samples should be avoided as the concentration of AST in erythrocytes is approximately 15 times higher than that of normal serum. Without pyridoxal phosphate activation.05 CV% 4. Specimen Test Procedure Serum and heparinised plasma: Stable in serum for 7 days when stored at 2…8°C and 4 days when stored at 15.84 0. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used.Without pyridoxal phosphate activation The reagents are ready for use and can be placed directly on board the instrument. For diagnostic purposes.25°C.7 Male (Adult) < 50 U/L (0. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. and if necessary determine its own reference interval according to good laboratory practice. OSR60180) is specifically for use on board 3-part-reagent enabled systems. P-5-P (Cat no OSR60180) is stable on board the instrument for 60 days.35 1. The paediatric application is suitable for use with small volume serum/plasma samples. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. 3-part-reagent enabled systems with P-5-P activation Reagent Preparation P-5-P Liquid (Cat. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. clinical examinations and other findings. results should always be assessed in conjunction with the patient's medical history. R1 and R2 are also ready for use and can be placed directly on board the instrument. Quality Control Controls Cat. For the AU2700/AU5400 this procedure needs to be performed for each ring. Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced. R2 stored on board the instrument is stable for 30 days. 66300 in the AB calibration mode.42 − 1.95 415 2. Pyridoxal Phosphate Liquid reagent (Cat no 60106) Once open. Reagent blank measurement is recommended when changing to a new lot of reagent. Plasma and Serum Samples. 8. In:Thomas L. Enzymes. User defined ¤ Analyser default value Values set for working in U/L.1 Rev. ed.29:301-08. Bonora R. Schumann G et al. refer to leaflet for further instruction Thomas L.40:725–733. 7. Diagnosis of icteric diseases. 8 Limitations Highly lipemic samples may exceed the reaction absorbance and will be flagged with a “@”. Müller M. 1999. ed. Schumann G. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37°C.2:23pp. Results of linear regression analysis were as follows: y = 1. Ashwood ER. Painter PC. Philadelphia:WB Saunders Company. Clinical laboratory diagnostics. Setting Sheet Footnotes # * § 1. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. Use and assessment of clinical laboratory results. 3.1802pp. Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood. Heil W. Fundamentals of clinical chemistry. Reference Procedure for the Measurement of Catalytic Concentration of Aspartate Aminotransferase. Schmidt FW. Reference information for the clinical laboratory. Aspartate aminotransferase (AST). Ceriotti F et al. BIBLIOGRAPHY EN.Method Comparison with pyridoxal phosphate activation Patient serum samples were used to compare this AST OSR6109 assay on the AU640 against the IFCC reference method. Clin Chem Lab Med 2002. Part 5. et al.997 n = 112 Sample range = 9 – 250 U/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin ® Lipemia: Interference less than 5% up to 300 mg/dL Intralipid Pyruvate: Interference less than 10% up to 1 mmol/L pyruvate Refer to Young for further information on interfering substances.01 BLOSR6x09.0. 2000. 2. 5th ed.109:139-146. Wisser H. J Lab Med 2005. 1987:369-373. To work in SI units (µkat/L) divide by 60. WHO/DIL/LAB/99. Thomas L. Tietz textbook of clinical chemistry. Effects of drugs on clinical laboratory tests. Schmidt E. Cope JY. Such samples should be diluted and re-run. eds.01 2009-08 Enzyme . 5.2 r = 0. 1998:55-65. Moss DW. For use in AB mode only. Schmitt Y. Alanine aminotransferase (ALT). Smith JL. In: Tietz NW. Philadelphia:WB Saunders Company. Zawta B. 6. Töpfer G. Frankfurt/Main: TH-Books Verlagsgesellschaft. In: Burtis CA. Dtsch Med Wschr 1984.032x . Kachmar JF. AACC Press. 4. Young DS. Henderson RA. Ehret W. . without Pyridoxal phosphate activation). # # ∇ 5. Point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. # # ∇ 2. OSR6109.60 Reagent OD limit: First L 1.5 2.1 Last L 1. H 10 50 50 Dil.5 2. # # ∇ 3. AU400/AU640 AST (IFCC. OSR6209 Specific Test Parameters General LIH ISE Range Test Name: AST ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 10 50 50 µL µL µL Dilution Dilution Dilution 0 50 100 µL µL µL Pri. None Selected 8. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Select using Space key. BSOSR6x09. OD H ∇ Operation: Yes ∇ Test No # Test name AST ∇ Sample type Ser ∇ Page 2. L 1. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. refer to leaflet for further instruction. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name AST ∇ MB ∇ Y=AX+B OD ∇ Conc Count Process Factor/OD-L # ∇ Factor/OD-H SERUM/PLASMA APPLICATION Calibration Specific General ISE Serum # Factor/OD-H Process: ∇ ∇ Test Name: Counts: AST ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. Vol Dil.5 ½ System Reagent: OSR6009. OSR6209 Reagent ID: 009 Serum/Plasma Application System Reagent: OSR6009. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name AST ∇ Sample type Ser 340 RATE First 14 First 15 YES Last Last 27 % ∇ Pre-Dilution Rate: 1 Min OD L 0. Reagent 1 vol Reagent 2 vol Fst. OD L 0. No. # # ∇ 6. without Pyridoxal phosphate activation).1 Lst. 14 Lst Lst Main 340 Sub 660 RATE 27 ∇ ∇ ∇ First H Last H H Sample vol.5 1000* B 30 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Fst Fst Sample Pre-dil. refer to IFU for further instruction. AU600 Serum/Plasma Application Reagent ID: 009 Specific test parameters Serum Max OD H 2. ∇ ∇ ∇ Sec.AST (IFCC. # # ∇ 7. L 1.02 2010-05 # User defined * Values set for working in U/L. Vol Dil. Vol 0 50 100 µL µL µL Max.5 2. # # ∇ 4.1 Dynamic Range: L 3* Correlation Factor: A 1 On-board stability period: Wave Method Reaction Point 1 Point 2 H A B Rate On-board stability period Min. OD CONC Factor/OD-L Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: § § §3650* §5470* § §3650* §5470* 1-Point Cal. OSR6109.5 2.60 Reagent OD limit Fst. H Lst. Point: With CONC-0 Slope Check: None ∇ Advanced Calibration: # ∇ MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 ∇ § Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.1 Dynamic range L 3* Correlation factor 1000* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range ∇ Level L # Age Y Y Y Y Y Y Page 2/2 Level H # Test Name: AST ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Enzyme . # # ∇ 5. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # U/L* Month # # # # # # L U/L* H Month # # # # # # Panic Value Low # High # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. # # # # ∇ 6. # # ∇ 7. None Selected 8. # # # # ∇ 7.5 2. # # # # ∇ 2. # # # # ∇ 3. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. Volume R1(R1-1) Min. # # ∇ 3. § OD CONC § Factor/OD-L §3650* Counts: # ∇ ∇ Range Low High Slope Check §3650* §5470* Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation None ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ 1-Point Cal. OSR6209.1 3* B 30 15 YES % ∇ Last Last 27 Test Name: Max OD H 2. Refer to IFU for further instruction ф AU680 <Point Cal.5 1000* 0 Name Sec.OD Reagent OD Limit First Low Last Low 5 1 25 µL ∇ µL AST ∇ Operation: Yes < > Type: ∇ ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 5 25 25 µL µL µL Dilution Dilution Dilution 0 25 50 µL µL µL Pri. Not within expected values Decimal Places Calibration Specific ISE Test Name: AST ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum ∇ Calibration Specific General ISE Type Serum Counts: Factor/OD-H §5470* # Process: ∇ ∇ SERUM/PLASMA APPLICATION Test Name: AST ∇ < > Use Serum Cal.5 ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test AST (IFCC.1 1. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: # 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration ∇ with Conc-0 Day Day Hour Hour Enzyme BSOSR6x09. AU680/AU480 Serum/Plasma Application System Reagent: OSR6009. No. OSR6209.OD Dilution 25 µL 0 µL OD Limit 2. OSR6109.AST (IFCC. No demographics 8. AU2700/AU5400 System Reagent: OSR6009.1 High High Max.5 2. ∇ ∇ ∇ Noneф 340 ∇nm RATE ∇ ∇ 14 Sec.1 1. 660 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A R2(R2-1) 25 µL Dilution 50 µL 3* 1 1 30 Day # ∇ +++++ ∇ +++++ ∇ + ∇ High B B 0 Sample Volume Pre-Dilution Rate Rgt. without Pyridoxal phosphate activation).02 2010-05 . Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Parameters General LIH AST ∇ < > ISE HbA1c Test Name: 340 RATE First 14 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 1000* 0 0 Hour % ∇ Specific Test Parameters General LIH ISE Serum # ∇ Range Test Name: AST ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. OSR6109. OSR6509 Specific Test Parameters General LIH ISE Operation Yes ∇ Range Serum 1 0.60 1. # # # # ∇ 4. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.5 2. For No. # # ∇ 4. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. # # # # ∇ 5.60 1. without Pyridoxal phosphate activation). # # ∇ 2.5 2. OSR6509 Reagent ID: 009 Serum/Plasma Application Reagent ID: 009 Parameters General LIH AST Dilution 0. # # ∇ 6. Point: with CONC-0 Slope Check: # Interval (RB/ACAL) Lot Calibration ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined * Values set for working in U/L. vol 0 50 100 µL µL µL Max.0 Reagent OD limit Fst. OD H ∇ Operation: Yes ∇ # Test name AST ∇ Sample type Ser ∇ Page 1/2 2. with OE60106 activation). None Selected 8. H Sample vol. vol Dil.5 Fst. OSR6209 Serum/Plasma Application Reagent ID: 009 System Reagent: OSR6009. # # ∇ 5. AU600 Application Reagent ID: 009 Specific test parameters Test No Serum 1 1. ∇ ∇ ∇ Sec.5 Wave Method Reaction Point 1 Point 2 660 RATE 27 ∇ ∇ ∇ Max OD H 2. 14 Lst Lst First H Last H 2. OD L 1. refer to IFU for further instruction. 660 ∇ Min. Reagent 1 vol Reagent 2 vol 10 50 50 Dil. L 1. Point: with CONC-0 Slope Check: None ∇ Advanced Calibration: # ∇ # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. # # ∇ 3. L 1. OSR6209 Specific Test Parameters General LIH ISE Range Test Name: AST ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 10 50 50 µL µL µL Dilution Dilution Dilution 0 50 100 µL µL µL Pri. BSOSR6x09.5 2. H Lst.3 Dynamic range L 3* Correlation factor H A B Rate Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. OSR6109.AST (IFCC. with OE60106 activation). To work in SI units (µkat/L) divide by 60 § For use in AB mode only.3 3* B 7 NO Linearity Fst No lag time 15 % Sec % ∇ 0 H 1000* Fst Fst Sample Pre-dil.5 System Reagent: OSR6009. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name AST ∇ MB ∇ Y=AX+B OD ∇ Conc Count Process Factor/OD-L # ∇ Factor/OD-H Calibration Specific General ISE Serum # Factor/OD-H Process: ∇ ∇ SERUM/PLASMA APPLICATION Test Name: Counts: AST ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. # # ∇ 7. AU400/AU640 Serum/Plasma AST (IFCC. # # ∇ 6. refer to IFU for further instruction.3 Lst.5 2. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name AST ∇ Sample type Ser 340 RATE First 14 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: On-board stability period 1000* 1 0 ¤ % ∇ 7 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range ∇ Level L # Age Y Y Y Y Y Y Page 2/2 Level H # Test Name: AST ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.0 Main 340 Sub 1. vol Dil.3 1. # # ∇ 2. Enzyme .5 2. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. No. point MB type factor Calibrator stability period # User defined * Values set for working in U/L. OSR6109.02 2010-05 MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 ∇ § Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. OD CONC Factor/OD-L Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: § § §3650* §5470* § §3650* §5470* 1-Point Cal. # # ∇ 4. 5 ∇ Operation: Yes ∇ Range Test Name: AST ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 5 25 25 µL µL µL Dilution Dilution Dilution 0 25 50 µL µL µL Pri. ∇ ∇ ∇ Sec. Refer to IFU for further instruction ф AU680 Enzyme BSOSR6x09. § OD CONC § Factor/OD-L §3650* 1-Point Cal. # # ∇ 4. # # ∇ 3.5 2.3 3* B 7 0 H 1000* First H Last H 2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 340 RATE First 14 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Serum # ∇ Range Test Name: AST ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.0 1. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. # # ∇ 2.02 2010-05 .5 Max OD H 2. No.3 1. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Panic Value: # # Calibration Specific General ISE Type Serum Counts: Factor/OD-H §5470* # Process: ∇ ∇ SERUM/PLASMA APPLICATION Test Name: AST ∇ < > Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal. None Selected 8. AU2700/AU5400 Serum/Plasma Reagent ID: 009 Application System Reagent: OSR6009. # # ∇ 6.AST (IFCC. # # ∇ 7. Point: with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: # User defined * Values set for working in U/L. OSR6109. OSR6209. # # ∇ 5. with OE60106 activation). OSR6509 Specific Test Parameters General LIH ISE Serum 1 1. # # # # ∇ 7.OD 2. Volume R1(R1-1) 5 1 25 0 µL Sample Volume Pre-Dilution Rate Rgt. # # # # ∇ 3. OSR6109. Not within expected values Month # # # # # # Low # # # # # # # # # High # # # # # # # # Panic Value Low # High # Unit U/L* Decimal Places # Parameters Calibrators General ∇ Use Serum Cal. For No. # # # # ∇ 4. # # # # ∇ 7. # # # # ∇ 3.0 1. Calibration Specific Calibration Parameters STAT Table Calibration Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum ∇ Use Serum Cal.3 1. OSR6509 Reagent ID: 009 AST (IFCC. # # # # ∇ 6. OSR6209. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 7 Day # ∇ +++++ ∇ +++++ ∇ + ∇ 15 YES % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 340 ∇nm RATE ∇ ∇ 14 Name Sec. # # # # ∇ 4. OSR6109. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: # 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration ∇ with Conc-0 Day Day Hour Hour MB Type Factor: # 1-Point Calibration Point ∇ with Conc-0 Enzyme BSOSR6x09. # # # # ∇ 5. No demographics 8.5 Max.3 1. Volume R1(R1-1) R1-2 5 1 25 5 OD Limit µL ∇ µL Dilution 25 µL Min.OD Dilution Dilution Dilution Name Sec.5 2. ISE Parameters Calibrators General Test Name: AST ∇ < > Type Serum SERUM/PLASMA APPLICATION Y=AX+B None ∇ Counts: # ∇ ∇ Range Low High Slope Check §3650* §5470* Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Lot Calibration Counts: # ∇ ∇ Range Low High Slope Check §3650* §5470* Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Interval (RB/ACAL) None ∇ # ∇ # Lot Calibration ∇ Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal. # # # # ∇ 2.5 Min.02 2010-05 .0 1. No demographics 8. AU680/AU480 Serum/Plasma Application Reagent ID: 009 System Reagent: OSR6009.3 R2(R2-1) 3* 1 1 0 Last Last 27 Hour High B B 1000* 0 0 25 µL High High 2. For No. Dynamic Range Low ф Correlation Factor A 660 ∇nm Factor for Maker A Last Last 27 R1-2 340 ∇nm RATE ∇ ∇ 14 15 YES % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 30 Day # ∇ +++++ ∇ +++++ ∇ + ∇ Parameters General Range Test Name: AST ∇ < > LIH ISE HbA1c Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Parameters General Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Test Name: AST ∇ < > Type: High # High # # # # # # # # Unit U/L* Panic Value Low # High # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. 660 # Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 3* 1 1 50 µL High B B 0 1000* 0 0 Hour 10 10 µL µL 0 µL OD Limit 2. with OSR60180 activation ).OD Reagent OD Limit First Low Last Low µL ∇ µL µL R2(R2-1) 25 µL Dilution 50 µL Common Rgt.5 2. # # # # ∇ 6. OSR6209.5 2. # # # # ∇ 5. # # # # ∇ 2. with OE60106 activation ).3 High High Max.AST (IFCC.5 ∇ Type: Serum < > ∇ ISE HbA1c Range ∇ Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6009.OD Reagent OD Limit First Low Last Low Sample Volume Pre-Dilution Rate Rgt. AU680 Serum/Plasma Application Range Parameters General LIH AST Dilution 1. OSR6509 Parameters General Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: AST ∇ < > Type: Operation Yes Operation Yes ∇ Dilution 1. Not within expected values Decimal Places Calibration Specific ISE AST ∇ Test Name: < Month # # # # # # Low # # # # # # # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Day Day Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration Hour Hour <Point Cal. OD L 0. H First H Last H H Sample vol.60 Reagent OD limit: First L 1. AU400/AU640 AST (IFCC. No.5 2. # # ∇ 3. refer to IFU for further instruction.1 Dynamic range L 3* Correlation factor 1000* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range Test Name: ASTP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.AST (IFCC.60 Reagent OD limit Fst. OSR6109. L 1. without Pyridoxal phosphate activation). Vol Dil. refer to IFU for further instruction. Enzyme .1 Lst. L 1. Reagent 1 vol Reagent 2 vol 10 50 50 Dil. OSR6109. Point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L.1 Last L 1. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Age Y Y Y Y Y Y L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name ASTP ∇ MB ∇ Y=AX+B OD ∇ Conc Count Process Factor/OD-L # ∇ Factor/OD-H PAEDIATRIC APPLICATION Calibration Specific General ISE Serum # Factor/OD-H Process: ∇ ∇ Test Name: ASTP ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Counts: Cal. OD H 2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period 340 RATE First 14 First 15 YES Last Last 27 % ∇ Pre-Dilution Rate: 1 Min OD L 0. # # ∇ 4. OD CONC Factor/OD-L Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: § § §3650* §5470* § §3650* §5470* 1-Point Cal.5 2. H Lst. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name ASTP ∇ Sample type Ser ∇ Level L # Page 2/2 Level H # 15 % Sec % ∇ 0 Sample Pre-dil. ∇ ∇ ∇ Sec. OSR6209 Reagent ID: 009 Paediatric Application System Reagent: OSR6009. # # ∇ 5. None Selected 8.5 1000* B 30 Linearity Fst No lag time NO Select using Space key. Vol Dil.1 Dynamic Range: L 3* Correlation Factor: A 1 On-board stability period: Wave Method Reaction Point 1 Point 2 H A B Rate Min. # # ∇ 7.02 2010-05 # User defined * Values set for working in U/L. AU600 Paediatric Application Reagent ID: 009 Specific test parameters Serum Max OD H 2. without Pyridoxal phosphate activation). Point: with CONC-0 Slope Check: None ∇ Advanced Calibration: # ∇ MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 ∇ § Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ∇ 2. BSOSR6x09.5 2. OSR6209 Specific Test Parameters General LIH ISE Range Test Name: ASTP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 10 50 50 µL µL µL Dilution Dilution Dilution 10 50 90 µL µL µL Pri. Fst Fst 14 Lst Lst Main 340 Sub 660 RATE 27 ∇ ∇ ∇ Fst. Vol 10 50 90 µL µL µL Max. # # ∇ 6. To work in SI units (µkat/L) divide by 60 § For use in AB mode only.5 2.5 ∇ Operation: Yes ∇ Test No # Test name ASTP ∇ Sample type Ser Page ∇ ½ System Reagent: OSR6009. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: # 1-Point Calibration Point ∇ with Conc-0 ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined * Values set for working in U/L.5 2. For No.AST (IFCC. AU2700/AU5400 System Reagent: OSR6009. Volume R1(R1-1) 5 1 25 µL ∇ µL ASTP ∇ Operation: Yes < > Type: ∇ ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 5 25 25 µL µL µL Dilution Dilution Dilution 10 25 40 µL µL µL Pri. OSR6509 Reagent ID: 009 Paediatric Application Reagent ID: 009 Parameters General LIH ASTP Dilution 0. # # ∇ 5. # # # # ∇ 4. OSR6209.1 High High Max. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Test Name: Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # L U/L* H Month # # # # # # Panic Value Low # High # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. Not within expected values U/L* Decimal Places Calibration Specific ISE ASTP ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum # Factor/OD-H §5470* Process: ∇ ∇ Test Name: ASTP ∇ < > Use Serum Cal. No demographics 8.02 2010-05 . Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ ∇ 14 1000* 0 0 Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 340 RATE First 14 First 15 YES % ∇ A 1 On-board stability period: Specific Test Parameters General LIH ISE Serum LIH ASTP ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # ASTP ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.OD Reagent OD Limit First Low Last Low 10 µL OD Limit 2. ∇ ∇ ∇ 3* Sec.5 1000* B 30 Last Last 27 15 YES % ∇ Name Sec. # # ∇ 4. AU680/AU480 Paediatric Application System Reagent: OSR6009. OSR6109. # # ∇ 6. # # # # ∇ 6. # # ∇ 7.5 ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test AST (IFCC. # # # # ∇ 5. § OD CONC § Factor/OD-L §3650* Counts: # ∇ ∇ Range Low High Slope Check §3650* §5470* Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. without Pyridoxal phosphate activation). Refer to IFU for further instruction ф AU680 Day Day Hour Hour Enzyme BSOSR6x09. None Selected 8. # # # # ∇ 2.5 2.OD Dilution 25 µL Min.1 R2(R2-1) ф 660 25 µL Dilution 40 µL Test Name: Max OD H 2. without Pyridoxal phosphate activation). OSR6509 Specific Test Parameters General LIH ISE Operation Yes ∇ Range Serum 1 0. # # ∇ 2.60 1.5 2. # # # # ∇ 3. No.1 1.60 1. OSR6109. # # # # ∇ 7. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. Point: with CONC-0 Slope Check: None # ∇ # Lot Calibration Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration <Point Cal. Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 3* 1 1 30 Day # ∇ +++++ ∇ +++++ ∇ + ∇ Sample Volume Pre-Dilution Rate Rgt. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Counts: Cal.5 2. OSR6209. # # ∇ 3. 660 ∇ Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: High B B 0 Common Rgt.1 1. refer to IFU for further instruction.5 Main 340 Sub 660 RATE 27 ∇ ∇ ∇ Fst. OSR6109.5 Sample vol. None Selected 8. # # ∇ 5.AST (IFCC. OD L 1.3 Dynamic range L 3* Correlation factor % ∇ A 1 On-board stability period: 1000* 1 0 ¤ 7 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range Test Name: ASTP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ∇ 6. vol Dil. Reagent 1 vol Reagent 2 vol 10 50 50 Dil. vol 10 50 90 µL µL µL Max.5 2.02 2010-05 # User defined * Values set for working in U/L. # # ∇ 7. H 1000* Fst Fst 14 Lst Lst First H Last H 2. OSR6209 Reagent ID: 009 Paediatric Application System Reagent: OSR6009. # # ∇ 4.3 1. with OE60106 activation).0 Reagent OD limit Fst. refer to IFU for further instruction. L 1.5 2. with OE60106 activation). To work in SI units (µkat/L) divide by 60 § For use in AB mode only. # # ∇ 3. ∇ ∇ ∇ Sec. OSR6209 Specific Test Parameters General LIH ISE Range Test Name: ASTP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 10 50 50 µL µL µL Dilution Dilution Dilution 10 50 90 µL µL µL Pri. H Lst.0 1. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Age Y Y Y Y Y Y L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name ASTP ∇ MB ∇ Y=AX+B OD ∇ Conc Count Process Factor/OD-L # ∇ Factor/OD-H PAEDIATRIC APPLICATION Calibration Specific General ISE Serum # Factor/OD-H Process: ∇ ∇ Test Name: ASTP ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Counts: Cal.3 Lst. AU600 Paediatric Application Reagent ID: 009 Specific test parameters Serum 1 1.5 ∇ Operation: Yes ∇ Test No # Test name ASTP ∇ Sample type Ser ∇ Page 1/2 System Reagent: OSR6009. BSOSR6x09. H Max OD H 2. OSR6109. AU400/AU640 AST (IFCC. OD CONC Factor/OD-L Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: § § §3650* §5470* § §3650* §5470* 1-Point Cal. L 1. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name ASTP ∇ Sample type Ser ∇ Level L # Page 2/2 Level H # 15 % Sec % ∇ 0 Sample Pre-dil. vol Dil. point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L.3 3* B 7 Linearity Fst No lag time NO Select using Space key. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period 340 RATE First 14 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. # # ∇ 2. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. No.5 2. Enzyme . OD H 2. Point: with CONC-0 Slope Check: None ∇ Advanced Calibration: # ∇ MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 ∇ § Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. AU2700/AU5400 Reagent ID: 009 Paediatric Application System Reagent: OSR6009. OSR6209.AST (IFCC. OSR6509 Specific Test Parameters General LIH ISE Serum 1 1. # # ∇ 5. Point: with CONC-0 Slope Check: None MB Type Factor: # Calibration Stability Period: # User defined * Values set for working in U/L.0 1. ∇ ∇ ∇ Sec. Refer to IFU for further instruction ф AU680 Enzyme BSOSR6x09. # # ∇ 4.5 2. # # ∇ 7. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 340 RATE First 14 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ A 1 On-board stability period: Specific Test Parameters General LIH ISE Serum # ∇ Range Test Name: ASTP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ∇ 2.02 2010-05 .5 ∇ Operation: Yes ∇ Range Test Name: ASTP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 5 25 25 µL µL µL Dilution Dilution Dilution 10 25 40 µL µL µL Pri.5 Max OD H 2. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Panic Value: # # PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum # Factor/OD-H §5470* Process: ∇ ∇ Test Name: ASTP ∇ < > Calibration Type: MB ∇ Formula: Y=AX+B ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: Advanced Calibration: # ∇ Cal. # # ∇ 6. # # ∇ 3. § OD CONC § Factor/OD-L §3650* 1-Point Cal. No.3 3* B 7 0 H 1000* First H Last H 2.3 1. None Selected 8. with OE60106 activation). OSR6109. AU680/AU480 Paediatric Application Reagent ID: 009 System Reagent: OSR6009. OSR6209. # # # # ∇ 5. # # # # ∇ 7. with OE60106 activation). Volume R1(R1-1) 5 1 25 Dilution 10 µL Sample Volume Pre-Dilution Rate Rgt. Not within expected values Month # # # # # # Low # # # # # # # # # High # # # # # # # # Panic Value Low # High # Unit U/L* Decimal Places # Parameters Calibrators General Serum ∇ Use Serum Cal. For No. No demographics 8. # # # # ∇ 6.OD Reagent OD Limit First Low Last Low Min. AU680 Paediatric Application Parameters General LIH ASTP Dilution 1. Dynamic Range Low ф Correlation Factor A 660 ∇nm Factor for Maker A Last Last 27 R1-2 340 ∇nm RATE ∇ ∇ 14 15 YES % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Common Rgt.5 2.5 Min. No demographics 8. Volume R1(R1-1) R1-2 5 1 25 5 µL ∇ µL Dilution 25 µL µL ∇ µL µL R2(R2-1) 25 µL Dilution 40 µL Common Rgt.3 R2(R2-1) 3* 1 1 0 Last Last 27 Hour High B B 1000* 0 0 25 µL High High 2. # # # # ∇ 2. OSR6209. # # # # ∇ 2. 660 # Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 3* 1 1 40 µL High B B 0 1000* 0 0 Hour 10 10 µL µL 10 µL OD Limit 2. # # # # ∇ 5.0 1.5 ∇ Type: Serum < > ∇ ISE HbA1c Range Specific Test Parameters Calculated Test System Reagent: OSR6009.0 1. with OSR60180 activation). OSR6109.02 2010-05 . # # # # ∇ 4. # # # # ∇ 3.5 Max. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: # 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration ∇ with Conc-0 Day Day Hour Hour MB Type Factor: # 1-Point Calibration Point ∇ Enzyme BSOSR6x09. ISE Parameters Calibrators General Test Name: ASTP ∇ < > Type PAEDIATRIC APPLICATION Y=AX+B None ∇ Counts: # ∇ ∇ Range Low High Slope Check §3650* §5470* Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Lot Calibration Counts: # ∇ ∇ Range Low High Slope Check §3650* §5470* Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Interval (RB/ACAL) None ∇ # ∇ # Lot Calibration ∇ Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal. # # # # ∇ 4. OSR6509 Parameters General Range Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: OD Limit 1. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 30 Day # ∇ +++++ ∇ +++++ ∇ + ∇ Parameters General Range Test Name: ASTP ∇ < > LIH ISE HbA1c Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Parameters General Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Test Name: ASTP ∇ < > Type: High # High # # # # # # # # Unit U/L* Panic Value Low # High # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1.OD 2.3 1. For No.OD Dilution Dilution Dilution Name Sec. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 7 Day # ∇ +++++ ∇ +++++ ∇ + ∇ 15 YES % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 340 ∇nm RATE ∇ ∇ 14 Name Sec.3 1. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Day Day with Conc-0 Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration Hour Hour <Point Cal.3 High High Max.5 2. Calibration Specific Calibration Parameters STAT Table Calibration Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum ∇ Use Serum Cal. # # # # ∇ 3. OSR6109. # # # # ∇ 6. # # # # ∇ 7. OSR6509 Reagent ID: 009 AST (IFCC.5 2.AST (IFCC.OD Reagent OD Limit First Low Last Low ASTP ∇ < > Type: Operation Test Name: Yes ∇ Operation Yes ∇ Sample Volume Pre-Dilution Rate Rgt. Not within expected values Decimal Places Calibration Specific ISE ASTP ∇ Test Name: < Month # # # # # # Low # # # # # # # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. CHOLINESTERASE OSR6114 Intended Use Kinetic colour test for the quantitative determination of cholinesterase. Safety data sheet available for professional user on request. in addition to the calculation of inhibition of enzyme activity toward specified substrates in the presence of dibucaine or fluoride. bile salts. hyperlipoproteinaemia Type IV. death will result. A 30-50% decrease in level is observed in acute hepatitis. Cholinesterase catalyses the hydrolysis of butyrylthiocholine to butyrate and thiocholine. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. If sufficient material is absorbed to inactivate all the acetylcholinesterase of nervous tissue. reagents stored on board the instrument are stable for 30 days. unopened.8 (CHE) in human serum and plasma on Beckman Coulter analysers. tertiary amines. citrate. and a drop of 80% is required before neuromuscular effects are apparent. Cholinesterase is competitively inhibited by the alkaloids prostigmine and physostigmine.01 BLOSR6x14. Gilbert’s syndrome. phenothiazines. Degradation of acetylcholine is necessary for the depolarisation of the nerve so that it can undergo repolarisation in the next conduction event. Once open.0 mmol/L 15 mmol/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. for detection of patients with atypical forms of the enzyme. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Thiocholine reduces yellow hexacyanoferrate (III) to colourless hexacyanoferrate (II). it is recommended that 5 separate calibration events should be used. pyrophosphate. The calibrator value is traceable to a standard method. Sensitivity to succinyldicholine is dependent on the phenotype of the patient.1. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. The decrease in absorbance at 410 nm is directly proportional to the cholinesterase activity in the sample. patients may be characterised by measurement of serum cholinesterase activity. including morphine. Storage and Stability The reagents are stable. or as a test of liver function.01 2009-08 Enzyme . a muscle relaxant used during surgical procedures. Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced. A fresh vial of calibrator. fluoride and borate. 4 Stable in serum and plasma for 1 year when stored at 2…25°C. and preoperative screening has been advocated to identify patients in whom complications may arise. coronary heart disease. Increased cholinesterase levels may be found in diabetes mellitus. Near zero levels of enzyme activity require emergency treatment of the patient with enzyme regulators such as pyridine-2-aldoxime. 1994). Protect R1 from light. quinine. Serum cholinesterase levels are useful as an indicator of insecticide poisoning. Sarin and tetraethyl pyrophosphate.2 Cholinesterase is responsible for the rapid hydrolysis of acetylcholine released at nerve endings to mediate the transmission of the neural impulse across the synapse. a familial variant which results in cholinesterase levels of 2-3 times normal . Reagent blank measurement is recommended when changing to a new lot of reagent. EC 3. should be used for each of these runs. 3 EN. 66300 in the AB calibration mode. Dispose of all waste material in accordance with local guidelines. Reagent Composition in the Test Tetra sodium diphosphate (pH 6. with decreases of 50-70% observed in advanced cirrhosis and carcinoma with metastases to the liver. For in vitro diagnostic use only. and those with Cynthiana variant. In these cases. chemicals which may be inhaled or absorbed by workers in the agriculture or organic chemical industries. utilising System Calibrator Cat No. Cholinesterase activity is also inhibited by organic phosphorous compounds including Parathion. Measurement of serum cholinesterase activity may also be used as a measure of the synthetic capacity of the liver. Normal levels are noted in chronic hepatitis. Test Principle3 Method based on the recommendations of the “German Society for Clinical Chemistry” (GSCC.1. For the AU2700/AU5400 this procedure needs to be performed for each ring. To provide a robust approach to generate the analyser specific MB factor. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced. Calibration The test is run in MB-mode. A wide variety of other compounds inhibit cholinesterase. up to the stated expiry date when stored at 2…8°C. Increased cholinesterase activity is not considered to be of clinical significance. 4 x 30 mL 4 x 6 mL R1 R2 Summary1.2) Ferricyanide (III) Butyrylthiocholine Preservative 75 mmol/L 2. Reaction principle Butyrylthiocholine + H2O 2 Thiocholine + 2 OH + 2 [Fe(CN)6] (Yellow) 3- CHE Butyric acid + Thiocholine Dithiobis(choline) + H2O + 2 [Fe(CN)6] (Colourless) 4- Contents. Patients with low levels or weakly active acetylcholine may undergo a period of prolonged apnoea on administration of succinyldicholine (suxamethonium). mild cirrhosis and obstructive jaundice. A 40% drop in serum cholinesterase activity occurs before the first symptoms are noted. Specimen Serum or heparinised plasma. sample type.26 Total CV% 0. clinical examinations and other findings.58 0.2 11. Use and assessment of clinical laboratory results. diet and geographical location. Henderson RA. Enzyme BLOSR6x14. Zawta B. 2000. If any trends or sudden shifts in values are detected.5 kU/L ( 77 – 192 µkat/L) 3. Setting Sheet Footnotes # * § User defined ¤ Analyser default value Values set for working in kU/L. In: Burtis CA. Method Comparison Patient serum samples were used to compare this CHE OSR6114 assay on the AU600 against another commercially available CHE assay.1 Rev.8 Within Run SD 0.Quality Control Controls Cat. Young DS. To work in SI units (µkat/L) multiply by 16.03 0. Calculation The Beckman Coulter analysers automatically compute the CHE activity of each sample. Moss DW. 1999. Each laboratory should establish its own control frequency. 5. Each laboratory should verify the transferability of the expected values to its own population. Frankfurt/Main: TH-Books Verlagsgesellschaft.05 0. For use in AB mode only. 4. n = 60 Mean kU/L 5. Limitations This product is not suitable for the determination of red cell cholinesterase.65 1. et al.5 – 14.93 – 10. AACC Press. et al. Heil W. Effects of drugs on clinical laboratory tests. Reference Intervals2 Male Female 4. Results of linear regression analysis were as follows: y = 1.009x + 0.43 0. Thomas L. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.1 kU/L. refer to leaflet for further instruction BIBLIOGRAPHY 1. Linearity The test is linear within an enzyme activity range of 1 – 15 kU/L (17 – 250 µkat/L).01 . Eur J Clin Chem Biochem 1992. In: Thomas L. eds. Proposal of standard methods for the determination of enzyme catalytic concentrations in serum and plasma at 37°C. 2. WHO/DIL/LAB/99. Clinical Enzymology.66. 5th ed.127 r = 1.77 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 0. Values obtained for the controls should fall within specified limits as defined by the user. Good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Töpfer G.000 n = 64 Sample range = 1.07 CV% 0. Schmitt Y. Ashwood ER. Data obtained in your laboratory may differ from these values.48 0. and if necessary determine its own reference interval according to good laboratory practice. sex. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. 3.708-711. The lowest detectable level represents the lowest measurable level of CHE that can be distinguished from zero. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.01 2009-08 EN.5 kU/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Ascorbate: Icterus: Haemolysis: Lipemia: Interference less than 3% up to 20 mg/dL ascorbate Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin Interference less than 3% up to 5 g/L haemoglobin ® Interference less than 5% up to 1000 mg/dL Intralipid 5 Refer to Young for further information on interfering substances. ed.62 – 11. Wisser H.30:163-170. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. 1998:65-71. For diagnostic purposes. Philadelphia:WB Saunders Company. Plasma and Serum Samples.8 kU/L ( 65 – 180 µkat/L) Expected values may vary with age. Clinical laboratory diagnostics. Ehret W.06 0. Cholinesterase. Schmidt E. No. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days.90 3. Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood.46 SD 0. results should always be assessed in conjunction with the patient's medical history.2:26pp.7 14. Tietz textbook of clinical chemistry. review all operating parameters. # # ο ∇ 5. point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in kU/L. OD H ∇ Operation: Yes Test No ∇ 2. AU600 Serum/Plasma Application System Reagent: OSR6114 Specific Test Parameters General LIH ISE Range Test Name: CHE ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 150 30 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.1 1.2 2. Reagent 1 vol Reagent 2 vol μL μL μL 3 150 30 Dil. L 1.1 Dynamic range L 1* Correlation factor % ∇ 15* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: CHE ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. L 1. # # ο ∇ 3. § OD CONC § Factor/OD-L §52* 1-Point Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. vol Dil.66.4 Main ∇ ∇ ∇ 410 Sub 1. # # ο ∇ 6. H 15* Fst Fst 16 Lst Lst First H Last H 2.5 2. § For use in AB mode only. H Sample vol. OD L 0. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CHE Sample type Ser ∇ On-board stability period 410 RATE First 16 First 15 NO Last Last 20 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min.1 1* B 30 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil. No. refer to IFU for further instruction.1 Lst.CHOLINESTERASE. § For use in AB mode only. # # ο ∇ 2. H Lst. vol 0 0 0 Max. Enzyme .66. Out of Range L # # # # # # # # Unit: kU/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name CHE ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §52* # ∇ Factor/OD-H §78* SERUM/PLASMA APPLICATION Calibration Specific General ISE Serum ∇ Process: ∇ Factor/OD-H §78* # Test Name: Counts: CHE ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal. refer to IFU for further instruction. To work in SI units (µkat/L)multiply by 16. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. vol Dil. ∇ ∇ ∇ Sec.2 2.2 480 RATE 20 Max OD H 2. BSOSR6x14. # # ο ∇ 7. To work in SI units (µkat/L) multiply by 16. AU400/AU640 Serum/Plasma Reagent ID: 014 Specific test parameters Serum ∇ 1 0.4 Reagent OD limit Fst.2 ∇ # Test name CHE Sample type Ser Page 1/2 System Reagent: OSR6114 Reagent ID: 014 Application CHOLINESTERASE.5 Fst. # # ο ∇ 4. None Selected 8.01 2009-08 # User defined * Values set for working in kU/L. § OD CONC § Factor/OD-L §52* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ ∇ Advanced Calibration: # None ∇ 1-Point Cal. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank Day Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # * § Ф User defined.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2. AU680 <Point Cal. ∇ # # # # ο 4. None Selected 8.01 2009-08 .66 For use in AB mode only.2 15* B 30 Last Last 20 15 NO % ∇ CHE ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 3 150 30 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L kU/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. # # ο ∇ 6. ∇ # # # # ο 5.1 1. For No.2 2.4 1. Values set for working in kU/L. # # ο ∇ 4.5 2. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. # # ο ∇ 2. ∇ # # # # ο 3.1 R2(R2-1) μL Name Sec.CHOLINESTERASE.4 1. # # ο ∇ 7.5 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x14. AU680/AU480 Serum/Plasma Application System Reagent: OSR6114 Specific Test Parameters General LIH ISE Serum ∇ 1 0. No. Not within expected values kU/L* Decimal Places Calibration Specific ISE CHE ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Low §52* Type Serum Counts: ∇ Range High §78* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H §78* # Process: SERUM/PLASMA APPLICATION Test Name: CHE ∇ < > Test Name: Use Serum Cal. ∇ 7. # # ο ∇ 3.1 1. # # ο ∇ 5. refer to IFU for further instruction. ∇ # # # # ο 2. 480 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 1* 1 1 μL High B B 0 15* 0 0 Hour 30 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.OD μL Min. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 410 ∇nm RATE ∇ ∇ 16 410 RATE First 16 First 15 NO Last Last 20 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH CHE ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # CHE ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.2 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6114 Reagent ID: 014 Application Operation Yes CHOLINESTERASE. To work in SI units (µkat/L) multiply by 16.1 High High Max. ∇ ∇ ∇ 1* Sec.2 2. ∇ # # # # ο 6. AU2700/AU5400 Serum/Plasma Reagent ID: 014 Parameters General LIH CHE ∇ Dilution μL 0. No demographics 8. Volume R1(R1-1) μL ∇ μL 3 1 150 Test Name: Max OD H 2. 2.2 (CK). CK is increased whenever there is necrosis or regeneration of muscle and is therefore elevated in most myopathies such as Duchenne-muscular dystrophy and in conditions associated with muscle necrosis such as rhabdomyolysis. contains a mixture of 5-chloro-2-methyl-4-isothiazolin-3-one [EC No 247-500-7] and 2-methyl-4-isothiazolin-3-one [EC No 220-239-6] (3:1).8 kU/L Precautions and Warnings Hazard Warnings and Risk Phrases: R2: Irritant. R43: May cause sensitisation by skin contact. prostate. CK-MM predominates in skeletal and cardiac muscle. Reaction Principle Creatine phosphate + ADP ATP + Glucose Glucose-6-phosphate + NADP + CK HK G6P-DH Creatine + ATP ADP + Glucose-6-phosphate 6-Phosphogluconate + NADPH + H + Contents.2 mmol/L 26 mmol/L 10 mmol/L 0. in human serum and plasma on Beckman Coulter analysers. The diagnostic sensitivity and specificity of total CK estimation for the diagnosis of an MI can be improved by determining the rate of increase ("slope") of CK on serial samples obtained on admission and at 4. Test Principle5 Method based on the recommendations of the “International Federation of Clinical Chemistry” (IFCC). EC 2. gut. lung.01 mmol/L ≥ 4. For in vitro diagnostic use only. CK reversibly catalyses the transfer of a phosphate group from creatine phosphate to adenosine diphosphate (ADP) to give creatine and adenosine triphosphate (ATP) as products. bladder.3. CK-MB and CK-BB. with a significant increase in both the CK-MM and CK-MB fractions. The rate of increase of absorbance at 340/660 nm due to the formation of NADPH is directly proportional to the activity of CK in the sample. CK-BB predominates in the brain.4 Creatine kinase (CK). In healthy individuals the total activity consists mainly of CK-MM while the other CK isoenymes and variants are only present in trace amounts or are undetectable. This reaction is catalysed by hexokinase (HK) which requires magnesium ions for maximum activity. the ratio reaching a peak within 1. For patients in need of an early diagnosis of a myocardial infarction a rapidly appearing biomarker such as CK-MB plus a biomarker that rises later e. CK-MB is present to varying degrees in heart muscle and also to a minor degree in skeletal muscle. Changes in the ratio of CK-MB to CK-MM may be used to diagnose a myocardial infarct (MI).5 @ 37°C) NADP ADP AMP EDTA Glucose Creatine phosphate N-acetylcysteine Activator 2+ Mg Diadenosine pentaphosphate HK G6P-DH Stabilisers Preservative 100 mmol/L 2.01 2009-08 Enzyme . The ATP formed is used to produce glucose-6-phosphate and ADP from glucose. The glucose-6-phosphate is oxidised by the action of the enzyme glucose6-phosphate dehydrogenase (G6P-DH) with simultaneous reduction of the coenzyme nicotinamide adenine dinucleotide (NADP) to give NADPH and 6-phosphogluconate. uterus. thyroid and the placenta.0 mmol/L 2. Measurements of CK are primarily used in the diagnosis and treatment of myocardial infarction as well as being the most sensitive indicator of muscle damage.0 kU/L ≥ 2. cardiac troponin is recommended for confirmation of the diagnosis.CK (NAC) OSR6179 OSR6279 4 x 22 mL 4 x 4 mL 4 x 6 mL 4 x 44 mL 4 x 8 mL 4 x 13 mL R1-1 R1-2 R2 R1-1 R1-2 R2 Intended Use Kinetic UV test for the quantitative determination of creatine kinase. 8 and 12 hours thereafter. Summary1.g.0 mmol/L 2. Reagent Composition in the Test Final concentration of reactive ingredients Immidazole (pH 6. The proportional rise in the CK-MB fraction to some extent depends on the size of the myocardial damage and on a history of previous myocardial damage. EN.0 mmol/L 5. A 50% incremental increase per hour over the time period differentiates between an acute MI and non-infarction with an overall efficiency of 94%.5 hours post MI. catalyses the reversible phosphorylation of creatine by ATP. Total CK can also be increased in diseases of the CNS such as Reyes Syndrome where a 70 fold increase in CK activity indicates the severity of the encephalopathy. liver. a dimer composed of M-muscle and /or B-brain subunits which associate to form the isoenzymes CK-MM. CK activity rises following myocardial damage.0 mmol/L 20 mmol/L 30 mmol/L 0.01 BLOSR6x79. kidney.7.3. 1903 U/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 1 g/L haemoglobin ® Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances.6 Stable in serum. sex. n = 80 Within Run Total Mean U/L SD CV% SD 99 2.20 3. Haemolysed samples should be avoided. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. 5.37 4.00 8.992 x + 0.Safety Phrases: S24. The calibrator value is traceable to the IFCC reference method.28 Sensitivity The lowest detectable level on an AU640 analyser was estimated at 3 U/L The lowest detectable level represents the lowest measurable level of CK that can be distinguished from zero. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced. Linearity The test is linear within an enzyme activity range of 10 – 2000 U/L (0. Each laboratory should establish its own control frequency. Refer to Safety Data Sheets for further information. review all operating parameters. To avoid the possible build-up of azide compounds. diet and geographical location. To provide a robust approach to generate the analyser specific MB factor. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. results should always be assessed in conjunction with the patient's medical history. Wear suitable gloves.01 8 . Avoid contact with skin. 66300 in the AB calibration mode. sample type. Enzyme BLOSR6x79. Mix by gentle inversion before placing on board the instrument. utilising System Calibrator Cat No. flush waste-pipes with water after the disposal of undiluted reagent.51 270 2. Results of linear regression analysis were as follows: y = 0.000 n = 109 Sample range = 22 . oxalate or citrate is not recommended.64 26. S60.22 0. Reagent Preparation R1: The entire contents of bottle R1-2 must be transferred into the entire volume of R1-1. Plasma with EDTA. Storage and Stability The reagents are stable. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed.01 2009-08 EN. R2: The reagent is ready for use and can be placed directly on board the instrument.85 µkat/L) ≤ 145 U/L (2.64 810 5.33 µkat/L). No. Data obtained in your laboratory may differ from these values.59 CV% 4. should be used for each of these runs. Dispose of all waste material in accordance with local guidelines. it is recommended that 5 separate calibration events should be used. Heparinised plasma. Quality Control Controls Cat. Once open. For the AU2700/AU5400 this procedure needs to be performed for each ring.70 1. Plasma samples may occasionally produce unpredictable rate reactions resulting 5 in false low results. Allow specimen to clot and remove serum from cells promptly to minimise haemolysis and contamination by adenylate kinase from the red cells.35 2. Specimen Serum is the recommended specimen. protected from light. Values obtained for the controls should fall within specified limits as defined by the user. Reference Intervals7 Male Female ≤ 171 U/L (2. A fresh vial of calibrator. reagents stored on board the instrument are stable for 30 days.026 r = 1. Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced. If any trends or sudden shifts in values are detected. This material and its container must be disposed of as hazardous waste. clinical examinations and other findings.55 3.42 µkat/L) Expected values may vary with age. can also be used. Each laboratory should verify the transferability of the expected values to its own population. unopened. Reagent blank measurement is recommended when changing to a new lot of reagent. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. Calibration The test is run in MB-mode.17 – 33. Precision The following data was obtained on an AU2700 using 3 serum pools analysed over 20 days. free from haemolysis. and if necessary determine its own reference interval according to good laboratory practice. Method Comparison Patient serum samples were used to compare this CK-Nac OSR6179 assay on the AU640 against another commercially available CK-Nac assay. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. up to the stated expiry date when stored at 2…8°C. S37. Calculation The Beckman Coulter analysers automatically compute the creatine kinase activity of each sample. For diagnostic purposes. for 8-12 hours when stored at 2…8°C and 4 hours when stored at 15…25°C. London: Arnold. Horder M.327:69-79. 8. Clinical enzymology. eds. Tietz textbook of clinical chemistry. Kachmar JF. Thygesen K. Young DS. 7. Klauke R. ed. IFCC method for creatine kinase. Henderson RA. Ashwood ER. Myocardial infarction redefined-A consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. 1987:376pp. ed. Creatine kinase isoenzymes and variants. User defined ¤ Analyser default value Values set for working in U/L. Part 7.1994:304-310.36:959-969. Mathieu M. Schumann G. Effects of drugs on clinical laboratory tests. Philadelphia:WB Saunders Company. AACC Press.Setting Sheet Footnotes # * § 1. To work in SI units (µkat/L) divide by 60 For use in AB mode only. Gerhardt W. In: Tietz NW.01 BLOSR6x79.J. 3. JACC 2000. Scientific division committee on enzymes: Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. Moss DW. 6th ed. 2000. 2. Clin Chim Acta 2003.29(7):435-56. International Federation of Clinical Chemistry. New IFCC reference procedures for the determination of catalytic activity concentrations of five enzymes in serum: preliminary upper reference limits obtained in hospitalised subjects. 1998:71-79. Creatine kinase (total activity). 4. Moss DW. 5. Frankfurt/Main: TH-Books Verlagsgesellschaft. 1999.01 2009-08 Enzyme . Henderson RA. Fundamentals of clinical chemistry. Elser R. Sampson E. 657-662. Alpert JS et al. Stein W. ed. Clinical chemistry in diagnosis and treatment. Enzymes. refer to leaflet for further instruction. 6. Clinical laboratory diagnostics. In: Burtis CA. In:Thomas L. Philadelphia:WB Saunders Company. BIBLIOGRAPHY EN. Eur J Clin Chem Biochem 1991. Mayne PD. 5th ed. Use and assessment of clinical laboratory results. . None Selected 8. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. refer to IFU for further instruction. OSR6279 Reagent ID: 079 Application CK (NAC). # # ο ∇ 2. vol 0 0 0 Max. point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. No. # # ο ∇ 6. OSR6279 Specific Test Parameters General LIH ISE Range Test Name: CK ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 120 30 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. or select from list displayed by Guide key Test No ∇ ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CK Sample type Ser ∇ On-board stability period 340 RATE + First 21 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. H 2000* Fst Fst 21 Lst Lst First H Last H 0. # # ο ∇ 7. § OD CONC § Factor/OD-L §6475* 1-Point Cal. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name CK ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §6475* # ∇ Factor/OD-H §9715* Calibration Specific General ISE Serum ∇ Process: ∇ Factor/OD-H §9715* # SERUM/PLASMA APPLICATION Test Name: Counts: CK ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal. Enzyme . OD L 0 Reagent OD limit Fst. L 0 Dynamic range L 10* Correlation factor % ∇ 2000* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: CK ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. refer to IFU for further instruction. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. AU600 Serum/Plasma Application System Reagent: OSR6179. # # ο ∇ 5. OD H 2 0.3 0. L 0 Lst. # # ο ∇ 3. ∇ ∇ ∇ Sec. AU400/AU640 Serum/Plasma Reagent ID: 079 Specific test parameters Serum ∇ 1 0 Main ∇ ∇ ∇ 340 Sub 0 0 10* B 30 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil.3 660 RATE + 27 Max OD H 2 Fst. # # ο ∇ 4.3 0. BSOSR6x79. H Sample vol. Reagent 1 vol Reagent 2 vol μL μL μL 3 120 30 Dil. vol Dil.3 ∇ Operation: Yes Test No ∇ ∇ # Test name CK Sample type Ser Page 1/2 System Reagent: OSR6179.01 2009-08 # User defined * Values set for working in U/L. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. vol Dil.CK (NAC). H Lst. ∇ # # # # ο 4. § OD CONC § Factor/OD-L §6475* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. No demographics 8. Not within expected values U/L* Decimal Places Calibration Specific ISE CK ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Range Low High §6475* §9715* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H §9715* # Process: SERUM/PLASMA APPLICATION Test Name: CK ∇ < > Test Name: Use Serum Cal. No. Volume R1(R1-1) μL ∇ μL 2.0 0. ∇ # # # # ο 5. OSR6279 Specific Test Parameters General LIH ISE Serum ∇ 1 0. ∇ # # # # ο 6. # # ο ∇ 7.01 2009-08 . Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank Day Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 10* 1 1 μL High B B 0 2000* 0 0 Hour 25 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.0 0. None Selected 8.3 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6179.CK (NAC).5 100 25 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x79.0 -0. # # ο ∇ 5. AU680/AU480 Serum/Plasma Application System Reagent: OSR6179.1 R2(R2-1) μL Name Sec.1 -0.3 0.1 -0. # # ο ∇ 6. ∇ # # # # ο 2. # # ο ∇ 4.1 High High Max. For No. ∇ 7.3 2000* B 30 Last Last 27 15 NO % ∇ CK ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. * Values set for working in U/L. To work in SI units (µkat/L) divide by 60. ∇ # # # # ο 3. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. # # ο ∇ 3. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ + ∇ 21 340 RATE + First 21 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ ++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH CK ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # CK ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.OD μL Min.3 0. ∇ ∇ ∇ 10* Sec. refer to IFU for further instruction.0 -0.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. Ф AU680 <Point Cal. AU2700/AU5400 Serum/Plasma Reagent ID: 079 Parameters General LIH CK ∇ Dilution μL 0.5 1 100 Test Name: Max OD H 2. § For use in AB mode only. OSR6279 Reagent ID: 079 Application Operation Yes CK (NAC). # # ο ∇ 2. The glucose-6-phosphate is oxidised by the action of the enzyme glucose-6-phosphate dehydrogenase (G6P-DH) with simultaneous reduction of the coenzyme nicotinamide adenine dinucleotide phosphate (NADP) to give NADPH and 6-phosphogluconate.3 Creatine kinase (CK) EC 2. For patients in need of an early diagnosis of a myocardial infarction a rapidly appearing biomarker such as CK-MB plus a biomarker that rises later e. Changes in the ratio of CK-MB to CK-MM may be used to diagnose a myocardial infarction (MI). unopened. Storage and Stability The reagents are stable. The B subunit of the enzyme remains free to act on the substrate present in R2. kidney. CK is increased whenever there is necrosis or regeneration of muscle and is therefore elevated in most myopathies such as Duchenne-muscular dystrophy and in conditions associated with muscle necrosis such as rhabdomyolysis. cardiac troponin is recommended for confirmation of the diagnosis.0 mmol/L ≥ 2. Safety Phrases: S24. CK-BB predominates in the brain. R2: The reagent is ready for use and can be placed directly on board the instrument.g.01 mmol/L 2. S37.01 BLOSR6x155.01 2009-08 Enzyme . lung.8 kU/L 2. Test Principle4. Reaction Principle5 Creatine Phosphate + ADP ATP + Glucose G-6-P + NADP + CK HK. Mix by gentle inversion before placing on board the instrument. This reaction is catalysed by hexokinase (HK) which requires magnesium ions for maximum activity. 2 x 22 mL 2 x 4 mL 2 x 6 mL R1-1 R1-2 R2 Summary1.3. Once open.0 mmol/L Diadenosine-pentaphosphate EDTA Glucose Creatine phosphate N-Acetylcysteine Activator Antibody to CK-M-subunit Preservative 0. R43: May cause sensitisation by skin contact. Dispose of all waste material in accordance with local guidelines. uterus.7) Hexokinase (HK) NADP G6P-DH ADP Mg-Acetate AMP 100 mmol/L ≥ 4.5 R1 contains an antibody which binds to the M subunit of CK in the serum sample thereby inhibiting the activity of the M subunit. Avoid contact with skin.2.0 kU/L 2. CK activity rises following myocardial damage. bladder. thyroid and the placenta. CK-MB is present to varying degrees in heart muscle and also to a minor degree in skeletal muscle. The proportional rise in the CK-MB fraction to some extent depends on the size of the myocardial damage and on a history of previous myocardial damage. In healthy individuals the total serum activity consists mainly of CK-MM while the other CK isoenymes and variants are only present in trace amounts or are undetectable. CK reversibly catalyses the transfer of a phosphate group from creatine phosphate to adenosine diphosphate (ADP) to give creatine and adenosine triphosphate (ATP) as products. Reagent Preparation R1: The entire contents of bottle R1-2 must be transferred into the entire volume of R1-1. The diagnostic sensitivity and specificity of total CK estimation for the diagnosis of an MI can be improved by determining the rate of increase ("slope") of CK on serial samples obtained on admission and at 4. For in vitro diagnostic use only. To avoid the possible build-up of azide compounds. Measurements of CK are primarily used in the diagnosis and treatment of myocardial infarction as well as being the most sensitive indicator of muscle damage. gut. the ratio reaching a peak within 1.0 mmol/L 20 mmol/L 30 mmol/L 0. A 50% incremental increase per hour over the time period differentiates between an acute MI and noninfarction with an overall efficiency of 94%. with a significant increase in both the CK-MM and CK-MB fractions. prostate.CK-MB OSR61155 Intended Use Enzymatic immuno-inhibition test for the quantitative determination of the creatine kinase-MB isoenzyme (CK-MB) in human serum and plasma on Beckman Coulter analysers. CK-MB and CK-BB. contains a mixture of 5-chloro-2-methyl-4-isothiazolin-3-one [EC No 247-500-7] and 2-methyl-4-isothiazolin-3-one [EC No 220-239-6] (3:1).2 mmol/L 26 mmol/L Variable Precautions and Warnings Hazard Warnings and Risk Phrases: R2: Irritant. up to the stated expiry date when stored at 2…8°C. flush waste-pipes with water after the disposal of undiluted reagent. 8 and 12 hours thereafter. a dimer composed of M-muscle and /or B-brain subunits which associate to form the isoenzymes CK-MM. The ATP formed is used to produce glucose-6-phosphate and ADP from glucose. Reagent Composition in the Test Final concentration of reactive ingredients: Imidazole buffer (pH 6. CK-MM predominates in skeletal and cardiac muscle. Mg 2+ Creatine + ATP ADP + Glucose-6-phosphate (G-6-P) 6-phosphogluconate + NADPH + H + G6P-DH Contents. catalyses the reversible phosphorylation of creatine by ATP. Refer to Safety Data Sheets for further information. Total CK can also be increased in diseases of the CNS such as Reye’s Syndrome where a 70 fold increase in CK activity indicates the severity of the encephalopathy. The rate of increase of absorbance at 340 nm due to the formation of NADPH is directly proportional to the activity of CK-MB in the sample. liver. S60. EN. Wear suitable gloves.0 mmol/L 10 mmol/L 5.5 hours post MI. This material and its container must be disposed of as hazardous waste.2. reagents stored on board the instrument are stable for 30 days.7. For diagnostic purposes. free from haemolysis. Reference Intervals Adults (37°C) < 24 U/L (0. sample type. Expected values may vary with age.76 Total CV% 5. Traceability: This method has been standardised against the CKtotal IFCC Reference Method with addition of antibody. Results of linear regression analysis were as follows: y = 1. Quality Control CK-MB Control Level 1 ODR30035 and Level 2 ODR30036 or other control materials with values determined by this Beckman Coulter system may be used. for 7 days when stored at 2…8°C. Good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. the infarction may be fresh.000 n = 103 Sample range = 12 – 1862 U/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin ® Lipemia: Interference less than 20% up to 900 mg/dL Intralipid Refer to Young for further information on interfering substances.69 0. Data obtained in your laboratory may differ from these values.54 SD 0.65 1. The lowest detectable level represents the lowest measurable level of CK-MB that can be distinguished from zero.6. Test Procedure Refer to the appropriate User’s Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Plasma samples may occasionally produce unpredictable rate reactions resulting in false low 6 results.7 -20°C.01 . diet and geographical location. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced.05 1. can also be used. results should always be assessed in conjunction with the patient's medical history. oxalate or citrate is not recommended. Method Comparison Patient serum samples were used to compare this CK-MB OSR61155 assay on the AU640 against another commercially available CK-MB assay. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 20 days.17 > 0. Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced.061x + 2. protected from light.04 CV% 4. Each laboratory should verify the transferability of the expected values to its own population. In this case the determinations should be repeated after 4 hours with a fresh sample.99 1. CK total CK-MB CK-MB activity is between 6 and 25 % of total CK U/L > 250 > 24 µkat/L > 4. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.Specimen Serum is the recommended specimen. A fraction of less than 6% indicates skeletal muscle damage.4 If myocardial infarction is suspected and the values found are below the stated limits. For the AU2700/AU5400 this procedure needs to be performed for each ring. due to the use of non-human materials in the controls. Lipaemic. Heparinised plasma.4 µkat/L) 2. Calibration The test is run in MB-mode.33 µkat/L). Allow specimen to clot and remove serum from cells promptly to minimise haemolysis and contamination by adenylate kinase from the red cells. Linearity The test is linear within an enzyme activity range of 10 – 2000 U/L (0.75 0. utilising CK-MB Calibrator Cat no ODR30034 in the AB calibration mode.90 Sensitivity The lowest detectable level on an AU640 analyser was calculated as 5 U/L. A fresh vial of calibrator. performed manually and calculated via molar absorption coefficient ε. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.03 0. it is recommended that 5 separate calibration events should be used.17 – 33.01 2009-08 EN. sex. CK/CK-MB is stable in serum. Plasma with EDTA.8 2 Myocardial infarction: the probability of myocardial damage is high when the following conditions are fulfilled . 1. Each laboratory should establish its own control frequency. 3.207 r = 1. To provide a robust approach to generate the analyser specific MB factor. Values obtained for the controls should fall within specified limits as defined by the user. clinical examinations and other findings. should be used for each of these runs. 2. and if necessary determine its own reference interval according to good laboratory practice. n = 80 Mean U/L 17 86 194 Within Run SD 0. review all operating parameters. for 2 days when stored at 20…25°C and up to 1 year when stored at 5. Calculation The Beckman Coulter analysers automatically compute the CK-MB activity of each sample. A fraction above 25 % may indicate the presence of Macro-CK and requires further 2 clarification. Please note that the recovery of non-Beckman Coulter controls may vary with reagent lots of immunoassay products. haemolysed and strongly icteric samples should be avoided. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.15 0. If any trends or sudden shifts in values are detected. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice.86 0. 9 Enzyme BLOSR6x155. Reagent blank measurement is recommended when changing to a new lot of reagent. CK-MB should be measured using a pre-diluted sample to ensure adequate inhibition of CK-M. Thygesen K. Refer to leaflet for further instruction. Hänninen KP. For inhibition of adenylate kinase the recommended inhibitors AMP/Ap5A are included. JACC 2000. 5th ed. Lang H. Sampson E. AACC Press. Philadelphia:WB Saunders Company. 7. In very rare cases.01 BLOSR6x155. Eur J Clin Chem Clin Biochem 1994. 9. Creatine kinase isoenzymes and variants. Part 7. The Quality of Diagnostic Samples in: Samples: From the Patient to the Laboratory./ 6th ed.01 2009-08 Enzyme . Frankfurt/Main: TH-Books Verlagsgesellschaft. 4.29(7):435-56. It is of no clinical significance. Generation of reference values for cardiac enzymes from hospital admission laboratory data. Klin Wschr 1976. especially monoclonal IgM (Waldenström’s macroglobulinemia) can cause unreliable results. Ferard F. Wisser H. IFCC method for creatine kinase. Weinheim: Wiley-VCH Verlag GmbH & Co. In:Thomas L. Guder WG.36:959-969. Clinical laboratory diagnostics. Use and assessment of clinical laboratory results. International Federation of Clinical Chemistry. Moss DW. Setting Sheet Footnotes # * § 1. Clinical enzymology.657-662. Mathieu M.Narayanan S. 54:357-360. In samples where the total CK activity exceeds 8000 U/L. Elser R. Zawta B. Henderson RA. 2005 in German. Pulkki K. Hennrich N. In: Burtis CA. It migrates electrophoretically between MM and MB and is found mainly in elderly women. Myocardial infarction redefined-A consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. 3. 3rd ed. Horder M.Limitations Macro-CK is an atypical form of CK that is composed of immunoglobulin complexes of normal isoenzymes. Leino A. 40:635-42. Kairisto V. To work in SI units (µkat/L) divide by 60. Scientific division committee on enzymes: Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. gammopathy.32:789-96. Gella F-J et al. BIBLIOGRAPHY EN. 1999. Alpert JS et al.75% at a CK-MM concentration of 2000 U/L and >99 % at a CK-MM concentration of 8000 U/L. Peltola O. Franck PFH. 5th ed. 1998:71-79. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37°C. but its presence may cause falsely elevated results. 6. Creatine kinase (total activity). Young DS. Gerhardt W. If Macro-CK contribution is suspected. Stein W. Effects of drugs on clinical laboratory tests.J. Eur J Clin Chem Biochem 1991. 2003. 2000. its presence should be confirmed by electrophoresis. Näntö V et al. Bestimmung der Aktivität von Kreatinkinase MB im Serum unter Verwendung inhibierender Antikörper. 5. ed. Tietz Textbook of Clinical Chemistry. eds. Clin Chem Lab Med 2002. 8. For use in AB mode only. KgaA. Appendix A. Ashwood ER. but as the inhibition can never be completely 100 % a residual activity could affect low CK-MB activity results. Würzburg U. The inhibition capacity of the anti-CK-MM antibody is >99. User defined ¤ Analyser default value Values set for working in U/L. 2. . Reagent 1 vol Reagent 2 vol 6 120 30 Dil. To work in SI units (µkat/L) divide by 60 § For use in AB mode only.3 Wave Method Reaction Point 1 Point 2 660 RATE + 27 Max OD H 2 Sample vol. OD H 2 ∇ Serum ∇ 1 0 Main ∇ ∇ ∇ 340 Sub 0 0 10* Sample Pre-dil. No. vol ∇ Operation: Yes # Test name CK-MB Sample type Ser Page 1/2 System Reagent: OSR61155 Reagent ID: 155 Application CK-MB. 660 ∇ Min. # # ο ∇ 3. # # ο ∇ 7. refer to IFU for further instruction. AU600 Serum/Plasma Application System Reagent: OSR61155 Specific Test Parameters General LIH ISE Range Test Name: CK-MB ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 6 120 30 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL 0. vol Dil. refer to IFU for further instruction. # # ο ∇ 2. point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. # # ο ∇ 5. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name CK-MB ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §5900* # ∇ Factor/OD-H §10900* Calibration Specific General ISE Serum ∇ Process: ∇ Factor/OD-H §10900* # SERUM/PLASMA APPLICATION Test Name: Counts: CK-MB ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal. Linearity Fst No lag time NO Select using Space key. Enzyme BSOSR6x155. ∇ ∇ ∇ Sec.CK-MB. H Lst. § OD CONC § Factor/OD-L §5900* 1-Point Cal. None Selected 8.3 0. # # ο ∇ 6. To work in SI units (µkat/L) divide by 60 § For use in AB mode only.3 0. vol Dil. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. L 0 Dynamic range L 10* Correlation factor H A B Rate Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: On-board stability period 340 RATE + First 21 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 2000* 1 0 ¤ % ∇ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Test Name: CK-MB ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.3 Pri. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CK-MB Sample type Ser ∇ Level L # Page 2/2 Level H # 15 % Sec B 30 % ∇ 0 H 2000* Fst Fst 21 Lst Lst First H Last H 0. L 0 Lst. # User defined * Values set for working in U/L. OD L 0 Reagent OD limit Fst. H Max. AU400/AU640 Serum/Plasma Reagent ID: 155 Specific test parameters Test No ∇ 0 0 0 μL μL μL Fst.01 2009-08 . # # ο ∇ 4. 0 0. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank Day Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # * § Ф User defined. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 10* 1 1 μL High B B 0 2000* 0 0 Hour 25 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.1 High High Max. To work in SI units (µkat/L) divide by 60. ∇ # # # # ο 6. refer to IFU for further instruction.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2. ∇ # # # # ο 3. ∇ 7. # # ο ∇ 6.3 0. AU680/AU480 Serum/Plasma Application System Reagent: OSR61155 Specific Test Parameters General LIH ISE Serum ∇ 1 0. None Selected 8. # # ο ∇ 5. ∇ # # # # ο 4. Values set for working in U/L.OD μL Min.1 R2(R2-1) μL Name Sec. # # ο ∇ 2. ∇ ∇ ∇ 10* Sec. No demographics 8. For use in AB mode only. AU680 <Point Cal.3 0.3 2000* B 30 Last Last 27 15 NO % ∇ CK-MB ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 5 100 25 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.0 -0. For No. ∇ # # # # ο 2. No. Volume R1(R1-1) μL ∇ μL 5 1 100 Test Name: Max OD H 2. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal.1 -0. ∇ # # # # ο 5.01 2009-08 .0 -0. # # ο ∇ 7.1 -0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x155. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ + ∇ 21 340 RATE + First 21 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ + ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH CK-MB ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # CK-MB ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.0 0.CK-MB. Not within expected values U/L* Decimal Places Calibration Specific ISE CK-MB ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Range Low High §5900* §10900* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H §10900* # Process: SERUM/PLASMA APPLICATION Test Name: CK-MB ∇ < > Test Name: Use Serum Cal. § OD CONC § Factor/OD-L §5900* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. AU2700/AU5400 Serum/Plasma Reagent ID: 155 Parameters General LIH CK-MB ∇ Dilution μL 0.3 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61155 Reagent ID: 155 Application Operation Yes CK-MB. # # ο ∇ 4. # # ο ∇ 3. Reaction Principle L-γ-Glutamyl-3-carboxy-4-nitroanilide + Glycylglycine γ-GT L-γ-Glutamylglycylglycine + 5-Amino-2-nitrobenzoate Contents. and in the majority of sera from people who are heavy drinkers. 5 Stable in serum and plasma for 7 days when stored at 2…25°C. This material and its container must be disposed of as hazardous waste. fatty livers. Once open. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced. 66300 in the AB calibration mode. Storage and Stability The reagents are stable. GLDH or CHE are also abnormal. contains a mixture of 5-chloro-2-methyl-4-isothiazolin-3-one [EC No 247-500-7] and 2-methyl-4-isothiazolin-3-one [EC No 220-239-6] (3:1). The enzyme only reacts with peptides or peptide-like compounds containing a terminal glutamate residue joined to the remainder of the compound through the terminal carboxyl. Specimen Serum and EDTA or heparinised plasma. A fresh vial of calibrator. Calibration The test is run in MB-mode. yielding 5-amino-2-nitrobenzoate. The paediatric application is suitable for use with small volume serum/plasma samples. 4 x 18 mL 4 x 18 mL 4 x 40 mL 4 x 40 mL 4 x 104 mL 4 x 104 mL R1 R2 R1 R2 R1 R2 Summary1. should be used for each of these runs. GGT is however of little value in attempting to discriminate between different kinds of liver disease. GGT is present in all cells of the body except those in muscle however the enzyme present in serum appears to originate primarily from the hepatobiliary system. alkaline phosphatase in cases of alcoholic liver disease and aspartate aminotransferase for distinguishing neonatal hepatitis from biliary atresia. to glycylglycine. GGT catalyses the transfer of the gamma-glutamyl group from the substrate. As elevated levels of GGT are observed in patients with alcoholic cirrhosis. reagents stored on board the instrument are stable for 30 days. Refer to Safety Data Sheets for further information.utilising System Calibrator Cat No. Test Principle4 Method based on the recommendations of the “International Federation for Clinical Chemistry” (IFCC). alcoholic liver damage and in monitoring alcohol abstinence.3 Gamma glutamyltransferase (GGT) belongs to a group of peptidases which catalyse the transfer of amino acids from one peptide to another and thus act as amino acid transferases. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. An increase in GGT is always a sign of liver damage if liver specific enzymes such as ALT.01 2009-08 Enzyme .2. GGT is dramatically increased in cases of intrahepatic or posthepatic biliary obstruction. Reagent Composition in the Test Final concentration of reactive ingredients: Glycylglycine.2. Safety Phrases: S24.GGT OSR6020 OSR6120 OSR6520 Intended Use Kinetic colour test for the quantitative determination of gamma-glutamyltransferase. It is more sensitive than alkaline phosphatase in detecting obstructive jaundice. up to the stated expiry date when stored at 2…8°C. Avoid contact with skin. cholangitis and cholecystitis and its rise occurs earlier and persists longer. The change in absorbance at 410/480 nm is due to the formation of 5-amino-2-benzoate and is directly proportional to the GGT activity in the sample. R43. GGT plays a role in the detection of alcoholism. May cause sensitisation by skin contact. it is recommended that 5 separate calibration events should be used. The enzyme is also useful in ratio with HDL-cholesterol in cases of alcohol abuse. Wear suitable gloves. EN. gamma-glutamyl-3-carboxy-4-nitroanlide. pH 7.3. EC 2. S37. For the AU2700/AU5400 this procedure needs to be performed for each ring. GGT is also increased in patients with infectious hepatitis. in acute and chronic pancreatitis and in patients receiving anticonvulsant drugs such as phenytoin and phenobarbital. unopened. S60. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.2 (GGT) in human serum and plasma on Beckman Coulter analysers. To provide a robust approach to generate the analyser specific MB factor. Dispose of all waste material in accordance with local guidelines.01 BLOSR6x20. For in vitro diagnostic use only.7 (37°C) L-γ-glutamyl-3-carboxy-4-nitroanilide Preservative 150 mmol/L 6 mmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: R1 and R2 reagents: Irritant. Effects of drugs on clinical laboratory tests.The calibrator value is traceable to the IFCC reference method and IRMM/IFCC-452. Moss DW.7 µkat/L) Female 15-132 U/L (0. 3.07-0. diet and geographical location. eds.21(10):633-646. Schmitt Y.95 1.80 4. Clinical guide to laboratory tests. clinical examinations and other findings. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Gamma glutamyltransferase (GGT). Töpfer G. No.00 µkat/L). Klauke R.269 U/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin Lipemia: Interference less than 5% up to 1000 mg/dL Intralipid In very rare cases gammopathy.1200 U/L (0. BIBLIOGRAPHY Enzyme BLOSR6x20. Setting Sheet Footnotes # * § 1. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days.02-0. The lowest detectable level represents the lowest measurable level of GGT that can be distinguished from zero.07-0. Frankfurt/Main: TH-Books Verlagsgesellschaft.37 µkat/L) 2-42 U/L (0. WHO/DIL/LAB/99. sample type. Clinical enzymology.2-2. Part 4 IFCC method for γ-glutamyltransferase.2 µkat/L) 1-39 U/L (0.79 1. and if necessary determine its own reference interval according to good laboratory practice.95 SD 0.03 µkat/L) 1-39 U/L (0.2:32pp. results should always be assessed in conjunction with the patient's medical history. Linearity The test is linear within an enzyme activity range of 5 .327:69-79. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Each laboratory should establish its own control frequency. AACC Press.63 µkat/L) Male 12-122 U/L (0. New IFCC reference procedures for the determination of catalytic activity concentrations of five enzymes in serum: preliminary upper reference limits obtained in hospitalised subjects. For use in AB mode only. 1999. Method Comparison Patient serum samples were used to compare this GGT OSR6120 assay on the AU640 against the IFCC Reference method. Henderson RA. London L.01 2009-08 EN. may cause unreliable results. Philadelphia:WB Saunders Company. Plasma and Serum Samples. Wisser H. Heil W.65 µkat/L) 3-22 U/L (0.3 r = 1.1 Rev. Good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed.01 . In: Burtis CA. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. Zawta B. 5. Theodorsen L. 5th ed. For diagnostic purposes. Clin Chem Clin Biochem 1983. et al. Clinical laboratory diagnostics. Values obtained for the controls should fall within specified limits as defined by the user.4 µkat/L) Expected values may vary with age.026x .73 Total CV% 0. 1998:80-86. Use and assessment of clinical laboratory results. Calculation The Beckman Coulter analysers automatically compute the GGT activity of each sample. Quality Control Controls Cat. 3rd ed.08 – 20. ed.000 n = 94 Sample range = 11 . In:Thomas L.27 0. Young DS. Tietz NW. To work in SI units (µkat/L) divide by 60. If any trends or sudden shifts in values are detected. Reference Intervals Male (Adult) Female (Adult) Children 1-182 days 183-365 days 1-12 years 13-18 years 1 6 < 55 U/L (0. Each laboratory should verify the transferability of the expected values to its own population. Tietz textbook of clinical chemistry.1995:286-87. review all operating parameters. Reagent blank measurement is recommended when changing to a new lot of reagent.37 µkat/L) 4-24 U/L (0. 7.02-0. 6. n = 60 Mean U/L 35 70 378 Within Run SD 0. Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced. sex.71 3. Stromme H. Ashwood ER.13 1. Data obtained in your laboratory may differ from these values.92 µkat/L) < 38 U/L (0. 7 Refer to Young for further information on interfering substances. Results of linear regression analysis were as follows: y = 1.25-2. especially monoclonal IgM (Waldenström’s macroglobulinemia). Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood. Clin Chim Acta 2003.33 0. Shaw M. 4. 2000.03-0. 2. User defined ¤ Analyser default value Values set for working in U/L.01 0. 686-89. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Thomas L. Schumann G.25 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 1 U/L.65 µkat/L) 4-22 U/L (0.57 CV% 0.05-0. refer to leaflet for further instruction. Ehret W. ed. Philadelphia: WB Saunders Company. 2 1. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. Point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L.2 Fst.2 ∇ # Test name GGT20 Sample type Ser Page ½ System Reagent: OSR6020. AU600 Serum/Plasma Application System Reagent: OSR6020. H Lst. # # ο ∇ 7. # # ο ∇ 3. AU400/AU640 Serum/Plasma Reagent ID: 020 Specific test parameters Serum ∇ 1 -0. None Selected 8.01 2009-08 # User defined * Values set for working in U/L.1 Lst. # # ο ∇ 6.2 480 RATE + 23 Max OD H 2. refer to IFU for further instruction.2 1. L -0. § OD CONC § Factor/OD-L §3540* 1-Point Cal.1 Reagent OD limit Fst. OSR6120 Reagent ID: 020 Application GGT (IFCC). OSR6120 Specific Test Parameters General LIH ISE Range Test Name: GGT20 ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 5 80 80 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. Vol Dil. ∇ ∇ ∇ Sec. Vol Dil. # # ο ∇ 5.2 1. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name GGT20 Sample type Ser ∇ On-board stability period 410 RATE + First 14 First 15 NO Last Last 23 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. H 1200* Fst Fst 14 Lst Lst First H Last H 1. L -0. No.1 -0. refer to IFU for further instruction. # # ο ∇ 2.1 Main ∇ ∇ ∇ 410 Sub -0. Enzyme . Point: ο With CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. OD H ∇ Operation: Yes Test No ∇ 2.GGT (IFCC). To work in SI units (µkat/L) divide by 60 § For use in AB mode only. H Sample vol.1 5* B 30 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil. BSOSR6x20. OD L -0. # # ο ∇ 4. Vol 0 0 0 Max. Reagent 1 vol Reagent 2 vol μL μL μL 5 80 80 Dil. To work in SI units (µkat/L) divide by 60 § For use in AB mode only.1 Dynamic range L 5* Correlation factor % ∇ 1200* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: GGT20 ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name GGT20 ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §3540* # ∇ Factor/OD-H §5755* SERUM/PLASMA APPLICATION Calibration Specific General ISE Serum ∇ Process: ∇ Factor/OD-H §5755* # Test Name: Counts: GGT20 ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal. No demographics 8. ∇ 7. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank Day Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # * § Ф User defined Values set for working in U/L.1 -0. # # ο ∇ 3. ∇ # # # # ο 3.2 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR66020. OSR6120. # # ο ∇ 2. § OD CONC § Factor/OD-L §4080* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal.1 R2(R2-1) μL Name Sec.01 2009-08 . 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x20. AU680 <Point Cal. No.2 1.2 1.1 High High Max.2 1200* B 30 Last Last 23 15 NO % ∇ GGT20 ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 4 64 64 μL μL μL Dilution Dilution Dilution 0 10 10 μL μL μL Pri.OD μL Min. Not within expected values U/L* Decimal Places Calibration Specific ISE GGT20 ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Range Low High §4080* §6630* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H §6630* # Process: SERUM/PLASMA APPLICATION Test Name: GGT20 ∇ < > Test Name: Use Serum Cal.1 -0. ∇ # # # # ο 4. # # ο ∇ 6. AU2700/AU5400 Serum/Plasma Reagent ID: 020 Parameters General LIH GGT20 ∇ Dilution μL -0. AU680/AU480 Serum/Plasma Application System Reagent: OSR6020. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.1 -0. ∇ # # # # ο 6.OD Reagent OD Limit First Low Last Low Dilution 10 0 OD Limit 2.GGT (IFCC). # # ο ∇ 7. None Selected 8.2 1. ∇ ∇ ∇ 5* Sec. ∇ # # # # ο 2. # # ο ∇ 5. To work in SI units (µkat/L) divide by 60 For use in AB mode only. refer to IFU for further instruction. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. Volume R1(R1-1) μL ∇ μL 4 1 64 Test Name: Max OD H 2. OSR6520 Specific Test Parameters General LIH ISE Serum ∇ 1 -0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 410 ∇nm RATE ∇ + ∇ 16 410 RATE + First 16 First 15 NO Last Last 23 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH GGT20 ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # GGT20 ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 4. 480 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 5* 1 1 μL High B B 0 1200* 0 0 Hour 64 Dilution 10 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. OSR6120. ∇ # # # # ο 5. OSR6520 Reagent ID: 020 Application Operation Yes GGT (IFCC).1 -0. For No.2 1. 2 1. # # ο ∇ 2. # # ο ∇ 4. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. vol 10 0 10 Max. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name GT20P Sample type Ser ∇ On-board stability period 410 RATE + First 14 First 15 NO Last Last 23 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. L -0.01 2009-08 # User defined * Values set for working in U/L.2 480 RATE + 23 Max OD H 2. vol Dil. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name GT20P ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §4216* # ∇ Factor/OD-H §6325* PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: ∇ Factor/OD-H §6325* # Test Name: Counts: GT20P ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal.1 Reagent OD limit Fst. BSOSR6x20. Reagent 1 vol Reagent 2 vol μL μL μL 5 80 80 Dil. OSR6120 Reagent ID: 020 Application GGT (IFCC). H Lst. # # ο ∇ 7.1 Dynamic range L 5* Correlation factor % ∇ 1200* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: GT20P ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. AU600 Paediatric Application System Reagent: OSR6020.2 Fst. OD H ∇ Operation: Yes Test No ∇ 2. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.GGT (IFCC).1 Main ∇ ∇ ∇ 410 Sub -0. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. L -0. ∇ ∇ ∇ Sec. No. AU400/AU640 Paediatric Reagent ID: 020 Specific test parameters Serum ∇ 1 -0.1 5* B 30 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil.2 ∇ # Test name GT20P Sample type Ser Page 1/2 System Reagent: OSR6020. H Sample vol. § OD CONC § Factor/OD-L §4216* 1-Point Cal. # # ο ∇ 5. vol Dil. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. None Selected 8. OSR6120 Specific Test Parameters General LIH ISE Range Test Name: GT20P ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 5 80 80 μL μL μL Dilution Dilution Dilution 10 0 10 μL μL μL Pri. # # ο ∇ 6.2 1.2 1.1 -0. Enzyme .1 Lst. refer to IFU for further instruction. point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. H 1200* Fst Fst 14 Lst Lst First H Last H 1. refer to IFU for further instruction. # # ο ∇ 3. OD L -0. 1 -0. ∇ # # # # ο 3.1 R2(R2-1) μL Name Sec. AU2700/AU5400 Paediatric Reagent ID: 020 Parameters General LIH GT20P ∇ Dilution μL -0. # # ο ∇ 6. No.OD μL Min. OSR6120. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x20.2 1.2 1. ∇ 7. 480 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.2 1.1 -0. # # ο ∇ 2.1 High High Max.OD Reagent OD Limit First Low Last Low Dilution 0 10 OD Limit 2. ∇ # # # # ο 4. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. # # ο ∇ 3. Volume R1(R1-1) μL ∇ μL 4 1 64 Test Name: Max OD H 2.GGT (IFCC). # # ο ∇ 7. None Selected 8.1 -0. No demographics 8. Not within expected values U/L* Decimal Places Calibration Specific ISE GT20P ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Range Low High §4080* §6630* ∇ # ο ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H §6630* # Process: Test Name: GT20P ∇ < > Test Name: Use Serum Cal. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 410 ∇nm RATE ∇ + ∇ 16 410 RATE + First 16 First 15 NO Last Last 23 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH GT20P ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # GT20P ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. OSR6120. refer to IFU for further instruction. ∇ # # # # ο 2.1 -0. # # ο ∇ 4.01 2009-08 . OSR6520 Reagent ID: 020 Application Operation Yes GGT (IFCC). ∇ # # # # ο 5.2 1. 480 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 5* 1 1 μL High B B 0 1200* 0 0 Hour 64 Dilution 10 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. AU680 <Point Cal. ∇ # # # # ο 6. # # ο ∇ 5. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank Day Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # * § Ф User defined Values set for working in U/L. ∇ ∇ ∇ 5* Sec. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. AU680/AU480 Paediatric Application System Reagent: OSR6020.2 1200* B 30 Last Last 23 15 NO % ∇ GT20P ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 4 64 64 μL μL μL Dilution Dilution Dilution 10 0 10 μL μL μL Pri. For No. To work in SI units (µkat/L) divide by 60 For use in AB mode only. OSR6520 Specific Test Parameters General LIH ISE Serum ∇ 1 -0.2 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR66020. § OD CONC § Factor/OD-L §4080* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. LDH-1 and LDH-2. utilising System Calibrator Cat No. Storage and Stability The reagents are stable. The anodal fraction of LDH isoenzymes (LDH-1 and LDH-2) shows a high activity with 2-oxobutyrate as substrate under suboptimal reaction conditions. The calibrator value is traceable to a Beckman Coulter master calibrator.3 (HBDH) in human serum and plasma on Beckman Coulter analysers. and calculation of the LDH/HBDH ratio is advocated as an alternative to the measurement of LDH isoenzymes. To provide a robust approach to generate the analyser specific MB factor. LDH-1 and LDH-2 activity is increased. The LDH activity obtained with 2-oxobutyrate as substrate is called 2-hydroxybutyrate dehydrogenase (2-HBDH).0 mmol/L 0. A fresh vial of calibrator.5. Reference Intervals4 Adults 90 – 180 U/L (1.2. Calibration The test is run in MB-mode. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced. Values obtained for the controls should fall within specified limits as defined by the user. Each laboratory should establish its own control frequency. For in vitro diagnostic use only. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used.01 BLOSR6x29. To avoid the possible build-up of azide compounds. If any trends or sudden shifts in values are detected.18 mmol/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. Dispose of all waste material in accordance with local guidelines. Calculation The Beckman Coulter analysers automatically compute the HBDH activity of each sample. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.6 to 2. Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced. up to the stated expiry date when stored at 2. 66300 in the AB calibration mode. 4 x 15 mL 4 x 15 mL R1 R2 Summary1 2-Hydroxybutyrate dehydrogenase (HBDH) activity is defined as the catalytic oxidation of 2-hydroxybutyrate to 2-oxobutyrate. The decrease in NADH concentration is measured at 340 nm and is directly proportional to the 2-HBDH activity in the sample. Specimen Test Procedure Serum and heparinised plasma: Stable in serum for 4 days when stored at 2…8°C and 7 days when stored at 15…25°C. review all operating parameters.8 to 1. Exact ratios are dependent on assay conditions. 3 Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. Test Principle2 Photometric UV determination based on the recommendations of the “German Society for Clinical Chemistry” (GSCC).HBDH OSR6129 Intended Use Kinetic UV test for the quantitative determination of 2-hydroxybutyrate dehydrogenase EC 2. Quality Control Controls Cat.. reagents stored on board the instrument are stable for 30 days. are relatively more active with 2–oxobutyrate than with pyruvate. flush waste-pipes with water after the disposal of undiluted reagent. Reagent Composition in the Test Final concentration of reactive ingredients: Phosphate buffer (pH 7. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument.2. 2-HBDH catalyses the reversible reduction of 2-oxobutyrate by NADH to 2-hydroxybutyrate. Reagent blank measurement is recommended when changing to a new lot of reagent. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. should be used for each of these runs. Patients with parenchymal disease have greater LDH-5 activity resulting in an increase in the LDH/HBDH ratio ranging from 1.. HBDH measurement. Good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed.01 2009-08 Enzyme .8°C. Reaction Principle 2-Oxobutyrate + NADH + H + HBDH 2-Hydroxybutyrate + NAD + Contents.2 to 1. For the AU2700/AU5400 this procedure needs to be performed for each ring. In myocardial infarction.5 – 3 µkat/L) EN. Haemolysed samples should be avoided.6.5) 2-Oxobutyrate NADH Preservative 50 mmol/L 3.4. it is recommended that 5 separate calibration events should be used. The LDH/HBDH ratio in healthy individuals varies from 1. No. with a resultant decrease in the LDH/HBDH ratio to levels ranging from 0. which constitute the largest proportions of monomer H. Once open. unopened. For use in AB mode only. 2000. Fundamentals of clinical chemistry. Zawta B. n = 60 Mean U/L 70 167 970 Within Run SD 1. Henderson RA. refer to leaflet for further instruction. results should always be assessed in conjunction with the patient's medical history. 4 Auflage. et al. WHO/DIL/LAB/99. Moss DW. Töpfer G.58 CV% 1. Marburg: Die Medizinische Verlagsgesellschaft. sample type. AACC Press. Such samples should be diluted and re-run. diet and geographical location. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. 5.76 8. 1987:381pp. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. User defined ¤ Analyser default value Values set for working in U/L.1 Rev. Kachmar JF.10:82-192.081x -11 r = 0. Enzymes.Expected values may vary with age. sex.98 2. In: Tietz NW. Clin Chem Biochem 1970. Effects of drugs on clinical laboratory tests.03 1. Bergmeyer HU. For diagnostic purposes. Ehret W. Empfehlungen der Deutschen Gesellschaft für Klinische Chemie. To work in SI units (µkat/L) divide by 60.55 12. BIBLIOGRAPHY Enzyme BLOSR6x29.67 µkat/L). Thomas L.38 3.67 – 16. The lowest detectable level represents the lowest measurable level of HBDH that can be distinguished from zero. ed.8:658-660 & 1972. Setting Sheet Footnotes # * § 1. Heil W. Data obtained in your laboratory may differ from these values. 5th ed.13 1. 3.997 n = 118 Sample range = 88 – 574 U/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Bilirubin: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin ® Lipemia: Interference less than 3% up to 400 mg/dL Intralipid 5 Refer to Young for further information on interfering substances.34 Sensitivity The lowest detectable level on an AU600 analyser was calculated as 3 U/L. Limitations Highly lipemic samples may exceed the reaction absorbance and will be flagged with a “@”. 4. Wisser H. Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood. 2. 1992:136pp. and if necessary determine its own reference interval according to good laboratory practice. Plasma and Serum Samples. Labor und Diagnose.88 SD 1.01 . Method Comparison Patient serum samples were used to compare this HBDH OSR6129 assay on the AU600 against another commercially available HBDH assay. Linearity The test is linear within an enzyme activity range of 40 .01 2009-08 EN. Schmitt Y.1000 U/L (0. clinical examinations and other findings. Philadelphia:WB Saunders Company. Results of linear regression analysis were as follows: y = 1.48 1.98 Total CV% 1.2:36pp. Each laboratory should verify the transferability of the expected values to its own population. Enzyme. Young DS.06 0. 0 1. Point: ο With CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. L 1. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # L # Test name HBDH Sample type Ser ∇ Level L # Page 2/2 Level H # 15 % Sec B 30 % ∇ 0 H 1000* Fst Fst 12 Lst Lst First H Last H 2. AU600 Serum/Plasma Application System Reagent: OSR6129 Specific Test Parameters General LIH ISE Range Test Name: HBDH ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 75 75 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL 2. # # ο ∇ 2.0 40* Sample Pre-dil. None Selected 8. # # ο ∇ 6. Refer to IFU for further instruction.5 Wave Method Reaction Point 1 Point 2 380 RATE 27 Max OD H 2. # # ο ∇ 5. No.6 Main ∇ ∇ ∇ 340 Sub 1. Enzyme BSOSR6x29. # User defined * Values set for working in U/L. Linearity Fst No lag time NO Select using Space key.01 2009-08 . Reagent 1 vol Reagent 2 vol μL μL μL 3 75 75 Dil. H Lst.6 Reagent OD limit Fst. vol Dil. ∇ ∇ ∇ Sec. # # ο ∇ 7. Refer to IFU for further instruction. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. vol 0 0 0 ∇ Operation: Yes # Test name HBDH Sample type Ser Page 1/2 System Reagent: OSR6129 Reagent ID: 029 Application HBDH. # # ο ∇ 4. point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L.5 Fst. # # ο ∇ 3.5 2. OD H 2.0 Lst.5 2. AU400/AU640 Serum/Plasma Reagent ID: 029 Specific test parameters Test No ∇ Max. 380 ∇ Min.5 Pri.5 ∇ Serum ∇ 1 0. L 1. vol Dil. Out of Range L # # # # # # # # Panic value Unit: U/L* Decimal places: # H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H L # # # # # # # # L # H # # # # # # # # H # Panic Value: # # Select the function using the Function key or the Mouse Calibration specific Test No # Test name HBDH ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §8025* # ∇ Factor/OD-H §13375* Calibration Specific General ISE Serum ∇ Process: ∇ Factor/OD-H §13375* # SERUM/PLASMA APPLICATION Test Name: Counts: HBDH ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal. § OD CONC § Factor/OD-L §8025* 1-Point Cal.HBDH. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. OD L 0. H Sample vol.0 Dynamic range L 40* Correlation factor H A B Rate Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: On-board stability period 340 RATE First 12 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 1000* 1 0 ¤ % ∇ 30 Specific Test Parameters General LIH ISE Serum ∇ # # # # # # # Age Y Y Y Y Y Y Range Test Name: HBDH ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. 0 1. Not within expected values U/L* Decimal Places Calibration Specific ISE HBDH ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Range Low High §5850 §9750 ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H §9750* # Process: SERUM/PLASMA APPLICATION Test Name: HBDH ∇ < > Test Name: Use Serum Cal. # # ο ∇ 4. For No. § OD CONC § Factor/OD-L §5850* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. To work in SI units (µkat/L) divide by 60 For use in AB mode only. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. None Selected 8. Calibration Type: MB ∇ Formula: Y=AX=B ∇ Cal.0 1. Refer to IFU for further instruction.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank Day Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # * § Ф User defined Values set for working in U/L.3 R2(R2-1) μL Name Sec.5 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6129 Reagent ID: 029 Application Operation Yes HBDH. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x29.HBDH. AU680/AU480 Serum/Plasma Application System Reagent: OSR6129 Specific Test Parameters General LIH ISE Serum ∇ 1 1.5 63 63 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.3 High High Max. # # ο ∇ 5. ∇ # # # # ο 3.OD μL Min. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ ∇ 13 340 RATE First 13 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ + ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH HBDH ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # HBDH ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 7. ∇ ∇ ∇ 40* Sec. # # ο ∇ 3. ∇ # # # # ο 2.01 2009-08 . ∇ # # # # ο 4. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.3 1.5 2. AU680 <Point Cal. # # ο ∇ 6.5 2.5 2.5 1000* B 30 Last Last 27 15 YES % ∇ HBDH ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 2. ∇ # # # # ο 6. ∇ # # # # ο 5.5 1 63 Test Name: Max OD H 2. AU2700/AU5400 Serum/Plasma Reagent ID: 029 Parameters General LIH HBDH ∇ Dilution μL 1.5 2. ∇ 7. No. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 40* 1 1 μL High B B 0 1000* 0 0 Hour 63 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.3 1. # # ο ∇ 2. No demographics 8. Volume R1(R1-1) μL ∇ μL 2. reagents stored on board the instrument are stable for 30 days. dermatomyositis.01 2009-08 Enzyme . shock. catalyses the reversible oxidation of L-lactate to pyruvate using NAD as a hydrogen acceptor. Elevated LDH may also be seen in Aran-Duchenne and Kugelberg-Welander spinal muscular atrophy. EC 1. skeletal muscle.2 mmol/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. should be used for each of these runs. an NAD oxidoreductase. up to the stated expiry date when stored at 2…8°C. Determination of LDH is therefore a reliable method for quantification of the extent of haemolysis. Elevations are especially high (10 times upper limit of normal) in toxic hepatitis with jaundice. Myocardial infarction is usually associated with a 3-4 fold elevation of total LDH. The paediatric application is suitable for use with small volume serum/plasma samples. Because the concentration of LDH in the tissues is 500 times higher than that in plasma. The calibrator value is traceable to a Beckman Coulter Master Calibrator. + LDH catalyses the reduction of pyruvate to lactate at a neutral pH.27 (LDH) in human serum and plasma on Beckman Coulter analysers. utilising System Calibrator Cat No. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. The total LDH measurable in serum consists of the activities of the 5 isoenzymes LDH-1 to LDH-5 which are differentiated on the basis of their subunit composition. pulmonary embolism/infarction and haemolytic and megaloblastic anemias. After prosthetic valve replacement there is a close correlation between the LDH level and shortened erythrocyte survival time. In Duchenne muscular dystrophy elevations of LDH activity are found years before the appearance of clinical symptoms. For the AU2700/AU5400 this procedure needs to be performed for each ring. Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced. High specific activities of the enzyme are found in the liver. A fresh vial of calibrator. 5 Stable in serum for 4 days when stored at 2…8°C and 7 days when stored at 15…25°C. Reagent blank measurement is recommended when changing to a new lot of reagent. polymyositis and as a result of strenuous physical exercise. This reaction is coupled with the oxidation of NADH to NAD . Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.LDH OSR6126 Intended Use Kinetic UV test for the quantitative determination of lactate dehydrogenase. Haemolysed serum must not be used because erythrocytes contain 150 times more LDH activity than serum. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced. cardiac muscle. slightly lower levels are observed in viral hepatitis and infectious mononucleosis. damage to even a small amount of tissue can lead to a significant increase in the activity of LDH in serum.18 mmol/L 1. + + Test Principle4 Method based on the recommendations of the Scandinavian Committee on Enzymes. flush waste-pipes with water after the disposal of undiluted reagent. Once open. Other diseases that can cause an increased activation of LDH include renal infarction.3 Lactate dehydrogenase. Specimen Serum and heparinised plasma. kidneys and erythrocytes. in the course of the disease the activity can increase approximately 5 fold. 4 x 50 mL 4 x 25 mL R1 R2 Summary1. Calibration The test is run in MB-mode.01 BLOSR6x26. electrical cardioversion and prosthetic valve replacement. pH 7. it is recommended that 5 separate calibration events should be used. care should be taken to avoid contamination with platelets which contain high concentrations of LDH. unopened.1. To provide a robust approach to generate the analyser specific MB factor. Storage and Stability The reagents are stable. Reaction Principle Pyruvate + NADH + H + LDH Lactate + NAD + Contents. Reagent Composition in the Test Final concentration of reactive ingredients: Bis-Tris-Propane. Korean haemorrhagic fever.000 and is composed of 4 peptide chains of 2 types: M and H. Dispose of all waste material in accordance with local guidelines. It is present in all cells of the body and is invariably found only in the cytoplasm of the cell. Elevations of LDH activity are observed in liver damage. chronic glomerular disease. 66300 in the AB calibration mode. similar increases in LDH can occur in myocarditis. For in vitro diagnostic use only. Where plasma is used. The main role of total LDH is therefore in the detection of minor tissue damage.4 (37°C) NADH Pyruvate Preservative 25 mmol/L 0. but these elevations are not as great as the increases in aminotransferase activity.2. cardiac dysrhythmias. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. Separate serum from the clot as soon as possible. To avoid the possible build-up of azide compounds. The LDH/AST ratio can be used to differentiate between prehepatic jaundice caused by haemolysis or dyserythropoiesis from hepatic jaundice. The enzyme has a molecular weight of 134. The decrease of NADH is measured at 340 nm and is directly proportional to the enzyme activity in the sample.1. EN. Data obtained in your laboratory may differ from these values. Töpfer G. 4. 5th ed.47 SD 5. Heil W.3000 U/L (0. Scand J Clin Lab Invest 1974. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.8 on AU640 Values set for working in U/L. Wisser H.555. refer to leaflet for further instruction Thomas L. clinical examinations and other findings. In: Burtis CA. 2000.64 29. In:Thomas L.38.998 n = 82 Sample range = 211 – 700 U/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the LDH method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin ® Lipemia: Interference less than 5% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances.65 1. Reference Intervals2. Schmitt Y. Method Comparison Patient serum samples were used to compare this LDH OSR6126 assay on the AU600 against another commercially available LDH assay. If any trends or sudden shifts in values are detected. 2.1 Rev. ed.009x + 1 r = 0. Linearity The test is linear within an enzymatic activity range of 50 . Clinical laboratory diagnostics. Ashwood ER. Results of linear regression analysis were as follows: y = 1. 5. For use in AB mode only. The lowest detectable level represents the lowest measurable level of LDH that can be distinguished from zero.13 1.47 – 6. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Zawta B. AACC Press. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. et al. Effects of drugs on clinical laboratory tests.6 and reagent OD limit low at 0. Klin. For diagnostic purposes.96 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 5 U/L.0 µkat/L). Henderson RA.41 2. 7. review all operating parameters. 1999.668-673.02 39. n = 60 Mean U/L 116 402 1992 Within Run SD 2. To work in SI units (µkat/L) divide by 60. Age-Dependent Reference Limits in Plasma.01 2009-08 EN.22 CV% 2. Plasma and Serum Samples. diet and geographical location. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. sex. 7 Setting Sheet Footnotes # ‡ * § 1. Fischbach F. eds.11 Total CV% 4. results should always be assessed in conjunction with the patient's medical history. Lactate dehydrogenase (LD). Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood.2:36pp. ed.378 U/L (3. Ehret W.10 10.9 µkat/L) <975 U/L (16. Each laboratory should verify the transferability of the expected values to its own population. and if necessary determine its own reference interval according to good laboratory practice. User defined ¤ Analyser default value Set min OD at 0. Zawta B.1 µkat/L) <1732 U/L (28. Clinical guide to laboratory tests. Tietz NW.46 6. No.49 1. sample type.01 . Lab 1992. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.1995:384-385. Calculation The Beckman Coulter analysers automatically compute the LDH activity of each sample.6 Adult Children 1 day 2 − 5 day 6 day − 6 month 4 − 6 year 208 . Frankfurt/Main: TH-Books Verlagsgesellschaft. Tietz textbook of clinical chemistry.Quality Control Controls Cat. Young DS.8 – 50. 3. Moss DW.30 µkat/L) <1327 U/L (22.3 µkat/L) <615 U/L (10. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. Clinical enzymology. 1998:89-94. 3rd ed. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. BIBLIOGRAPHY Enzyme BLOSR6x26. WHO/DIL/LAB/99.3 µkat/L) Expected values may vary with age. Recommended methods for the determination of four enzymes in blood. Philadelphia:WB Saunders Company. The Committee on Enzymes of the Scandinavian Society for Clinical Chemistry and Clinical Physiology. Use and assessment of clinical laboratory results. 6. Philadelphia: WB Saunders Company.33:291-306. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems. The results obtained by any individual laboratory may vary from the given mean value. H Lst. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name LDH26 Sample type Ser ∇ On-board stability period 340 RATE First 12 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. # # ο ∇ 7.7‡ Main ∇ ∇ ∇ 340 Sub 1. 380 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.0‡ 1.5 2. Vol Dil. AU600 Serum/Plasma Application System Reagent: OSR6126 Specific Test Parameters General LIH ISE Range Test Name: LDH26 ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 100 50 μL μL μL Dilution Dilution Dilution 0 25 75 μL μL μL Pri. # # ο ∇ 5. # # ο ∇ 2. # # ο ∇ 3. Point: ο With CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 2.01 2009-08 # ‡ * § User defined Set min OD at 0. § OD CONC § Factor/OD-L §13230* 1-Point Cal. H 3000* Fst Fst 12 Lst Lst First H Last H 2. refer to IFU for further instruction BSOSR6x26.5 2. None Selected 8.0‡ 50* B 30 Linearity Fst No lag time 15 % Sec 0 NO % ∇ 0 Sample Pre-dil.5 Fst.5 380 RATE 27 Max OD H 2.LDHP (SCE). Reagent 1 vol Reagent 2 vol μL μL μL 3 100 50 Dil. No. L 0.6 and reagent OD limit low at 0. L 0. # # ο ∇ 6. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name LDH26 ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §13230* # ∇ Factor/OD-H §19840* Calibration Specific General ISE Serum ∇ Process: ∇ Factor/OD-H §19840* # SERUM/PLASMA APPLICATION Test Name: Counts: LDH26 ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal.6 Reagent OD limit Fst.5 ∇ # Test name LDH26 Sample type Ser Page ½ System Reagent: OSR6126 Reagent ID: 026 Application LDHP (SCE). # # ο ∇ 4. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. H Sample vol. OD L 0.8 on AU640 Values set for working in U/L. ∇ ∇ ∇ Sec. Vol Dil. To work in SI units (µkat/L) divide by 60 For use in AB mode only.8 Dynamic range L 50* Correlation factor % ∇ 3000* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: LDH26 ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Vol 0 25 75 Max. Point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. OD H ∇ Operation: Yes Test No ∇ 2. AU400/AU640 Serum/Plasma Reagent ID: 026 Specific test parameters Serum ∇ 1 0. refer to IFU for further instruction Enzyme .8 Lst. ∇ # # # # ο 6.25 1. No. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ ∇ 13 340 RATE First 13 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ + ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH LDH26 ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # LDH26 ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.OD μL Min.8 1 60 Test Name: Max OD H 2.5 3000* B 30 Last Last 27 15 YES % ∇ LDH26 ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 1. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. ∇ # # # # ο 3.5 2.8 60 30 μL μL μL Dilution Dilution Dilution 0 15 45 μL μL μL Pri. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x26.OD Reagent OD Limit First Low Last Low Dilution 15 0 OD Limit 2.5 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6126 Reagent ID: 026 LDHP (SCE). ∇ # # # # ο 4. # # ο ∇ 2. ∇ # # # # ο 2.5 2.Serum/Plasma Application Reagent ID: 026 Parameters General LIH LDH26 ∇ Dilution μL 0. AU2700/AU5400 System Reagent: OSR6126 Operation Yes LDHP (SCE). # # ο ∇ 5. # # ο ∇ 4. # # ο ∇ 3. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank Day Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # * § ф User defined Values set for working in U/L. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.5 2. ∇ ∇ ∇ 50* Sec. # # ο ∇ 6.5 2.25 R2(R2-1) μL Name Sec. Volume R1(R1-1) μL ∇ μL 1. refer to IFU for further instruction AU680 <Point Cal. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. AU680/AU480 Serum/Plasma Application Specific Test Parameters General LIH ISE Serum ∇ 1 0. ∇ # # # # ο 5.25 High High Max. None Selected 8.8 1. For No.01 2009-08 . Not within expected values U/L* Decimal Places Calibration Specific ISE LDH26 ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Range Low High §10700* §16060* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H §16060* # Process: SERUM/PLASMA APPLICATION Test Name: LDH26 ∇ < > Test Name: Use Serum Cal. § OD CONC § Factor/OD-L §10700* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. To work in SI units (µkat/L) divide by 60 For use in AB mode only. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 50* 1 1 μL High B B 0 3000* 0 0 Hour 30 Dilution 45 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. No demographics 8.25 1. ∇ 7.8 1. # # ο ∇ 7. vol 10 25 65 Max.5 2. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name LD26P ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §13230* # ∇ Factor/OD-H §19840* PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: ∇ Factor/OD-H §19840* # Test Name: Counts: LD26P ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ Cal. # # ο ∇ 4.01 2009-08 # ‡ * § User defined Set min OD at 0. § OD CONC § Factor/OD-L §13230* 1-Point Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 ∇ # Test name LD26P Sample type Ser Page 1/2 System Reagent: OSR6126 Reagent ID: 026 Application LDHP (SCE). refer to IFU for further instruction BSOSR6x26.8 Lst. To work in SI units (µkat/L) divide by 60 For use in AB mode only. Reagent 1 vol Reagent 2 vol μL μL μL 3 100 50 Dil.0‡ 50* B 30 Linearity Fst No lag time 15 % Sec 0 NO % ∇ 0 Sample Pre-dil. vol Dil.7‡ Main ∇ ∇ ∇ 340 Sub 1. 380 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.5 2.8 Dynamic range L 50* Correlation factor % ∇ 3000* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: LD26P ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. AU400/AU640 Paediatric Reagent ID: 026 Specific test parameters Serum ∇ 1 0. # # ο ∇ 2. point MB type factor Calibrator stability period # Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in U/L. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name LD26P Sample type Ser ∇ On-board stability period 340 RATE First 12 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. AU600 Paediatric Application System Reagent: OSR6126 Specific Test Parameters General LIH ISE Range Test Name: LD26P ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 100 50 μL μL μL Dilution Dilution Dilution 10 25 65 μL μL μL Pri. H Lst. vol Dil. No. # # ο ∇ 5. OD H ∇ Operation: Yes Test No ∇ 2. L 0. H 3000* Fst Fst 12 Lst Lst First H Last H 2.5 380 RATE 27 Max OD H 2. None Selected 8.6 Reagent OD limit Fst. OD L 0. # # ο ∇ 7. ∇ ∇ ∇ Sec. # # ο ∇ 6.8 on AU640 Values set for working in U/L. L 0.LDHP (SCE). refer to IFU for further instruction Enzyme .0‡ 1. To work in SI units (µkat/L) divide by 60 § For use in AB mode only.5 Fst. H Sample vol.5 2. # # ο ∇ 3.6 and reagent OD limit low at 0. ∇ # # # # ο 5. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x26.01 2009-08 . Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal.8 1. refer to IFU for further instruction AU680 <Point Cal.OD Reagent OD Limit First Low Last Low Dilution 15 10 OD Limit 2. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 50* 1 1 μL High B B 0 3000* 0 0 Hour 30 Dilution 35 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. # # ο ∇ 4. ∇ # # # # ο 4. # # ο ∇ 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ ∇ 13 340 RATE First 13 First 15 YES Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ + ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH LD26P ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # LD26P ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.25 1.5 3000* B 30 Last Last 27 15 YES % ∇ LD26P ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 1. ∇ # # # # ο 2.8 1 60 Test Name: Max OD H 2. Not within expected values U/L* Decimal Places Calibration Specific ISE LD26P ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Range Low High §10700* §16060* ∇ # ο ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H §16060* # Process: Test Name: LD26P ∇ < > Test Name: Use Serum Cal.25 High High Max. # # ο ∇ 3. AU2700/AU5400 Paediatric Reagent ID: 026 Parameters General LIH LD26P ∇ Dilution μL 0.5 2. No. § OD CONC § Factor/OD-L §10700* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal.8 1. ∇ # # # # ο 6. # # ο ∇ 6. ∇ 7. # # ο ∇ 5.LDHP (SCE). No demographics 8. ∇ # # # # ο 3. None Selected 8. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank Day Calibration Day MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # * § ф User defined Values set for working in U/L.5 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6126 Reagent ID: 026 Application Operation Yes LDHP (SCE).5 2.25 1.5 2.5 2. To work in SI units (µkat/L) divide by 60 For use in AB mode only.25 R2(R2-1) μL Name Sec.8 60 30 μL μL μL Dilution Dilution Dilution 10 15 35 μL μL μL Pri. ∇ ∇ ∇ 50* Sec. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.OD μL Min. AU680/AU480 Paediatric Application System Reagent: OSR6126 Specific Test Parameters General LIH ISE Serum ∇ 1 0. Volume R1(R1-1) μL ∇ μL 1. For No. # # ο ∇ 7. Calibration The test is run in MB-mode. Specimen Serum and heparinsied plasma. A fresh vial of calibrator. similar increases in LDH can occur in myocarditis. Dispose of all waste material in accordance with local guidelines.01 BLOSR6x28. Storage and Stability The reagents are stable. This material and its container must be disposed of as hazardous waste. + LDH catalyses the oxidation of lactate to pyruvate coupled with the reduction of NAD to NADH. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. unopened. For the AU2700/AU5400 this procedure needs to be performed for each ring. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. The paediatric application is suitable for use with small volume serum/plasma samples. It is present in all cells of the body and is invariably found only in the cytoplasm of the cell. Myocardial infarction is usually associated with a 3-4 fold elevation of total LDH. Where plasma is used. Safety Phrases: S24. Separate serum from the clot as soon as possible. skeletal muscle. polymyositis and as a result of strenuous physical exercise. S37. cardiac muscle. catalyses the reversible oxidation of L-lactate to pyruvate using NAD as a hydrogen acceptor. To provide a robust approach to generate the analyser specific MB factor. dermatomyositis. Avoid contact with skin. contains a mixture of 5-chloro-2-methyl-4-isothiazolin-3-one [EC No 247-500-7] and 2-methyl-4-isothiazolin-3-one [EC No 220-239-6] (3:1). For in vitro diagnostic use only.27 (LDH) in human serum and plasma on Beckman Coulter analysers. an NAD oxidoreductase. Haemolysed samples must not be used because erythrocytes contain 150 times more LDH activity than serum/plasma. The total LDH measurable in serum consists of the activities of the 5 isoenzymes LDH-1 to LDH-5 which are differentiated on the basis of their subunit composition. The LDH/AST ratio can be used to differentiate between prehepatic jaundice caused by haemolysis or dyserythropoiesis from hepatic jaundice. EN. Korean haemorrhagic fever. + + Test Principle4 Method based on the recommendations of the “International Federation of Clinical Chemistry” (IFCC). shock. Because the concentration of LDH in the tissues is 500 times higher than that in plasma. kidneys and erythrocytes.000 and is composed of 4 peptide chains of 2 types: M and H. but these elevations are not as great as the increases in aminotransferase activity. S60. damage to even a small amount of tissue can lead to a significant increase in the activity of LDH in serum. Reagent Composition in the Test Final concentration of reactive ingredients: D(-)N-Methylglucamin buffer.LDH OSR6128 Intended Use Kinetic UV test for the quantitative determination of lactate dehydrogenase. R43. electrical cardioversion and prosthetic valve replacement. 5 Stable in serum for 4 days when stored at 2…8°C and 7 days when stored at 15…25°C. High specific activities of the enzyme are found in the liver. care should be taken to avoid contamination with platelets which contain high concentrations of LDH. 4 x 40 mL 4 x 20 mL R1 R2 Summary1. May cause sensitisation by skin contact. Elevations of LDH activity are observed in liver damage. slightly lower levels are observed in viral hepatitis and infectious mononucleosis.1. pulmonary embolism/infarction and haemolytic and megaloblastic anemias. Other diseases that can cause an increased activation of LDH include renal infarction. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. 66300 in the AB calibration mode. The increase of NADH is measured at 340nm and is directly proportional to the enzyme activity in the sample. The enzyme has a molecular weight of 134.01 2009-08 Enzyme .utilising System Calibrator Cat No.2. Once open. Determination of LDH is therefore a reliable method for quantification of the extent of haemolysis. up to the stated expiry date when stored at 2…8°C. cardiac dysrhythmias. EC 1. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced. In Duchenne muscular dystrophy elevations of LDH activity are found years before the appearance of clinical symptoms. reagents stored on board the instrument are stable for 30 days. Reaction Principle + Lactate + NAD LDH + Pyruvate + NADH + H Contents.3 Lactate dehydrogenase. After prosthetic valve replacement there is a close correlation between the LDH level and shortened erythrocyte survival time. Elevations are especially high (10 times upper limit of normal) in toxic hepatitis with jaundice.4 (37°C) Lactate + NAD Preservative 325 mmol/L 50 mmol/L 10 mmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: R1 and R2 reagents: Irritant. Elevated LDH may also be seen in Aran-Duchenne and Kugelberg-Welander spinal muscular atrophy. it is recommended that 5 separate calibration events should be used. Wear suitable gloves. in the course of the disease the activity can increase approximately 5 fold. chronic glomerular disease. The main role of total LDH is therefore in the detection of minor tissue damage. should be used for each of these runs.1. Refer to Safety Data Sheets for further information. pH 9. Effects of drugs on clinical laboratory tests. results should always be assessed in conjunction with the patient's medical history. Philcox M.92 μkat/L) 545 − 2000 U/L (9. and if necessary determine its own reference interval according to good laboratory practice. Calculation The Beckman Coulter analysers automatically compute the lactate dehydrogenase activity of each sample. 7. 2.2 μkat/L) 110 − 295 U/L (1. Schumann G.78 2. The lowest detectable level represents the lowest measurable level of LDH that can be distinguished from zero. n = 60 Mean U/L 157 237 430 Within Run SD 1. Wisser H. IFCC method for lactate dehydrogenase.549 U/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 μmol/L bilirubin ® Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances. Moss DW. Method Comparison Patient serum samples were used to compare this LDH OSR6128 assay on the AU640 against the IFCC reference method. review all operating parameters. eds. Henderson RA. Heil W. Philadelphia:WB Saunders Company. Reference information for the clinical laboratory. Eur J Clin Chem Clin Biochem 1994. diet and geographical location. 5th ed.92 μkat/L) Expected values may vary with age.36 1.23 6. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Each laboratory should establish its own control frequency. WHO/DIL/LAB/99. Clinical guide to laboratory tests.83 – 12. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Clinical enzymology. clinical examinations and other findings. Lactate dehydrogenase (LD). Philadelphia:WB Saunders Company. For diagnostic purposes. User defined ¤ Analyser default value Values set for working in U/L. Tietz textbook of clinical chemistry. Good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed.54 1.1 – 33. New IFCC reference procedures for the determination of catalytic activity concentrations of five enzymes in serum: preliminary upper reference limits obtained in hospitalised subjects. Töpfer G. Data obtained in your laboratory may differ from these values. Smith JL. Ashwood ER. In: Burtis CA. 1999. Cope JY. Depends on usage pattern in the laboratory. Part 8.1822pp. Klauke R. Young DS.43 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 3 U/L.13 μkat/L) 290 − 775 U/L (4.32:639-55. Each laboratory should verify the transferability of the expected values to its own population. 2000.1 Rev. 8 Setting Sheet Footnotes # * § ‡ 1.13 0. Frankfurt/Main: THBooks Verlagsgesellschaft.12 3. No. eds.16 Total CV% 1.989 n = 111 Sample range = 73 .0 µkat/L).12 μkat/L) < 248 U/L (4. Use and assessment of clinical laboratory results.011x + 5. Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood. ed.42 3.2:36pp. sample type. 1998:89-94.83 – 4. In: Thomas L. If any trends or sudden shifts in values are detected. In: Burtis CA. 4. Bais R. sex.668-673. Reagent blank measurement is recommended when changing to a new lot of reagent. 3.01 2009-08 EN. 8. Tietz NW. Quality Control Controls Cat. Plasma and Serum Samples. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. ed.4 .01 . International Federation of Clinical Chemistry (IFCC) Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes.76 SD 2. Limitations Highly lipemic samples may exceed the reaction absorbance and will be flagged with a “@”.89 0. Thomas L. Reference Intervals6. Re-establishment of the analyser specific MB factor is recommended when a critical part of the analyser is replaced. 6.The calibrator value is traceable to the IFCC reference method and IRMM/IFCC-453.1200 U/L (0.1995:385pp.0 – 7. Ehret W. 1999. Painter PC. Linearity The test is linear within an enzyme activity range of 25 . To work in SI units (μkat/L) divide by 60.7 Female Male Children 0 − 4 day 4 − 10 day 10 day − 24 month 24 month − 12 year < 247 U/L (4. Clin Chim Acta 2003. 3rd ed.192 r = 0. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. Schmitt Y. Clinical laboratory diagnostics. Such samples should be diluted and re-run.28 CV% 1. Zawta B. For use in AB mode only. Values obtained for the controls should fall within specified limits as defined by the user. Ashwood ER. et al.3 μkat/L) 180 − 430 U/L (3. Results of linear regression analysis were as follows: y = 1. AACC Press. Philadelphia: WB Saunders Company. BIBLIOGRAPHY Enzyme BLOSR6x28.20. 5.327:69-79. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. refer to leaflet for further instruction. Tietz textbook of clinical chemistry. Reagent 1 vol Reagent 2 vol μL μL μL 3 80 40 Dil. Point MB type factor Calibrator stability period # ‡ Select the function using the Function key or the Mouse # * § ‡ BSOSR6x28. Vol 0 0 40 Max.LDH (IFCC). L -0. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name LDH28 Sample type Ser ∇ On-board stability period 340 RATE + First 14 First 15 NO Last Last 23 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. # # ο ∇ 2. No. Depends on usage pattern in the Laboratory Enzyme .5 0. 380 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. Depends on usage pattern in the Laboratory # * § ‡ User defined Values set for working in U/L. L -0.1 Dynamic range L 25* Correlation factor % ∇ 1200* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: LDH28 ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. AU600 Serum/Plasma Application System Reagent: OSR6128 Specific Test Parameters General LIH ISE Range Test Name: LDH28 ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 80 40 μL μL μL Dilution Dilution Dilution 0 0 40 μL μL μL Pri. ∇ ∇ ∇ Sec.8 Fst. AU400/AU640 Serum/Plasma Reagent ID: 028 Specific test parameters Serum ∇ 1 -0. # # ο ∇ 5. § OD CONC § Factor/OD-L §8500* 1-Point Cal. H Sample vol. Vol Dil.5 380 RATE + 23 Max OD H 0. To work in SI units (µkat/L) divide by 60 For use in AB mode only. # # ο ∇ 4. refer to IFU for further instruction.1 Main ∇ ∇ ∇ 340 Sub -0. To work in SI units (µkat/L) divide by 60 For use in AB mode only. None Selected 8.1 -0. OD H ∇ Operation: Yes Test No ∇ 0.1 25* B 30 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil. # # ο ∇ 3. refer to IFU for further instruction. Vol Dil.01 2009-08 User defined ¤ Analyser default value Values set for working in U/L. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name LDH28 ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §8500* # ∇ Factor/OD-H §12800* Calibration Specific General ISE Serum ∇ Process: ∇ Factor/OD-H §12800* # SERUM/PLASMA APPLICATION Test Name: Counts: LDH28 ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ Cal.1 Lst. OD L -0.8 0. H Lst.1 Reagent OD limit Fst. # # ο ∇ 7. H 1200* Fst Fst 14 Lst Lst First H Last H 0.5 0. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ο ∇ 6.5 ∇ # Test name LDH28 Sample type Ser Page ½ System Reagent: OSR6128 Reagent ID: 028 Application LDH (IFCC). # # ο ∇ 7. To work in SI units (µkat/L) divide by 60 § For use in AB mode only.OD Reagent OD Limit First Low Last Low Dilution 21 0 OD Limit 1. For No. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.1 -0.1 -0. ‡ Depends on usage pattern in the Laboratory ф AU680 <Point Cal. # # ο ∇ 2.1 High High Max. § OD CONC § Factor/OD-L §6900* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.6 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6128 Reagent ID: 028 Application Operation Yes LDH (IFCC).7 0. ∇ # # # # ο 3. No. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. ∇ # # # # ο 6. None Selected 8. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 25* 1 1 μL High B B 0 1200* 0 0 Hour 31 Dilution 10 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. ∇ # # # # ο 5. # # ο ∇ 6.3 62 31 μL μL μL Dilution Dilution Dilution 0 21 10 μL μL μL Pri. # # ο ∇ 5.LDH (IFCC). Volume R1(R1-1) μL ∇ μL 2. AU680/AU480 Serum/Plasma Application System Reagent: OSR6128 Specific Test Parameters General LIH ISE Serum ∇ 1 -0. # # ο ∇ 4. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration ‡ Day ‡ MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined * Values set for working in U/L.7 0.1 R2(R2-1) μL Name Sec. ∇ ∇ ∇ 25* Sec. # # ο ∇ 3. ∇ 7.6 0. ∇ # # # # ο 2. AU2700/AU5400 Serum/Plasma Reagent ID: 028 Parameters General LIH LDH28 ∇ Dilution μL -0.OD μL Min. ∇ # # # # ο 4. refer to IFU for further instruction.1 -0.01 2009-08 . Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ + ∇ 15 340 RATE + First 15 First 15 NO Last Last 23 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ + ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH LDH28 ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # LDH28 ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.6 1200* B 30 Last Last 23 15 NO % ∇ LDH28 ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 2. Not within expected values U/L* Decimal Places Calibration Specific ISE LDH28 ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Range Low High §6900* §11640* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H §11640* # Process: SERUM/PLASMA APPLICATION Test Name: LDH28 ∇ < > Test Name: Use Serum Cal. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x28.1 -0.3 1 62 Test Name: Max OD H 1. No demographics 8.6 0. # # ο ∇ 7.5 ∇ # Test name LD28P Sample type Ser Page 1/2 System Reagent: OSR6128 Reagent ID: 028 Application LDH (IFCC). None Selected 8.LDH (IFCC).8 Fst. # # ο ∇ 6. ∇ ∇ ∇ Sec. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name LD28P ∇ MB ∇ Y=AX+B OD ∇ Conc § Count Process Factor/OD-L §8500* # ∇ Factor/OD-H §12800* PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: ∇ Factor/OD-H §12800* # Test Name: Counts: LD28P ∇ < > Type Calibration Type: MB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: # Calibration Stability Period: Cal type 1 Formula 1 Selection calibrator Cal No Point 1 § ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.1 Main ∇ ∇ ∇ 340 Sub -0.1 Dynamic range L 25* Correlation factor % ∇ 1200* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: LD28P ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 380 RATE + 23 Max OD H 0.1 25* B 30 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil. § OD CONC § Factor/OD-L §8500* 1-Point Cal. refer to IFU for further instruction. No.8 0.1 Lst. # # ο ∇ 4. vol Dil. AU600 Paediatric Application System Reagent: OSR6128 Specific Test Parameters General LIH ISE Range Test Name: LD28P ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 80 40 μL μL μL Dilution Dilution Dilution 10 0 30 μL μL μL Pri. refer to IFU for further instruction. To work in SI units (µkat/L) divide by 60 For use in AB mode only. vol Dil.1 -0. 380 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. H Lst. L -0. vol 10 0 30 Max. OD H ∇ Operation: Yes Test No ∇ 0. AU400/AU640 Paediatric Reagent ID: 028 Specific test parameters Serum ∇ 1 -0. point MB type factor Calibrator stability period # ‡ Select the function using the Function key or the Mouse # * § ‡ BSOSR6x28. Reagent 1 vol Reagent 2 vol μL μL μL 3 80 40 Dil. L -0. # # ο ∇ 3. H 1200* Fst Fst 14 Lst Lst First H Last H 0. # # ο ∇ 2.5 0. To work in SI units (µkat/L) divide by 60 For use in AB mode only.5 0. Depends on usage pattern in the Laboratory # * § ‡ User defined Values set for working in U/L.01 2009-08 User defined ¤ Analyser default value Values set for working in U/L. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name LD28P Sample type Ser ∇ On-board stability period 340 RATE + First 14 First 15 NO Last Last 23 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. H Sample vol.1 Reagent OD limit Fst. OD L -0. Depends on usage pattern in the Laboratory Enzyme . # # ο ∇ 5. OD Reagent OD Limit First Low Last Low Dilution 11 10 OD Limit 1. Not within expected values U/L* Decimal Places Calibration Specific ISE LD28P ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Range Low High §6900* §11640* ∇ # ο ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H §11640* # Process: Test Name: LD28P ∇ < > Test Name: Use Serum Cal. AU680/AU480 Paediatric Application System Reagent: OSR6128 Specific Test Parameters General LIH ISE Serum ∇ 1 -0. # # ο ∇ 2.3 62 31 μL μL μL Dilution Dilution Dilution 10 11 10 μL μL μL Pri.1 High High Max. ∇ # # # # ο 3. # # ο ∇ 6.6 0. ∇ ∇ ∇ 25* Sec.1 -0. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 25* 1 1 μL High B B 0 1200* 0 0 Hour 31 Dilution 10 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. No demographics 8.1 -0.3 1 62 Test Name: Max OD H 1. Calibration Type: MB ∇ Formula: Y=AX+B ∇ Cal. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. For No. To work in SI units (µkat/L) divide by 60 § For use in AB mode only. ∇ # # # # ο 4. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. # # ο ∇ 3. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x28.OD μL Min. No.1 R2(R2-1) μL Name Sec.7 0. refer to IFU for further instruction. # # ο ∇ 5.LDH (IFCC).1 -0. ∇ 7. ∇ # # # # ο 6. ‡ Depends on usage pattern in the Laboratory ф AU680 <Point Cal. None Selected 8. § OD CONC § Factor/OD-L §6900* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal.6 0. AU2700/AU5400 Paediatric Reagent ID: 028 Parameters General LIH LD28P ∇ Dilution μL -0. Volume R1(R1-1) μL ∇ μL 2. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration ‡ Day ‡ MB Type Factor: # 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: MB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: § § ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined * Values set for working in U/L. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ + ∇ 15 340 RATE + First 15 First 15 NO Last Last 23 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ + ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH LD28P ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # LD28P ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.6 1200* B 30 Last Last 23 15 NO % ∇ LD28P ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 2. # # ο ∇ 7.6 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6128 Reagent ID: 028 Application Operation Yes LDH (IFCC). ∇ # # # # ο 2.1 -0. ∇ # # # # ο 5.7 0.01 2009-08 . # # ο ∇ 4. 2 Lipase is produced in the acinar cells of the pancreas and is responsible for the hydrolysis of water-insoluble long chain fatty acid esters of glycerol. cholecystitis. and ileus. Test Principle3 Pancreatic lipase hydrolyses esters of long chain fatty acids from their triglycerides.25 mmol/L TAPS (pH 8. duodenal diverticulum. glycerol kinase (GK). Biological materials of human origin contained in this product were tested for Anti-HCV. Mix gently by inversion and place on board the instrument. acute episodes of chronic pancreatitis and obstructive pancreatitis. Reagent Composition in the Test Buffer MES/BES (pH 6.0 mol/L Co-lipase > 15 kU/L GPO > 15 kU/L ATP > 0.3 mL 30 mL 10 mL R1 Buffer R1 Lyo R2 Calibrator R1 Buffer R1 Lyo R2 Calibrator OSR6230 2x Intended Use Kinetic colour test for the quantitative determination of lipase in human serum and plasma on Beckman Coulter analysers. hyperlipasemia of up to 5 times the upper reference limit may be found in penetrating duodenal ulcer. where there is pancreatic involvement. flush waste-pipes with water after the disposal of undiluted reagent. or treatment with opiates. The enzyme activity requires the presence of co-lipase. may also result in serum lipase elevation.2-Diglyceride is hydrolysed to 2-Monoglyceride and fatty acid. glycerol phosphate oxidase (GPO) and peroxidase (POD). this product should be handled as a potentially infectious material. Serum lipase may be elevated in acute pancreatitis. To avoid the possible build-up of azide compounds.2-Diglyceride + H2O 2-Monoglyceride + H2O Glycerol + ATP Glycerol-3-phosphate + O2 2 H2O2 + 4-aminophenazone + TOOS Lipase MGLP GK GPO POD 2-Monoglyceride + fatty acid Glycerol + fatty acid Glycerol-3-phosphate + ADP Dihydroxyacetone-P + H2O2 Quinonediimine-dye + 4 H2O Contents. viral hepatitis. In acute upper quadrant abdominal syndrome. For in vitro diagnostic use only.04 mmol/L Monoglyceride lipase > 400 U/L Glycerol kinase > 100 U/L POD > 500 U/L 4-Aminophenazone 0. usually pancreatitis.2-Diglyceride substrate 0. R2 is ready for use and can be placed directly on board the instrument. Lipase levels are also elevated in renal insufficiency. due to involvement of the pancreas. Summary1. Reaction Principle 1. However it should be noted that the severe destruction of the acinar cells in the later stages of chronic pancreatitis results in a reduction of the amount of enzyme entering the circulation. Pancreatic specific 1.LIPASE OSR6130 4x 4x 4x 2x 4x 4x 4x 10 mL 3.01 BLOSR6x30. abdominal typhoid and sarcoidosis. particularly where dialysis is required. Safety data sheet available for professional user on request. Investigation of the biliary tract by endoscopic retrograde pancreatography. epidemic parotiditis. with levels up to 80 times the upper reference limit found in acute serious inflammation.7) 50 mmol/L TOOS 1. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive.01 2009-08 Enzyme . As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Lipase measurement in serum and plasma is used exclusively for the investigation of pancreatic disorders.8) 27 mmol/L 1. Reagent Preparation R1: Dissolve the contents of one vial of R1 Lyo completely with the contents of one vial of R1 buffer.85 mol/L Preservative Calibrator: Human serum containing porcine lipase. EN. Marginal or no increase of lipase is therefore not unusual in this disease. The 2-Monoglyceride is then measured by coupled enzyme reactions catalysed by monoglyceride lipase (MGLP). Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. Slight elevations are also frequently present in diabetic ketoacidosis. Dispose of all waste material in accordance with local guidelines. 68 2. n = 60 Mean U/L 25 51 242 Within Run SD 0. The calibrator value is traceable to a Beckman Coulter master calibrator. 4. Major preventative maintenance was performed on the analyser or a critical part was replaced. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. up to the stated expiry date when stored at 2.0 mL.51 Total CV% 3. sex.12 – 0. Add 3. and if necessary determine its own reference interval according to good laboratory practice. Storage and Stability The reagents are stable.28 Sensitivity The lowest detectable level on an AU600 analyser was calculated as 1 U/L. Results of linear regression analysis were as follows: y = 0. unopened. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used.13 µkat/L) 5 – 31 U/L (0. 4 Stable in serum and plasma for 3 weeks when stored at 2…8°C and 7 days when stored at 15…25°C. diet and geographical location..79 CV% 1. avoiding any loss of lyophilised material.Calibrator Preparation 1. 5. No.8°C.45 0.01 2009-08 EN. Enzyme BLOSR6x30. sample type. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.30 5.42 0.. No.0 mL of sterile deionised water at 15…25°C to the lyophilised material using a volumetric pipette calibrated to deliver exactly 3.83 1..: 66300 instructions for use for further information. reagents stored on board the instrument are stable for 21 days. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Reconstituted lipase calibrator is stable for 60 days when stored at 2. Specimen Serum and EDTA or heparinised plasma. Each laboratory should verify the transferability of the expected values to its own population.74 SD 0. Quality Control Controls Cat. Data obtained in your laboratory may differ from these values.999 n = 84 Sample range = 5 – 715 U/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Ascorbate: Icterus: Haemolysis: Lipemia: Interference less than 5% up to 20 mg/dL ascorbate Interference less than 10% up to 12 mg/dL or 205 µmol/L bilirubin Interference less than 10% up to 5 g/L haemoglobin ® Interference less than 10% up to 80 mg/dL Intralipid 7 In very rare cases gammopathy. Continue mixing until the solution is homogeneous and all lyophilized material is reconstituted. Note: System Calibrator Cat. dissolve the contents completely by gently mixing for 30 minutes. clinical examinations and other findings. unopened. Reference Intervals Adult 6 Children 5 < 1y 1 – 9y 10 – 18y < 67 U/L (< 1. Good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Once open or prepared. Calibration Calibrator provided in the kit: For value assigned to the calibrator provided in the kit. may cause unreliable results. Record the date the calibrator was reconstituted on the bottle label. No.72 1.91 1. For diagnostic purposes. Each laboratory should establish its own control frequency.. Calculation The Beckman Coulter analysers automatically compute the lipase activity of each sample. Carefully remove the cap and rubber stopper from the bottle.65 µkat/L) Expected values may vary with age.56 2.984x – 3 r = 0.8°C. Method Comparison Patient serum samples were used to compare this Lipase OSR6130 assay on the AU600 against another commercially available lipase assay.01 . The lipase calibrator is stable. please refer to bottle label. Refer to System Calibrator Cat.52 µkat/L) 7 – 39 U/L (0. With the rubber stopper back in place.8°C. Recalibrate the assay every 7 days. results should always be assessed in conjunction with the patient's medical history.08 – 0. 2.: 66300 can also be used.. The lowest detectable level represents the lowest measurable level of lipase that can be distinguished from zero. Refer to Young for further information on interfering substances. Lipemic and icteric samples should be avoided. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. Linearity The test is linear within an enzyme activity range of 3 – 600 U/L (0. 3. review all operating parameters.12 µkat/L) 0 – 8 U/L (0 – 0.. Avoid foaming. If any trends or sudden shifts in values are detected. or when the following occur: Change in reagent bottle number or significant shift in control values. especially monoclonal IgM (Waldenström’s macroglobulinemia). Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. Values obtained for the controls should fall within specified limits as defined by the user. up to the stated expiry date when stored at 2.05 – 10 µkat/L). Imamura S. 2005:113-117. Schmitt Y. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. Lipase.2:36pp. An enzymatic method using 1. Henderson RA. WHO/DIL/LAB/99.1 Rev. AACC Press. Zawta B. 7. et al. Clin Chem 1989.Channel 2 and HDL – Channel 3. Philadelphia:WB Saunders Company. Takao K. EN.01 2009-08 Enzyme . 35:1126. Data on File. Lorentz K. Lipase. 1999. Clinical Enzymology. In:Thomas L. it is recommended that the programming of these tests is set up such that Lipase is the first test to be run followed by LDL and then HDL. For AU400/AU480/AU640/AU680 customers who use Lipase OSR6x30. BIBLIOGRAPHY 1. In:Thomas L. Arai T. In: Burtis CA. Frankfurt/Main: TH-Books Verlagsgesellschaft. refer to leaflet for further instruction. Töpfer G. Moss DW. 2000. 5th ed. 3. plasma and serum samples. Effects of drugs on clinical laboratory tests.Limitations Carry over from Triglyceride. For example: Lipase – Channel 1. Clinical laboratory diagnostics. Values set for working in U/L. 4. ed. eds. Indikation und bewertung von laborbefunden für die medizinische diagnostik. Heil W. Ashwood ER. 2. Young DS. HDL-Cholesterol and LDL-Cholesterol reagents to Lipase reagent results in elevated lipase values. All other tests can be programmed in the remaining test channels. Use and assessment of clinical laboratory results. Tietz textbook of clinical chemistry. Ehret W. 1998:95-97.2-Diglyceride for pancreatic lipase test in serum. Labor und Diagnose. Setting Sheet Footnotes # † * User defined ¤ Analyser default value For use in AB mode only. 5. Hirayama T. 698-704. Misaki H. hrsg. Wisser H. Lorentz K. LDL .01 BLOSR6x30. 6. HDL-Cholesterol OSR6x87 and LDL-Cholesterol OSR6x83. Frankfurt/Main: TH-Books Verlagsgesellschaft. Please refer to contamination parameters. To work in SI units (µkat/L) divide by 60. . 1 3* B 21 Linearity Fst No lag time NO 15 % Sec % ∇ 0 Sample Pre-dil. AU400/AU640 Serum/Plasma Reagent ID: 030 Specific test parameters Serum ∇ 1 -0.LIPASE.5 Fst. # # ο ∇ 3.15 ∇ # Test name LIP Sample type Ser Page 1/2 System Reagent: OSR6130. # # ο ∇ 4.000* # SERUM/PLASMA APPLICATION Test Name: Counts: LIP ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 7 ∇ Advanced Calibration: # ∇ Cal. OD L -0. vol Dil. OD H ∇ Operation: Yes Test No ∇ 2. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. H Lst.1 -0. # # ο ∇ 2.15 800 RATE + 27 Max OD H 2. None Selected 8. OSR6230 Specific Test Parameters General LIH ISE Range Test Name: LIP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 180 60 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. vol Dil.1 Reagent OD limit Fst. L -0. To work in SI units (µkat/L) divide by 60 Enzyme .1 Lst. or select from list displayed by Guide key Test No ∇ ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name LIP Sample type Ser ∇ On-board stability period 540 RATE + First 17 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. # # ο ∇ 6.01 2009-08 # User defined † For use in AB mode only. ∇ ∇ ∇ Sec.15 0.5 0. refer to IFU for further instructions * Values set for working in U/L.1 Main ∇ ∇ ∇ 540 Sub -0. Out of Range L # # # # # # # # Unit: U/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name LIP ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 5000* # Conc Factor/OD-H 10000* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 10. H Sample vol.15 0. OSR6230 Reagent ID: 030 Application LIPASE. refer to IFU for further instrucation * Values set for working in U/L. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. To work in SI units (µkat/L) divide by 60 BSOSR6x30.1 Dynamic range L 3* Correlation factor % ∇ 600* 1 0 ¤ 21 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: LIP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # OD CONC † Factor/OD-L 5000* 1-Point Cal. point MB type factor Calibrator stability period 7 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † For use in AB mode only. # # ο ∇ 5. No. AU600 Serum/Plasma Application System Reagent: OSR6130. L -0. # # ο ∇ 7. vol 0 0 0 Max. Reagent 1 vol Reagent 2 vol μL μL μL 2 180 60 Dil. H 600* Fst Fst 17 Lst Lst First H Last H 0. 1 -0.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.OD μL Min. # # ο ∇ 7.6 1 144 Test Name: Max OD H 2. Volume R1(R1-1) μL ∇ μL 1.1 -0. ∇ # # # # ο 5. Not within expected values U/L* Decimal Places Calibration Specific ISE LIP ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 5000* 10000* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 10000* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: LIP ∇ < > Test Name: Use Serum Cal.15 600* B 21 Last Last 27 15 NO % ∇ LIP ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 1. No demographics 8.1 R2(R2-1) μL Name Sec.1 -0. AU680/AU480 Serum/Plasma Application System Reagent: OSR6130. ∇ # # # # ο 2.6 144 48 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. # # ο ∇ 2. ∇ # # # # ο 3. ∇ 7. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L U/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. For No. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 540 ∇nm RATE ∇ + ∇ 17 540 RATE + First 17 First 15 NO Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 21 Day # ∇ + ∇ +++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH LIP ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # LIP ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 3* 1 1 μL High B B 0 600* 0 0 Hour 48 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.LIPASE. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal.15 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6130. None Selected 8. # # ο ∇ 6. ∇ # # # # ο 6. OSR6230 Specific Test Parameters General LIH ISE Serum ∇ 1 -0.5 0. # # ο ∇ 4. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Enzyme BSOSR6x30.01 2009-08 . AU2700/AU5400 Serum/Plasma Reagent ID: 030 Parameters General LIH LIP ∇ Dilution μL -0. ∇ ∇ ∇ 3* Sec. No. OSR6230 Reagent ID: 030 Application Operation Yes LIPASE. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 7 Day 0 Calibration 7 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: ICF: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined For use in AB mode only. ∇ # # # # ο 4.1 -0. # # ο ∇ 5.15 0.1 High High Max. # OD CONC † Factor/OD-L 5000* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 7 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. To work in SI units (µkat/L) divide by 60 AU680 <Point Cal.15 0.5 0. refer to IFU for further instructions Values set for working in U/L. # # ο ∇ 3. 4 Separate from cells immediately. contains a mixture of 5-chloro-2-methyl-4-isothiazolin-3-one [EC No 247-500-7] and 2-methyl-4-isothiazolin-3-one [EC No 220-239-6] (3:1).g. Safety Phrases: S24. Storage and Stability The reagent is stable. reduced absorption of amino acids caused by malabsorption syndromes or malnutrition. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Wear suitable gloves. R43: May cause sensitisation by skin contact. protein loss to the exterior as observed in nephrotic syndrome. up to the stated expiry date when stored at 2…25°C. Reaction Principle pH 4. enteropathy or burns. in liver disease or in protein deficient diets. Once open. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.g. Specimen Serum and EDTA or heparinised plasma. Dispose of all waste material in accordance with local guidelines. representing 55-65% of the total protein. in ascites.ALBUMIN OSR6102 OSR6202 Intended Use Photometric colour test for the quantitative determination of albumin in human serum and plasma on Beckman Coulter analysers.2 mmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: R1: Irritant. Calibration System Calibrator Cat. S60. Major preventative maintenance was performed on the analyser or a critical part was replaced. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Severe hypoalbuminemia results in a serious imbalance of intravascular oncotic pressure causing the development of edema. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. 66300. Reagent Preparation The reagent is ready for use and can be placed directly on board the instrument. No. 4 x 29 mL 4 x 54 mL R1 R1 Summary1. Reagent Composition in the Test Final concentration of reactive ingredients: Succinate buffer (pH 4. unopened. Separated plasma and serum is stable at 2…8°C for 30 days and at 15…25°C for 7 days.01 2009-08 Metabolite . Refer to Safety Data Sheets for further information. The absorbance of the albumin-BCG complex is measured bichromatically (600/800nm) and is proportional to the albumin concentration in the sample. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. This material and its container must be disposed of as hazardous waste. Recalibrate the assay when the following occur: Change in reagent lot number or significant shift in control values. EN. Its primary biological functions are to transport and store a wide variety of ligands.2 Albumin + Bromocresol Green Green Complex Contents. Measurements of albumin concentrations are vital to the understanding and interpretation of calcium and magnesium levels because these ions are bound to albumin. The paediatric application is suitable for use with small volume serum/plasma samples. and so decreases of albumin are also directly responsible for depression of their concentrations.2 Albumin is the most abundant protein in human plasma. If any trends or sudden shifts in values are detected. No. S37. The results obtained by any individual laboratory may vary from the given mean value. to maintain the plasma oncotic pressure and to serve as a source of endogenous amino acids. increased catabolism as a result of tissue damage and inflammation. Quality Control Controls Cat. The calibrator albumin value is traceable to IFCC (International Federation of Clinical Chemistry) standard CRM 470. For in vitro diagnostic use only. Test Principle3 A coloured complex is formed when bromocresol green reacts with albumin. reagent stored on board the instrument is stable for 90 days. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used.01 BLOSR6x02. Hyperalbuminemia is infrequent and is caused by severe dehydration and excessive venous stasis. Hypoalbuminemia may be caused by impaired synthesis e. and altered distribution e.2) Bromocresol green Preservative 100 mmol/L 0. Avoid contact with skin. review all operating parameters. Albumin binds and solubilises non-polar compounds such as plasma bilirubin and long-chain fatty acids as well as binding numerous pharmaceuticals. Christenson RH. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP international reference material CRM 470.63 0. User defined ¤ Analyser default value System Calibrator Cat. 1987:328-329.50 0.77 Within Run SD 0. Baudner S. Amino acids and proteins.67 1. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Clin Chim Acta 1971. may cause unreliable results.860 r = 0. BIBLIOGRAPHY Metabolite BLOSR6x02. Philadelphia:WB Saunders Company.01 2009-08 EN. The lowest detectable level represents the lowest measurable level of albumin that can be distinguished from zero. Watson WA. ed. Data obtained in your laboratory may differ from these values. 6. ed. Tietz textbook of clinical chemistry. Biggs HG. 7. clinical examinations and other findings. 1997:3-15-3-16.01 .03 Total CV% 2. Reference Intervals5. 1996:244245.: 66300 Values set for working in SI units (g/L).17 0. especially monoclonal IgM (Waldenström’s macroglobulinemia).70 – 50.04 42.5 – 5. For diagnostic purposes.93 57.Calculation The Beckman Coulter analysers automatically compute the albumin concentration of each sample.85 g/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 4. ed. Reference information for the clinical laboratory. Effects of preanalytical variables on clinical laboratory tests.62 1. 5th ed. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Specific proteins.6 Serum (Adults) Serum (Newborn 0 – 4 day) 35 – 52 g/L (3.982x – 3. eds.5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 800 mg/dL Intralipid In very rare cases gammopathy.994 n = 121 Sample range = 11. Doumas BT. Clinical diagnosis and management by laboratory methods. 2nd ed. Silverman LM.4 g/dL) Expected values may vary with age. In: Burtis CA. Philadelphia:WB Saunders Company. 3. Albumin standards and the measurement of serum albumin with bromcresol green. 1999.55 1. results should always be assessed in conjunction with the patient's medical history. 7 Setting Sheet Footnotes # † * 1. sex. J Lab Med 1996. Grant GH.92 SD 0. and if necessary determine its own reference interval according to good laboratory practice. No.8 – 4.31:87-96. Dati F. Method Comparison Patient serum samples were used to compare this Albumin OSR6102 assay on the AU600 against another commercially available albumin assay. To work in g/dL divide by 10. Young DS.43 0. 2000. Cope JY. In: Henry JB. Washington:AACC Press.20:145-152.0 g/dL) Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. Refer to Young for further information on interfering substances. McPherson RA. 2. Results of linear regression analysis were as follows: y = 0.07 g/L.2 g/dL) 28 – 44 g/L (2. Young DS. Philadelphia:WB Saunders Company. Fundamentals of clinical chemistry.80 1. Linearity The test is linear within a concentration range of 15 – 60 g/L (1. diet and geographical location. Smith JL.5 – 6. Each laboratory should verify the transferability of the expected values to its own population. 1800pp. AACC Press. Painter PC. sample type. In: Tietz NW.53 CV% 1.79 Sensitivity The lowest detectable level in serum on an AU600 analyser was estimated at 0. Effects of drugs on clinical laboratory tests. 4. Ashwood ER. 5. n = 60 Mean g/L 24. L -0. ∇ ∇ ∇ Sec. AU600 Serum/Plasma Application System Reagent: OSR6102.1 Dynamic range L 15* Correlation factor % ∇ 60* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: ALB ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 Lst. L -0. # # ο ∇ 4. H -0. OSR6202 Reagent ID: 002 Application ALBUMIN. OD H 0. To work in g/dL divide by 10 BSOSR6x02.5 0. OSR6202 Specific Test Parameters General LIH ISE Range Test Name: ALB ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 58 0 μL μL μL Dilution Dilution Dilution 0 242 0 μL μL μL Pri. No. None Selected 8. # # ο ∇ 3. Vol Dil. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. H 60* Fst Fst 0 Lst Lst First H Last H 0.1 -0. OD L Reagent OD limit Fst. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat.1 15* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. Reagent 1 vol Reagent 2 vol μL μL μL 2 58 0 Dil. AU400/AU640 Serum/Plasma Reagent ID: 002 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 600 Sub Fst. H Lst. To work in g/dL divide by 10 Metabolite .01 2009-08 # User defined † System Calibrator Cat. Vol Dil. # # ο ∇ 6. No.ALBUMIN. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ο ∇ 2.: 66300 * Values set for working in SI units (g/L).: 66300 * Values set for working in SI units (g/L). Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name ALB ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 54* # Conc Factor/OD-H 88* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 88* # SERUM/PLASMA APPLICATION Test Name: Counts: ALB ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 Advanced Calibration: # ∇ Cal. # # ο ∇ 7.5 0. # OD CONC † Factor/OD-L 54* 1-Point Cal. No. # # ο ∇ 5.5 800 END + 1 Sample vol. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name ALB Sample type Ser ∇ On-board stability period 600 END + First 0 First Last Last 1 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. Vol 0 242 0 Max.5 ∇ Operation: Yes Test No ∇ ∇ # Test name ALB Sample type Ser Page ½ System Reagent: OSR6102. # OD CONC † Factor/OD-L 54* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: 999 ∇ # None ∇ 1-Point Cal. ∇ 7. ∇ # # # # ο 3. None Selected 8. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 600 ∇nm END ∇ + ∇ 0 600 END + First 0 First Last Last 1 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH ALB ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # ALB ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 -0. # # ο ∇ 2. Volume R1(R1-1) μL ∇ μL 1.5 0. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.: 66300 Values set for working in SI units (g/L). ∇ # # # # ο 6.5 0. ∇ ∇ ∇ 15* Sec.ALBUMIN. # # ο ∇ 3.6 46 0 0. ∇ # # # # ο 2.1 High High 0.1 -0. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. AU2700/AU5400 Serum/Plasma Reagent ID: 002 Parameters General LIH ALB ∇ Dilution μL Max.OD Reagent OD Limit First Low Last Low Dilution 194 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6102.01 2009-08 .OD -0.5 60* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 194 0 μL μL μL Pri.5 μL Min. # # ο ∇ 6. # # ο ∇ 5. To work in g/dL divide by 10 AU680 <Point Cal. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x02. AU680/AU480 Serum/Plasma Application System Reagent: OSR6102. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L g/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. # # ο ∇ 7. ∇ # # # # ο 4. System Calibrator Cat. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 15* 1 1 μL High B B 0 60* 0 0 Hour 0 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. No. OSR6202 Reagent ID: 002 Application Operation Yes ALBUMIN. Not within expected values g/L* Decimal Places Calibration Specific ISE ALB ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 54* 96* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 96* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: ALB ∇ < > Test Name: Use Serum Cal.6 1 46 Range Operation: ∇ Yes Test Name: ALB ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 Last Last 1 % ∇ 1. OSR6202 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0.1 R2(R2-1) μL Name Sec. No demographics 8. # # ο ∇ 4. No. Point: ο with Conc-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined. ∇ # # # # ο 5. For No. No. vol Dil.1 -0.1 Dynamic range L 15* Correlation factor % ∇ 60* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: ALBP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. To work in g/dL divide by 10 Metabolite .5 0. ∇ ∇ ∇ Sec. OD H 0.ALBUMIN.: 66300 * Values set for working in SI units (g/L).1 15* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. # # ο ∇ 6. # # ο ∇ 4. None Selected 8. OSR6202 Reagent ID: 002 Application ALBUMIN. # # ο ∇ 5. vol 10 232 0 Max.01 2009-08 # User defined † System Calibrator Cat.: 66300 * Values set for working in SI units (g/L). or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name ALBP Sample type Ser ∇ On-board stability period 600 END + First 0 First Last Last 1 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name ALBP ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 54* # Conc Factor/OD-H 88* ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 88* # Test Name: Counts: ALBP ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. No.1 Lst. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. AU600 Paediatric Application System Reagent: OSR6102. # # ο ∇ 7. OD L Reagent OD limit Fst. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. H 60* Fst Fst 0 Lst Lst First H Last H 0.5 ∇ Operation: Yes Test No ∇ ∇ # Test name ALBP Sample type Ser Page 1/2 System Reagent: OSR6102. H Lst. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat. H -0. L -0. To work in g/dL divide by 10 BSOSR6x02. Reagent 1 vol Reagent 2 vol μL μL μL 2 58 0 Dil. OSR6202 Specific Test Parameters General LIH ISE Range Test Name: ALBP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 58 0 μL μL μL Dilution Dilution Dilution 10 232 0 μL μL μL Pri. No. AU400/AU640 Paediatric Reagent ID: 002 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 600 Sub Fst.5 0. # # ο ∇ 3. # OD CONC † Factor/OD-L 54* 1-Point Cal.5 800 END + 1 Sample vol. L -0. vol Dil. # # ο ∇ 2. ∇ # # # # ο 5.: 66300 * Values set for working in SI units (g/L). Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L g/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. # # ο ∇ 6. To work in g/dL divide by 10 ф AU680 <Point Cal.OD Reagent OD Limit First Low Last Low Dilution 184 10 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6102. ∇ ∇ ∇ 15* Sec. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. # OD CONC † Factor/OD-L 54* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal. OSR6202 Reagent ID: 002 Application Operation Yes ALBUMIN.1 High High 0.1 -0. No. # # ο ∇ 7.ALBUMIN. ∇ # # # # ο 6.1 R2(R2-1) μL Name Sec.1 -0. ∇ # # # # ο 3. # # ο ∇ 4. ∇ # # # # ο 2. Not within expected values g/L* Decimal Places Calibration Specific ISE ALBP ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 54* 96* ∇ # ο ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 96* # Process: CONC ∇ Test Name: ALBP ∇ < > Test Name: Use Serum Cal. No. # # ο ∇ 2. ∇ 7. ∇ # # # # ο 4. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 600 ∇nm END ∇ + ∇ 0 600 END + First 0 First Last Last 1 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH ALBP ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # ALBP ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 μL Min.6 1 46 Range Operation: ∇ Yes Test Name: ALBP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 Last Last 1 % ∇ 1. OSR6202 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0.OD -0. No demographics 8. # # ο ∇ 5. † System Calibrator Cat. AU2700/AU5400 Paediatric Reagent ID: 002 Parameters General LIH ALBP ∇ Dilution μL Max. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 15* 1 1 μL High B B 0 60* 0 0 Hour 0 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. None Selected 8.5 0. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. For No.6 46 0 0.5 60* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 10 184 0 μL μL μL Pri. Volume R1(R1-1) μL ∇ μL 1. AU680/AU480 Paediatric Application System Reagent: OSR6102.5 0.01 2009-08 . Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. # # ο ∇ 3. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x02. If any trends or sudden shifts in values are detected. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.2 mmol/L Magnesium 2. An elevation of the HCO3 level may be observed in compensated respiratory acidosis and metabolic alkalosis. This oxidation of the NADH results in a decrease in absorbance of the reaction mixture measured bichromatically at 380/410 nm proportional to the HCO3 content of the sample. reagent composition in the test Final concentration of reactive ingredients: MD (microbial) > 2000 U/L PEPC (microbial) > 572 U/L NADH 1. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Calibration Bicarbonate Calibrator Cat No. The determination of bicarbonate (HCO3 ) is used in conjunction with other clinical and laboratory information for the evaluation of acid-base status.BICARBONATE OSR6190 OSR6290 Intended Use System reagent for the quantitative determination of bicarbonate in human serum and plasma on Beckman Coulter analysers. EN. Test Principle The Bicarbonate reagent utilizes an enzymatic method to measure bicarbonate in human serum and plasma. Storage and Stability The reagent is stable unopened. Major preventative maintenance was performed on the analyser or a critical part was replaced. Recalibrate the assay every day. reagent stored on board the instrument is stable for 7 days. Once open. review all operating parameters.01 BLOSR6x90. 4 x 25 mL 4 x 50 mL R1 R1 Summary Bicarbonate measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.01 2009-08 Metabolite . Low HCO3 levels may be observed 1 in compensated respiratory alkalosis and metabolic acidosis. Quality Control Control materials with values determined by this Beckman Coulter system may be used. The results obtained by any individual laboratory may vary from the given mean value. 1 Once separated from cells. The paediatric application is suitable for use with small volume serum/plasma samples. HCO3 in serum is stable for several hours when stored at 2…8°C and protected from exposure to air. up to the stated expiry date when stored at 2…8°C. - Reaction Principle PEP + HCO3 - PEPC Magnesium + Oxaloacetate + H2PO4 + - Oxaloacetate + NADH + H MD Malate + NAD Contents. Additional laboratory determinations will permit differentiation between metabolic and respiratory conditions.8 mmol/L Also contains preservatives. The calibrator bicarbonate value is traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 351. ODC0019. Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. Malate dehydrogenase (MD) catalyzes the reduction of oxaloacetate to malate with the concomitant oxidation of a reduced nicotinamide adenine dinucleotide (NADH).6 mmol/L PEP 8. Reagent Preparation The reagent is ready for use and can be placed directly on board the instrument. This effect will vary depending upon the rate of use. For in vitro diagnostic use only. In this procedure bicarbonate (HCO3 ) and phosphoenolpyruvate (PEP) are converted to oxaloacetate and phosphate in the reaction catalyzed by phosphoenolpyruvate carboxylase (PEPC). Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Consequently each laboratory should set a calibration frequency in the instrument parameters appropriate to their usage pattern. Absorption of atmospheric CO2 by the reagent on board the analyser can impair calibration stability. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Specimen Serum and heparinised plasma samples free from haemolysis are the recommended specimens. Separate serum or plasma from cells promptly to minimise haemolysis. Dispose of all waste material in accordance with local guidelines. or when the following occur: Change in reagent lot number or significant shift in control values. 31 2.98 n = 102 Sample range = 9.02 2. Painter PC. Philadelphia:WB Saunders Company.1 34.B. Ashwood ER. AACC Press.71 mmol/L. 2. Kaplan. A.® Haemolysis: Interference less than 10% up to 500 mg/dL haemoglobin Icterus: Interference less than 5% up to 40 mg/dL billirubin Refer to Young for further information on interfering substances.. Metabolite BLOSR6x90. eds.9 Within run SD 0.58 0.W. Reference information for the clinical laboratory. Cope JY. Young DS.1803pp. NCCLS. n = 80 Mean. Effects of drugs on clinical laboratory tests. Tietz. 1986. Corelation 3rd Edition. 2000. 6 Setting Sheet Footnotes # † * ‡ 1. Smith JL. In:Burtis CA. The lowest detectable level represents the lowest measurable level of bicarbonate that can be distinguished from zero. L. 1999. Precision 4 The following data was obtained on an AU640 using 3 serum pools analysed over 20 days. 1999. BIBLIOGRAPHY . Clinical Chemistry Theory. sample type.05 SD 0. Hg. 5th ed. NCCLS. Each laboratory should verify the transferability of the expected values to its own population.29 0.02 Sensitivity The lowest detectable level on an AU640 analyser was estimated at 0.A.0 to 45.0 mmol/L. For diagnostic purposes. y = 0.207 5 r = 0.37 CV% 4..Calculation The Beckman Coulter analysers automatically compute the bicarbonate concentration of each sample. Fundamentals of Clinical Chemistry. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. CV Mosbey. Data obtained in your laboratory may differ from these values.15 1.37 0.4 – 32. Analysis. and if necessary determine its own reference interval according to good laboratory practice.71 Total CV% 7. Method Comparison Patient samples were used to compare this Bicarbonate Reagent OSR6190 on an AU640 to a blood gas analyser method.63 0. and Pesce. 3rd edition. sex.0 25. 3.01 2009-08 EN. results should always be assessed in conjunction with the patient's medical history.15 1. clinical examinations and other findings. 5. 6. mmol/L 9. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. N. Evaluation Protocol EP5-A. 1996. Reference Intervals2. Linearity The test is linear within a concentration range of 2.01 . diet and geographical location. Interference Testing in Clinical Chemistry EP7-P. Tietz textbook of clinical chemistry. 4.2 mmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: AU600/AU640 Lipemia: Interference less than 5% up to 1000 mg/dL Intralipid. W.999x – 1. 1999.J. User defined ¤ Analyser default value Bicarbonate Calibrator Catalogue Number ODC0019 Values set for working in mmol/L Depends on usage pattern in the laboratory. Saunders Company.3 Adult Newborn Infant 2 months − 2 years 21 − 31 mmol/L 17 − 24 mmol/L 19 − 24 mmol/L 16 − 24 mmol/L Expected values may vary with age. 5 2.300* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 0. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 10 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. vol 0 210 0 Max. H Lst. # # ο ∇ 2.: ODC0019 Values set for working in mmol/L Depends on usage pattern in the Laboratory Metabolite .100* 1-Point Cal. 410 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.200* 0.300* # SERUM/PLASMA APPLICATION Test Name: Counts: CO2 ∇ < > Type Calibration Type: 2AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ‡ ∇ Advanced Calibration: # ∇ Cal.5 ∇ # Test name CO2 Sample type Ser Page 1/2 System Reagent: OSR6190. H 45* Fst Fst 1 Lst Lst First H Last H 2.14 Reagent OD limit Fst. # # ο ∇ 6. vol Dil.5 2.5 Fst.5 2. # # ο ∇ 5. point MB type factor Calibrator stability period ‡ Select the function using the Function key or the Mouse # † * ‡ BSOSR6x90.01 2009-08 User defined ¤ Analyser default value Bicarbonate Calibrator Cat. No. L -2.100* # Conc Factor/OD-H 0. Reagent 1 vol Reagent 2 vol μL μL μL 3 50 0 Dil. No. L -2. # # OD CONC 20 40 Factor/OD-L 0.0 2* B 7 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil.200* 0. OSR6290 Reagent ID: 090 Application BICARBONATE (CO2). H Sample vol. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CO2 Sample type Ser ∇ On-board stability period 380 FIXED First 1 First Last Last 9 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min.0 Dynamic range L 2* Correlation factor % ∇ 45* 1 0 ¤ 7 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: CO2 ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. OSR6290 Specific Test Parameters General LIH ISE Range Test Name: CO2 ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 50 0 μL μL μL Dilution Dilution Dilution 0 210 0 μL μL μL Pri.14 Main ∇ ∇ ∇ 380 Sub -2. # # ο ∇ 3.5 410 FIXED 9 Max OD H 2. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name CO2 ∇ 2AB ∇ POLYGONAL OD ∇ Conc 20 40 Count Process Factor/OD-L 0. AU600 Serum/Plasma Application System Reagent: OSR6190. AU400/AU640 Serum/Plasma Reagent ID: 090 Specific test parameters Serum ∇ 1 0. # # ο ∇ 7. OD L 0.050* 0.0 Lst.: ODC0019 Values set for working in mmol/L Depends on usage pattern in the Laboratory # † * ‡ User defined Bicarbonate Calibrator Cat. None Selected 8. ∇ ∇ ∇ Sec. OD H ∇ Operation: Yes Test No ∇ 2.BICARBONATE (CO2). No. vol Dil.050* 0.0 -2. # # ο ∇ 4. ∇ 7.100* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ ‡ ∇ Advanced Calibration: # + ∇ 1-Point Cal.5 2. # # ο ∇ 7. Not within expected values mmol/L* Decimal Places Calibration Specific ISE CO2 ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum Counts: ∇ OD Range Low High 0. AU680/AU480 Serum/Plasma Application Specific Test Parameters General LIH ISE Serum ∇ 1 0. OSR6290 Operation Yes BICARBONATE (CO2).Serum/Plasma Application Reagent ID: 090 Parameters General LIH CO2 ∇ Dilution μL 0. No demographics 8.14 -2.300* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: CO2 ∇ < > Test Name: Use Serum Cal. # # ο ∇ 4.5 42 0 μL μL μL Dilution Dilution Dilution 0 175 0 μL μL μL Pri. ∇ # # # # ο 5.01 2009-08 . 410 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. No.050* 0. # # OD CONC 20 40 Factor/OD-L 0.300* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 0. OSR6290 Reagent ID: 090 BICARBONATE (CO2).0 -2. ∇ # # # # ο 4. AU2700/AU5400 System Reagent: OSR6190. ∇ # # # # ο 6.5 2.5 2. Volume R1(R1-1) μL ∇ μL 2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration ‡ Day ‡ MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 2AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # 20 ∇ Point 2: # 40 ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 380 ∇nm FIXED ∇ ∇ 1 380 FIXED First 1 First Last Last 9 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 7 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH CO2 ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # CO2 ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.14 -2. For No. 410 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 2* 1 1 μL High B B 0 45* 0 0 Hour 0 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. # # ο ∇ 3.OD μL Min.100* 0.200* 0. Calibration Type: 2AB ∇ Formula: POLYGONAL ∇ Cal.200* 0.050* 0.5 1 42 Test Name: Max OD H 2.0 -2. ∇ # # # # ο 2.0 High High Max. # # ο ∇ 2.5 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6190. No. ∇ # # # # ο 3. # # ο ∇ 6. ∇ ∇ ∇ 2* Sec. None Selected 8. † Bicarbonate Calibrator Cat. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x90.OD Reagent OD Limit First Low Last Low Dilution 175 0 OD Limit 2. # # ο ∇ 5.5 2.5 45* B 7 Last Last 9 % ∇ CO2 ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 2.: ODC0019 * Values set for working in mmol/L ‡ Depends on usage pattern in the Laboratory ф AU680 <Point Cal.0 R2(R2-1) μL Name Sec. 14 Reagent OD limit Fst.050* 0. # # OD CONC 20 40 Factor/OD-L 0.01 2009-08 User defined ¤ Analyser default value Bicarbonate Calibrator Cat. L -2.5 2. # # ο ∇ 6. H 45* Fst Fst 1 Lst Lst First H Last H 2.0 Dynamic range L 2* Correlation factor % ∇ 45* 1 0 ¤ 7 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: CO2P ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 ∇ # Test name CO2P Sample type Ser Page 1/2 System Reagent: OSR6190.200* 0.100* # Conc Factor/OD-H 0. AU400/AU640 Paediatric Reagent ID: 090 Specific test parameters Serum ∇ 1 0. OSR6290 Reagent ID: 090 Application BICARBONATE (CO2).300* ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 0. No.5 2. L -2.5 Fst. Reagent 1 vol Reagent 2 vol μL μL μL 3 50 0 Dil.: ODC0019 Values set for working in mmol/L Depends on usage pattern in the Laboratory # † * ‡ User defined Bicarbonate Calibrator Cat. None Selected 8. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CO2P Sample type Ser ∇ On-board stability period 380 FIXED First 1 First Last Last 9 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. vol Dil. vol 10 200 0 Max.200* 0. OSR6290 Specific Test Parameters General LIH ISE Range Test Name: CO2P ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 50 0 μL μL μL Dilution Dilution Dilution 10 200 0 μL μL μL Pri. H Sample vol. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name CO2P ∇ 2AB ∇ POLYGONAL OD ∇ Conc 20 40 Count Process Factor/OD-L 0. # # ο ∇ 2. # # ο ∇ 4. point MB type factor Calibrator stability period ‡ Select the function using the Function key or the Mouse # † * ‡ BSOSR6x90. No. # # ο ∇ 3. AU600 Paediatric Application System Reagent: OSR6190.0 Lst. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 10 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. OD L 0.050* 0.300* # Test Name: Counts: CO2P ∇ < > Type Calibration Type: 2AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ ‡ Advanced Calibration: # ∇ Cal. # # ο ∇ 7.100* 1-Point Cal.14 Main ∇ ∇ ∇ 380 Sub -2. vol Dil. OD H ∇ Operation: Yes Test No ∇ 2.0 2* B 7 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil.: ODC0019 Values set for working in mmol/L Depends on usage pattern in the Laboratory Metabolite .5 2. ∇ ∇ ∇ Sec. # # ο ∇ 5.0 -2. 410 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. No.5 410 FIXED 9 Max OD H 2.BICARBONATE (CO2). H Lst. 100* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ ‡ ∇ Advanced Calibration: # + ∇ 1-Point Cal. # # ο ∇ 2. OSR6290 Specific Test Parameters General LIH ISE Serum ∇ 1 0. AU680/AU480 Paediatric Application System Reagent: OSR6190.200* 0. No demographics 8. For No. None Selected 8.0 High High Max.0 R2(R2-1) μL Name Sec.0 -2. # # ο ∇ 7.5 42 0 μL μL μL Dilution Dilution Dilution 10 165 0 μL μL μL Pri.300* # Process: CONC ∇ Test Name: CO2P ∇ < > Test Name: Use Serum Cal. OSR6290 Reagent ID: 090 Application Operation Yes BICARBONATE (CO2). # # ο ∇ 6.100* 0. ∇ 7.BICARBONATE (CO2). ∇ ∇ ∇ 2* Sec. 410 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.0 -2. ∇ # # # # ο 4.5 2. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration ‡ Day ‡ MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 2AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # 20 ∇ Point 2: # 40 ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. # # ο ∇ 5. Not within expected values mmol/L* Decimal Places Calibration Specific ISE CO2P ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum Counts: ∇ OD Range Low High 0.050* 0. No. Calibration Type: 2AB ∇ Formula: POLYGONAL ∇ Cal.300* ∇ # ο ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 0. # # OD CONC 20 40 Factor/OD-L 0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x90.: ODC0019 * Values set for working in mmol/L ‡ Depends on usage pattern in the Laboratory ф AU680 <Point Cal.050* 0.OD μL Min. # # ο ∇ 4. 410 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 2* 1 1 μL High B B 0 45* 0 0 Hour 0 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) μL ∇ μL 2.5 45* B 7 Last Last 9 % ∇ CO2P ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 2.200* 0. No. AU2700/AU5400 Paediatric Reagent ID: 090 Parameters General LIH CO2P ∇ Dilution μL 0.5 2. ∇ # # # # ο 5.01 2009-08 . Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 380 ∇nm FIXED ∇ ∇ 1 380 FIXED First 1 First Last Last 9 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 7 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH CO2P ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # CO2P ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 1 42 Test Name: Max OD H 2.5 2.OD Reagent OD Limit First Low Last Low Dilution 165 10 OD Limit 2.5 2. ∇ # # # # ο 2. † Bicarbonate Calibrator Cat. ∇ # # # # ο 3. ∇ # # # # ο 6.14 -2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.14 -2. # # ο ∇ 3.5 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6190. 1 Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. No. In case of contact with eyes. S45. Because of its poor solubility in water unconjugated bilirubin (indirect bilirubin) is transferred to the liver bound to albumin. Major preventative maintenance was performed on the analyser or a critical part was replaced. Even slight haemolysis can cause a reduction in value and such samples should be avoided. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. The paediatric application is suitable for use with small volume serum/plasma samples. This material and its container must be disposed of as hazardous waste. catalases and from bone marrow as a result of ineffective erythropoiesis.01 2009-08 Metabolite . For in vitro diagnostic use only. S30.07 mmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: DBILB and DBILC: Corrosive. 4 x 6 mL 4 x 6 mL 4 x 20 mL 4 x 20 mL R1 DBILC R1 DBILB R1 DBILC R1 DBILB Summary1. Chronic congenital conjugated hyperbilirubinemias include Dubin-Johnson and Rotor syndrome. Lipemic samples should also be avoided. EN. Once open. reagents stored on board the instrument are stable for 21 days. Never add water to this product.01 BLOSR6x11. S36/37/39.2 80 – 85% of bilirubin produced daily originates from haemoglobin released by the breakdown of senescent erythrocytes.5 Dichlorophenyl diazonium tetrafluoroborate 0. rinse immediately with plenty of water and seek medical advice. or when the following occur: Change in reagent lot or significant shift in control values. The calibrator value is traceable to a Beckman Coulter Master Calibrator.and diglucuronide (direct bilirubin) which are then excreted in bile together with all other normal biliary constituents. gloves and eye/face protection. cytochromes. Whereas prehepatic jaundice (e. The differentiation between chronic congenital hyperbilirubinemias and acquired types of bilirubininemia is accomplished via the measurement of bilirubin fractions and the detection of normal liver enzyme activities. Storage and Stability The reagents are stable. seek medical advice immediately (show the label where possible). Calibration System Calibrator Cat. Reagent Composition in the Test Final concentration of reactive ingredients: 3. Recalibrate the assay every 21 days. R35. 3. Contains sulphuric acid. unopened. When using do not eat or drink. up to the stated expiry date when stored at 2…8°C. protected from light. Wear suitable protective clothing. Refer to Safety Data Sheets for further information.DIRECT BILIRUBIN OSR6111 OSR6211 Intended Use Photometric colour test for the quantitative determination of direct bilirubin in human serum and plasma on Beckman Coulter analysers.g. Inside the hepatocytes it is rapidly conjugated with glucuronic acid to produce bilirubin mono.5 Dichlorophenyl diazonium tetrafluoroborate (DPD) couples directly with direct (conjugated) bilirubin in an acid medium to form azobilirubin. Diseases of post hepatic origin with predominantly conjugated hyperbilirubinemia include extrahepatic cholestasis and liver transplant rejection. The absorbance at 570 nm is proportional to the direct bilirubin concentration in the sample. Causes severe burns. Specimen Serum and heparinised plasma: stable for 3 days when protected from light and stored 15…25°C. In case of accident or if you feel unwell. liver cirrhosis and hepatocellular carcinoma. S60. the assessment of direct bilirubin is helpful in the determination of hepatic and post-hepatic jaundice. 66300. Test Principle3 A stabilised diazonium salt. Safety Phrases: S20. S26. haemolytic anemia and neonatal jaundice) is primarily associated with an increase in unconjugated bilirubin. Dispose of all waste material in accordance with local guidelines. the remaining 15 – 20% results from the breakdown of haem-containing proteins such as myoglobin. Diseases of hepatic origin with predominantly conjugated hyperbilirubinemia include acute and chronic viral hepatitis. Reaction Principle Bilirubin + DPD Azobilirubin Contents. Bilirubin. In: Tietz NW. Use and assessment of clinical laboratory results.55 Total CV% 3.51 1. 4 Setting Sheet Footnotes ‡ # † * § ж N The above parameters must be entered twice using test names DBILC (colour) and DBILB (blank). especially monoclonal IgM (Waldenström’s macroglobulinemia). ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. and if necessary determine its own reference interval according to good laboratory practice. Liver Function. The lowest detectable level represents the lowest measurable level of direct bilirubin that can be distinguished from zero.18 0.789x – 0. Clinical laboratory diagnostics. Fundamentals of clinical chemistry. 2000. review all operating parameters. 1998:192-202. Mueller P. ed. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems.20 Sensitivity The lowest detectable level on an AU600 analyser was calculated as 0. Data obtained in your laboratory may differ from these values.: 66300 Values set for working in SI units (µmol/L).01 2009-08 EN. Metabolite BLOSR6x11. Biochem Z 1916. Calculation The Beckman Coulter analysers automatically compute the direct bilirubin concentration of each sample. Refer to Young for further information on interfering substances. results should always be assessed in conjunction with the patient's medical history.01 .1 Set the factor range for the blank reagent at –99999 to 99999 Set the test as SAMPLE BLANK in the COMMON TEST PARAMETERS TEST NAME SAMPLE BLANK menu. Ueber eine direkte and indirekte diazoreaktion auf bilirubin. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. 2.5 µmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: ® Lipemia: Interference less than 10% up to 300 mg/dL Intralipid In very rare cases gammopathy. Effects of drugs on clinical laboratory tests. 77:90. The results obtained by any individual laboratory may vary from the given mean value. Balistreri WF. If any trends or sudden shifts in values are detected. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. 1987:733-737.2 mg/dL) Expected values may vary with age.34 CV% 1. n = 60 Mean µmol/L 10 17 116 Within Run SD 0. No. 4. sample type.4 µmol/L (< 0. sex.16 SD 0. Each laboratory should verify the transferability of the expected values to its own population.92 2. Philadelphia:WB Saunders Company.26 1.Quality Control Controls Cat.7 r = 0. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.33 0. diet and geographical location. Frankfurt/Main: TH-Books Verlagsgesellschaft.50 2.78 1. BIBLIOGRAPHY 1. ed. Thomas L. AACC Press. Reference Intervals1 Adults and Children < 3. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. clinical examinations and other findings.2 – 151. To work in mg/dL divide by 17. may cause unreliable results. Results of linear regression analysis were as follows: y = 0. Shaw LM. Young DS. Hymans van den Bergh AA. Set the test as SAMPLE BLANK in the INTER RELATED TEST menu User defined ¤ Analyser default value System Calibrator Cat. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. 5th ed. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.998 n = 99 Sample range = 0. For diagnostic purposes. Method Comparison Patient serum samples were used to compare this Direct Bilirubin (OSR6111) assay on the AU640 against another commercially available direct bilirubin assay. No. In: Thomas L. Linearity The test is linear within a concentration range of 0 – 171 µmol/L (0 – 10 mg/dL). 3.24 µmol/L.24 2. # OD CONC † Factor/OD-L 580*§ 1-Point Cal.: 66300 * Values set for working in SI units (μmol/L). # # ο ∇ 2. OD L Reagent OD limit Fst. Vol 0 120 0 Max. No. To work in mg/dL divide by 17. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.DIRECT BILIRUBIN. Point MB type factor Calibrator stability period 21 Select the function using the Function key or the Mouse ‡ The above parameters must be entered twice using test names DBILC (Colour Rg) and DBILB (Blank Rg). No.1 ∇ ∇ # Test name DBIL‡ Sample type Ser Page ½ Application DIRECT BILIRUBIN. # User defined † System Calibrator Cat. AU600 Serum/Plasma Application System Reagent: OSR6111. ∇ ∇ ∇ Sec. AU400/AU640 Serum/Plasma System Reagent: OSR6111.1 Lst.: 66300 * Values set for working in SI units (μmol/L). # # ο ∇ 5. Set the test as SAMPLE BLANK in the INTER RELATED TEST menu. # # ο ∇ 4.1 660 END + 2 Operation: Yes Range Test Name: DBIL‡ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 30 0 μL μL μL Dilution Dilution Dilution 0 120 0 μL μL μL Pri.01 2009-08 . H ∇ ∇ ∇ Main 570 Sub 3 30 0 Dil. # # ο ∇ 6. # # ο ∇ 3. To work in mg/dL divide by 17. H 171* Fst Fst 0 Lst Lst First H Last H 0.1 0* B 21 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. OSR6211 Reagent ID: R1 COLOUR (DBILC) 011.1 Dynamic range L 0* Correlation factor % ∇ 171* 1 0 ¤ 21 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: DBIL‡ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Vol Dil.1 0. R1 BLANK (DBILB) 010 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0. Vol Dil. No. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ο ∇ 7.1 § Set the factor range for the blank reagent at –99999 to 99999 ‡ The above parameters must be entered twice using test names DBILC (Colour Rg) and DBILB (Blank Rg). R1 BLANK (DBILB) 010 Specific test parameters Test No ∇ Sample vol. Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # Calibration specific H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 960*§ # Test No # Test name DBIL‡ ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 580*§ # Conc Factor/OD-H 960*§ ∇ SERUM/PLASMA APPLICATION Test Name: Counts: DBIL‡ ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 21 ∇ Advanced Calibrator: # ∇ Cal.1 § Set the factor range for the blank reagent at –99999 to 99999 Metabolite BSOSR6x11. Set the test as SAMPLE BLANK in the INTER RELATED TEST menu # User defined ¤ Analyser default value † System Calibrator Cat. L -0. H Lst. OSR6211 Reagent ID: R1 COLOUR (DBILC) 011.1 -0. OD H 0.1 0. None Selected 8. L -0. Reagent 1 vol Reagent 2 vol μL μL μL Fst. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name DBIL‡ Sample type Ser ∇ On-board stability period 570 END + First 0 First Last Last 2 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. # User defined † System Calibrator Cat.5 25 0 μL μL μL Dilution Dilution Dilution 0 100 0 μL μL μL Pri. # OD CONC † Factor/OD-L 580*§ 1-Point Cal. OSR6211 Reagent ID: R1 COLOUR (DBILC) 011. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: ‡ The above parameters must be entered twice using test names DBILC (Colour Rg) and DBILB (Blank Rg).DIRECT BILIRUBIN. R1 BLANK (DBILB) 010 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0. Set the test as SAMPLE BLANK in the INTER RELATED TEST menu.1 ∇ Operation: Yes Range Test Name: DBIL‡ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2. # # ο ∇ 6. # # ο ∇ 4. # # ο ∇ 3. AU2700/AU5400 Serum/Plasma Application System Reagent: OSR6111.1 § Set the factor range for the blank reagent at –99999 to 99999 Metabolite BSOSR6x11. ∇ ∇ ∇ Sec.1 0.1 0* B 21 0 H 171* First H Last H 0. None Selected 8.01 2009-08 . # # ο ∇ 2.1 -0. Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Panic Value: # # Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 960*§ # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: DBIL‡ ∇ < > Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ Advanced Calibration: 21 ∇ # Cal. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 570 END + First 0 First Last Last 2 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Serum ∇ # Range Test Name: DBIL‡ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. No. # # ο ∇ 7.: 66300 * Values set for working in SI units (μmol/L). To work in mg/dL divide by 17. No. # # ο ∇ 5. : 66300 Values set for working in SI units (μmol/L). 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0* 1 1 μL High B B 0 171* 0 0 Hour 0 Dilution 0 High High 0. No. For No. AU680/AU480 Serum/Plasma Application Operation Yes System Reagent: OSR6111. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 21 Day # ∇ +++++ ∇ +++++ ∇ + ∇ % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 570 ∇nm END ∇ + ∇ 0 Name Sec.5 1 25 0 μL OD Limit μL ∇ μL Dilution 100 μL Min. AU680/AU480 Serum/Plasma Reagent ID: R1 COLOR (DBILC) 011 System Reagent: OSR6111. # User defined † System Calibrator Cat.OD Reagent OD Limit First Low Last Low Sample Volume Pre-Dilution Rate Rgt.1 AU680 ж Set the test as SAMPLE BLANK in the COMMON TEST PARAMETERS TEST NAME SAMPLE BLANK menu.01 2009-08 .OD -0.1 R2(R2-1) μL Name Sec. Volume R1(R1-1) 2.1 ф AU680 Metabolite BSOSR6x11. ISE Parameters Calibrators General Test Name: DBILCж ∇ < > Type Serum Y=AX+B None ∇ Counts: # ∇ ∇ Factor Range Low High Slope Check 580* 960* Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation # ∇ # ∇ Interval (RB/ACAL) Counts: # ∇ ∇ Factor Range Low High Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) None ∇ SERUM/PLASMA APPLICATION # ∇ # ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal.1 0. To work in mg/dL divide by 17. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm END ∇ + ∇ 0 21 Day # ∇ +++++ ∇ +++++ ∇ + ∇ Parameters Calibrators General Calibration Specific ISE DBILBж ∇ Y=AX+B < > Type ∇ ο Use Serum Cal.1 -0. For No.DIRECT BILIRUBIN.1 μL Dilution 100 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range ∇ Test Name: Specific Test Parameters Calculated Test ∇ DIRECT BILIRUBIN.OD Reagent OD Limit First Low Last Low Sample Volume Pre-Dilution Rate Rgt.: 66300 * Values set for working in SI units (μmol/L). Volume R1(R1-1) 2. OSR6211 Parameters General Serum LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: DBILCж ∇ < > Type: Operation Yes Dilution Max.1 -0.1 High High 0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 21 Day 0 Calibration 21 Day 0 ∇ ο with Conc-0 Hour Hour MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ж # † * ф Set the test as SAMPLE BLANK in the COMMON TEST PARAMETERS TEST NAME SAMPLE BLANK menu.1 0. To work in mg/dL divide by 17. No.OD -0.1 μL ∇ μL Min. User defined System Calibrator Cat.5 1 25 R2(R2-1) 0* 1 1 0 Last Last 2 Hour High B B 171* 0 0 0 μL Dilution 0 μL Common Rgt. Test Name: Calibration Specific Calibration Parameters STAT Table Calibration Calibration Parameters STAT Table Calibration Serum ∇ ο Use Serum Cal. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 21 Day 0 Calibration 21 Day 0 <Point Cal. OSR6211 Reagent ID: R1 BLANK (DBILB) 010 Application Range Parameters General LIH DBILBж ∇ Dilution μL Max. Dynamic Range Low ф Correlation Factor A 660 ∇nm Factor for Maker A Last Last 2 % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Common Rgt. No.1 Dynamic range L 0* Correlation factor 171* 1 0 ¤ % ∇ A 1 On-board stability period: 21 Specific Test Parameters General LIH ISE Serum ∇ # # # # # # # Age Y Y Y Y Y Y Range Test Name: DBILP‡ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. To work in mg/dL divide by 17. AU600 Paediatric Application System Reagent: OSR6111. ∇ ∇ ∇ Sec. R1 BLANK (DBILB) 010 Specific test parameters Test No ∇ Sample vol. None Selected 8.: 66300 * Values set for working in SI units (μmol/L).01 2009-08 . vol Dil.1 0* B 21 Linearity Fst No lag time Select using Space key.1 0. or select from list displayed by Guide key Test No ∇ # ∇ H # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ M M M M M M Age Y Y Y Y Y Y # # # # # # L # Test name DBILP‡ Sample type Ser ∇ Level L # Page 2/2 Level H # % Sec % ∇ 0 Sample Pre-dil. # # ο ∇ 7. To work in mg/dL divide by 17.1 -0. H Lst. H 171* Fst Fst 0 Lst Lst First H Last H 0. # # ο ∇ 2. Point: ο with CONC-0 Slope Check: None MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. OD L Reagent OD limit Fst.1 660 END + 2 H A B Rate Operation: Yes Range Test Name: DBILP‡ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3. Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name DBILP‡ ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L §530* # Conc Factor/OD-H §804* ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H §804* # Test Name: DBILP‡ ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: Advanced Calibration: 21 # ∇ Cal. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period 570 END + First 0 First Last Last 2 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 Min. OSR6211 Reagent ID: R1 COLOUR (DBILC) 011. H 0. # User defined † System Calibrator Cat. OSR6211 Reagent ID: R1 COLOUR (DBILC) 011. No. # OD CONC † Factor/OD-L §530* 1-Point Cal.5 35 0 Dil.1 § Set the factor range for the blank reagent at –99999 to 99999 Metabolite BSOSR6x11. Reagent 1 vol Reagent 2 vol μL μL μL Fst. vol Dil. R1 BLANK (DBILB) 010 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0. Set the test as SAMPLE BLANK in the INTER RELATED TEST menu.DIRECT BILIRUBIN.1 § Set the factor range for the blank reagent at –99999 to 99999 ‡ The above parameters must be entered twice using test names DBILC (Colour Rg) and DBILB (Blank Rg). # # ο ∇ 3.1 Lst.: 66300 * Values set for working in SI units (μmol/L). AU400/AU640 Paediatric System Reagent: OSR6111. L -0. No. Set the test as SAMPLE BLANK in the INTER RELATED TEST menu # User defined ¤ Analyser default value † System Calibrator Cat. point MB type factor Calibrator stability period 21 Select the function using the Function key or the Mouse ‡ The above parameters must be entered twice using test names DBILC (Colour Rg) and DBILB (Blank Rg).1 0. # # ο ∇ 6. # # ο ∇ 5. # # ο ∇ 4.5 35 0 μL μL μL Dilution Dilution Dilution 10 130 0 μL μL μL Pri. OD H ∇ ∇ # Test name DBILP‡ Sample type Ser Page 1/2 Application DIRECT BILIRUBIN.1 ∇ ∇ ∇ Main 570 Sub 3. vol 10 130 0 Max. L -0. Set the test as SAMPLE BLANK in the INTER RELATED TEST menu. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 570 END + First 0 First Last Last 2 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ A 1 On-board stability period: Specific Test Parameters General LIH ISE Serum ∇ # Range Test Name: DBILP‡ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2.1 § Set the factor range for the blank reagent at –99999 to 99999 Metabolite BSOSR6x11. AU2700/AU5400 Paediatric Application System Reagent: OSR6111.1 0* B 21 0 H 171* First H Last H 0. # # ο ∇ 4. Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Panic Value: # # PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ # Factor/OD-H §804* Process: CONC ∇ Test Name: DBILP‡ ∇ < > Calibration Type: AB ∇ Formula: Y=AX+B ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: ∇ 21 # Cal.1 -0. # User defined † System Calibrator Cat. No. No. None Selected 8. # # ο ∇ 7. R1 BLANK (DBILB) 010 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0.1 0.: 66300 * Values set for working in SI units (μmol/L). # OD CONC † Factor/OD-L §530* 1-Point Cal. To work in mg/dL divide by 17.1 ∇ Operation: Yes Range Test Name: DBILP‡ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2. OSR6211 Reagent ID: R1 COLOUR (DBILC) 011. Point: ο with CONC-0 Slope Check: None MB Type Factor: Calibration Stability Period: ‡ The above parameters must be entered twice using test names DBILC (Colour Rg) and DBILB (Blank Rg). # # ο ∇ 6.01 2009-08 .DIRECT BILIRUBIN.7 27 0 μL μL μL Dilution Dilution Dilution 10 97 0 μL μL μL Pri. # # ο ∇ 3. # # ο ∇ 5. ∇ ∇ ∇ Sec. 7 1 27 R2(R2-1) 0 μL Dilution 0 μL Common Rgt. No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 21 Day 0 Calibration 21 Day 0 ∇ ο with Conc-0 Hour Hour MB Type Factor: 1-Point Calibration Point ∇ ж Set the test as SAMPLE BLANK in the COMMON TEST PARAMETERS TEST NAME SAMPLE BLANK menu. OSR6211 Reagent ID: R1 BLANK (DBILB) 010 Application Range Parameters General LIH DBILPBж ∇ Dilution μL Max. Volume R1(R1-1) 2.01 2009-08 . Test Name: Calibration Specific Calibration Parameters STAT Table Calibration Calibration Parameters STAT Table Calibration Type Serum ∇ ο Use Serum Cal.1 R2(R2-1) μL Name Sec.1 Min. ISE Parameters Calibrators General Test Name: DBILPCж ∇ < > Type Y=AX+B None ∇ Counts: # ∇ ∇ Factor Range Low High Slope Check 530* 804* Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation # ∇ # ∇ Interval (RB/ACAL) Counts: # ∇ ∇ Factor Range Low High Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) PAEDIATRIC APPLICATION None ∇ # ∇ # ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal. OSR6211 Parameters General Serum LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: OD Limit Max.DIRECT BILIRUBIN. No.1 0.7 1 27 Dilution 10 μL μL ∇ μL Dilution 97 μL Sample Volume Pre-Dilution Rate Rgt. For No. Volume R1(R1-1) 2. To work in mg/dL divide by 17. AU680/AU480 Paediatric Application Operation Yes System Reagent: OSR6111.1 0.OD Reagent OD Limit First Low Last Low μL ∇ μL Min.1 AU680 Metabolite BSOSR6x11.1 -0.: 66300 Values set for working in SI units (μmol/L).OD -0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour ο with Conc-0 Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 21 Day 0 Calibration 21 Day 0 <Point Cal. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm END ∇ + ∇ 0 21 Day # ∇ +++++ ∇ +++++ ∇ + ∇ Parameters Calibrators General Calibration Specific ISE DBILPBж ∇ < > Y=AX+B Serum ∇ ο Use Serum Cal.1 -0.: 66300 * Values set for working in SI units (μmol/L). AU680/AU480 Paediatric Reagent ID: R1 COLOR (DBILC) 011 System Reagent: OSR6111.1 μL Dilution 97 10 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range ∇ Test Name: Specific Test Parameters Calculated Test ∇ DIRECT BILIRUBIN. User defined System Calibrator Cat.1 High High 0.OD -0.OD Reagent OD Limit First Low Last Low DBILPCж ∇ < > Type: Operation Yes Sample Volume Pre-Dilution Rate Rgt.1 ф AU680 ж # † * ф Set the test as SAMPLE BLANK in the COMMON TEST PARAMETERS TEST NAME SAMPLE BLANK menu. For No. To work in mg/dL divide by 17. # User defined † System Calibrator Cat. Dynamic Range Low ф Correlation Factor A 660 ∇nm Factor for Maker A Last Last 2 % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 21 Day # ∇ +++++ ∇ +++++ ∇ + ∇ % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 570 ∇nm END ∇ + ∇ 0 Name Sec. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0* 1 1 μL High B B 0 171* 0 0 Hour 0* 1 1 0 Last Last 2 Hour High B B 171* 0 0 0 Dilution 0 High High 0. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values.31 mmol/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. the remaining 15 – 20% results from the breakdown of haem-containing proteins such as myoglobin. extracorpuscular haemolytic anemia e. Depending on the disorder unconjugated or conjugated bilirubin or both are major contributors to the resulting hyperbilirubinemia. Major preventative maintenance was performed on the analyser or a critical part was replaced.2 80 – 85% of bilirubin produced daily originates from haemoglobin released by the breakdown of senescent erythrocytes. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. A number of diseases affect one or more of the steps involved in the production. storage. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. Storage and Stability The reagents are stable. up to the stated expiry date when stored at 2…8°C. Post hepatic Jaundice: Diseases of post-hepatic origin with predominantly conjugated hyperbilirubinemia include extrahepatic cholestasis and liver transplant rejection. Once open. Specimen Serum and EDTA or heparinised plasma. The absorbance at 540 nm is proportional to the total bilirubin concentration. EN. Safety data sheet available for professional user on request. 3. Haemolysed samples should be avoided. A separate sample blank is performed to reduce endogenous serum interference.01 BLOSR6x12. Reaction Principle Bilirubin + DPD Caffeine Surfactant Azobilirubin Contents.5-dichlorophenyldiazonium tetrafluoroborate Surfactant Preservative 2. metabolism and excretion of bilirubin. 4 x 15 mL 4 x 15 mL 4 x 40 mL 4 x 40 mL R1 TBILC R1 TBILB R1 TBILC R1 TBILB Summary1. Protect TBILC from light. cytochromes. Test Principle3 A stabilised diazonium salt. The paediatric application is suitable for use with small volume serum/plasma samples. Hepatic Jaundice: Diseases of hepatic origin with predominantly conjugated hyperbilirubinemia include acute and chronic viral hepatitis.g. neonatal jaundice and haemolytic disease of the newborn. Hyperbilirubinemia can be classified as follows: Prehepatic Jaundice: Diseases of prehepatic origin with predominantly unconjugated hyperbilirubinemia include corpuscular haemolytic anemias e. Chronic congenital hyperbilirubinemias include the unconjugated hyperbilirubinemias Crigler-Najjar syndrome and Gilbert's syndrome as well as the conjugated hyperbilirubinemias Dubin-Johnson syndrome and Rotor syndrome. Calibration System Calibrator Cat. 4 Stable in serum and plasma for 7 days when stored at 2…8°C and 1 day when stored at 15…25°C. unopened.1 mmol/L 0. thalassemia and sickle cell anemia. blood transfusion reaction due to ABO and Rh incompatibility. Reagent Composition in the Test Final concentration of reactive ingredients: Caffeine 3.TOTAL BILIRUBIN OSR6112 OSR6212 Intended Use Photometric colour test for the quantitative determination of total bilirubin in human serum and plasma on Beckman Coulter analysers. liver cirrhosis and hepatocellular carcinoma. reagents stored on board the instrument are stable for 90 days. The calibrator total bilirubin value is traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 916a. uptake. For in vitro diagnostic use only. 66300.01 2009-08 Metabolite .g. Protect samples from light. Dispose of all waste material in accordance with local guidelines. No. catalases and from bone marrow as a result of ineffective erythropoiesis. The differentiation between chronic congenital hyperbilirubinemias and acquired types of bilirubinemia is accomplished via the measurement of bilirubin fractions and the detection of normal liver enzyme activities.5-dichlorophenyldiazonium tetrafluoroborate (DPD). reacts with conjugated bilirubin directly and with unconjugated bilirubin in the presence of an accelerator to form azobilirubin. 4. Each laboratory should verify the transferability of the expected values to its own population.06 1. 1987:733-737.5 – 12. Liver Function. Shaw LM. If any trends or sudden shifts in values are detected. Philadelphia:WB Saunders Company. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. ed. Tolman KG. Zawta B. clinical examinations and other findings. Ashwood ER. Clinical laboratory diagnostics. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Results of linear regression analysis were as follows: y = 0. 2 3.2 mg/dL) Serum (Children) 0 − 1 day 24 – 149 µmol/L (1. Effects of drugs on clinical laboratory tests.998 n = 111 Sample range = 0.17 1. Reference Intervals5 Serum (Adults) 5 – 21 µmol/L (0.3 – 1. In: Burtis CA. et al.5 mg/dL) 3 − 5 days 26 – 205 µmol/L (1. Rej R. Smith JL. The above parameters must be entered twice using test names TBILC (colour) and TBILB (blank).01 . especially monoclonal IgM (Waldenström’s macroglobulinemia). 5.942x + 0. eds.4 – 11. Philadelphia:WB Saunders Company. diet and geographical location. 1999.86 – 447. Tietz textbook of clinical chemistry. Reference information for the clinical laboratory. Fundamentals of clinical chemistry.39 µmol/L. Thomas L. In: Thomas L. Linearity The test is linear within a concentration range of 0 – 513 µmol/L (0 – 30 mg/dL).1803pp. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.12 CV% 1.392 r = 0.94 0.Quality Control Controls Cat.58 17.1 Set the factor range for the blank reagent at –99999 to 99999 Set the test as SAMPLE BLANK in the COMMON TEST PARAMETERS TEST NAME SAMPLE BLANK menu. Ashwood ER.41 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 0. Tietz textbook of clinical chemistry. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used.10 0. 2000. 6. The lowest detectable level represents the lowest measurable level of total bilirubin that can be distinguished from zero.01 2009-08 EN. AACC Press.34 µmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Haemolysis: Interference less than 10% up to 0. For diagnostic purposes. and if necessary determine its own reference interval according to good laboratory practice. 1999. Set the test as SAMPLE BLANK in the INTER RELATED TEST menu User defined ¤ Analyser default value System Calibrator Cat. 5th ed.2: 24pp.79 2.0 mg/dL) Expected values may vary with age. may cause unreliable results. Young DS. Data obtained in your laboratory may differ from these values. Method Comparison Patient serum samples were used to compare this Total Bilirubin OSR6112 assay on the AU600 against another commercially available total bilirubin assay.50 SD 0.76 222. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.1136-1137.37 3. Philadelphia: WB Saunders Company. No. sample type. Töpfer G. Cope JY. Wisser H.15 Total CV% 1.75 Within Run SD 0. Schmitt Y. The results obtained by any individual laboratory may vary from the given mean value.: 66300 Values set for working in SI units (µmol/L ).14 0. eds.1 Rev. WHO/DIL/LAB/99.7 mg/dL) 1 − 2 days 58 – 197 µmol/L (3. Frankfurt/Main: TH-Books Verlagsgesellschaft. Calculation The Beckman Coulter analysers automatically compute the total bilirubin concentration of each sample. In: Tietz NW. 6 Setting Sheet Footnotes ‡ # † * § ж 1. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. Heil W. plasma and serum samples. n = 60 Mean µmol/L 7.45 g/L haemoglobin ® Lipemia: Interference less than 10% up to 1000 mg/dL Intralipid In very rare cases gammopathy. BIBLIOGRAPHY Metabolite BLOSR6x12. 1998:192-202. Bilirubin. Refer to Young for further information on interfering substances. Liver Function. sex. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. To work in mg/dL divide by 17. ed.4 – 8. Balistreri WF. No.35 0. Ehret W. review all operating parameters. Painter PC. results should always be assessed in conjunction with the patient's medical history. In: Burtis CA. Use and assessment of clinical laboratory results. 1 § Set the factor range for the blank reagent at –99999 to 99999 Metabolite BSOSR6x12. L -0. Vol 0 120 0 Max. No. No. To work in mg/dL divide by 17. # # ο ∇ 3. H 513* Fst Fst 0 Lst Lst First H Last H 0. OD L Reagent OD limit Fst. Vol Dil. ∇ ∇ ∇ Sec.01 2009-08 . Set the test as SAMPLE BLANK in the INTER RELATED TEST menu.: 66300 * Values set for working in SI units (µmol/L). # OD CONC † Factor/OD-L §428* 1-Point Cal. # # ο ∇ 5.1 ∇ ∇ # Test name TBIL‡ Sample type Ser Page ½ Application TOTAL BILIRUBIN. # # ο ∇ 4.TOTAL BILIRUBIN. No. OSR6212 Reagent ID: RI COLOUR (TBILC) 012. # # ο ∇ 2. OSR6212 Reagent ID: RI COLOUR (TBILC) 012. Reagent 1 vol Reagent 2 vol μL μL μL Fst.1 Lst. AU600 Serum/Plasma Application System Reagent: OSR6112. To work in mg/dL divide by 17. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.1 0. L -0. R1 BLANK (TBILB) 025 Specific test parameters Test No ∇ Sample vol. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name TBIL‡ Sample type Ser ∇ On-board stability period 540 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. AU400/AU640 Serum/Plasma System Reagent: OSR6112. R1 BLANK (TBILB) 025 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0. Set the test as SAMPLE BLANK in the INTER RELATED TEST menu # User defined ¤ Analyser default value † System Calibrator Cat. OD H 0.1 Dynamic range L 0* Correlation factor % ∇ 513* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: TBIL‡ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 § Set the factor range for the blank reagent at –99999 to 99999 ‡ The above parameters must be entered twice using test names TBILC (Colour) and TBILB (Blank). Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # Calibration specific H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H §752* # Test No # Test name TBIL‡ ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L §428* # Conc Factor/OD-H §752* ∇ SERUM/PLASMA APPLICATION Test Name: Counts: TBIL‡ ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 Advanced Calibrator: # ∇ Cal.1 660 END + 10 Operation: Yes Range Test Name: TBIL‡ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 6 30 0 μL μL μL Dilution Dilution Dilution 0 120 0 μL μL μL Pri.1 -0. # # ο ∇ 7.1 0* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. H Lst. H ∇ ∇ ∇ Main 540 Sub 6 30 0 Dil. # # ο ∇ 6. # User defined † System Calibrator Cat. Vol Dil. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse ‡ The above parameters must be entered twice using test names TBILC (Colour) and TBILB (Blank).1 0.: 66300 * Values set for working in SI units (µmol/L). None Selected 8. To work in mg/dL divide by 17. Set the test as SAMPLE BLANK in the INTER RELATED TEST menu.1 0. OSR6212 Reagent ID: RI COLOUR (TBILC) 012. # # ο ∇ 5.1 ∇ Operation: Yes Range Test Name: TBIL‡ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 5 25 0 μL μL μL Dilution Dilution Dilution 0 100 0 μL μL μL Pri. # # ο ∇ 7. No.1 0* B 90 0 H 513* First H Last H 0. # # ο ∇ 6. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: ‡ The above parameters must be entered twice using test names TBILC (Colour) and TBILB (Blank). Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Panic Value: # # Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H §752* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: TBIL‡ ∇ < > Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # Cal. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 540 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Serum ∇ # Range Test Name: TBIL‡ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. None Selected 8. # OD CONC † Factor/OD-L §428* 1-Point Cal. AU2700/AU5400 Serum/Plasma Application System Reagent: OSR6112. # # ο ∇ 4.TOTAL BILIRUBIN. ∇ ∇ ∇ Sec. # User defined † System Calibrator Cat.1 § Set the factor range for the blank reagent at –99999 to 99999 Metabolite BSOSR6x12.01 2009-08 . R1 BLANK (TBILB) 025 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0.: 66300 * Values set for working in SI units (µmol/L). # # ο ∇ 3.1 -0. No. # # ο ∇ 2. OD Reagent OD Limit First Low Last Low Sample Volume Pre-Dilution Rate Rgt. To work in mg/dL divide by 17. Test Name: Calibration Specific Calibration Parameters STAT Table Calibration Calibration Parameters STAT Table Calibration Serum ∇ ο Use Serum Cal. To work in mg/dL divide by 17. Volume R1(R1-1) 5 1 25 R2(R2-1) 0* 1 1 0 Last Last 10 Hour High B B 513* 0 0 0 μL Dilution 0 μL Common Rgt.: 66300 Values set for working in SI units (µmol/L). of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 ∇ ο with Conc-0 Hour Hour MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ж # † * ф Set the test as SAMPLE BLANK in the COMMON TEST PARAMETERS TEST NAME SAMPLE BLANK menu. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0* 1 1 μL High B B 0 513* 0 0 Hour 0 Dilution 0 High High 0.1 0. Volume R1(R1-1) 5 1 25 0 μL OD Limit μL ∇ μL Dilution 100 μL Min.1 μL Dilution 100 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range ∇ Test Name: Specific Test Parameters Calculated Test ∇ TOTAL BILIRUBIN. For No.OD -0.1 -0. OSR6212 Parameters General Serum LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: TBILCж ∇ < > Type: Operation Yes Dilution Max.1 AU680 Metabolite BSOSR6x12. AU680/AU480 Serum/Plasma Reagent ID: R1 COLOUR (TBILC) 012 System Reagent: OSR6112. User defined System Calibrator Cat. Dynamic Range Low ф Correlation Factor A 660 ∇nm Factor for Maker A Last Last 10 % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Common Rgt.OD Reagent OD Limit First Low Last Low Sample Volume Pre-Dilution Rate Rgt. OSR6212 Reagent ID: R1 BLANK (TBILB) 025 Application Range Parameters General LIH TBILBж ∇ Dilution μL Max.1 AU680 ж # † * ф Set the test as SAMPLE BLANK in the COMMON TEST PARAMETERS TEST NAME SAMPLE BLANK menu.TOTAL BILIRUBIN. AU680/AU480 Serum/Plasma Application Operation Yes System Reagent: OSR6112.1 0.1 R2(R2-1) μL Name Sec. No.: 66300 Values set for working in SI units (µmol/L). ISE Parameters Calibrators General Test Name: TBILCж ∇ < > Type Serum Y=AX+B None ∇ Counts: # ∇ ∇ Factor Range Low High Slope Check 428* 752* Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation # ∇ # ∇ Interval (RB/ACAL) Counts: # ∇ ∇ Factor Range Low High Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) None ∇ SERUM/PLASMA APPLICATION # ∇ # ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal.1 μL ∇ μL Min. For No.OD -0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 <Point Cal. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 540 ∇nm END ∇ + ∇ 0 90 Day # ∇ +++++ ∇ +++++ ∇ + ∇ Parameters Calibrators General Calibration Specific ISE TBILBж ∇ Y=AX+B < > Type ∇ ο Use Serum Cal. User defined System Calibrator Cat.1 High High 0.01 2009-08 . Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 90 Day # ∇ +++++ ∇ +++++ ∇ + ∇ % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 540 ∇nm END ∇ + ∇ 0 Name Sec.1 -0. No. 1 § Set the factor range for the blank reagent at –99999 to 99999 ‡ The above parameters must be entered twice using test names TBILC (Colour) and TBILB (Blank). OSR6212 Reagent ID: RI COLOUR (TBILC) 012. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period 570 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 Min. vol Dil. # OD CONC † Factor/OD-L §1120* 1-Point Cal.1 Dynamic range L 0* Correlation factor 513* 1 0 ¤ % ∇ A 1 On-board stability period: 90 Specific Test Parameters General LIH ISE Serum ∇ # # # # # # # Age Y Y Y Y Y Y Range Test Name: TBILP‡ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. ∇ ∇ ∇ Sec. No. # # ο ∇ 3. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse ‡ The above parameters must be entered twice using test names TBILC (Colour) and TBILB (Blank). R1 BLANK (TBILB) 025 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0. H 0. To work in mg/dL divide by 17. Reagent 1 vol Reagent 2 vol μL μL μL Fst. vol 10 118 0 Max. AU400/AU640 Paediatric System Reagent: OSR6112.01 2009-08 Metabolite . Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # Calibration specific H # # # # # # # # H # Select the function using the Function key or the Mouse PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H §1680* # Test No # Test name TBILP‡ Test Name: TBILP‡ ∇ < > Type ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L §1120* # Conc Factor/OD-H §1680* ∇ Calibration Type: AB ∇ Formula: Y=AX+B ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. R1 BLANK (TBILB) 025 Specific test parameters Test No ∇ Sample vol. OSR6212 Reagent ID: RI COLOUR (TBILC) 012.1 0. L -0. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. OD H ∇ ∇ # Test name TBILP‡ Sample type Ser Page 1/2 Application TOTAL BILIRUBIN.1 0* B 90 Linearity Fst No lag time Select using Space key.TOTAL BILIRUBIN. or select from list displayed by Guide key Test No ∇ # ∇ H # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ M M M M M M Age Y Y Y Y Y Y # # # # # # L # Test name TBILP‡ Sample type Ser ∇ Level L # Page 2/2 Level H # % Sec % ∇ 0 Sample Pre-dil. OD L Reagent OD limit Fst. # # ο ∇ 4. # User defined † System Calibrator Cat. AU600 Paediatric Application System Reagent: OSR6112. To work in mg/dL divide by 17. vol Dil. # # ο ∇ 7. # # ο ∇ 6.1 660 END + 10 H A B Rate Operation: Yes Range Test Name: TBILP‡ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 6 32 0 μL μL μL Dilution Dilution Dilution 10 118 0 μL μL μL Pri.: 66300 * Values set for working in SI units (µmol/L).1 § Set the factor range for the blank reagent at –99999 to 99999 BSOSR6x12.1 -0.1 Lst. None Selected 8. No. # # ο ∇ 5. H Lst. # # ο ∇ 2.: 66300 * Values set for working in SI units (µmol/L). Set the test as SAMPLE BLANK in the INTER RELATED TEST menu.1 ∇ ∇ ∇ Main 570 Sub 6 32 0 Dil. H 513* Fst Fst 0 Lst Lst First H Last H 0.1 0. L -0. No. Set the test as SAMPLE BLANK in the INTER RELATED TEST menu # User defined ¤ Analyser default value † System Calibrator Cat. # # ο ∇ 7. OSR6212 Reagent ID: RI COLOUR (TBILC) 012. No. None Selected 8.: 66300 * Values set for working in SI units (µmol/L).01 2009-08 .1 -0. Set the test as SAMPLE BLANK in the INTER RELATED TEST menu. To work in mg/dL divide by 17. # User defined † System Calibrator Cat. # # ο ∇ 3. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 570 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ A 1 On-board stability period: Specific Test Parameters General LIH ISE Serum ∇ # Range Test Name: TBILP‡ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. ∇ ∇ ∇ Sec. # # ο ∇ 2. # # ο ∇ 4. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: ‡ The above parameters must be entered twice using test names TBILC (Colour) and TBILB (Blank).1 ∇ Operation: Yes Range Test Name: TBILP‡ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 5 26 0 μL μL μL Dilution Dilution Dilution 10 95 0 μL μL μL Pri. AU2700/AU5400 Paediatric Application System Reagent: OSR6112.1 § Set the factor range for the blank reagent at –99999 to 99999 Metabolite BSOSR6x12.1 0* B 90 0 H 513* First H Last H 0. Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Panic Value: # # PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ # Factor/OD-H §1680* Process: CONC ∇ Test Name: TBILP‡ ∇ < > Calibration Type: AB ∇ Formula: Y=AX+B ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # Cal. # # ο ∇ 6.1 0.TOTAL BILIRUBIN. # OD CONC † Factor/OD-L §1120* 1-Point Cal. No. # # ο ∇ 5. R1 BLANK (TBILB) 025 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0. For No. AU680/AU480 Paediatric Application Operation Yes System Reagent: OSR6112. OSR6212 Parameters General LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: OD Limit Max.OD Reagent OD Limit First Low Last Low μL ∇ μL Min.1 -0.OD -0. Volume R1(R1-1) 5 1 26 Dilution 10 μL μL ∇ μL Dilution 95 μL Sample Volume Pre-Dilution Rate Rgt. For No.OD -0.1 μL Dilution 95 10 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range ∇ Test Name: Specific Test Parameters Calculated Test Serum ∇ TOTAL BILIRUBIN.TOTAL BILIRUBIN. Test Name: Calibration Specific Calibration Parameters STAT Table Calibration Calibration Parameters STAT Table Calibration Type Serum ∇ ο Use Serum Cal.01 2009-08 . To work in mg/dL divide by 17. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 90 Day # ∇ +++++ ∇ +++++ ∇ + ∇ % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 570 ∇nm END ∇ + ∇ 0 Name Sec.1 High High 0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 ∇ ο with Conc-0 Hour Hour MB Type Factor: 1-Point Calibration Point ∇ ж # † * ф Set the test as SAMPLE BLANK in the COMMON TEST PARAMETERS TEST NAME SAMPLE BLANK menu. No. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0* 1 1 μL High B B 0 513* 0 0 Hour 0 Dilution 0 High High 0.1 Min. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour ο with Conc-0 Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 <Point Cal. User defined System Calibrator Cat. No. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm END ∇ + ∇ 0 90 Day # ∇ +++++ ∇ +++++ ∇ + ∇ Parameters Calibrators General Calibration Specific ISE TBILPBж ∇ < > Y=AX+B Serum ∇ ο Use Serum Cal. User defined System Calibrator Cat.OD Reagent OD Limit First Low Last Low TBILPCж ∇ < > Type: Operation Yes Sample Volume Pre-Dilution Rate Rgt. AU680/AU480 Paediatric Reagent ID: R1 COLOUR (TBILC) 012 System Reagent: OSR6112. Dynamic Range Low ф Correlation Factor A 660 ∇nm Factor for Maker A Last Last 10 % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Common Rgt. Volume R1(R1-1) 5 1 26 R2(R2-1) 0* 1 1 0 Last Last 10 Hour High B B 513* 0 0 0 μL Dilution 0 μL Common Rgt. To work in mg/dL divide by 17.1 0.1 AU680 Metabolite BSOSR6x12.1 0.1 R2(R2-1) μL Name Sec.: 66300 Values set for working in SI units (µmol/L).1 AU680 ж # † * ф Set the test as SAMPLE BLANK in the COMMON TEST PARAMETERS TEST NAME SAMPLE BLANK menu. ISE Parameters Calibrators General Test Name: TBILPCж ∇ < > Type Y=AX+B None ∇ Counts: # ∇ ∇ Factor Range Low High Slope Check 1120* 1680* Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation # ∇ # ∇ Interval (RB/ACAL) Counts: # ∇ ∇ Factor Range Low High Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) PAEDIATRIC APPLICATION None ∇ # ∇ # ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal.1 -0.: 66300 Values set for working in SI units (µmol/L). OSR6212 Reagent ID: R1 BLANK (TBILB) 025 Application Range Parameters General LIH TBILPBж ∇ Dilution μL Max. ODC0025 for urine application. Refer to Safety Data Sheets for further information.3 Calcium ions react with o-Cresolphthalein-complexone in an alkaline medium to form a purple coloured complex. up to the stated expiry date when stored at 2…25°C. which strongly affect the level of ionised calcium. No. contains 2-aminoethanol. and complex-bound calcium. Reagent Composition in the Test Final concentration of reactive ingredients: Ethanolamine (pH 10. The resulting increase in absorbance of the reaction mixture is directly proportional to the calcium concentration in the sample. In this method the absorbance of the Ca-oCPC complex is measured bichromatically at 570/660 nm.375 mol/L 7. mainly to phosphate. Wear suitable protective clothing. This material and its container must be disposed of as hazardous waste. Recalibrate the assay every day or. The calcium values of both calibrators are traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 909b Level 1. respiratory system and skin.. A significant reduction in calcium ion concentration results in muscle tetany.6 Ca-oCPC Complex (purple) 2+ Contents. Sodium Citrate. plasma and urine on Beckman Coulter analysers. S45. 66300 for serum/plasma application and Urine Calibrator Cat. This effect will vary depending upon the rate of use. Sodium Fluoride or Oxalate. in the maintenance of normal muscle contractility. Storage and Stability The reagents are stable. EN. reagents stored on board the instrument are stable for 30 days. when the following occur: Change in reagent bottle or significant shift in control values.01 BLOSR6x13. Do not use the following 4 anticoagulants in collecting blood for use in this test: EDTA. It may be estimated from total calcium given knowledge of the protein content and pH of the blood. rinse immediately with plenty of water and seek medical advice. chronic renal disease.CALCIUM oCPC OSR6113 OSR6213 Intended Use Photometric colour test for the quantitative determination of total calcium in human serum. unopened. The paediatric application is suitable for use with small volume serum/plasma samples. For in vitro diagnostic use only. Store at 2. S60. Test Principle2. The ionised calcium is physiologically most significant. 45%. Reaction Principle Ca 2+ 8-Hydroxyquinoline + oCPC pH 10. Consequently each laboratory should set a calibration frequency in the instrument parameters appropriate to their usage pattern. No. Major preventative maintenance was performed on the analyser or a critical part was replaced.6) 8-Hydroxyquinoline o-Cresolphthalein complexone 0.. Safety Phrases: S26 – S36/37/39.0 µmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: R1 reagent: Irritant. 5 Stable in serum when stored at 2.8°C. A higher than normal concentration of calcium ions produces lowered neuromuscular excitability and muscle weakness along with other more complex symptoms. 50%. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument.01 2009-08 Metabolite . and in the process of coagulation. but has proven difficult to assay directly.. gloves and eye/face protection. Calcium ions are important in the transmission of nerve impulses. citrate. Specimen Serum or heparinised plasma should be promptly separated to avoid the uptake of calcium by erythrocytes. Collect timed 24 hour specimen using standard laboratory procedures. Once open.8°C for up to 1 week. urolithiasis and tetany (intermittent muscular contractions or spasms). a variety of bone diseases. Absorption of atmospheric CO2 by the reagent on board the analyser can impair calibration stability. protein bound calcium most of which is bound to albumin with only a small portion bound to globulins. 5%. 4 x 27 mL 4 x 27 mL 4 x 50 mL 4 x 50 mL R1 R2 R1 R2 Summary1 Measurement of calcium is used in the diagnosis and treatment of parathyroid disease. Total serum calcium is composed of three fractions: free or ionised calcium. In case of accident or if you feel unwell. and bicarbonate. Urine : Acidified with 6M HCl. In case of contact with eyes. seek medical advice immediately (show the label where possible).16 mmol/L 82. Irritating to eyes. Dispose of all waste material in accordance with local guidelines. R36/37/38. 6 Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.. Calibration Use System Calibrator Cat. as a cofactor in several enzyme reactions. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.Quality Control Controls Cat. The lowest detectable level in urine on the AU2700 was estimated at 0. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.01 0.07 – 7.997 n = 125 Sample range = 0.01 2009-08 EN. Data obtained in your laboratory may differ from these values.14 3.6 – 10.5 mmol/L (0 – 18 mg/dL) for serum and plasma. Biorad Liquichek Urine Chemistry Controls Cat. Metabolite BLOSR6x13.04 4. The test is linear within a concentration range of 0 – 10 mmol/L (0 – 40 mg/dL) for urine.0 g/L haemoglobin ® Lipemia: Interference less than 10% up to 1000 mg/dL Intralipid Results of urine studies conducted to evaluate the susceptibility of the method to interference were as follows: Ascorbate: Interference less than 3% up to 50 mg/dL ascorbate Magnesium: Interference less than 3% up to 40mg/dL magnesium Refer to Young for further information on interfering substances. 8 Limitations Care should be taken when interpreting calcium results from patients who have received gadolinium containing contrast medium within the 9.27 0. No. The results obtained by any individual laboratory may vary from the given mean value.49 0.02 0.004 r = 0. 397 and 398 or other control materials with values determined by this Beckman Coulter system may be used for the urine application.002 r = 0. Precision The following data was obtained on an AU640 using 3 serum control materials analysed over 20 days.60 mmol/L or 7.51 0.02 0. especially if the patient has impaired renal function.65 0. review all operating parameters. sex. No.4 mg/dL 2.33 1. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. diet and geographical location. Reference Intervals Serum. samples should be drawn prior to administration of such contrast media.65 mmol/L or 8.03 1. If non-colorimetric assays are unavailable.57mmol/L Patient urine samples were used to compare this Calcium oCPC OSR6113 assay on the AU2700 against another commercially available calcium assay. Children 0 – 10 day Serum.06 9. If any trends or sudden shifts in values are detected. plasma – Adults 7 Serum.90 – 2.63 0. Results of linear regression analysis were as follows: y = 0.01 .20 – 2.8 – 10.37 – 3.02 2.57 mmol/mmol (0.6 mg/dL 1.5 mmol (300mg) Male and Female ≤ 0. Results of linear regression analysis were as follows: y = 0. 11 Such samples should be assayed using non-colorimetric previous 24 hours.971x + .40 The following data was obtained on an AU640 using 3 urine pools analysed over 20 days.17 Sensitivity The lowest detectable level in serum on an AU640 analyser was estimated at 0. Children 2 – 12 year 1 1 2.1 mmol (4 mg)/kg of body weight Small Children: ≤ 0.03 mmol/L.03 0.62 0. Calculation The Beckman Coulter analysers automatically compute the calcium concentration of each sample.2g/g) of creatinine Male < 7.8 mg/dL Urine : 24h urine 2h urine Female < 6. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.60 0.2 mmol (250 mg) Male and Female ≤ 0.53 0.986x + .10 mmol/L. For diagnostic purposes.8 – 10. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used for the serum/plasma application.04 1.72 2. ion selective electrodes or emission spectroscopy.20 – 2. techniques e.11 CV% 3.985 n = 106 Sample range = 1. sample type.05 0. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed.05 1. n = 80 Within Run Total Mean mmol/L SD CV% SD CV% 2. clinical examinations and other findings.02 0. Linearity The test is linear within a concentration range of 0 – 4. n = 80 Within Run Total Mean mmol/L SD CV% SD 1.75 0. 10.73mmol/L Interfering Substances Results of serum studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5. Method Comparison Patient serum samples were used to compare this Calcium oCPC OSR6113 assay on the AU640 against a flame photometry method.42 0.70 mmol/L or 8.13 0.93 1.g. and if necessary determine its own reference interval according to good laboratory practice. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.8 g/g creatinine Expected values may vary with age. Each laboratory should verify the transferability of the expected values to its own population. results should always be assessed in conjunction with the patient's medical history. The lowest detectable level represents the lowest measurable level of calcium that can be distinguished from zero. 2nd ed. 8. 2000. Berthommier C. Ashwood ER. Transportation. et al.01 2009-08 Metabolite . Effects of time and temperature on 22 serum analytes. 5. Summary of Product Characteristics OMNISCAN. Gitelman HJ. Martin JV. AACC. Analyst 1956. Scand J Clin Lab Invest 1995. Eriochrome Black T and with oCresolphthalein-Complexone. EN. Reference information for the clinical laboratory. An improved automated procedure for the determination of calcium in biochemical specimen.55:421-426. Anal. Normann PT. Frankfurt/Main: TH-Books Verlagsgesellschaft. Interference of gadodiamide injection (OMNISCAN®) on the colorimetric determination of serum calcium. To work in mg/dL multiply by 4. St Louis: Mosby. ed. and correlation. 9. Approved Guideline. Young DS. 1998:231-241. Biochem 1967. 10. Painter PC. 5th ed. Idee JM. Effects of Drugs on Clinical Laboratory Tests.21:931-943. BIBLIOGRAPHY Thomas L. Clinical Laboratory Diagnostics Use and Assessment of Clinical Laboratory Results. eds. 6. 81:348-353. No. Clinical Chemistry Theory. NCCLS Document GP16-A2. Pollard FH. User defined ¤ Analyser default value System Calibrator Cat. Port M.01 BLOSR6x13. Heil W. Storage of serum or whole blood samples. Frøysa A. 1st ed. AACC Press. 3. Svaland M. Smith JL. 11. Kaplan LA. 7. 2. 3rd ed. 1999. 1996:550pp. Heins M. Pennsylvania: NCCLS.:ODC0025 Values set for working in SI units (mmol/L). Withold W. Tietz textbook of clinical chemistry. Urinalysis and Collection. eds. NCCLS.18: 521-531. The Spectrophotometric Determination of the Alkaline-earth Metals with Murexide. Lin J. Interference of magnetic resonance imaging contrast agents with the serum calcium measurement technique using colorimetric reagents. 4.: 66300/ Urine Calibrator Cat. Diai A. 2001. Cope JY. J Pharm Biomed Analysis 1999. analysis. Philadelphia:WB Saunders Company. Pesce AJ. Depends on usage pattern in the laboratory.1804pp. No.Setting Sheet Footnotes # † * ‡ 1. As communicated to Beckman Coulter Biomedical Ltd by Amersham Health. and Preservation of Urine Specimens. In: Burtis CA. Eur J Clin Chem Clin Biochem 1995. June 1999. Robert M.33:231-238. . Vol Dil. # # ο ∇ 4. H 4.5* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: CA ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. H -0. L -0. OSR6213 Reagent ID: 013 Application CALCIUM oCPC. To work in mg/dL multiply by 4 Depends on usage pattern in the Laboratory Metabolite . No. No. # # ο ∇ 2. ∇ ∇ ∇ Sec. # # ο ∇ 5. or select from list displayed by Guide key Test No ∇ ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CA Sample type Ser ∇ On-board stability period 570 END + First 0 First 0 Pri.1 0* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. # # ο ∇ 6. OD L Reagent OD limit Fst. AU600 Serum/Plasma Application System Reagent: OSR6113. AU400/AU640 Serum/Plasma Reagent ID: 013 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 570 Sub Fst. OD H 0. L -0. 660 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min.1 -0.2 1.: 66300 Values set for working in SI units (mmol/L). H Lst. # # ο ∇ 7.: 66300 Values set for working in SI units (mmol/L).0 ∇ Operation: Yes Test No ∇ ∇ # Test name CA Sample type Ser Page ½ System Reagent: OSR6113. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name CA ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 2* # Conc Factor/OD-H 8* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 8* # SERUM/PLASMA APPLICATION Test Name: Counts: CA ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ Cal. Vol 0 110 10 Max. None Selected 8.2 1. To work in mg/dL multiply by 4 Depends on usage pattern in the Laboratory # † * ‡ User defined System Calibrator Cat. OSR6213 Specific Test Parameters General LIH ISE Range Test Name: CA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 5 60 60 μL μL μL Dilution Dilution Dilution 0 110 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.5* Fst Fst 0 0 Lst Lst First H Last H 0. Vol Dil.0 Wave Method Reaction Point 1 Point 2 660 END + 27 10 Sample vol. # OD CONC † Factor/OD-L 2* 1-Point Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. Point MB type factor Calibrator stability period ‡ Select the function using the Function key or the Mouse # † * ‡ BSOSR6x13. # # ο ∇ 3.1 Lst.1 Dynamic range L 0* Correlation factor % ∇ 4. No.CALCIUM oCPC. Reagent 1 vol Reagent 2 vol μL μL μL 5 60 60 Dil.01 2009-08 User defined ¤ Analyser default value System Calibrator Cat. Cal. To work in mg/dL multiply by 4 ‡ Depends on usage pattern in the Laboratory ф AU680 <Point Cal. For No. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0* 1 1 μL High B B 0 4. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. 660 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ # Range Test Name: CA ∇ < > Type: Level L: # Level H: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. None Selected 8.OD -0. # # ο ∇ 2. AU2700/AU5400 Serum/Plasma Reagent ID: 013 Parameters General LIH CA ∇ Dilution μL Max. No demographics 8. Not within expected values mmol/L* Decimal Places Calibration Specific ISE CA ∇ < Month # # # # # # Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 2* 8* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 8* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: CA ∇ < > Calibration Type: AB ∇ Formula: Y=AX+B ∇ Test Name: Use Serum Cal. # # ο ∇ 5. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x13.01 2009-08 . ∇ # # # # ο 4. # # ο ∇ 3. ∇ # # # # ο 5.1 R2(R2-1) μL Name Sec. ∇ # # # # ο 2.7 45 45 0.CALCIUM oCPC.1 -0. ∇ ∇ ∇ 0* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 570 END + First 0 First 0 Sec.0 μL Dilution 80 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6113.1 High High 0.: 66300 * Values set for working in SI units (mmol/L).7 1 45 Test Name: ∇ CA ∇ < > Type: Operation: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 Last Last 27 10 3. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General LIH CA ∇ < > ISE HbA1c Test Name: Noneф 570 ∇nm END ∇ + ∇ 0 0 % ∇ μL μL μL Dilution Dilution Dilution 0 80 10 μL μL μL Pri.2 1. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration ‡ Day ‡ MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. ∇ # # # # ο 3. † System Calibrator Cat.OD Reagent OD Limit First Low Last Low 3.5* 0 0 Hour 45 Dilution 10 Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) μL ∇ μL Min. # # ο ∇ 6. OSR6213 Reagent ID: 013 Application Operation Yes CALCIUM oCPC.2 1.1 -0. # OD CONC † Factor/OD-L 2* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ ‡ ∇ Advanced Calibration: # None ∇ 1-Point Cal.0 4. OSR6213 Specific Test Parameters General LIH ISE Range Serum ∇ 1 Max OD H -0. No. No. # # ο ∇ 7.5* 0 Common Rgt. ∇ # # # # ο 6. ∇ 7. AU680/AU480 Serum/Plasma Application System Reagent: OSR6113. # # ο ∇ 4. point MB type factor Calibrator stability period ‡ Select the function using the Function key or the Mouse # † * ‡ BSOSR6x13. # # ο ∇ 6. To work in mg/dL multiply by 4 Depends on the usage pattern in the laboratory Metabolite .: ODC0025 Values set for working in SI units (mmol/L). No. AU400/AU640 Urine Reagent ID: 013 Specific test parameters Urine ∇ 1 Max OD H Main ∇ ∇ ∇ 570 Sub Fst. OD H 0. OD L Reagent OD limit Fst.1 0* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. ∇ ∇ ∇ Sec. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # URINE APPLICATION Select the function using the Function key or the Mouse Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 20* # Calibration specific Test No # Test name CA ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 5* # Conc Factor/OD-H 20* ∇ Test Name: Counts: CA ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ Cal.1 Dynamic range L 0* Correlation factor % ∇ 10* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Urine ∇ # Range Page 2/2 Level L # Level H # Test Name: CA ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 4. # # ο ∇ 5. H 10* Fst Fst 0 0 Lst Lst First H Last H 0. vol Dil.1 Lst.2 1. # # ο ∇ 3. # # ο ∇ 2. # # ο ∇ 7.: ODC0025 Values set for working in SI units (mmol/L). L -0. or select from list displayed by Guide key Test No ∇ ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CA Sample type Uri ∇ On-board stability period 570 END + First 0 First 0 Pri. L -0.0 ∇ Operation: Yes Test No ∇ ∇ # Test name CA Sample type Uri Page 1/2 System Reagent: OSR6113. H Lst.01 2009-08 User defined ¤ Analyser default value Urine Calibrator Cat. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. vol Dil. vol 0 110 10 Max. No. No. OSR6213 Reagent ID: 013 Application CALCIUM oCPC. Reagent 1 vol Reagent 2 vol μL μL μL 2 60 60 Dil. To work in mg/dL multiply by 4 Depends on the usage pattern in the laboratory # † * ‡ User defined Urine Calibrator Cat. # OD CONC † Factor/OD-L 5* 1-Point Cal. 660 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. H -0.1 -0. AU600 Urine Application System Reagent: OSR6113. None Selected 8. OSR6213 Specific Test Parameters General LIH ISE Range Test Name: CA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 60 60 μL μL μL Dilution Dilution Dilution 0 110 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.2 1.CALCIUM oCPC.0 Wave Method Reaction Point 1 Point 2 660 END + 27 10 Sample vol. No. Cal. OSR6213 Specific Test Parameters General LIH ISE Range Urine ∇ 1 Max OD H -0. To work in mg/dL multiply by 4 Depends on the usage pattern in the laboratory AU680 <Point Cal.1 -0.OD -0.0 μL Dilution 80 0 OD Limit < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6113. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Parameters General LIH CA ∇ < > ISE HbA1c Test Name: Noneф 570 ∇nm END ∇ + ∇ 0 0 % ∇ 1.5 45 45 0. # # ο ∇ 2. # OD CONC † Factor/OD-L 5* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ ‡ ∇ Advanced Calibration: # None ∇ 1-Point Cal. Urine Calibrator Cat.0 10* μL μL μL Dilution Dilution Dilution 0 80 10 μL μL μL Pri. ∇ # # # # ο 3. 660 Onboard Stability Period Last Last 27 10 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0* 1 1 30 Day μL High B B 0 10* 0 0 Hour 45 Dilution 10 Sample Volume Pre-Dilution Rate Rgt. For No.: ODC0025 Values set for working in SI units (mmol/L). ∇ # # # # ο 5. 660 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Urine ∇ # Range Test Name: CA ∇ < > Type: Level L: # Level H: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. ∇ ∇ ∇ 0* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 570 END + First 0 First 0 Sec. # # ο ∇ 3. Not within expected values mmol/L* Decimal Places Calibration Specific ISE CA ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ Factor Range Low High 5* 20* ∇ # ο ∇ Calibration Specific General ISE Type Urine ∇ Counts: Factor/OD-H 20* # Process: CONC ∇ Test Name: CA ∇ < > Calibration Type: AB ∇ Formula: Y=AX+B ∇ Test Name: Use Serum Cal. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H URINE APPLICATION Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.1 R2(R2-1) μL Name Sec.CALCIUM oCPC. OSR6213 Reagent ID: 013 Application Operation Yes CALCIUM oCPC. # # ο ∇ 7. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration ‡ Day ‡ MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ‡ ф User defined.1 High High 0. No demographics 8. ∇ # # # # ο 2. AU2700/AU5400 Urine Reagent ID: 013 Parameters General LIH CA ∇ Dilution μL Max. AU680/AU480 Urine Application System Reagent: OSR6113. ∇ 7.1 -0. ∇ # # # # ο 6.01 2009-08 . # # ο ∇ 5. ∇ # # # # ο 4. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x13.OD Reagent OD Limit First Low Last Low 1. No.2 1. Volume R1(R1-1) μL ∇ μL Min. # # ο ∇ 6.5 1 45 Test Name: ∇ CA ∇ < > Type: Operation: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 0 Common Rgt. None Selected 8.2 1. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 3.1 Lst. # # ο ∇ 4.1 -0.0 ∇ Operation: Yes Test No ∇ ∇ # Test name CAP Sample type Ser Page 1/2 System Reagent: OSR6113.01 2009-08 User defined ¤ Analyser default value System Calibrator Cat. H -0. vol 10 100 10 Max.1 0* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil.5* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: CAP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. To work in mg/dL multiply by 4 Depends on usage pattern in the Laboratory # † * ‡ User defined System Calibrator Cat. No. AU400/AU640 Paediatric Reagent ID: 013 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 570 Sub Fst. vol Dil.5* Fst Fst 0 0 Lst Lst First H Last H 0.2 1. H Lst. point MB type factor Calibrator stability period ‡ Select the function using the Function key or the Mouse # † * ‡ BSOSR6x13. ∇ ∇ ∇ Sec. To work in mg/dL multiply by 4 Depends on usage pattern in the Laboratory Metabolite . Reagent 1 vol Reagent 2 vol μL μL μL 5 60 60 Dil.: 66300 Values set for working in SI units (mmol/L). L -0. OSR6213 Specific Test Parameters General LIH ISE Range Test Name: CAP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 5 60 60 μL μL μL Dilution Dilution Dilution 10 100 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. OD L Reagent OD limit Fst. OSR6213 Reagent ID: 013 Application CALCIUM oCPC. L -0. # # ο ∇ 7. None Selected 8.2 1. 660 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name CAP ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 2* # Conc Factor/OD-H 8* ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 8* # Test Name: Counts: CAP ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ Cal. # OD CONC † Factor/OD-L 2* 1-Point Cal. vol Dil. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.0 Wave Method Reaction Point 1 Point 2 660 END + 27 10 Sample vol. AU600 Paediatric Application System Reagent: OSR6113. No.: 66300 Values set for working in SI units (mmol/L).CALCIUM oCPC. H 4. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CAP Sample type Ser ∇ On-board stability period 570 END + First 0 First 0 Pri.1 Dynamic range L 0* Correlation factor % ∇ 4. # # ο ∇ 6. No. # # ο ∇ 2. OD H 0. ∇ 7. # # ο ∇ 5. OSR6213 Specific Test Parameters General LIH ISE Range Serum ∇ 1 Max OD H -0.0 μL Dilution 80 10 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6113.OD Reagent OD Limit First Low Last Low 3.2 1.: 66300 * Values set for working in SI units (mmol/L). # # ο ∇ 3.CALCIUM oCPC. # # ο ∇ 7. ∇ # # # # ο 3. 660 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ # Range Test Name: CAP ∇ < > Type: Level L: # Level H: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.0 4. # # ο ∇ 6. No. # # ο ∇ 2. Cal. To work in mg/dL multiply by 4 ‡ Depends on usage pattern in the Laboratory ф AU680 <Point Cal.01 2009-08 .1 R2(R2-1) μL Name Sec.5* 0 Common Rgt.1 -0. None Selected 8.7 1 45 Test Name: ∇ CAP ∇ < > Type: Operation: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 Last Last 27 10 3.1 -0.1 High High 0.OD -0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General LIH CAP ∇ < > ISE HbA1c Test Name: Noneф 570 ∇nm END ∇ + ∇ 0 0 % ∇ μL μL μL Dilution Dilution Dilution 10 80 0 μL μL μL Pri. Not within expected values mmol/L* Decimal Places Calibration Specific ISE CAP ∇ < Month # # # # # # Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 2* 8* ∇ # ο ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H 8* # Process: CONC Test Name: CAP ∇ < > Calibration Type: AB ∇ Formula: Y=AX+B ∇ Test Name: Use Serum Cal. ∇ # # # # ο 4.7 45 45 0.5* 0 0 Hour 45 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0* 1 1 μL High B B 0 4. For No. OSR6213 Reagent ID: 013 Application Operation Yes CALCIUM oCPC. # OD CONC † Factor/OD-L 2* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ ‡ ∇ Advanced Calibration: # None ∇ 1-Point Cal. † System Calibrator Cat. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration ‡ Day ‡ MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. Volume R1(R1-1) μL ∇ μL Min. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x13. ∇ # # # # ο 6. # # ο ∇ 4. No.2 1. AU680/AU480 Paediatric Application System Reagent: OSR6113. AU2700/AU5400 Paediatric Reagent ID: 013 Parameters General LIH CAP ∇ Dilution μL Max. ∇ # # # # ο 5. ∇ ∇ ∇ 0* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 570 END + First 0 First 0 Sec. ∇ # # # # ο 2. No demographics 8. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. No. Store at 2. ODC0025 for urine application. Once open. 45%. The resulting increase in absorbance of the reaction mixture is directly proportional to the calcium concentration in the sample. A significant reduction in calcium ion concentration results in muscle tetany. Reagent Preparation The reagent is ready for use and can be placed directly on board the instrument. as a cofactor in several enzyme reactions. No. The paediatric application is suitable for use with small volume serum/plasma samples. which strongly affect the level of ionised calcium. The calcium values of both calibrators are traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 909b Level 1. To avoid the possible build-up of azide compounds. Recalibrate the assay when the following occur: Change in reagent lot number or significant shift in control values. unopened. No. Safety data sheet available for professional user on request. Urine: Acidified with 6M HCl.2’-[1. For in vitro diagnostic use only.7-bisazo]bisbenzenearsonic acid) to form an intense purple coloured complex. The ionised calcium is physiologically most significant.CALCIUM ARSENAZO III OSR60117 OSR61117 Intended Use Photometric colour test for the quantitative determination of total calcium in human serum. Collect timed 24 hr specimen using standard laboratory procedures.5 may result in a negative bias. 4 x 15 mL 4 x 29 mL R1 R1 Summary1 Measurement of calcium is used in the diagnosis and treatment of parathyroid disease.3 This Calcium procedure is based on calcium ions (Ca ) reacting with Arsenazo III (2. 5%. A higher than normal concentration of calcium ions produces lowered neuromuscular excitability and muscle weakness along with other more complex symptoms.9) Arsenazo III 0. up to the stated expiry date when stored at 2…8°C. 397 and 398 or other control materials with values determined by this Beckman Coulter system may be used for the urine application.. 66300 for serum/plasma application and Urine Calibrator Cat. Calibration Use System Calibrator Cat.02 2010-04 Metabolite . chronic renal disease. In this method the absorbance of the Ca-Arsenazo III complex is measured bichromatically at 660/700 nm.9 Ca-Arsenazo III complex (purple) Contents. It may be estimated from total calcium given knowledge of the protein content and pH of the blood. and complex-bound calcium. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used for the serum/plasma application.8-Dihydroxy-3. flush waste pipes with water after the disposal of undiluted reagent. Do not use the following anticoagulants in 4 collecting blood for use in this test: EDTA. mainly to phosphate. Storage and Stability The reagent is stable.6-disulphonaphthylene-2. Quality Control Controls Cat. 50%. Total serum calcium is composed of three fractions: free or ionised calcium. protein bound calcium most of which is bound to albumin with only a small portion bound to globulins. and bicarbonate. but has proven difficult to assay directly. Specimen Serum or heparinised plasma should be promptly separated to avoid the uptake of calcium by erythrocytes. Major preventative maintenance was performed on the analyser or a critical part was replaced. No. 5 Stable in serum and plasma for 3 weeks when stored at 2…8°C and 7 days when stored at 15…25°C. urolithiasis and tetany (intermittent muscular contractions or spasms). Test Principle2.8°C. Samples with urine pH below 1. Calcium ions are important in the transmission of nerve impulses. Dispose of all waste material in accordance with local guidelines. Reagent Composition in the Test Final concentration of reactive ingredients: Imidazole (pH 6. Magnesium does not significantly interfere in calcium determination using Arsenazo III. Sodium Fluoride or Oxalate. EN.. Biorad Liquichek Urine Chemistry Controls Cat. 5 Stable in urine for 4 days when stored at 2…8°C and 2 days when stored at 15…25°C.01 BLOSR6x117.2% Triton X-100 Preservative Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. plasma and urine on AU Beckman Coulter analysers. 2+ Reaction Principle Ca 2+ + Arsenazo III pH 6. 6 Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. reagent stored on board the instrument is stable for 90 days. citrate.1 – 0. in the maintenance of normal muscle contractility. and in the process of coagulation. Sodium Citrate. a variety of bone diseases. 94 CV% 2.60 mmol/L (7.09 0. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. 10.57 mmol/mmol (0. n = 80 Within Run Total Mean mmol/L SD CV% SD 0.999 n = 94 Sample range = 0.00 0. The lowest detectable level represents the lowest measurable level of calcium that can be distinguished from zero. electrodes or emission spectroscopy. ion selective 24 hours.04 The following data was obtained on an AU2700 using 3 urine pools analysed over 20 days.00 5. If any trends or sudden shifts in values are detected. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.2 g/g) of creatinine Expected values may vary with age. sample type.015 r = 0. review all operating parameters. The test is linear within a concentration range of 0 – 10 mmol/L (0 – 40 mg/dL) for urine.g.000x + -0. Calculation The Beckman Coulter analysers automatically compute the calcium concentration of each sample. 11 Such samples should be assayed using non-colourimetric techniques e.02 2. 8 Limitations Care should be taken when interpreting calcium results from patients who have received gadolinium containing contrast medium within the previous 9. No.8 – 10.60 1. The results obtained by any individual laboratory may vary from the given mean value.01 0.25 – 2. results should always be assessed in conjunction with the patient's medical history. plasma – Adults 7 Serum.05 0.Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. sex.52 0.1 mmol (4 mg)/kg of body weight Small Children: 2. Setting Sheet Footnotes # † * User defined ¤ Analyser default value System Calibrator Cat.96 0.65 mmol/L (8. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems.21 1.95 0. diet and geographical location.50 – 9.10 1. Precision The following data was obtained on an AU2700 using 3 serum pools analysed over 20 days. Each laboratory should verify the transferability of the expected values to its own population. BLOSR6x117. Results of linear regression analysis were as follows: y = 1.20 – 2. especially if the patient has impaired renal function.07 9.03 4. Method Comparison Patient serum samples were used to compare this Calcium Arsenazo III reagent OSR61117 on the AU640 against Calcium Arsenazo III OSR6176. To work in mg/dL multiply by 4.01 Metabolite .5 mmol (300 mg) Male and Female ≤ 0.40 Sensitivity The lowest detectable level using serum settings on an AU640 analyser was estimated as 0.:ODC0025 Values set for working in SI units (mmol/L).03 – 3.90 – 2.6 mg/dL) 1. Children 10 day – 24 months 7 Serum. n = 80 Within Run Total Mean mmol/L SD CV% SD 1.28 mmol/mmol (≤ 0. Children 0 – 10 day 7 Serum.0 mg/dL) 2.02 0.02 2010-04 EN.06 1.8 mg/dL) 2h urine Male and Female ≤ 0. Reference Intervals Serum.11 0.0 – 11. For diagnostic purposes. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.2 mmol (250 mg) Male < 7. samples should be drawn prior to administration of such contrast media.70 mmol/L (8.00 2.8 – 10.999 n = 105 Sample range = 1. No.02 0.65 0.52 0.48 0.20 – 2.19 0.4 mg/dL) 2. Results of linear regression analysis were as follows: y = 1.038 r = 0.13 CV% 0. Data obtained in your laboratory may differ from these values. The lowest detectable level using urine settings on the AU2700 was estimated as 0.8 g/g) creatinine 1 1 2. If non-colourimetric assays are unavailable.003x + 0.0 g/L haemoglobin ® Lipemia: Interference less than 10% up to 1000 mg/dL Intralipid Magnesium: Interference less than 10% up to 4 mmol/L magnesium Results of urine studies conducted to evaluate the susceptibility of the method to interference were as follows: Ascorbate : Interference less than 3% up to 50 mg/dL ascorbate Magnesium: Interference less than 3% up to 4 mmol/L magnesium Refer to Young for further information on interfering substances. and if necessary determine its own reference interval according to good laboratory practice.03 mmol/L.6 – 10.: 66300/ Urine Calibrator Cat. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.83 mmol/L Patient urine samples were used to compare this Calcium Arsenazo III reagent OSR61117 on the AU640 against Calcium Arsenazo III OSR6176.33 0.62 mmol/L Interfering Substances Results of serum studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5.61 0. Linearity The test is linear within a concentration range of 1 – 5 mmol/L (4 – 20 mg/dL) for serum and plasma. clinical examinations and other findings.01 mmol/L.57 0. Children 2 – 12 year Urine: 24h urine Female < 6.75 mmol/L (9. Ashwood ER.1999.01 BLOSR6x117. Frøysa A. Clinical chemistry theory. Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood.BIBLIOGRAPHY Thomas L. and correlation. Kazmierczak SC. Smith JL. Methods of analysis-calcium. Affinity and stoichiometry of calcium binding by arsenazo III. Urinalysis and collection. In: Burtis CA. Interference of magnetic resonance imaging contrast agents with the serum calcium measurement technique using colorimetric reagents. 5. 1996:550pp. June 1999. Diai A. Clinical laboratory diagnostics. Use and assessment of clinical laboratory results. 6. Zawta B.110:61-72. 5th ed. Philadelphia:WB Saunders Company. In: Kaplan LA. 4. NCCLS. 2. Frankfurt/Main: THBooks Verlagsgesellschaft.02 2010-04 Metabolite . 1998:231-241. NCCLS Document GP16-A2. 2nd ed. J Pharm Biomed Analysis 1999. transportation.1804pp. et al. Michaylova V. Pesce AJ. Effects of drugs on clinical laboratory tests. Lin J. Wisser H. EN.46pp. Anal Chim Acta 1971. and preservation of urine specimens. 10. Ehret W. 11. et al. 9. 8. AACC. AACC Press. Bauer PJ. Plasma and Serum Samples. 2000. In: Thomas L. Pennsylvania: NCCLS.55:421-426. Svaland M. Photometric determination of micro amounts of calcium with arsenazo III. Robert M. eds. Young DS. Reference information for the clinical laboratory. Painter PC. Cope JY. eds. Interference of gadodiamide injection (OMNISCAN®) on the colorimetric determination of serum calcium.21:931-943. Berthommier C. Heil W. Port M.1 Rev. Calcium (Ca). Schmitt Y. Töpfer G. As communicated to Beckman Coulter Biomedical Ltd by Amersham Health. Tietz textbook of clinical chemistry. Anal Biochem 1981.2:26. analysis. WHO/DIL/LAB/99. approved guideline. 7. Normann PT. Scand J Clin Lab Invest 1995. 1. St Louis: Mosby. Summary of product characteristics OMNISCAN. Ilkova P.53:194-198. Idee JM. ed. 2001. 3. . CALCIUM ARSENAZO, AU400/AU640 Serum/Plasma Reagent ID: 117 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 660 Sub Fst. H Lst. H -0.1 -0.1 1* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. H 5* Fst Fst 0 Lst Lst First H Last H 2.0 2.0 700 END + 10 Sample vol. Reagent 1 vol Reagent 2 vol μL μL μL 3.5 29 0 Dil. vol Dil. vol Dil. vol 0 204 0 Max. OD H 2.0 2.0 ∇ Operation: Yes Test No ∇ ∇ # Test name CALA Sample type Ser Page 1/2 System Reagent: OSR60117, OSR61117 Reagent ID: 117 Application CALCIUM ARSENAZO, AU600 Serum/Plasma Application System Reagent: OSR60117, OSR61117 Specific Test Parameters General LIH ISE Range Test Name: CALA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3.5 29 0 μL μL μL Dilution Dilution Dilution 0 204 0 μL μL μL Pri. ∇ ∇ ∇ Sec. 700 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key, or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CALA Sample type Ser ∇ On-board stability period 660 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. OD L Reagent OD limit Fst. L -0.1 Lst. L -0.1 Dynamic range L 1* Correlation factor % ∇ 5* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: CALA ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name CALA ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 2.5* # Conc Factor/OD-H 4.6* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 4.6* # SERUM/PLASMA APPLICATION Test Name: Counts: CALA ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. No. # OD CONC † Factor/OD-L 2.5* 1-Point Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat. No.: 66300 * Values set for working in SI units (mmol/L). To work in mg/dL multiply by 4 BSOSR6x117.01 2009-08 # User defined † System Calibrator Cat. No.: 66300 * Values set for working in SI units (mmol/L). To work in mg/dL multiply by 4 Metabolite CALCIUM ARSENAZO, AU2700/AU5400 Serum/Plasma Reagent ID: 117 Parameters General LIH CALA ∇ Dilution μL Max.OD -0.1 -0.1 High High 2.0 2.0 μL Min.OD Reagent OD Limit First Low Last Low Dilution 150 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR60117, OSR61117 Reagent ID: 117 Application Operation Yes CALCIUM ARSENAZO, AU680/AU480 Serum/Plasma Application System Reagent: OSR60117, OSR61117 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0.1 -0.1 R2(R2-1) μL Name Sec. 700 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 1* 1 1 μL High B B 0 5* 0 0 Hour 0 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) μL ∇ μL 2.5 1 21 Range Operation: ∇ Yes Test Name: CALA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 Last Last 10 % ∇ 2.5 21 0 2.0 2.0 5* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 150 0 μL μL μL Pri. ∇ ∇ ∇ 1* Sec. 700 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 660 ∇nm END ∇ + ∇ 0 660 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH CALA ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # CALA ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 2. ∇ # # # # ο 3. ∇ # # # # ο 4. ∇ # # # # ο 5. ∇ # # # # ο 6. ∇ 7. No demographics 8. Not within expected values mmol/L* Decimal Places Calibration Specific ISE CALA ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 2.5* 4.6* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 4.6* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: CALA ∇ < > Test Name: Use Serum Cal. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. No. # OD CONC † Factor/OD-L 2.5* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined. System Calibrator Cat. No.: 66300 Values set for working in SI units (mmol/L). To work in mg/dL multiply by 4 AU680 <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x117.01 2009-08 CALCIUM ARSENAZO, AU400/AU640 Urine Reagent ID: 117 Specific test parameters Urine ∇ 1 Max OD H Main ∇ ∇ ∇ 660 Sub Fst. H Lst. H -0.1 -0.1 0* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. H 10* Fst Fst 0 Lst Lst First H Last H 2.0 2.0 700 END + 10 Sample vol. Reagent 1 vol Reagent 2 vol μL μL μL 2 25 0 Dil. vol Dil. vol Dil. vol 0 225 0 Max. OD H 2.0 2.0 ∇ Operation: Yes Test No ∇ ∇ # Test name CALA Sample type Urine Page 1/2 System Reagent: OSR60117, 61117 Reagent ID: 117 Application CALCIUM ARSENAZO, AU600 Urine Application System Reagent: OSR60117, 61117 Specific Test Parameters General LIH ISE Range Test Name: CALA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 25 0 μL μL μL Dilution Dilution Dilution 0 225 0 μL μL μL Pri. ∇ ∇ ∇ Sec. 700 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key, or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CALA Sample type Uri ∇ On-board stability period 660 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. OD L Reagent OD limit Fst. L -0.1 Lst. L -0.1 Dynamic range L 0* Correlation factor % ∇ 10* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Urine ∇ # Range Page 2/2 Level L # Level H # Test Name: CALA ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # URINE APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name CALA ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 5.0* # Conc Factor/OD-H 9.3* ∇ Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 9.3* # Test Name: Counts: CALA ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. No. # OD CONC † Factor/OD-L 5.0* 1-Point Cal. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Urine Calibrator Cat. No.: ODC0025 * Values set for working in SI units (mmol/L). To work in mg/dL multiply by 4 BSOSR6x117.01 2009-08 # User defined † Urine Calibrator Cat. No.: ODC0025 * Values set for working in SI units (mmol/L). To work in mg/dL multiply by 4 Metabolite CALCIUM ARSENAZO, AU2700/AU5400 Urine Reagent ID: 117 Parameters General LIH CALA ∇ Dilution μL Max.OD -0.1 -0.1 High High 2.0 2.0 μL Min.OD Reagent OD Limit First Low Last Low Dilution 225 0 OD Limit < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR60117, OSR61117 Reagent ID: 117 Application Operation Yes CALCIUM ARSENAZO, AU680/AU480 Urine Application System Reagent: OSR60117, 61117 Specific Test Parameters General LIH ISE Urine ∇ 1 Max OD H -0.1 -0.1 R2(R2-1) μL Name Sec. 700 Onboard Stability Period Last Last 10 90 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0* 1 1 Day μL High B B 0 10* 0 0 Hour 0 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) μL ∇ μL 2.0 1 25 Range Operation: ∇ Yes Test Name: CALA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 % ∇ 2.0 25 0 2.0 2.0 10* 0 μL μL μL Dilution Dilution Dilution 0 225 0 μL μL μL Pri. ∇ ∇ ∇ 0* Sec. 700 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 660 ∇nm END ∇ + ∇ 0 660 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine ∇ LIH CALA ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # CALA ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General ISE CALA ∇ < > Y=AX+B Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 2. ∇ # # # # ο 3. ∇ # # # # ο 4. ∇ # # # # ο 5. ∇ # # # # ο 6. ∇ 7. No demographics 8. Not within expected values mmol/L* Decimal Places Calibration Specific Low # # # # # # # # # URINE APPLICATION High # # # # # # # # Calibration Parameters STAT Table Calibration Type Urine Counts: ∇ Factor Range Low High 5.0* 9.3* ∇ # ο ∇ Calibration Specific General ISE Type Urine ∇ # Factor/OD-H 9.3* Process: CONC ∇ Test Name: Test Name: CALA ∇ < > Use Serum Cal. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Counts: Cal. No. # OD CONC † Factor/OD-L 5.0* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: ∇ 999 None ∇ 1-Point Cal. Point: ο with CONC-0 Slope Check: None # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined. Urine Calibrator Cat. No.: ODC0025 Values set for working in SI units (mmol/L). To work in mg/dL multiply by 4 AU680 <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x117.01 2009-08 CALCIUM ARSENAZO, AU400/AU640 Paediatric Reagent ID: 117 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 660 Sub Fst. H Lst. H -0.1 -0.1 1* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. H 5* Fst Fst 0 Lst Lst First H Last H 2.0 2.0 700 END + 10 Sample vol. Reagent 1 vol Reagent 2 vol μL μL μL 3.5 29 0 Dil. vol Dil. vol Dil. vol 10 194 0 Max. OD H 2.0 2.0 ∇ Operation: Yes Test No ∇ ∇ # Test name CALAP Sample type Ser Page 1/2 System Reagent: OSR60117, OSR61117 Reagent ID: 117 Application CALCIUM ARSENAZO, AU600 Paediatric Application System Reagent: OSR60117, OSR61117 Specific Test Parameters General LIH ISE Range Test Name: CALAP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3.5 29 0 μL μL μL Dilution Dilution Dilution 10 194 0 μL μL μL Pri. ∇ ∇ ∇ Sec. 700 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key, or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CALAP Sample type Ser ∇ On-board stability period 660 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. OD L Reagent OD limit Fst. L -0.1 Lst. L -0.1 Dynamic range L 1* Correlation factor % ∇ 5* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: CALAP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name CALAP ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 2.5* # Conc Factor/OD-H 4.6* ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 4.6* # Test Name: Counts: CALAP ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. No. # OD CONC † Factor/OD-L 2.5* 1-Point Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat. No.: 66300 * Values set for working in SI units (mmol/L). To work in mg/dL multiply by 4 BSOSR6x117.01 2009-08 # User defined † System Calibrator Cat. No.: 66300 * Values set for working in SI units (mmol/L). To work in mg/dL multiply by 4 Metabolite CALCIUM ARSENAZO, AU2700/AU5400 Paediatric Reagent ID: 117 Parameters General LIH CALAP ∇ Dilution μL Max.OD -0.1 -0.1 High High 2.0 2.0 μL Min.OD Reagent OD Limit First Low Last Low Dilution 140 10 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR60117, OSR61117 Reagent ID: 117 Application Operation Yes CALCIUM ARSENAZO, AU680/AU480 Paediatric Application System Reagent: OSR60117, OSR61117 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0.1 -0.1 R2(R2-1) μL Name Sec. 700 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 1* 1 1 μL High B B 0 5* 0 0 Hour 0 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) μL ∇ μL 2.5 1 21 Range Operation: ∇ Yes Test Name: CALAP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 Last Last 10 % ∇ 2.5 21 0 2.0 2.0 5* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 10 140 0 μL μL μL Pri. ∇ ∇ ∇ 1* Sec. 700 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 660 ∇nm END ∇ + ∇ 0 660 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH CALAP ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # CALAP ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 2. ∇ # # # # ο 3. ∇ # # # # ο 4. ∇ # # # # ο 5. ∇ # # # # ο 6. ∇ 7. No demographics 8. Not within expected values mmol/L* Decimal Places Calibration Specific ISE CALAP ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 2.5* 4.6* ∇ # ο ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 4.6* # Process: CONC ∇ Test Name: CALAP ∇ < > Test Name: Use Serum Cal. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. No. # OD CONC † Factor/OD-L 2.5* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined. System Calibrator Cat. No.: 66300 Values set for working in SI units (mmol/L). To work in mg/dL multiply by 4 AU680 <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x117.01 2009-08 CHOLESTEROL OSR6116 OSR6216 *OSR6516 Intended Use Enzymatic colour test for the quantitative determination of cholesterol in human serum and plasma on Beckman Coulter AU analysers. For in vitro diagnostic use only. *Cholesterol reagent OSR6516 for use on the AU2700 and AU5400 systems only. 4 x 22.5 mL 4x 45 mL 4 x 107 mL R1 R1 R1 Summary1 Cholesterol is synthesised ubiquitously throughout the body and is an essential component of cell membranes and lipoproteins as well as being a precursor for the synthesis of steroid hormones and bile acids. The individual predictive value of total cholesterol concentration with regard to coronary risk is low. Cholesterol is mainly transported in two lipoprotein classes (LDL and HDL), both of which play a contradictory role in the pathogenesis of lipid disorders. The total cholesterol concentration therefore provides only a baseline value that indicates whether further laboratory investigations of lipoprotein metabolism should be carried out (HDL, LDL, and triglycerides). Test Principle2 The Cholesterol reagent utilises an enzymatic method to measure cholesterol in human serum and plasma. In this procedure cholesterol esters in a sample are hydrolysed by cholesterol esterase (CHE). The free cholesterol produced is oxidised by cholesterol oxidase (CHO) to cholestene-3-one with the simultaneous production of hydrogen peroxide (H2O2), which oxidatively couples with 4-aminoantipyrine and phenol in the presence of peroxidase (POD) to yield a chromophore. The red quinoneimine dye formed can be measured spectrophotometrically at 540/600 nm as an increase in absorbance. Reaction Principle 2 Cholesterol esters + 2 H2O 2 Cholesterol + 2 O2 2 H2O2 + 4-Aminoantipyrine + Phenol CHE CHO POD 2 Cholesterol + 2 Fatty acids 2 Cholestene-3-one + 2 H2O2 Quinoneimine + 4 H2O Contents, Reagent Composition in the Test Final concentration of reactive ingredients: Phosphate buffer (pH 6.5) 4-Aminoantipyrine Phenol Cholesterol esterase Cholesterol oxidase Peroxidase Preservative 103 mmol/L 0.31 mmol/L 5.2 mmol/L ≥ 0.2 kU/L (3.3 µkat/L) ≥ 0.2 kU/L (3.3 µkat/L) ≥ 10.0 kU/L (166.7 µkat/L) Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. To avoid the possible build-up of azide compounds, flush waste-pipes with water after the disposal of undiluted reagent. Dispose of all waste material in accordance with local guidelines. Safety data sheet available for professional user on request. Reagent Preparation The reagent is ready for use and can be placed directly on board the instrument. Storage and Stability The reagent is stable, unopened, up to the stated expiry date when stored at 2…8 °C. Once open, reagent stored on board the instrument is stable for 90 days. Specimen3 Serum and EDTA or heparinised plasma. Icteric samples should be avoided. Plasma is not recommended using anticoagulants such as oxalate, citrate or fluoride. Stable in serum and plasma for 7 days when stored at 2...8 °C. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Calibration System Calibrator Cat. No. 66300. The calibrator cholesterol value is traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 909b 4 Level 1 (Isotope Dilution Mass Spectrometry). This method is also certified against the Centers of Disease Control Reference Method (Abell-Kendall). Recalibrate the assay when the following occur: Change in reagent lot number or significant shift in control values; Major preventative maintenance was performed on the analyser or a critical part was replaced. EN.01 BLOSR6x16.02 2010-04 Metabolite Quality Control Controls Cat. No. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. The results obtained by any individual laboratory may vary from the given mean value. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. If any trends or sudden shifts in values are detected, review all operating parameters. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Calculation The Beckman Coulter analysers automatically compute the cholesterol concentration of each sample. 5 Total cholesterol levels in plasma should be corrected by multiplying the result obtained by 1.03 to be equivalent to serum levels of total cholesterol. Reference Intervals National Cholesterol Education Program Adult Treatment Panel III recommendations: < 5.2 mmol/L (200 mg/dL) Desirable 5.2 – 6.2 mmol/L (200 – 239 mg/dL) Borderline High High ≥ 6.2 mmol/L (240 mg/dL) 7 6 European Atherosclerosis Society recommendations: < 5.2 mmol/L (< 200 mg/dL) No Lipid metabolism disorder Cholesterol < 2.3 mmol/L (< 200 mg/dL) Triglyceride Cholesterol 5.2 – 7.8 mmol/L (200 – 300 mg/dL) Lipid metabolism disorder if HDL-Cholesterol is < 0.9 mmol/L (< 35 mg/dL) Cholesterol > 7.8 mmol/L (> 300 mg/dL) Lipid metabolism disorder. Triglyceride > 2.3 mmol/L (> 200mg/dL) National and regional guidelines for interpretation and treatment may differ from the above recommendations. Please follow the guidelines which are applicable to your population. Expected values may vary with age, sex, sample type, diet and geographical location. Each laboratory should verify the transferability of the expected values to its own population, and if necessary determine its own reference interval according to good laboratory practice. For diagnostic purposes, results should always be assessed in conjunction with the patient's medical history, clinical examinations and other findings. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Data obtained in your laboratory may differ from these values. Linearity The test is linear within a concentration range of 0.5 – 18.0 mmol/L (20 – 700 mg/dL). Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. n = 60 Mean mmol/L 3.07 5.92 11.18 Within Run SD 0.03 0.04 0.08 CV% 0.91 0.72 0.72 SD 0.03 0.09 0.13 Total CV% 1.06 1.45 1.13 Sensitivity The lowest detectable level in serum on an AU600 analyser was estimated at 0.07 mmol/L. The lowest detectable level represents the lowest measurable level of cholesterol that can be distinguished from zero. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Method Comparison Patient serum samples were used to compare this Cholesterol OSR6116 assay on the AU2700 against another commercially available cholesterol assay. Results of linear regression analysis were as follows: y = 1.017x – 0.031 r = 0.996 n = 511 Sample range = 1.32 – 12.20 mmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Ascorbate: Interference less than 10% up to 8 mg/dL ascorbate Icterus: Interference less than 10% up to 8 mg/dL or 137 µmol/L bilirubin Haemolysis: Interference less than 10% up to 5 g/L haemoglobin ® Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances. 8 Setting Sheet Footnotes # † * 1. 2. 3. 4. 5. 6. 7. 8. User defined ¤ Analyser default value System Calibrator Cat. No.: 66300 Values set for working in SI units (mmol/L). To work in mg/dL multiply by 38.7. Riesen WF. Lipid Metabolism. In: Thomas L, ed. Clinical laboratory diagnostics. Use and assessment of clinical laboratory results. Frankfurt/Main: TH-Books Verlagsgesellschaft, 1998:167–169. Allain CC, Poon LS, Chan CSG, Richmond W, Fu PC. Enzymatic determination of total serum cholesterol. Clin Chem 1974;20:470-475. World Health Organization (2002). Use of Anticoagulants in Diagnostic Laboratory Investigations (Stability of Blood, Plasma and serum samples); WHO/DIL/LAB/99.1 Rev.2: 1-64 Data on file. Current status of blood cholesterol measurement in clinical laboratories in the United States: a report from the Laboratory Standardization Panel of the National Cholesterol Education Program. Clin Chem 1988;34:193-201. National cholesterol education program expert panel. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001;285:2486-2497. Study Group, European Atherosclerosis Society, Strategies for the prevention of coronary heart disease: A policy statement of the European Atherosclerosis Society. European Heart Journal 1987; 8, 77-88. Young DS. Effects of drugs on clinical laboratory tests, 5th ed. AACC Press, 2000. BLOSR6x16.02 2010-04 EN.01 BIBLIOGRAPHY Metabolite CHOLESTEROL, AU400/AU640 Serum/Plasma Reagent ID: 016 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 540 Sub Fst. H Lst. H -0.1 -0.1 0.5* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. H 18.0* Fst Fst 0 Lst Lst First H Last H 0.3 0.3 600 END + 27 Sample vol. Reagent 1 vol Reagent 2 vol μL μL μL 3 45 0 Dil. vol Dil. vol Dil. vol 0 180 0 Max. OD H 0.3 0.3 ∇ Operation: Yes Test No ∇ ∇ # Test name CHOL Sample type Ser Page 1/2 System Reagent: OSR6116, OSR6216 Reagent ID: 016 Application CHOLESTEROL, AU600 Serum/Plasma Application System Reagent: OSR6116, OSR6216 Specific Test Parameters General LIH ISE Range Test Name: CHOL ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 45 0 μL μL μL Dilution Dilution Dilution 0 180 0 μL μL μL Pri. ∇ ∇ ∇ Sec. 600 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key, or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CHOL Sample type Ser ∇ On-board stability period 540 END + First 0 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. OD L Reagent OD limit Fst. L -0.1 Lst. L -0.1 Dynamic range L 0.5* Correlation factor % ∇ 18.0* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: CHOL ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name CHOL ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 16* # Conc Factor/OD-H 30* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 30* # SERUM/PLASMA APPLICATION Test Name: Counts: CHOL ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. No. # OD CONC † Factor/OD-L 16* 1-Point Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat. No.: 66300 * Values set for working in SI units (mmol/L). To work in mg/dL multiply by 38.7 BSOSR6x16.01 2009-08 # User defined † System Calibrator Cat. No.: 66300 * Values set for working in SI units (mmol/L). To work in mg/dL multiply by 38.7 Metabolite CHOLESTEROL, AU2700/AU5400 Serum/Plasma Reagent ID: 016 Parameters General LIH CHOL ∇ Dilution μL Max.OD -0.1 -0.1 High High 0.3 0.3 μL Min.OD Reagent OD Limit First Low Last Low Dilution 96 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6116, OSR6216, OSR6516 Reagent ID: 016 Application Operation Yes CHOLESTEROL, AU680/AU480 Serum/Plasma Application System Reagent: OSR6116, OSR6216, OSR6516 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0.1 -0.1 R2(R2-1) μL Name Sec. 600 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.5* 1 1 μL High B B 0 18.0* 0 0 Hour 0 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) μL ∇ μL 1.6 1 24 Range Operation: ∇ Yes Test Name: CHOL ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 Last Last 27 % ∇ 1.6 24 0 0.3 0.3 18.0* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 96 0 μL μL μL Pri. ∇ ∇ ∇ 0.5* Sec. 600 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 540 ∇nm END ∇ + ∇ 0 540 END + First 0 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ ++ ∇ ++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH CHOL ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # CHOL ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 2. ∇ # # # # ο 3. ∇ # # # # ο 4. ∇ # # # # ο 5. ∇ # # # # ο 6. ∇ 7. No demographics 8. Not within expected values mmol/L* Decimal Places Calibration Specific ISE CHOL ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 16* 30* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 30* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: CHOL ∇ < > Test Name: Use Serum Cal. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. No. # OD CONC † Factor/OD-L 16* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined † System Calibrator Cat. No.: 66300 * Values set for working in SI units (mmol/L). To work in mg/dL multiply by 38.7 ф AU680 <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x16.01 2009-08 CREATININE OSR6178 OSR6578 Intended Use Kinetic colour test (Jaffé method) for the quantitative determination of creatinine in human serum, plasma and urine on Beckman Coulter AU analysers. For in vitro diagnostic use only. The OSR6x78 reagents may be used in two ways for the serum application: Method A : Kinetic Jaffe (compensated method) traceable to the IDMS reference method. Method B : Kinetic Jaffe uncompensated. Creatinine reagent OSR6578 for use on the AU2700 and AU5400 systems only. 4 x 51 mL 4 x 51 mL 4 x 103 mL 4 x 103 mL R1 R2 R1 R2 Summary1,2,3 Creatinine is a metabolic product of creatine and phosphocreatine, which are both found almost exclusively in muscle. Thus, creatinine production is proportional to muscle mass and varies little from day to day. Measurements of creatinine are used in the diagnosis and treatment of renal disease and prove useful in the evaluation of kidney glomerular function and in monitoring renal dialysis. However, the serum level is not sensitive to early renal damage and responds more slowly than blood urea nitrogen (BUN) to haemodialysis during treatment of renal failure. Both serum creatinine and BUN are used to differentiate prerenal and postrenal (obstructive) azotemia. An increase in serum BUN without concomitant increase of serum creatinine is key to identifying prerenal azotemia. In post renal conditions where obstruction to the flow of urine is present e.g. malignancy, nephrolithiasis and prostatism, both the plasma creatinine and urea levels will be increased; in these situations the rise is disproportionately greater for BUN due to the increased back diffusion of urea. Serum creatinine varies with the subject’s age, body weight, and sex. It is sometimes low in subjects with relatively small muscle mass, cachectic patients, amputees, and in older persons. A serum creatinine level that would usually be considered normal does not rule out the presence of impaired renal function. Test Principle4,5,6 Creatinine forms a yellow-orange coloured compound with picric acid in an alkaline medium. The rate of change in absorbance at 520/800 nm is proportional to the creatinine concentration in the sample. Reaction Principle Creatinine + picric acid Creatinine picrate complex Contents, Reagent Composition in the Test Final concentration of reactive ingredients: Sodium hydroxide Picric acid Preservative 120 mmol/L 2.9 mmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: R1 reagent: Irritant. R36/38 Irritating to eyes and skin. Safety Phrases: S26, S37, S60: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Wear suitable gloves. This material and its container must be disposed of as hazardous waste. R2 contains picric acid. Risk of explosion by shock, friction, fire or other sources of ignition. Dilute any spills with water and wipe up immediately. Dispose of all waste material in accordance with local guidelines. Refer to Safety Data Sheets for further information. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. Storage and Stability The reagents are stable, protected from light, unopened, up to the stated expiry date when stored at 2…8°C. Once open, reagents stored on board the instrument are stable for 14 days. Specimen Serum and EDTA or heparinised plasma. 7 Stable in serum and plasma for 7 days when stored at 2…25°C. Strongly lipemic samples should be avoided. Urine: Collect urine without using preservatives. Store at 2...8°C. 8 Test Procedure Two distinct test procedures are available for the serum application of this reagent: A: Interference from protein is mathematically corrected by subtracting 18 µmol/L from each test result (Specific Test Parameters: Correlation factor B = -18). B: Uncompensated Jaffe (no protein compensation, B = 0) Both methods require different calibrator set points and deliver slightly different results for patients and control sera at low creatinine concentrations which results in different reference ranges. Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. The paediatric application is suitable for use with small volume serum/plasma samples. EN.01 BLOSR6x78.02 2009-11 Metabolite Calibration Use System Calibrator Cat. No. 66300 for serum and plasma application and Urine Calibrator Cat. No. ODC0025 for urine application. The serum calibrator creatinine value for method A is traceable to the Isotope Dilution Mass Spectroscopy (IDMS) method via National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 967. The serum calibrator creatinine value for method B is traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 909b Level 2. The urine calibrator creatinine value is traceable to the IDMS method. Recalibrate the assay every day, or when the following occur: Change in reagent bottle or significant shift in control values; Major preventative maintenance was performed on the analyser or a critical part was replaced. Absorption of atmospheric CO2 by the reagent on board the analyser can impair calibration stability. This effect will vary depending upon the rate of use. Consequently each laboratory should set a calibration frequency in the instrument parameters appropriate to their usage pattern. Quality Control Controls Cat. No. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used for the serum/plasma application. Biorad Liquichek Urine Chemistry Controls Cat. No. 397 and 398 or other control materials with values determined by this Beckman Coulter system may be used for the urine application. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. The results obtained by any individual laboratory may vary from the given mean value. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. If any trends or sudden shifts in values are detected, review all operating parameters. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Calculation The Beckman Coulter analysers automatically compute the creatinine concentration of each sample. Reference Intervals Method A (IDMS traceable) 9,10 Serum/Plasma Male 59 – 104 µmol/L (0.67 – 1.17 mg/dL) Female 45 – 84 µmol/L (0.51 – 0.95 mg/dL) Neonate 27 – 87 µmol/L (0.31 – 0.98 mg/dL) Infant 14 – 34 µmol/L (0.16 – 0.39 mg/dL) Child 23 – 68 µmol/L (0.26 – 0.77 mg/dL) Urine 11 Male Female 124 – 230 µmol/kg/d (14 – 26 mg/kg/d) 97 – 177 µmol/kg/d (11 – 20 mg/kg/d) Method B (Uncompensated Jaffe) 3,12 Serum/Plasma Male < 50 years 74 – 110 µmol/L (0.84 – 1.25 mg/dL) Male >50 years 72 – 127 µmol/L (0.81 – 1.44 mg/dL) Female 58 – 96 µmol/L (0.66 – 1.09 mg/dL) Neonate 45 – 105 µmol/L (0.5 – 1.2 mg/dL) Infant 35 – 62 µmol/L (0.4 – 0.7 mg/dL) Child 45 – 105 µmol/L (0.5 – 1.2 mg/dL) 11 Urine Male 124 – 230 µmol/kg/d (14 – 26 mg/kg/d) Female 97 – 177 µmol/kg/d (11 – 20 mg/kg/d) Expected values may vary with age, sex, sample type, diet and geographical location. Each laboratory should verify the transferability of the expected values to its own population, and if necessary determine its own reference interval according to good laboratory practice. For diagnostic purposes, results should always be assessed in conjunction with the patient's medical history, clinical examinations and other findings. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Data obtained in your laboratory may differ from these values. Linearity Method A is linear within a concentration range of 5 – 2200 µmol/L (0.06 – 25.0 mg/dL) for serum and plasma. Method B is linear within a concentration range of 18 – 2200 µmol/L (0.2 – 25.0 mg/dL) for serum and plasma. The test is linear within a concentration range of 88 – 35360 µmol/L (1 – 400 mg/dL) for urine. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. n = 60 Within Run Total Mean µmol/L SD CV% SD 105.06 1.26 1.19 2.10 152.70 1.45 0.95 2.47 1049.87 9.00 0.86 16.93 The following data was obtained on an AU640 using 3 urine pools analysed over 20 days. n = 80 Within Run Total Mean µmol/L SD CV% SD 2,600 24.82 0.96 64.53 13,100 97.30 0.74 202.22 34,560 215.88 0.62 454.32 CV% 2.00 1.62 1.61 CV% 2.48 1.54 1.31 Sensitivity The lowest detectable level of method A using serum settings on an AU400 analyser was established at 2.4 µmol/L (0.027 mg/dL). The lowest detectable level of method B using serum settings on an AU640 analyser was established at 3.15 µmol/L (0.036 mg/dL). The lowest detectable level using urine settings on an AU2700 analyser was established at 0.1 µmol/L (0.001 mg/dL). The lowest detectable level represents the lowest measurable level of creatinine that can be distinguished from zero. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Method Comparison Patient serum samples were used to compare this Creatinine OSR6178 assay (method A) on the AU2700 against the Creatinine OSR6178 assay (method B). Results of linear regression analysis were as follows: y = 1.04x – 17 r = 0.999 n = 701 Sample range = 26.5 – 1024 µmol/L Patient serum samples were used to compare this Creatinine OSR6178 assay (method A) on the AU2700 against a commercially available enzymatic creatinine assay which has demonstrated equivalence to the IDMS reference method. Results of linear regression analysis were as follows: y = 1.01x + 2.8 Metabolite r = 0.997 n = 701 Sample range = 13.3 – 1007 µmol/L BLOSR6x78.02 2009-11 EN.01 Patient urine samples were used to compare this Creatinine OSR6178 assay on the AU2700 against another commercially available creatinine assay. Results of linear regression analysis were as follows: y = 0.916x + 266.607 r = 0.998 n = 124 Sample range = 1246 – 32562 µmol/L Interfering Substances Results of serum studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 600 mg/dL Intralipid. Protein: Interference less than 6% between 3 and 10 g/dL protein for method A Interference less than 20% between 3 and 12 g/dL protein for method B Results of urine studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin Ascorbate: Interference less than 3% up to 50 mg/dL ascorbate Glucose: Interference less than 3% up to 3000mg/dL glucose In very rare cases gammopathy, especially monoclonal IgM (Waldenström’s macroglobulinemia), may cause unreliable results. Refer to Young for further information on interfering substances. 13 Setting Sheet Footnotes # † * ^ ‡ 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. User defined ¤ Analyser default value System Calibrator Cat. No.: 66300/ Urine Calibrator Cat. No.:ODC0025 Values set for working in SI units (µmol/L). To work in mg/dL divide by 88.4. Equivalent to 5 µmol/L due to B = -18. Depends on usage pattern in the laboratory. Newman DJ, Price CP. Renal function and nitrogen metabolites. In: Burtis CA, Ashwood ER, eds. Tietz textbook of clinical chemistry. Philadelphia: WB Saunders Company, 1999;1239-1242. Mayne PD, ed. Clinical chemistry in diagnosis and treatment, 6th ed. London: Arnold,1994:18pp. Thomas L. Creatinine. In: Thomas L, ed. Clinical laboratory diagnostics. Use and assessment of clinical laboratory results. Frankfurt/Main: TH-Books Verlagsgesellschaft, 1998:366-371. Folin O. Beitrag zur chemie des kreatinins und kreatins im harne. Physiol Chem 1904;41:223-42. Cook JGH. Creatinine assay in the presence of protein. Clin Chim Acta 1971;32:485-6. Larsen K. Creatinine assay in the presence of protein with LKB 8600 reaction rate analyser. Clin Chim Acta 1972;38:475-6. Ehret W, Heil W, Schmitt Y, Töpfer G, Wisser H, Zawta B, et al. Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood, Plasma and Serum Samples. WHO/DIL/LAB/99.1 Rev.2:28pp. nd NCCLS. Urinalysis and collection, transportation, and preservation of urine specimens; approved guideline. NCCLS Document GP16-A2, 2 ed. Pennsylvania: NCCLS, 2001. Mazzachi BC, Peake MJ, Ehrhard V.; Reference range and method comparison studies for enzymatic and Jaffe creatinine assays in plasma and serum and early morning urine. Clin. Lab. 2000; 46: 53-55. Schlebusch H, Liappis N, Klein G. Creatinine and ultrasensitive CRP: Reference intervals from infancy to childhood. Clin. Chem. Lab. Med. 2001; 39 Special supplement pp S1-S448, May 2001. PO-T042. Painter PC, Cope JY, Smith JL. Reference information for the clinical laboratory. In: Burtis CA, Ashwood ER, eds. Tietz textbook of clinical chemistry. Philadelphia:WB Saunders Company, 1999;1809pp. Soldin SJ, Brugnara C, Wong EC, eds. Pediatric Reference Ranges. 4th ed. AACC Press, 2003:71-72. th Young DS. Effects of drugs on clinical laboratory tests, 5 ed. AACC Press, 2000. BIBLIOGRAPHY EN.01 BLOSR6x78.02 2009-11 Metabolite . 5 Sub Sample vol.5 Operation: Yes Range Test Name: CRE ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 20 120 120 μL μL μL Dilution Dilution Dilution 0 90 0 μL μL μL Pri. vol ∇ Operation: Yes Range Method B Specific test parameters Sample type μL μL μL ∇ ∇ ∇ Lst Lst Ser ∇ Max.2 0. OD L -0. H Lst. vol Dil. H 0. Reagent 1 vol Reagent 2 vol 20 120 120 Dil. OD L -0. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.4. AU600 Serum/Plasma Application System Reagent: OSR6178 Method A Specific Test Parameters General LIH ISE Serum ∇ 1 -0. No. H ∇ ∇ ∇ Main 520 Sub 20 120 120 Dil.CREATININE. point MB type factor Calibrator stability period ‡ Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat.2 520 FIXED + First 13 First A 1 On-board stability period: Last Last 24 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 800 FIXED + 24 Min. vol Dil. AU400/AU640 Serum/Plasma Reagent ID: 078 System Reagent: OSR6178 Reagent ID: 078 Application Method A Specific test parameters Test No ∇ Sample vol. or select from list displayed by Guide key Method A and/or Method B Calibration specific Test No # Test name CRE ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 4900* # Conc Factor/OD-H 14000* ∇ SERUM/PLASMA APPLICATION Test Name: Counts: CRE ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ ‡ Advanced Calibration: # ∇ Cal.2 23*^ B 14 Linearity Fst No lag time % Sec % ∇ -18* Sample Pre-dil H 2200* Fst Fst 13 Lst Lst First H Last H 0. OD H Page 1/2 2. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.2 Max OD H 2.01 2009-08 . # OD CONC † Factor/OD-L 4900* 1-Point Cal.2 Dynamic range L 18* Correlation factor Sample Pre-dil Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Linearity Fst No lag time % % ∇ H A B Rate Sec 2200* 1 0 ¤ Method A and/or Method B % ∇ On-board stability period 14 Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 14000* # Select using Space key. OD H ∇ 2. 800 ∇ Fst.2 ∇ # Test name CRE Sample type Ser Page 1/2 CREATININE.2 Reagent OD limit Fst. L -0. No.2 -0. No. vol Dil. L -0. L -0. Depends on usage pattern in the Laboratory Equivalent to 5µmol/L due to B = -18 Metabolite BSOSR6x78.2 Lst. vol 0 90 0 Max. vol Dil. ∇ ∇ ∇ Sec.: OE66300 Values set for working in SI units (µmol/L).4. Reagent 1 vol Reagent 2 vol μL μL μL Fst. To work in mg/dL divide by 88.2 Reagent OD limit Fst.2 -0. H Lst. ‡ Depends on usage pattern in the Laboratory ^Equivalent to 5 µmol/L due to B = -18 # † * ‡ ^ User defined System Calibrator Cat.2 800 FIXED + 24 Max OD H 2.5 0.2 Lst. L -0.2 0.5 Test Name: 0 90 0 CRE ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 20 120 120 μL μL μL Dilution Dilution Dilution 0 90 0 μL μL μL Pri. or select from list displayed by Guide key On-board stability period 520 FIXED + First 13 First Last Last 24 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min.2 0.2 Dynamic range L 23*^ Correlation factor % ∇ 2200* 1 -18* ¤ 14 Method B Specific Test Parameters General LIH ISE Serum ∇ Test No # Test name CRE ∇ 1 -0. To work in mg/dL divide by 88.2 Main 520 18* B 14 0 Fst Fst H 2200* Wave Method Reaction Point 1 Point 2 13 First H Last H 0.: OE66300 * Values set for working in SI units (µmol/L).2 -0. ∇ ∇ ∇ Sec.2 0.2 -0. ∇ # # # # ο 5.2 0. Volume R1(R1-1) μL ∇ μL 8 1 48 Test Name: Max OD H 2.2 < > ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6178.2 -0.2 -0.2 -0. Depends on usage pattern in the Laboratory Equivalent to 5µmol/L due to B = -18 Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ ф AU680 <Point Cal. No demographics 8.2 High High Max. ∇ 7. # OD CONC † Factor/OD-L 4500* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ ‡ ∇ Advanced Calibration: # None ∇ 1-Point Cal.OD μL Min. 800 ∇ 520 FIXED + First 13 First A 1 On-board stability period: Noneф 520 ∇nm FIXED ∇ + ∇ 13 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Last Last 24 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: High B B 0 2200* 0 -18* Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. OSR6578 Reagent ID: 078 Application Operation Yes CREATININE.01 2009-08 .OD Reagent OD Limit First Low Last Low Dilution 36 0 OD Limit 2. To work in mg/dL divide by 88.: OE66300 Values set for working in SI units (µmol/L). Cal. ∇ # # # # ο 2.2 0. ∇ ∇ ∇ Sec. Not within expected values Unit Parameters Calibrators General µmol/L* Decimal Places Calibration Specific ISE CRE ∇ < % ∇ Month # # # # # # Method A and/or Method B Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 4500* 13000* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 13000* # Process: CONC ∇ Test Name: CRE ∇ < > SERUM/PLASMA APPLICATION Test Name: Calibration Type: AB ∇ Formula: Y=AX+B ∇ Use Serum Cal.5 0.2 18* B 14 0 H 2200* First H Last H 0. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # Interval (RB/ACAL) ∇ # ∇ # † * ‡ ^ User defined System Calibrator Cat. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Parameters General LIH CRE ∇ < > ISE HbA1c Test Name: % ∇ Method B Specific Test Parameters General LIH ISE Serum ∇ 1 -0.2 -0.2 0.5 0. No. ∇ # # # # ο 4. 800 ∇ Panic Value Low # High # Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 520 FIXED + First 13 First Last Last 24 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.4.2 Max OD H 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration ‡ Day ‡ ∇ ο with Conc-0 Hour Hour Metabolite BSOSR6x78.CREATININE. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 23*^ 1 1 CRE ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H -18* 8 48 48 μL μL μL Dilution Dilution Dilution 0 36 0 μL μL μL Pri. ∇ # # # # ο 6. No. OSR6578 Method A Specific Test Parameters General LIH ISE Serum ∇ 1 -0.2 -0. AU2700/AU5400 Serum/Plasma Reagent ID: 078 Parameters General LIH CRE ∇ ∇ Dilution μL -0. AU680/AU480 Serum/Plasma Application Method A System Reagent: OSR6178.2 R2(R2-1) μL ф 800 μL 48 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.2 2200* B 14 Last Last 24 % ∇ Name Sec. For No. ∇ ∇ ∇ 23*^ Sec.2 -0. ∇ # # # # ο 3.5 ∇ Operation: Yes 14 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Range Test Name: CRE ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Sample: Reagents: Volume R1 Volume R2 Volume 8 48 48 μL μL μL Dilution Dilution Dilution 0 36 0 μL μL μL Pri. 4.OD 2.2 -0.2 0. For No. ∇ 7.OD Reagent OD Limit First Low Last Low R2(R2-1) 48 μL Dilution 0 μL Name Sec. ∇ # # # # ο 6. No demographics 8. Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: CRE ∇ < > Type Serum Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Y=AX+B ∇ Factor Range Low High 4500* 13000* Counts: <Point Cal. AU680/AU480 Serum/Plasma Reagent ID: 078 Application Method B Range Serum ∇ ∇ System Reagent: OSR6178.5 Sample Volume Pre-Dilution Rate Rgt. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration ‡ Day ‡ Hour Hour MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 # † * ‡ ^ ф User defined System Calibrator Cat. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 14 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Noneф 520 ∇nm FIXED ∇ + ∇ 13 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 18* 1 1 High B B 2200* 0 0 Last Last 24 % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General Range Serum ∇ Panic Value Low # High # LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: CRE ∇ < > Type: High # High # # # # # # # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.: OE66300 Values set for working in SI units (µmol/L). OSR6578 Parameters General LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: CRE ∇ < > Type: Operation Yes Dilution -0. To work in mg/dL divide by 88. ∇ # # # # ο 5.2 High High 0.01 2009-08 . No. 0 Hour ф Common Rgt.2 -0. Not within expected values Month # # # # # # Low # # # # # # # # Unit µmol/L* Decimal Places # Parameters Calibrators General ∇ # ∇ None ∇ Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation # ∇ # ∇ Interval (RB/ACAL) ο Use Serum Cal. ∇ # # # # ο 4. Volume R1(R1-1) 8 1 48 0 μL OD Limit μL ∇ μL Dilution 36 μL Min. ∇ # # # # ο 2.2 Max.CREATININE. Depends on usage pattern in the Laboratory Equivalent to 5µmol/L due to B = -18 AU680 Metabolite BSOSR6x78. ∇ # # # # ο 3. 0 First H 2.: ODC0025 Values set for working in SI units (µmol/L). vol 0 43 0 Max. Depends on usage pattern in the laboratory. No. To work in mg/dL divide by 88. # # ο ∇ 2.5 2.CREATININE. vol Dil.01 2009-08 User defined ¤ Analyser default value Urine Calibrator Cat. No. AU400/AU640 Urine Reagent ID: 078 Specific test parameters Urine ∇ Sample vol. H Lst. L -2.2 Reagent OD limit Fst. OD H ∇ Operation: Yes Test No ∇ ∇ # Test name CRE Sample type Uri Page 1/2 System Reagent: OSR6178 Reagent ID: 078 Application CREATININE. To work in mg/dL divide by 88. L -2.0 Lst. or select from list displayed by Guide key Test No ∇ # ∇ H # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ M M M M M M Age Y Y Y Y Y Y # # # # # # L # Test name CRE Sample type Uri ∇ Level L # % Sec ∇ ∇ ∇ Fst Fst Lst Lst Sec. Reagent 1 vol Reagent 2 vol μL μL μL 2. vol Dil.5 ∇ ∇ ∇ Main 520 Sub 2 58 58 Dil. point MB type factor Calibrator stability period ‡ Select the function using the Function key or the Mouse # † * ‡ BSOSR6x78. OD L -0.2 H 2. AU600 Urine Application System Reagent: OSR6178 Specific Test Parameters General LIH ISE Range Test Name: CRE ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 58 58 μL μL μL Dilution Dilution Dilution 0 43 0 μL μL μL Pri. 13 Sample Pre-dil Linearity Fst No lag time Select using Space key.4* Correlation factor 35360* 1 0 ¤ Specific Test Parameters General LIH ISE Urine ∇ # # # # # # # Age Y Y Y Y Y Y Range Page 2/2 Level H # Test Name: CRE ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. H 2.5 Last L -2. Depends on usage pattern in the laboratory.4.0 Last H 2. # # ο ∇ 4. # † * ‡ User defined Urine Calibrator Cat. # # ο ∇ 5. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period 520 FIXED + First 13 First Last Last 24 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L -0. Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # URINE APPLICATION Select the function using the Function key or the Mouse Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 70000* # Calibration specific Test No # Test name CRE ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 21000* # Conc Factor/OD-H 70000* ∇ Test Name: CRE ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ Cal.4* H 35360* Correlation Factor: A 1 B 0 On-board stability period: 14 Wave Method Reaction Point 1 Point 2 H A B Rate 800 FIXED + 24 14 Min. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ο ∇ 3.4. # OD CONC † Factor/OD-L 21000* 1-Point Cal. No.5 Dynamic Range: L 88.5 Reagent OD limit: First L -2.5 Fst. Metabolite . # # ο ∇ 7.0 Dynamic range L 88.: ODC0025 Values set for working in SI units (µmol/L). None Selected 8. # # ο ∇ 6. 6 47 47 μL μL μL Dilution Dilution Dilution 0 35 0 μL μL μL Pri.2 -2. ∇ 7. AU680/AU480 Urine Application System Reagent: OSR6178. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Ф AU680 Metabolite BSOSR6x78. AU2700/AU5400 Urine Reagent ID: 078 Parameters General LIH CRE ∇ ∇ Dilution μL -0.0 High High 0. ∇ # # # # ο 6.4. No.2 H 2. <Point Cal. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Counts: Cal. ∇ # # # # ο 2.5 μL Min. No. Depends on usage pattern in the laboratory.2 Max.OD 2.5 Reagent OD limit: First L -2.OD Reagent OD Limit First Low Last Low Dilution 35 0 OD Limit < > ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6178. Volume R1(R1-1) μL ∇ μL 1. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check % ∇ Noneф 520 ∇nm FIXED ∇ + ∇ 13 520 FIXED + First 13 First Last Last 24 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L -0. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General ISE CRE ∇ < > Y=AX+B µmol/L* Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µmol/L* H Month # # # # # # URINE APPLICATION Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. # # ο ∇ 5.01 2009-08 . 800 Onboard Stability Period Last Last 24 14 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 88. # # ο ∇ 6.CREATININE.2 Last L -2.4* 1 1 Day μL High B B 0 35360* 0 0 Hour 47 Dilution 0 1.0 First H 0.0 Last H 0. OSR6578 Reagent ID: 078 Application Operation Yes CREATININE. To work in mg/dL divide by 88. # # ο ∇ 3.0 -2.2 0. ∇ # # # # ο 3. Not within expected values Decimal Places Calibration Specific Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration Type Urine Counts: ∇ Factor Range Low High 21000* 70000* ∇ # ο ∇ Calibration Specific General ISE Type Urine ∇ # Factor/OD-H 70000* Process: CONC ∇ Test Name: Test Name: CRE ∇ < > Use Serum Cal. OSR6578 Specific Test Parameters General LIH ISE Urine ∇ Sample Volume Pre-Dilution Rate Rgt. Point: ο with CONC-0 Slope Check: None # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration ‡ Day ‡ MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ‡ User defined Urine Calibrator Cat. # # ο ∇ 7. # # ο ∇ 2. # # ο ∇ 4.4* H 35360* Correlation Factor: A 1 B 0 On-board stability period: 14 Specific Test Parameters General LIH ISE Urine ∇ LIH CRE ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # CRE ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. ∇ # # # # ο 5. ∇ # # # # ο 4.: ODC0025 Values set for working in SI units (µmol/L). No demographics 8. None Selected 8.6 1 47 Range Operation: ∇ Yes Test Name: CRE ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec. For No. # OD CONC † Factor/OD-L 21000* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ ‡ Advanced Calibration: ∇ # None ∇ 1-Point Cal. ∇ ∇ ∇ Sec.2 Dynamic Range: L 88. # OD CONC † Factor/OD-L 4900* 1-Point Cal.2 -0.2 800 FIXED + 24 H A B Rate Max OD H 2.2 Lst.2 -0. 800 ∇ Fst. vol Dil.CREATININE.2 Main 520 18* B 14 Linearity Fst No lag time 0 Fst Fst 13 H 2200* Wave Method Reaction Point 1 Point 2 First H Last H 0.5 0. H Lst.2 Reagent OD limit Fst.2 Sub Max OD H 2.5 Sample vol.2 Lst.2 23*^ B 14 Linearity Fst No lag time Select using Space key. Depends on usage pattern in the Laboratory ^Equivalent to 5µmol/L due to B = -18 # † * ‡ ^ User defined System Calibrator Cat. AU400/AU640 Paediatric Reagent ID: 078 System Reagent: OSR6178 Reagent ID: 078 Application Method A Specific test parameters Serum ∇ 1 -0.: OE66300 Values set for working in SI units (µmol/L). vol Dil. Depends on usage pattern in the Laboratory Equivalent to 5µmol/L due to B = -18 Metabolite BSOSR6x78. No.2 20 120 120 Dil. OD H Page 1/2 2. vol 10 80 0 Max.01 2009-08 .2 0.4. or select from list displayed by Guide key % Sec % ∇ -18* Sample Pre-dil H 2200* Fst Fst 13 Lst Lst First H Last H 0.5 Sample vol. H 0. AU600 Paediatric Application System Reagent: OSR6178 Method A Specific Test Parameters General LIH ISE Range Test Name: CREP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 20 120 120 μL μL μL Dilution Dilution Dilution 10 80 0 μL μL μL Pri.5 Test Name: CREP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 20 120 120 μL μL μL Dilution Dilution Dilution 10 80 0 μL μL μL Pri.2 520 FIXED + First 13 First Last Last 24 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 800 FIXED + 24 Min. OD H ∇ Operation: Yes Test No ∇ ∇ # Test name CREP Sample type Ser Page 1/2 CREATININE. OD L -0.2 Reagent OD limit Fst.4. point MB type factor Calibrator stability period # † * ‡ ‡ Select the function using the Function key or the Mouse User defined ¤ Analyser default value System Calibrator Cat. Point: ο with CONC-0 Slope Check: None MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.2 -0. vol Dil. OD L -0. vol Dil.2 0. To work in mg/dL divide by 88. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period 520 FIXED + First 13 First Last Last 24 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 Min. Reagent 1 vol Reagent 2 vol μL μL μL 2. ∇ ∇ ∇ Sec. H Lst. No. L -0. L -0.2 Dynamic range L 18* Correlation factor Sample Pre-dil % Sec Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ A 1 On-board stability period: H A B Rate 2200* 1 0 ¤ Method A and/or Method B % ∇ On-board stability period 14 Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 14000* # Select using Space key.2 0. or select from list displayed by Guide key Method A and/or Method B Calibration specific Test No # Test name CREP ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 4900* # Conc Factor/OD-H 14000* ∇ PAEDIATRIC APPLICATION Test Name: CREP ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: ‡ # ∇ Cal. L -0.2 Dynamic range L 23*^ Correlation factor 2200* 1 -18* ¤ % ∇ A 1 On-board stability period: 14 Method B Method B Specific Test Parameters General LIH ISE Serum ∇ Test No ∇ # Test name CREP 1 -0.: OE66300 Values set for working in SI units (µmol/L).2 Main ∇ ∇ ∇ 520 Sub Fst. vol 10 80 0 ∇ Operation: Yes Range Specific test parameters Sample type μL μL μL ∇ ∇ ∇ Lst Lst Ser ∇ Max. Reagent 1 vol Reagent 2 vol 20 120 120 Dil. No. H -0. L -0. To work in mg/dL divide by 88. ∇ ∇ ∇ Sec.2 0. 2 -0.2 -0. Volume R1(R1-1) μL ∇ μL 8 1 48 Test Name: Max OD H 2.2 R2(R2-1) μL ф 800 μL 48 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.CREATININE.2 -0.2 Max. To work in mg/dL divide by 88. 800 ∇ 520 FIXED + First 13 First Noneф 520 ∇nm FIXED ∇ + ∇ 13 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Last Last 24 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: High B B 0 2200* 0 -18* Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.OD Reagent OD Limit First Low Last Low Dilution 26 10 OD Limit < > ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6178. Depends on usage pattern in the Laboratory Equivalent to 5µmol/L due to B = -18 Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ ф AU680 <Point Cal.2 -0. ∇ # # # # ο 4.2 High High 0. ∇ # # # # ο 3.2 0. No.5 0. # OD CONC † Factor/OD-L 4500* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: ∇ ‡ # None ∇ 1-Point Cal. Not within expected values Unit Parameters Calibrators General ISE CREP ∇ < > Y=AX+B Test Name: µmol/L* Decimal Places Calibration Specific % ∇ A 1 On-board stability period: Month # # # # # # Method A and/ or Method B Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration Type Serum Counts: ∇ Factor Range Low High 4500* 13000* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ # Factor/OD-H 13000* Process: CONC ∇ PAEDIATRIC APPLICATION Test Name: CREP ∇ < > Calibration Type: AB ∇ Formula: Y=AX+B ∇ Counts: Use Serum Cal. OSR6578 Reagent ID: 078 Application Operation Yes CREATININE.5 μL Min. ∇ 7. ∇ ∇ ∇ Sec.2 Max OD H 2. No demographics 8.2 0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Parameters General LIH CREP ∇ < > ISE HbA1c Test Name: Specific Test Parameters Calculated Test Type: High # Serum ∇ 14 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ A 1 On-board stability period: Method B Specific Test Parameters General LIH ISE Serum ∇ 1 -0. For No. AU680/AU480 Paediatric Application Method A System Reagent: OSR6178. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration ‡ Day ‡ ∇ ο with Conc-0 Hour Hour Metabolite BSOSR6x78.2 0. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 23*^ 1 1 CREP ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H -18* 8 48 48 μL μL μL Dilution Dilution Dilution 10 26 0 μL μL μL Pri.01 2009-08 . Point: ο with CONC-0 Slope Check: None MB Type Factor: Calibration Stability Period: # ∇ # ∇ # † * ‡ ^ User defined System Calibrator Cat. ∇ ∇ ∇ 23*^ Sec. AU2700/AU5400 Paediatric Reagent ID: 078 Parameters General LIH CREP ∇ ∇ Dilution μL -0.2 -0. ∇ # # # # ο 2. ∇ # # # # ο 5. No.2 -0.4.: OE66300 Values set for working in SI units (µmol/L). 800 ∇ Panic Value Low # High # Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 520 FIXED + First 13 First Last Last 24 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. OSR6578 Method A Specific Test Parameters General LIH ISE Serum ∇ 1 -0. Cal.5 ∇ Operation: Yes Range Test Name: CREP ∇ < > Type: Range Sample: Reagents: Volume R1 Volume R2 Volume 8 48 48 μL μL μL Dilution Dilution Dilution 10 26 0 μL μL μL Pri.2 2200* B 14 Last Last 24 % ∇ Name Sec. ∇ # # # # ο 6.OD 2.2 18* B 14 0 H 2200* First H Last H 0. No demographics 8.2 Max. Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: CREP ∇ < > Type Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Y=AX+B ∇ Factor Range Low High 4500* 13000* <Point Cal. ∇ # # # # ο 2.4.2 -0.2 High High 0. ∇ # # # # ο 5.OD Reagent OD Limit First Low Last Low CREP ∇ < > Type: Operation Yes Sample Volume Pre-Dilution Rate Rgt. ∇ # # # # ο 3. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ ο with Conc-0 Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration ‡ Day ‡ Hour Hour MB Type Factor: 1-Point Calibration Point ∇ # † * ‡ ^ User defined System Calibrator Cat. Not within expected values Month # # # # # # Low # # # # # # # # Unit µmol/L* Decimal Places # Parameters Calibrators General Serum ∇ # ∇ None ∇ Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation # ∇ # ∇ Interval (RB/ACAL) ο Counts: Use Serum Cal. ∇ 7. No. ∇ # # # # ο 4.5 Min. Volume R1(R1-1) 8 1 48 Dilution 10 μL μL ∇ μL Dilution 26 μL R2(R2-1) 48 μL Dilution 0 μL Name Sec. ∇ # # # # ο 6.2 0. For No.01 2009-08 .: OE66300 Values set for working in SI units (µmol/L). 0 Hour ф Common Rgt. Depends on usage pattern in the Laboratory Equivalent to 5µmol/L due to B = -18 ф AU680 Metabolite BSOSR6x78.CREATININE.OD 2. To work in mg/dL divide by 88.2 -0. OSR6578 Parameters General LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: OD Limit -0. AU680/AU480 Paediatric Reagent ID: 078 Application Method B Range Serum ∇ ∇ System Reagent: OSR6178. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 14 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Noneф 520 ∇nm FIXED ∇ + ∇ 13 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 18* 1 1 High B B 2200* 0 0 Last Last 24 % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General Range Serum ∇ Panic Value Low # High # LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: CREP ∇ < > Type: High # High # # # # # # # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. Measurements of creatinine are used in the diagnosis and treatment of renal disease and prove useful in the evaluation of kidney glomerular function and in monitoring renal dialysis. unopened. amputees. body weight. reagents stored on board the instrument are stable for 60 days. For in vitro diagnostic use only. both the plasma creatinine and urea levels will be increased. Sarcosine oxidase catalyzes the oxidative demethylation of the sarcosine to yield glycine. EN. To avoid the possible build-up of azide compounds. which are both found almost exclusively in muscle. up to the stated expiry date when stored at 2…8°C. the serum level is not sensitive to early renal damage and responds more slowly than blood urea nitrogen (BUN) to haemodialysis during treatment of renal failure. Storage and Stability The reagents are stable.68 mmol/L 100 IU/mL 12.3 IU/mL 15 IU/mL 0. the hydrogen peroxide formed reacts by quantitative oxidation condensation with N-(3-sulfopropyl)-3-methoxy-5-methylaniline (HMMPS) and 4-aminoantipyrine to yield a blue pigment. Dispose of all waste material in accordance with local guidelines.3 Creatinine is a metabolic product of creatine and phosphocreatine. creatinine production is proportional to muscle mass and varies little from day to day. An increase in serum BUN without concomitant increase of serum creatinine is key to identifying prerenal azotemia. flush waste-pipes with water after the disposal of undiluted reagent.01 BLOSR6x204.2.5 U/mL 1. plasma and urine on Beckman Coulter analysers. Once open. formaldehyde and hydrogen peroxide.53 mmol/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. and in older persons. The creatine formed is hydrolysed by creatinase to sarcosine and urea. Thus.01 2009-08 Metabolite .CREATININE (ENZYMATIC) OSR61204 Intended Use Enzymatic assay for the quantitative determination of creatinine in human serum. 4 Stable in serum and plasma for 7 days when stored at 2…25°C. However. race and sex. Reaction Principle Creatininase Creatinine + H2O Creatinase Creatine Sarcosine + Urea Sarcosine Oxidase Creatine + H2O Sarcosine + H2O + O2 POD Glycine + Formaldehyde + H2O2 Blue Pigment H2O2 + 4-aminoantipyrine + HMMPS Contents. Reagent Composition in the Test Final concentration of reactive ingredients: Good's Buffer Creatinase Sarcosine oxidase HMMPS Creatininase Peroxidase 4-Aminoantipyrine Preservative 50 mmol/L 56. Serum creatinine varies with the subject’s age. in these situations the rise is disproportionately greater for BUN due to the increased back diffusion of urea. A serum creatinine level that would usually be considered normal does not rule out the presence of impaired renal function. Store at 2…8°C. Both serum creatinine and BUN are used to differentiate prerenal and postrenal (obstructive) azotemia. Test Principle Creatinine is hydrolysed by creatininase to creatine. malignancy. 4 x 45 mL 4 x 15 mL R1 R2 Summary1. In post renal conditions where obstruction to the flow of urine is present e. The creatinine concentration is proportional to the change in absorbance at 600/700 nm. In the presence of peroxidase (POD). It is sometimes low in subjects with relatively small muscle mass. Urine: Collect urine without using preservatives.g. cachectic patients. nephrolithiasis and prostatism. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. 5 Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use Statement. Specimen Serum and heparinised plasma. 15 – 0.11 µmol/L.4 – 4420 µmol/L (0. n = 80 Within Run Total Mean µmol/L SD CV% SD 62.0 mg/dL) for serum and plasma. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.2 1.6 2.997 n = 151 Sample range = 707 – 19793 µmol/L Interfering Substances Results of serum studies conducted to evaluate the susceptibility of the method to interference were as follows: ® Lipemia: Interference less than 10% up to 1000 mg/dL Intralipid. or when the following occur: Change in reagent lot or significant shift in control values.768 r = 1. For diagnostic purposes.7 0. Data obtained in your laboratory may differ from these values. clinical examinations and other findings. limit of blank = 0. No. No. Method Comparison Patient serum samples were used to compare this Creatinine (Enzymatic) OSR61204 assay on the AU2700 against another commercially available enzymatic creatinine assay.55 – 1.9 µmol/L. The limit of detection for creatinine using urine settings on an AU640 analyser was established at 13.0 The following data was obtained on an AU2700 using 3 urine pools analysed over 20 days.2 2. Major preventative maintenance was performed on the analyser or a critical part was replaced. based on 150 determinations.2 CV% 2. sample type. Precision The following data was obtained on an AU2700 using 3 serum pools analysed over 20 days. sex.4 – 1966 µmol/L Patient urine samples were used to compare this Creatinine (Enzymatic) OSR61204 assay on the AU2700 against another commercially available IDMS traceable creatinine assay.1 SD 51 189 331 Total CV% 2. The urine calibrator creatinine value is traceable to the IDMS method. No. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. No. 397 and 398 or other control materials with values determined by this Beckman Coulter system may be used for the urine application.3 1. Calculation The Beckman Coulter analysers automatically compute the creatinine concentration of each sample.26 – 1. ODC0025 for the urine application. The results obtained by any individual laboratory may vary from the given mean value.6 1. The test is linear within a concentration range of 88 – 44200 µmol/L (1 – 500 mg/dL) for urine.986x .577 r = 0.18 mg/dL) 49 –90 µmol/L (0. with 60 blank and 90 low-level samples.1 µmol/L.2 0.1 0.02 mg/dL) 22 – 90 µmol/L (0.01 . review all operating parameters. Recalibrate the serum and plasma application every 14 days and the urine application every 30 days. Each laboratory should verify the transferability of the expected values to its own population.000 n = 237 Sample range = 12.7 14.2 1.9 908.3 6.88 µmol/L. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.4 180. Quality Control Controls Cat. Linearity The test is linear within a concentration range of 4. 66300 for the serum and plasma application and Urine Calibrator Cat. diet and geographical location. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used for the serum/plasma application. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. The serum calibrator creatinine value is traceable to the Isotope Dilution Mass Spectroscopy (IDMS) method via National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 967. Results of linear regression analysis were as follows: y = 1.05 – 50.73 mg/dL) Urine Male 124 – 230 µmol/kg/day (14 – 26 mg/kg/day) Female 97 – 177 µmol/kg/day (11 – 20 mg/kg/day) Expected values may vary with age.Calibration Use System Calibrator Cat.7 1. n = 80 Mean µmol/L 2335 8601 15146 Within Run SD 37 111 159 CV% 1.24 – 0.3 1.104.01 2009-08 EN. Results of linear regression analysis were as follows: y = 0.6 1. Icterus: Interference less than 7% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin Ascorbate: Interference less than 5% up to 20 mg/dL ascorbate Creatine: Interference less than 5% up to 30 mg/dL creatine Metabolite BLOSR6x204. 8 The limit of detection was determined consistent with the guidelines in the NCCLS protocol EP17-A with proportions of false positives less than 5% and false negatives less than 5%.2 2.5 Sensitivity The limit of detection for creatinine using serum settings on an AU640 analyser was established at 0. results should always be assessed in conjunction with the patient's medical history. Biorad Liquichek Urine Chemistry Controls Cat. limit of blank = 3. If any trends or sudden shifts in values are detected. and if necessary determine its own reference interval according to good laboratory practice.37 mg/dL) 21 – 65 µmol/L (0.014x + 1.01 mg/dL) 11 – 34 µmol/L (0. Reference Intervals Serum/Plasma Male Female Neonate Infant (2 months – < 3 years) Child (3 – < 15 years) 7 6 64 – 104 µmol/L (0.72 – 1. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. In: Burtis CA. Reference intervals for serum creatinine concentrations: Assessment of available data for global application. Henny J. nd NCCLS. Kairisto V. Panteghini M. User defined ¤ Analyser default value System Calibrator Cat. Frankfurt/Main: TH-Books Verlagsgesellschaft.4. Tietz textbook of clinical chemistry. Protocols for determination of limits of detection and limits of quantitation. To work in mg/dL divide by 88. Urinalysis and collection. Tietz textbook of clinical chemistry. No. 54(3): 559-566. Heil W.1241-1246. 9. Klein G. 9 Setting Sheet Footnotes # † * 1.1 Rev.1809pp. Clin Chem. In: Burtis CA. 1999. Zawta B. Refer to Young for further information on interfering substances. 2008. th Young DS. Philadelphia: WB Saunders Company. 1998:366-371. 1999. Renal function and nitrogen metabolites. 5. especially monoclonal IgM (Waldenström’s macroglobulinemia). BIBLIOGRAPHY EN. Boyd JC. Painter PC. Cope JY.: 66300 / Urine Calibrator Cat. eds. Effects of drugs on clinical laboratory tests. Pennsylvania: NCCLS. Queraltó J. and preservation of urine specimens. 2 ed. Smith JL. Wisser H.01 2009-08 Metabolite . 2. Creatinine. 7. Schmitt Y. 8. 2000. Philadelphia:WB Saunders Company. London: Arnold. Ceriotti F. th Mayne PD. Clinical laboratory diagnostics. Plasma and Serum Samples. approved guideline. transportation. No. Reference information for the clinical laboratory. Price CP.2:28pp.:ODC0025 Values set for working in SI units (µmol/L). Newman DJ. 6 ed. Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood. 2001. Ashwood ER.1994:18pp. et al. 2004. NCCLS Document EP17-A. Use and assessment of clinical laboratory results. may cause unreliable results.01 BLOSR6x204. 6. Pennsylvania: NCCLS. Clinical chemistry in diagnosis and treatment. AACC Press. 4. approved guideline. NCCLS Document GP16-A2. Töpfer G. ed.Results of urine studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 50 mg/dL conjugated bilirubin Ascorbate: Interference less than 5% up to 20 mg/dL ascorbate Glucose: Interference less than 5% up to 3000 mg/dL glucose In very rare cases gammopathy. Thomas L. eds. 3. WHO/DIL/LAB/99. NCCLS. Ashwood ER. Ehret W. In: Thomas L. ed. 5 ed. . AU400/AU640 Serum/Plasma Reagent ID: 204 Specific test parameters Serum 1 Max OD H -0.1 Dynamic range L 4. H 4420* Fst Fst 0 0 Lst Lst First H Last H 0.4.1 Lst. † System Calibrator Cat.4* Correlation factor % ∇ 4420* 1 0 ¤ 60 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L # Age Y Y Y Y Y Y Level H # Test Name: CREZ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. OD H 0.2 ∇ Operation: Yes ∇ Test No # Test name CREZ ∇ Sample type Ser ∇ Page 1/2 System Reagent: OSR61204 Reagent ID: 204 Application CREATININE (ENZYMATIC). point MB type factor Calibrator stability period 14 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in SI units (µmol/L).: OE66300 # User defined * Values set for working in SI units (µmol/L). H Sample vol. Reagent 1 vol Reagent 2 vol 7 150 50 Dil. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. ∇ ∇ ∇ Sec. # # ∇ 4. No. L -0.2 0.4.1 -0. # # ∇ 5.: OE66300 Metabolite BSOSR6x204.02 2009-11 . # # ∇ 6. None Selected 8. AU600 Serum/Plasma Application System Reagent: OSR61204 Specific Test Parameters General LIH ISE Range Test Name: CREZ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 7 150 50 µL µL µL Dilution Dilution Dilution 10 0 0 µL µL µL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. 700 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. # OD CONC † Factor/OD-L 3900* 1-Point Cal. To work in mg/dL divide by 88. H Lst. L -0.2 0. vol Dil.1 4. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name CREZ ∇ Sample type Ser ∇ On-board stability period 600 END + First 0 First 0 Pri. vol Dil. To work in mg/dL divide by 88. # # ∇ 3. # # ∇ 7. † System Calibrator Cat. Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name CREZ ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 3900* # Conc Factor/OD-H 5900* ∇ Calibration Specific General ISE Serum # Factor/OD-H 5900* Process: CONC ∇ ∇ SERUM/PLASMA APPLICATION Test Name: Counts: CREZ ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: 14 # ∇ Cal. No.CREATININE (ENZYMATIC).4* B 60 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. # # ∇ 2.2 Wave Method Reaction Point 1 Point 2 Main 600 Sub 700 END + 27 10 ∇ ∇ ∇ Fst. OD L Reagent OD limit Fst. vol 10 0 0 µL µL µL Max. No. Not within expected values µmol/L * Decimal Places Calibration Specific ISE CREZ ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum ∇ Calibration Specific General ISE Type Serum Counts: Factor/OD-H 5900* # Process: CONC ∇ ∇ SERUM/PLASMA APPLICATION Test Name: CREZ ∇ < > Use Serum Cal.4. # # ∇ 3.4* 1 1 40 µL Dilution 0 µL High B B 0 4420* 0 0 Hour Sample Volume Pre-Dilution Rate Rgt.OD -0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Parameters General LIH CREZ ∇ < > ISE HbA1c Test Name: ф 600 ∇nm END ∇ + ∇ 0 0 % ∇ 600 END + First 0 First 0 Sec. No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point ∇ with Conc-0 # ∇ # Lot Calibration ∇ MB Type Factor: ICF: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # * † ф User defined Values set for working in SI units (µmol/L). System Calibrator Cat. # # ∇ 2.6 1 120 µL ∇ µL Test Name: CREZ ∇ Operation: Yes < > Type: ∇ ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 Last Last 27 10 5. AU680/AU480 Serum/Plasma System Reagent: OSR61204 Reagent ID: 204 Application Range System Reagent: OSR61204 Parameters General LIH CREZ Dilution Max. # # # # ∇ 6. # # # # ∇ 3.2 0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µmol/L * H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. No. 700 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 60 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum # ∇ Range Test Name: CREZ ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # # # ∇ 4. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal.2 Dilution 0 µL Min. None Selected 8.1 High High 0.6 120 40 0.CREATININE (ENZYMATIC). # # ∇ 5. # # ∇ 6. To work in mg/dL divide by 88. For No. # # # # ∇ 7. # # # # ∇ 2. ∇ ∇ ∇ 4. Point: with CONC-0 Slope Check: Advanced Calibration Operation Interval (RB/ACAL) Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration <Point Cal. 700 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 4. # # ∇ 7. # # ∇ 4. # # # # ∇ 5.4* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.1 R2(R2-1) Name Sec.02 2009-11 .2 4420* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis µL µL µL Dilution Dilution Dilution 10 0 0 µL µL µL Pri.1 -0.OD Reagent OD Limit First Low Last Low 10 µL OD Limit ∇ Type: Serum < > ∇ ISE HbA1c Test Name: Specific Test Parameters Calculated Test Reagent ID: 204 Specific Test Parameters General LIH ISE Operation Yes ∇ Range Serum 1 Max OD H -0. AU2700/AU5400 Serum/Plasma Application CREATININE (ENZYMATIC). No demographics 8.2 0. # OD CONC † Factor/OD-L 3900* Counts: # ∇ ∇ Factor Range Low High Slope Check 3900* 5900* Allowance Range Check Reagent Blank Calibration Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: 14 # ∇ None ∇ 1-Point Cal.: OE66300 AU680 14 14 Day Day 0 0 Hour Hour Metabolite BSOSR6x204. Volume R1(R1-1) 5.1 -0. : ODC0025 Metabolite BSOSR6x204.: ODC0025 # User defined * Values set for working in SI units (µmol/L). # # ∇ 3. # # ∇ 5. To work in mg/dL divide by 88.4. AU600 Urine Application System Reagent: OSR61204 Specific Test Parameters General LIH ISE Range Test Name: CREZ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 1 150 50 µL µL µL Dilution Dilution Dilution 0 0 0 µL µL µL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. 700 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min.1 Lst.1 88* B 60 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil.4. OD L Reagent OD limit Fst. To work in mg/dL divide by 88. † Urine Calibrator Cat. No. # # ∇ 2.1 Dynamic range L 88* Correlation factor % ∇ 44200* 1 0 ¤ 60 Specific Test Parameters General LIH ISE Urine # # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L # Age Y Y Y Y Y Y Level H # Test Name: CREZ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. point MB type factor Calibrator stability period 30 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value * Values set for working in SI units (µmol/L).CREATININE (ENZYMATIC). # # ∇ 4. # # ∇ 6. Reagent 1 vol Reagent 2 vol 1 150 50 Dil. H 44200* Fst Fst 0 0 Lst Lst First H Last H 0.2 0. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name CREZ ∇ Sample type Uri ∇ On-board stability period 600 END + First 0 First 0 Pri. L -0. AU400/AU640 Urine Reagent ID: 204 Specific test parameters Urine 1 Max OD H -0.2 ∇ Operation: Yes ∇ Test No # Test name CREZ ∇ Sample type Uri ∇ Page 1/2 System Reagent: OSR61204 Reagent ID: 204 Application CREATININE (ENZYMATIC). vol Dil. vol 0 0 0 µL µL µL Max. No.2 0. # # ∇ 7. ∇ ∇ ∇ Sec. # OD CONC † Factor/OD-L 24000* 1-Point Cal. Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # URINE APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name CREZ ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 24000* # Conc Factor/OD-H 41000* ∇ Calibration Specific General ISE Urine # Factor/OD-H 41000* Process: CONC ∇ ∇ Test Name: Counts: CREZ ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: 30 # ∇ Cal.2 Wave Method Reaction Point 1 Point 2 Main 600 Sub 700 END + 27 10 ∇ ∇ ∇ Fst. H Sample vol. L -0. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. H Lst. None Selected 8.1 -0.02 2009-11 . † Urine Calibrator Cat. No. vol Dil. OD H 0. 2 1 150 50 µL µL µL Dilution Dilution Dilution 0 0 0 µL µL µL Pri. 700 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Urine LIH CREZ ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # CREZ ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.CREATININE (ENZYMATIC).2 0. AU680/AU480 Urine Application System Reagent: OSR61204 Specific Test Parameters General LIH ISE Urine 1 Max OD H -0.1 High High 0. ∇ ∇ ∇ 88* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. # # ∇ 4. None Selected 8. Onboard Stability Period Last Last 27 10 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 88* 1 1 60 Day µL High B B 0 44200* 0 0 Hour Sample Volume Pre-Dilution Rate Rgt. No. # # ∇ 6. Not within expected values µmol/L * Decimal Places Calibration Specific ISE CREZ ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine ∇ Calibration Specific General ISE Type Urine Counts: Factor/OD-H 41000* # Process: CONC ∇ ∇ Test Name: CREZ ∇ < > Use Serum Cal. # # # # ∇ 4. Point: with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration <Point Cal. AU2700/AU5400 Urine Reagent ID: 204 Parameters General LIH CREZ Dilution Max. To work in mg/dL divide by 88. No.4. # # ∇ 7. # # # # ∇ 6. # # # # ∇ 5.1 R2(R2-1) ф 700 50 µL Dilution 0 Name Sec. Volume R1(R1-1) 1 1 150 µL ∇ µL Range ∇ Operation: Yes ∇ Test Name: CREZ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 0 44200* 0. # # # # ∇ 3. # # # # ∇ 2. # # ∇ 2.OD Reagent OD Limit First Low Last Low 0 µL OD Limit ∇ Type: Urine < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61204 Reagent ID: 204 Application Operation Yes ∇ CREATININE (ENZYMATIC). For No. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µmol/L * H Month # # # # # # URINE APPLICATION Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. # # ∇ 3. # # # # ∇ 7.: ODC0025 AU680 30 30 Day Day 0 0 Hour Hour Metabolite BSOSR6x204. Urine Calibrator Cat. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point ∇ with Conc-0 Lot Calibration ∇ # ∇ MB Type Factor: ICF: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # * † ф User defined Values set for working in SI units (µmol/L).OD -0.2 Dilution 0 µL Min. No demographics 8.2 0. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal.02 2009-11 . # OD CONC † Factor/OD-L 24000* Counts: # ∇ ∇ Factor Range Low High Slope Check 24000* 41000* Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: 30 # ∇ None ∇ 1-Point Cal.1 -0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check ф 600 ∇nm END ∇ + ∇ 0 0 % ∇ 600 END + First 0 First 0 Sec.1 -0. # # ∇ 5. In meningitis or encephalitis due to viral infections. Glucose in stabilised haemolysate and plasma is stable for up to 7 days when stored at 2…8°C and 2 days when stored at 15. A fall in blood glucose to a critical level (approximately 2.2. which ensures that levels are maintained within precise limits. Reaction principle HK. Hyperglycaemia most commonly occurs as a result of a deficiency in either the amount or efficiency of insulin. cryptococcal. Icteric and strongly lipemic samples should be avoided. hepatic dysfunction. such as occurs in a number of pathological conditions in which blood glucose may be elevated (hyperglycaemia) or depressed (hypoglycaemia). up to the stated expiry date when stored at 2…8°C. unopened.6 . These fluctuations are increased further where there is dysregulation. where there is suspected hyperglycaemia.5 mL 4 x 53 mL 4 x 27 mL 4 x 102 mL 4 x 52 mL R1 R2 R1 R2 R1 R2 Summary1.. Blood glucose concentrations show intra-individual fluctuations. tubular or carcinomatous meningitis. flush waste-pipes with water after the disposal of undiluted reagent. Reye’s syndrome. and is characterised by muscle weakness.01 BLOSR6x21. CSF glucose may be low or undetectable in patients with acute bacterial. haemolysate and cerebrospinal fluid on Beckman Coulter AU analysers.02 2010-04 Metabolite 5. septicaemia and chronic renal failure. toxaemia of pregnancy. Specimen Serum.3 In the fasting state. blood sugar levels are regulated by the liver. insulin antibodies. To avoid the possible build-up of azide compounds. Test Principle4 Glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6phosphate and adenosine diphosphate (ADP). plasma. The increase in absorbance at 340nm is proportional to the glucose concentration in the sample. which are dependent on muscular activity and the time interval since food intake. probably due to consumption of glucose by leucocytes or other rapidly metabolising cells. evaluation of carbohydrate metabolism.GLUCOSE OSR6121 OSR6221 OSR6521 Intended Use Enzymatic UV test (hexokinase method) for the quantitative determination of glucose in human serum.59 kU/L G6P-DH ≥ 1. EDTA or heparinised plasma. alcohol ingestion.0 mmol/L + NAD ≥ 1. lack of coordination and mental confusion. nonpancreatic neoplasms. Once open. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument.37 mmol/L Mg Hexokinase ≥ 0. reagents stored on board the instrument are stable for 30 days. EN. insulin-producing pancreatic tumours (insulinomas). urine. a condition known as diabetes mellitus.5 mM) leads to dysfunction of the central nervous system. This manifests as hypoglycaemia.32 mmol/L 2+ 2. acute pancreatitis and Addison’s disease. Dispose of all waste material in accordance with local guidelines. Glucose-6-phosphate dehydrogenase (G6P-DH) specifically oxidises glucose-6-phosphate to + gluconate-6-phosphate with the concurrent reduction of NAD to NADH. which occurs during ingestion of carbohydrates. Blood glucose measurement is used as a screening test for diabetes mellitus. 4 x 25 mL 4 x 12.0 mmol/L ATP ≥ 2. congenital enzyme defects. for example in gestational diabetes acute hepatitis. random collections are recommended for urine specimens.58 kU/L Preservative Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. This disease is characterised by the elevation of blood glucose to such an extent that the renal threshold is exceeded and sugar appears in the urine (glycosuria). 7 Urine: Fresh. Stable in urine for 2 hours when stored at 2…25°C. Reagent Composition in the Test Final concentration of reactive ingredients: PIPES buffer (pH 7. Mg2+ Glucose + ATP Glucose-6-Phosphate + NAD + Glucose-6-phosphate + ADP G6P-DH Gluconate-6-P + NADH + H + Contents. monitoring of therapy in diabetes mellitus. Glucose reagent OSR6521 for use on the AU2700 and AU5400 systems only. it is usually normal. The rapid and precise manner in which fasting blood sugar levels are regulated is in marked contrast to the rapid increase in blood sugar. monoiodoacetate or mannose.6) 24. Storage and Stability The reagents are stable. or in cerebral abscess. Specimens that cannot be rapidly separated should be collected into tubes containing fluoride. For in vitro diagnostic use only. Hypoglycaemia is associated with a range of pathological conditions including neonatal respiratory distress syndrome.. Further decrease in blood glucose levels leads to hypoglycaemic coma. 7 Cerebrospinal fluid: Process immediately to avoid falsely low results. Analyse as soon 5 as possible.25°C. To minimise loss of glucose through glycolysis serum should be removed from red cells as soon as possible. 2 – 3.1 Serum/Plasma (fasting) Haemolysate Urine CSF Adults Children Adults Adult 4. plasma.09 4.1 – 0. No. Reference Intervals8.12 0.5 mmol/L (60 – 100 mg/dL) 0. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. diet and geographical location. Major preventative maintenance was performed on the analyser or a critical part was replaced. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.0 mmol/L or (c) 2-h postload glucose ≥ 11.6 mmol/L (60 – 100 mg/dL) 3. The lowest detectable level represents the lowest measurable level of glucose that can be distinguished from zero.8 mmol/L (1 – 15 mg/dL) 2. n = 80 Within Run Total Mean mmol/L SD CV% SD 0. 66300.02 2010-04 EN. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. on an AU600 analyser was estimated at 0. Urine: Use Urine Calibrator Cat. CSF: Control materials with values determined by this Beckman Coulter system may be used.18 The following data was obtained on an AU640 using 3 urine pools analysed over 20 days.94 0. ODC0025.27 0. sex.03 0. Data obtained in your laboratory may differ from these values. n = 80 Within Run Total Mean mmol/L SD CV% SD CV% 2.1 – 5. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. using serum settings.01 11. Linearity The test is linear within a concentration range of 0. Urine: Biorad Liquichek Urine Chemistry Controls Cat. Rolf Greiner Cat No. No.9 mmol/L (74 – 106 mg/dL) 3.04 mmol/L. using urine settings.31 0.13 0.11 CV% 2.20 3. haemolysate and CSF. No. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. No. The results obtained by any individual laboratory may vary from the given mean value. and if necessary determine its own reference interval according to good laboratory practice. unless there is unequivocal hyperglycaemia with acute metabolic decompensation.04 mmol/L. If any trends or sudden shifts in values are detected.01 1. For diagnostic purposes. sample type. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.67 0.46 0.39 0.82 0. Calculation The Beckman Coulter analysers automatically compute the glucose concentration of each sample. H10582 or Hatado Cat No. or when the following occur: Change in reagent lot or significant shift in control values.9 mmol/L (40 – 70 mg/dL) ≈ 60% of plasma value 9 The generally accepted cut-off levels for the diagnosis of diabetes are: (a) random plasma glucose of ≥ 11. n = 60 Within Run Total Mean mmol/L SD CV% SD 3. The paediatric application is suitable for use with small volume serum/plasma samples.02 0. 60690201.90 Sensitivity The lowest detectable level.0 mmol/L (10 – 800 mg/dL) for serum.06 16.09 0.41 18.1 mmol/L (b) fasting plasma glucose (FPG) ≥ 7.04 6. The lowest detectable level.45 0. If any one of these criteria is met.52 CV% 1.46 1.08 0.54 0.70 0. Quality Control Serum/plasma/haemolysate: controls Cat. review all operating parameters.35 1.1 mmol/L during an oral glucose tolerance test (OGTT). It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.51 0.36 0.6 0. Calibration Serum/plasma/haemolysate/CSF: Use System Calibrator Cat.Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.30 0. Metabolite BLOSR6x21. clinical examinations and other findings.6 – 45. Recalibrate the assay every 30 days.01 .54 0.09 1. The glucose values of both calibrators are traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 965.25 0. For Haemolysate application use either of the following reagents.27 0.17 42.3 – 5. Expected values may vary with age.97 1. The test is linear within a concentration range of 0 – 45 mmol/L (1 – 800 mg/dL) for urine. on an AU2700 analyser was estimated at 0. results should always be assessed in conjunction with the patient's medical history.22 The following data was obtained on an AU2700 using 3 haemolysate analysed over 20 days.53 1. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed.05 2.15 5. Each laboratory should verify the transferability of the expected values to its own population.40 0. results must be confirmed by repeat testing on a subsequent day. 397 and 398 or other control materials with values determined by this Beckman Coulter system may be used.25 0.3 – 5. eds. 9.7 mmol/L Interfering Substances Results of serum studies conducted to evaluate the susceptibility of the method to interference were as follows: Ascorbate : Interference less than 3% up to 20 mg/dL ascorbate Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 700 mg/dL Intralipid Results of urine studies conducted to evaluate the susceptibility of the method to interference were as follows: Ascorbate : Interference less than 3% up to 50 mg/dL ascorbate Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Results of haemolysate studies conducted to evaluate the susceptibility of the method to interference were as follows: Haemolysis: Interference less than 20% up to 150 g/L haemoglobin Icterus: Interference less than 10% up to 16 mg/dL or 273. 5. User defined ¤ Analyser default value System Calibrator Cat.1995:272pp. Philadelphia:WB Saunders Company. 10 Limitations Please note that there is a requirement to dedicate a separate test channel specifically for Haemolysate sample settings when assigning this Glucose application on AU680/480/2700/5400 analyers. In: Burtis CA. 1998:131-37.3 mmol/L Patient urine samples were used to compare this Glucose assay OSR6121 on the AU2700 against another commercially available glucose assay. 10. 3rd ed. Wisser H. Pretreat all samples: 20 µL sample and 1000 µL haemolysing reagent. Diabetes mellitis. ed.998 n = 117 Sample range = 0.Oxford: Blackwell Science. Clinical chemistry theory. 47pp. Walker SW. Goldstein DE. Ehret W. ed.23 mmol/L Patient CSF samples were used to compare this Glucose assay OSR6121 on the AU600 against another commercially available glucose assay. Rae PWH. 4. Cope JY.2:32pp. eds. Use and assessment of clinical laboratory results.081 r = 0.02 r = 0. 6. Results of linear regression analysis were as follows: y = 1. 5th ed.48:436-72. Clinical laboratory diagnostics.: 66300/ Urine Calibrator Cat.40:585-589. plasma and serum samples.1998:283pp.:ODC0025 Values set for working in SI units (mmol/L).02 2010-04 Metabolite . Painter PC. may cause unreliable results. Enzymatische Bestimmungen der Glucose in Blut. No. 7.008 r = 1.8 – 7. Refer to Young for further information on interfering substances. especially monoclonal IgM (Waldenström’s macroglobulinemia). Young DS. No. Smith AF. 1996:635pp.037x – 0. Results of linear regression analysis were as follows. eds. and correlation. Dods RF.001x – 0.06 – 26. Clinical guide to laboratory tests. Parrott M. Results of linear regression analysis were as follows: y = 1. In: Burtis CA. 3.000 n = 120 Sample range = 0. BIBLIOGRAPHY Thomas L. Clin Chem 2002. St Louis: Mosby. Frankfurt/Main: TH-Books Verlagsgesellschaft. Lecture notes on clinical biochemisty. 6th ed. eds. 8. In:Thomas L.01 BLOSR6x21. Klin Wschr 1962. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. 1815pp. 2. Philadelphia: WB Saunders Company. Pesce AJ. Liquor und Harn. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus.6 µmol/L bilirubin ® Lipemia: Interference less than 10% up to 700 mg/dL Intralipid In very rare cases gammopathy.Method Comparison Patient serum samples were used to compare this Glucose assay OSR6121 on the AU600 against another commercially available glucose assay. Beckett GJ. et al. Smith JL. Separate the Haemolysate application from other setting types. y = 0. Töpfer G.3 – 43. 2000. Schmitt Y.97x – 0. To work in mg/dL multiply by 18. Ashwood ER. 1999. Sacks DB. MacLaren NK. Ashwood ER. Tietz textbook of clinical chemistry.991 n = 101 Sample range 1.1 Rev. Carbohydrates. In: Kaplan LA. McDonald JM. WHO/DIL/LAB/99. Tietz NW. analysis. Reference information for the clinical laboratory. 766-85. Zawta B. Barthelmai W. Philadelphia:WB Saunders Company. Czok R. Effects of drugs on clinical laboratory tests. Tietz textbook of clinical chemistry. Setting Sheet Footnotes # † * ‡ ∂ 1. AACC Press. EN. 1999. Bruns DE. Blood glucose. Heil W. Sacks DB. . 6* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. OD L Reagent OD limit Fst. Metabolite . Vol Dil.5 0. OSR6221 Specific Test Parameters General LIH ISE Range Test Name: GLUC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 50 25 µL µL µL Dilution Dilution Dilution 0 150 25 µL µL µL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. AU600 Serum/Plasma Application System Reagent: OSR6121. # # ∇ 5. BSOSR6x21. None Selected 8. # # ∇ 7.1 -0.0* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L # Age Y Y Y Y Y Y Level H # Test Name: GLUC ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # OD CONC † Factor/OD-L 21* 1-Point Cal. L -0. Point MB type factor Calibrator stability period 30 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat.: 66300 * Values set for working in SI units (mmol/L).1 Lst. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. To work in mg/dL multiply by 18. H Sample vol. To work in mg/dL multiply by 18. OD H 0. No.1 Dynamic range L 0. ∇ ∇ ∇ Sec. # # ∇ 4. Vol 0 150 25 µL µL µL Max. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name GLUC ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 21* # Conc Factor/OD-H 35* ∇ Calibration Specific General ISE Serum # Factor/OD-H 35* Process: CONC ∇ ∇ SERUM/PLASMA APPLICATION Test Name: Counts: GLUC ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ Cal. 380 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. No.5 0.6* Correlation factor % ∇ 45.02 2010-06 # User defined † System Calibrator Cat. L -0.: 66300 * Values set for working in SI units (mmol/L).5 ∇ Operation: Yes ∇ Test No # Test name GLUC ∇ Sample type Ser ∇ Page ½ System Reagent: OSR6121. AU400/AU640 Serum/Plasma Reagent ID: 021 Specific test parameters Serum 1 Max OD H -0.5 Wave Method Reaction Point 1 Point 2 Main 340 Sub 380 END + 27 10 ∇ ∇ ∇ Fst. # # ∇ 2.1 0. No. # # ∇ 6. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name GLUC ∇ Sample type Ser ∇ On-board stability period 340 END + First 0 First 0 Pri. Reagent 1 vol Reagent 2 vol 2 50 25 Dil. Vol Dil. H 45. H Lst.GLUCOSE. # # ∇ 3. OSR6221 Reagent ID: 021 Application GLUCOSE.0* Fst Fst 0 0 Lst Lst First H Last H 0. None Selected 8. # # ∇ 2.02 2010-06 . To work in mg/dL multiply by 18. OSR6521 Specific Test Parameters General LIH ISE Serum 1 Max OD H -0. ∇ ∇ ∇ 0. OSR6221. No.1 -0.: 66300 Values set for working in SI units (mmol/L). Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. OSR6521 Reagent ID: 021 Application Operation Yes ∇ GLUCOSE. AU680/AU480 Serum/Plasma Application System Reagent: OSR6121.OD Reagent OD Limit First Low Last Low 0 µL OD Limit ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6121. # # # # ∇ 3. # # ∇ 5. 660 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ ++++ ∇ ++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum LIH GLUC ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # GLUC ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 Dilution 120 µL Min.6* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. # OD CONC † Factor/OD-L 18* ∇ Factor Range Low High 18* 27* Slope Check Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. OSR6221. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point ∇ with Conc-0 Lot Calibration ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined.OD -0.6 40 20 0.1 R2(R2-1) ф 660 20 µL Dilution 20 Name Sec. # # ∇ 3. # # # # ∇ 2. AU2700/AU5400 Serum/Plasma Reagent ID: 021 Parameters General LIH GLUC Dilution Max. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.GLUCOSE.1 -0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ 340 END + First 0 First 0 Sec.6* 1 1 µL High B B 0 45.0* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis µL µL µL Dilution Dilution Dilution 0 120 20 µL µL µL Pri.1 High High 0. # # ∇ 4. For No.0* 0 0 Hour Sample Volume Pre-Dilution Rate Rgt.5 0. # # # # ∇ 4. # # ∇ 7. System Calibrator Cat. # # ∇ 6. Not within expected values mmol/L* Decimal Places Calibration Specific ISE GLUC ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ # ∇ Calibration Specific General ISE Type Serum Counts: # Factor/OD-H 27* Process: CONC ∇ ∇ SERUM/PLASMA APPLICATION Test Name: GLUC ∇ < > Use Serum Cal. Volume R1(R1-1) 1. # # # # ∇ 5. # # # # ∇ 6.5 0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1.5 45. AU680 30 30 Day Day 0 0 Hour Hour Metabolite BSOSR6x21. # # # # ∇ 7. No demographics 8. No. Point: with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration <Point Cal.6 1 40 µL ∇ µL Range ∇ Operation: Yes ∇ Test Name: GLUC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 Last Last 27 10 1. 5 0. H Lst. # OD CONC † Factor/OD-L 20* 1-Point Cal. H Sample vol. L -0. None Selected 8.02 2010-06 # User defined † Urine Calibrator Cat. AU400/AU640 Urine Reagent ID: 021 Specific test parameters Urine 1 Max OD H -0. OSR6221 Reagent ID: 021 Application GLUCOSE. To work in mg/dL multiply by 18. vol Dil. Metabolite .1 Dynamic range L 0* Correlation factor % ∇ 44. # # ∇ 5. OD L Reagent OD limit Fst.1 0* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. H 44. ∇ ∇ ∇ Sec. No.GLUCOSE. # # ∇ 3. point MB type factor Calibrator stability period 30 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Urine Calibrator Cat. BSOSR6x21. AU600 Urine Application System Reagent: OSR6121. No. # # ∇ 6. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. OD H 0. L -0.: ODC0025 * Values set for working in SI units (mmol/L). # # ∇ 4.1 -0.5 Wave Method Reaction Point 1 Point 2 Main 340 Sub 380 END + 27 10 ∇ ∇ ∇ Fst.: ODC0025 * Values set for working in SI units (mmol/L). To work in mg/dL multiply by 18. No.5 ∇ Operation: Yes ∇ Test No # Test name GLUC ∇ Sample type Uri ∇ Page 1/2 System Reagent: OSR6121. # # ∇ 2. vol 0 150 25 µL µL µL Max. 380 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. OSR6221 Specific Test Parameters General LIH ISE Range Test Name: GLUC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 50 25 µL µL µL Dilution Dilution Dilution 0 150 25 µL µL µL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name GLUC ∇ Sample type Uri ∇ On-board stability period 340 END + First 0 First 0 Pri. vol Dil.44* Fst Fst 0 0 Lst Lst First H Last H 0.44* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Urine # # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L # Age Y Y Y Y Y Y Level H # Test Name: GLUC ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 0. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # URINE APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name GLUC ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 20* # Conc Factor/OD-H 36* ∇ Calibration Specific General ISE Urine # Factor/OD-H 36* Process: CONC ∇ ∇ Test Name: Counts: GLUC ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibrations: # ∇ Cal.1 Lst. # # ∇ 7. Reagent 1 vol Reagent 2 vol 2 50 25 Dil. ∇ ∇ ∇ 0* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0* 1 1 30 Day µL High B B 0 44. To work in mg/dL multiply by 18. No. # # ∇ 4. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point ∇ with Conc-0 Lot Calibration ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined.OD Reagent OD Limit First Low Last Low 0 µL OD Limit ∇ Type: Urine < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6121. OSR6521 Reagent ID: 021 Application Operation Yes ∇ GLUCOSE.5 1. # # ∇ 2.: ODC0025 Values set for working in SI units (mmol/L).GLUCOSE.1 High High 0.2 1 30 µL ∇ µL Range ∇ Operation: Yes ∇ Test Name: GLUC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 0 44. # # ∇ 5. # # ∇ 3.5 Dilution 90 µL Min. # # # # ∇ 2.1 -0. 660 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Urine LIH GLUC ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # GLUC ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Not within expected values mmol/L* Decimal Places Calibration Specific ISE GLUC ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ # ∇ Calibration Specific General ISE Type Urine Counts: Factor/OD-H 27* # Process: CONC ∇ ∇ Test Name: GLUC ∇ < > Use Serum Cal. # # ∇ 7. # # # # ∇ 3.5 0.1 R2(R2-1) ф 660 Onboard Stability Period Last Last 27 10 15 µL Dilution 15 Name Sec. AU680/AU480 Urine Application System Reagent: OSR6121. Point: with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration <Point Cal. # # # # ∇ 6. OSR6521 Specific Test Parameters General LIH ISE Urine 1 Max OD H -0. None Selected 8. # # # # ∇ 4. OSR6221. AU680 30 30 Day Day 0 0 Hour Hour Metabolite BSOSR6x21. Volume R1(R1-1) 1.2 30 15 µL µL µL Dilution Dilution Dilution 0 90 15 µL µL µL Pri.OD -0. # # # # ∇ 5. No. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ 340 END + First 0 First 0 Sec. # OD CONC † Factor/OD-L 15* ∇ Factor Range Low High 15* 27* Slope Check Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. AU2700/AU5400 Urine Reagent ID: 021 Parameters General LIH GLUC Dilution Max. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # URINE APPLICATION Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1.1 -0. # # ∇ 6.44* 0 0 Hour Sample Volume Pre-Dilution Rate Rgt. For No. Urine Calibrator Cat. OSR6221. No demographics 8.44* 0.5 0. # # # # ∇ 7.02 2010-06 . Vol Dil. To work in mg/dL multiply by 18.1 Lst. H Sample vol. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name GLUCP ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 21* # Conc Factor/OD-H 35* ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Serum # Factor/OD-H 35* Process: CONC ∇ ∇ Test Name: Counts: GLUCP ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ Cal.02 2010-06 # User defined † System Calibrator Cat.1 -0. Vol Dil.6* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. H 45. # # ∇ 6. To work in mg/dL multiply by 18. Reagent 1 vol Reagent 2 vol 2 50 25 Dil.: 66300 * Values set for working in SI units (mmol/L). Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. L -0. # # ∇ 5.0* Fst Fst 0 0 Lst Lst First H Last H 0. No.1 0.0* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L # Age Y Y Y Y Y Y Level H # Test Name: GLUCP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 ∇ Operation: Yes ∇ Test No # Test name GLUCP ∇ Sample type Ser ∇ Page ½ System Reagent: OSR6121. None Selected 8. # # ∇ 2. ∇ ∇ ∇ Sec. H Lst. AU600 Paediatric Application System Reagent: OSR6121.GLUCOSE.: 66300 * Values set for working in SI units (mmol/L). # # ∇ 4. No. No. # # ∇ 3. # # ∇ 7. Vol 10 150 15 µL µL µL Max. BSOSR6x21. OD L Reagent OD limit Fst.1 Dynamic range L 0.5 0. OSR6221 Specific Test Parameters General LIH ISE Range Test Name: GLUCP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 50 25 µL µL µL Dilution Dilution Dilution 10 150 15 µL µL µL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. AU400/AU640 Paediatric Reagent ID: 021 Specific test parameters Serum 1 Max OD H -0. 380 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. Metabolite .5 0. # OD CONC † Factor/OD-L 21* 1-Point Cal. L -0. Point MB type factor Calibrator stability period 30 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name GLUCP ∇ Sample type Ser ∇ On-board stability period 340 END + First 0 First 0 Pri.5 Wave Method Reaction Point 1 Point 2 Main 340 Sub 380 END + 27 10 ∇ ∇ ∇ Fst. OD H 0. OSR6221 Reagent ID: 021 Application GLUCOSE.6* Correlation factor % ∇ 45. # # # # ∇ 7. No. 660 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ ++++ ∇ ++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum LIH GLUCP ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # GLUCP ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # OD CONC † Factor/OD-L 18* ∇ Factor Range Low High 18* 27* Slope Check Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal.6 40 20 0.OD Reagent OD Limit First Low Last Low 10 µL OD Limit ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6121. Point: with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration <Point Cal. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1.6 1 40 µL ∇ µL Range ∇ Operation: Yes ∇ Test Name: GLUCP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 Last Last 27 10 1. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ 340 END + First 0 First 0 Sec. OSR6221. # # # # ∇ 3.5 Dilution 120 µL Min. # # ∇ 6.5 0. No demographics 8. ∇ ∇ ∇ 0.6* 1 1 µL High B B 0 45. None Selected 8. # # ∇ 3.5 45.0* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis µL µL µL Dilution Dilution Dilution 10 120 10 µL µL µL Pri. System Calibrator Cat. OSR6521 Specific Test Parameters General LIH ISE Serum 1 Max OD H -0. AU2700/AU5400 Paediatric Reagent ID: 021 Parameters General LIH GLUCP Dilution Max. # # ∇ 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point ∇ with Conc-0 Lot Calibration ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined.0* 0 0 Hour Sample Volume Pre-Dilution Rate Rgt. Not within expected values mmol/L* Decimal Places Calibration Specific ISE GLUCP ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ # ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum Counts: Factor/OD-H 27* # Process: CONC ∇ ∇ Test Name: GLUCP ∇ < > Use Serum Cal.: 66300 Values set for working in SI units (mmol/L). Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.GLUCOSE.OD -0.6* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. OSR6221.1 -0.1 High High 0. AU680 30 30 Day Day 0 0 Hour Hour Metabolite BSOSR6x21.1 -0. # # # # ∇ 2.1 R2(R2-1) ф 660 20 µL Dilution 10 Name Sec. For No.02 2010-06 . To work in mg/dL multiply by 18. # # # # ∇ 6. Volume R1(R1-1) 1. # # ∇ 7. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. # # ∇ 5. OSR6521 Reagent ID: 021 Application Operation Yes ∇ GLUCOSE. # # # # ∇ 5. AU680/AU480 Paediatric Application System Reagent: OSR6121.5 0. # # ∇ 4. No. # # # # ∇ 4. # OD CONC † Factor/OD-L 21* 1-Point Cal. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name GLUC ∇ Sample type Others ∇ On-board stability period 340 END + First 0 First 0 Pri. point MB type factor Calibrator stability period 30 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat.: 66300 * Values set for working in SI units (mmol/L). None Selected 8. L -0. # # ∇ 4. 380 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min.6* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil.1 Lst. # # ∇ 3. Reagent 1 vol Reagent 2 vol 2 50 25 Dil. H 45. OD H 0. OD L Reagent OD limit Fst. AU600 CSF Application System Reagent: OSR6121. OSR6221 Reagent ID: 021 Application GLUCOSE.5 0. No. # # ∇ 2.1 Dynamic range L 0. Metabolite .5 ∇ Operation: Yes ∇ Test No # Test name GLUC ∇ Sample type Others ∇ Page 1/2 System Reagent: OSR6121. AU400/AU640 CSF Reagent ID: 021 Specific test parameters Others 1 Max OD H -0.0* Fst Fst 0 0 Lst Lst First H Last H 0.GLUCOSE. H Lst.0* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Others # # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L # Age Y Y Y Y Y Y Level H # Test Name: GLUC ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. vol 0 150 25 µL µL µL Max. # # ∇ 7. # # ∇ 6. ∇ ∇ ∇ Sec.: 66300 * Values set for working in SI units (mmol/L). OSR6221 Specific Test Parameters General LIH ISE Range Test Name: GLUC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 50 25 µL µL µL Dilution Dilution Dilution 0 150 25 µL µL µL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. No. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.6* Correlation factor % ∇ 45. BSOSR6x21. vol Dil.1 0. vol Dil.5 Wave Method Reaction Point 1 Point 2 Main 340 Sub 380 END + 27 10 ∇ ∇ ∇ Fst. No. H Sample vol. To work in mg/dL multiply by 18. L -0.02 2010-06 # User defined † System Calibrator Cat.5 0. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H CSF APPLICATION Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name GLUC ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 21* # Conc Factor/OD-H 35* ∇ Calibration Specific General ISE Others # Factor/OD-H 35* Process: CONC ∇ ∇ Test Name: Counts: GLUC ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ Cal.1 -0. To work in mg/dL multiply by 18. # # ∇ 5. OSR6221. # # ∇ 3. AU2700/AU5400 CSF Reagent ID: 021 Parameters General LIH GLUC Dilution Max. ∇ ∇ ∇ 0.02 2010-06 . No.1 -0. Volume R1(R1-1) 1.5 0. OSR6521 Specific Test Parameters General LIH ISE Others 1 Max OD H -0. OSR6521 Reagent ID: 021 Application Operation Yes ∇ GLUCOSE.6* 1 1 30 Day µL High B B 0 45.GLUCOSE. No demographics 8. # # ∇ 4.0* 0. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal.0* 0 0 Hour Sample Volume Pre-Dilution Rate Rgt. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # CSF APPLICATION Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1.5 Dilution 120 µL Min. # OD CONC † Factor/OD-L 18* ∇ Factor Range Low High 18* 27* Slope Check Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. AU680 30 30 Day Day 0 0 Hour Hour Metabolite BSOSR6x21. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ 340 END + First 0 First 0 Sec.OD Reagent OD Limit First Low Last Low 0 µL OD Limit ∇ Type: Others < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6121. # # # # ∇ 4. None Selected 8.OD -0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point ∇ with Conc-0 Lot Calibration ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined. To work in mg/dL multiply by 18.1 R2(R2-1) ф 660 Onboard Stability Period Last Last 27 10 20 µL Dilution 20 Name Sec.6* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. For No. # # # # ∇ 3. # # # # ∇ 5. # # ∇ 2. # # ∇ 6.1 -0. AU680/AU480 CSF Application System Reagent: OSR6121. OSR6221.5 0.: 66300 Values set for working in SI units (mmol/L). Point: With CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration <Point Cal.1 High High 0. # # # # ∇ 7.5 1. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. Not within expected values mmol/L* Decimal Places Calibration Specific ISE GLUC ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Others Counts: ∇ # ∇ Calibration Specific General ISE Type Others Counts: Factor/OD-H 27* # Process: CONC ∇ ∇ Test Name: GLUC ∇ < > Use Serum Cal. No.6 40 20 µL µL µL Dilution Dilution Dilution 0 120 20 µL µL µL Pri. # # ∇ 5. # # # # ∇ 2.6 1 40 µL ∇ µL Range ∇ Operation: Yes ∇ Test Name: GLUC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 0 45. # # # # ∇ 6. System Calibrator Cat. # # ∇ 7. 660 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Others LIH GLUC ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # GLUC ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Others ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. H Sample vol.0* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Others # # # # # # # Age Y Y Y Y Y Y ∇ Range Test Name: GLUC ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.0* Fst Fst 0 0 Lst Lst First H Last H 0.1 -0. H 45. # # ∇ 7. L -0.6* B 30 Linearity Fst No lag time Select using Space key. L -0. ∇ ∇ ∇ Sec. OD H 0. No. Pretreat all samples: 20µL + 1000µL Haemolysing Reagent # † * ‡ User defined System Calibrator Cat. OSR6221 Reagent ID: 021 Application GLUCOSE. # # ∇ 6. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Age Y Y Y Y Y Y L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name GLUC ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 140* # Conc Factor/OD-H 184* ∇ Calibration Specific General ISE Others # Factor/OD-H 184* Process: CONC ∇ ∇ HAEMOLYSATE APPLICATION Test Name: Counts: GLUC ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ Cal.1 Dynamic range L 0. Values set for working in SI units (mmol/L). AU600 Haemolysate Application System Reagent: OSR6121. # OD CONC † Factor/OD-L 140* 1-Point Cal. # # ∇ 4.5 Wave Method Reaction Point 1 Point 2 Main 340 Sub 380 END + 27 10 ∇ ∇ ∇ Fst. point MB type factor Calibrator stability period # † * ‡ 30 Select the function using the Function key or the Mouse User defined ¤ Analyser default value System Calibrator Cat.5 0.: 66300 Values set for working in SI units (mmol/L). Point: With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. To work in mg/dL multiply by 18.5 0. # # ∇ 3. vol 0 150 25 µL µL µL Max.: 66300. 380 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. Pretreat all samples: 20µL + 1000µL Haemolysing Reagent Metabolite BSOSR6x21. No.02 2010-06 . # # ∇ 2. vol Dil. # # ∇ 5. OD L Reagent OD limit Fst. To work in mg/dL multiply by 18.1 0. Reagent 1 vol Reagent 2 vol 20 50 25 Dil. None Selected 8.6* Correlation factor % ∇ 45. H Lst. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name GLUC ∇ Sample type Others ∇ Level L # Page 2/2 Level H # % Sec % ∇ 0 Sample Pre-dil.GLUCOSE. AU400/AU640 Haemolysate Reagent ID: 021 Specific test parameters Others 1 Max OD H -0. No.1 Lst. OSR6221 Specific Test Parameters General LIH ISE Range Test Name: GLUC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 20 50 25 µL µL µL Dilution Dilution Dilution 0 150 25 µL µL µL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: On-board stability period 340 END + First 0 First 0 Pri.5 ∇ Operation: Yes ∇ Test No # Test name GLUC ∇ Sample type Others ∇ Page 1/2 System Reagent: OSR6121. vol Dil. Cal.1 -0.5 0. OSR6521 Specific Test Parameters General LIH ISE Range Others 1 Max OD H -0. Volume R1(R1-1) 16 1 40 Min.1 High High 0. For No. ‡ Pretreat all samples: 20µL + 1000µL Haemolysing Reagent ф AU680 ∂ Separate the Haemolysate application from other setting types(see IFU for further instruction) 30 30 Day Day 0 0 Hour Hour Metabolite BSOSR6x21. Not within expected values mmol/L* Decimal Places Calibration Specific ISE GLUC ∇ Test Name: < Month # # # # # # Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Others Counts: ∇ # ∇ HAEMOLYSATE APPLICATION Calibration Specific General ISE Type Others Counts: Factor/OD-H 184* # Process: CONC ∇ ∇ Test Name: GLUC ∇ < > Calibration Type: AB ∇ Formula: Y=AX+B ∇ Use Serum Cal. No.0* µL µL µL Dilution Dilution Dilution 0 120 20 µL µL µL Pri.6* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 340 END + First 0 First 0 Sec. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # Interval (RB/ACAL) Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration <Point Cal. # # # # ∇ 4. No demographics 8. # # ∇ 5. # OD CONC † Factor/OD-L 140* ∇ Factor Range Low High 140* 184* Slope Check Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal.1 R2(R2-1) Name Sec.5 0.GLUCOSE. * Values set for working in SI units (mmol/L).OD -0. # # ∇ 7. AU2700/AU5400 Haemolysate Reagent ID: 021 Parameters General LIH GLUC Dilution Max. † System Calibrator Cat.5 Dilution 120 µL 0 µL OD Limit ∇ Type: Others < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6121. # # ∇ 3.1 -0. # # # # ∇ 5. No. # # # # ∇ 6.: 66300.6* 1 1 30 Day 20 µL Dilution 20 µL High B B 0 45. 380 Onboard Stability Period Last Last 27 10 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. OSR6221. 380 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Others # ∇ Range Test Name: GLUC ∇ < > Type: Level L: # Level H: Specific Test Parameters Calculated Test Type: High # Others ∇ Range Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Parameters General LIH GLUC ∇ < > ISE HbA1c Test Name: Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ 16 40 20 0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. OSR6221. # # ∇ 2. To work in mg/dL multiply by 18. OSR6521 Reagent ID: 021 Application∂ GLUCOSE. None Selected 8.OD Reagent OD Limit First Low Last Low µL ∇ µL Test Name: GLUC ∇ Operation: Yes < > Type: ∇ ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 0 Common Rgt. # # # # ∇ 2.0* 0 0 Hour Sample Volume Pre-Dilution Rate Rgt. # # ∇ 4.02 2010-06 . # # # # ∇ 7. # # # # ∇ 3. AU680/AU480 Haemolysate Operation Yes ∇ Application∂ System Reagent: OSR6121. ∇ ∇ ∇ 0. # # ∇ 6. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point ∇ with Conc-0 Lot Calibration ∇ # ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined.5 45. A fall in blood glucose to a critical level (approximately 2. blood sugar levels are regulated by the liver.01 BLOSR6x40. The calibrator glucose value provided in the calibrator package insert is traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 965. monitoring of therapy in diabetes mellitus. alcohol ingestion. Glucose-6-phosphate dehydrogenase (G6P-DH) specifically oxidises glucose-6-phosphate to + gluconate-6-phosphate with the concurrent reduction of NAD to NADH. lack of coordination and mental confusion. up to the stated expiry date when stored at 2…8°C.59 kU/L ≥1. EN. No. Blood glucose concentrations show intra-individual fluctuations.5 mM) leads to dysfunction of the central nervous system. These fluctuations are increased further where there is dysregulation.6) ATP + NAD 2+ Mg Hexokinase G6P-DH Preservative 24. To avoid the possible build-up of azide compounds. Hyperglycaemia most commonly occurs as a result of a deficiency in either the amount or efficiency of insulin.0 mmol/L ≥2. The increase in absorbance at 340nm is proportional to the glucose concentration in the sample. Reagent Preparation Slowly add the contents of the bottle labelled R1-2 to the bottle labelled R1. Dispose of all waste material in accordance with local guidelines. Quality Control Controls Cat. Blood glucose measurement is used as a screening test for diabetes mellitus. insulin antibodies. which ensures that levels are maintained within precise limits. such as occurs in a number of pathological conditions in which blood glucose may be elevated (hyperglycaemia) or depressed (hypoglycaemia).01 2009-08 Metabolite . Specimens that cannot be rapidly separated should be collected into tubes containing fluoride. Hypoglycaemia is associated with a range of pathological conditions including neonatal respiratory distress syndrome. Further decrease in blood glucose levels leads to hypoglycaemic coma. No. or when the following occur: Change in reagent lot or significant shift in control values.GLUCOSE . Storage and Stability The reagents are stable. septicaemia and chronic renal failure. This disease is characterised by the elevation of blood glucose to such an extent that the renal threshold is exceeded and sugar appears in the urine (glycosuria).58 kU/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. Major preventative maintenance was performed on the analyser or a critical part was replaced. a condition known as diabetes mellitus.5 mL R1 R1-2 Summary1. For in vitro diagnostic use only. monoiodoacetate or mannose. evaluation of carbohydrate metabolism. which are dependent on muscular activity and the time interval since food intake. reagents stored on board the instrument are stable for 30 days. and is characterised by muscle weakness.32 mmol/L 2.37 mmol/L ≥0. Test Principle3 Glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6phosphate and adenosine diphosphate (ADP).0 mmol/L ≥1. Calibration System Calibrator Cat. 4 x 25 mL 4 x 12. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. Specimen Serum. 66300. Once prepared.5 Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. This manifests as hypoglycaemia. which occurs during ingestion of carbohydrates. Recalibrate the assay every 30 days. Reaction principle Glucose + ATP Glucose-6-Phosphate + NAD + HK+ Mg 2+ Glucose-6-phosphate + ADP Gluconate-6-P + NADH + H + G6P-DH Contents. where there is suspected hyperglycaemia. nonpancreatic neoplasms. 4. toxaemia of pregnancy.2 In the fasting state. Glucose in stabilised haemolysate and plasma is stable for up to 7 days when stored at 2…8°C and 2 days when stored at 15…25°C. Reagent Composition in the Test Final concentration of reactive ingredients: PIPES buffer (pH 7. for example in gestational diabetes acute hepatitis. flush waste-pipes with water after the disposal of undiluted reagent. insulin-producing pancreatic tumours (insulinomas). congenital enzyme defects. acute pancreatitis and Addison’s disease. Lipemic and strongly icteric samples should be avoided. EDTA or heparinised plasma : To minimise loss of glucose through glycolysis serum should be removed from red cells as soon as possible.STAT OSR6140 Intended Use Enzymatic UV test (hexokinase method) for the quantitative determination of glucose in human serum and plasma on Beckman Coulter analysers. Mix gently by inversion and place on-board the instrument. Reye’s syndrome. unopened. hepatic dysfunction. The rapid and precise manner in which fasting blood sugar levels are regulated is in marked contrast to the rapid increase in blood sugar. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. 7. Philadelphia:WB Saunders Company. Heil W. Clinical laboratory diagnostics. Goldstein DE. Tietz textbook of clinical chemistry.05 mmol/L. Clin Chem 2002. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Use and assessment of clinical laboratory results. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. (b) fasting plasma glucose (FPG) ≥ 7.40:585-589. Pesce AJ. Klin Wschr 1962. Diabetes mellitus.90 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 0. n = 60 Mean mmol/L 3. Parrott M.07 CV% 0. and correlation. AACC Press. For diagnostic purposes. eds. Ashwood ER.06 1. liquor und harn. Refer to Young for further information on interfering substances. To work in mg/dL multiply by 18.01 2009-08 EN.02 0.1815pp. Expected values may vary with age. Blood glucose. analysis.30 16. Enzymatische Bestimmungen der glucose in blut. Tietz textbook of clinical chemistry.03 0. 1996:635pp. Young DS. unless there is unequivocal hyperglycaemia with acute metabolic decompensation. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.74 0.0 mmol/L (10 – 800 mg/dL). Effects of drugs on clinical laboratory tests. If any one of these criteria is met.13 Within Run SD 0. Calculation The Beckman Coulter analysers automatically compute the glucose concentration of each sample. Töpfer G. McDonald JM.40 6. Schmitt Y. may cause unreliable results. results must be confirmed by repeat testing on a subsequent day. Ashwood ER. and if necessary determine its own reference interval according to good laboratory practice. ed.: 66300 Values set for working in SI units (mmol/L). results should always be assessed in conjunction with the patient's medical history.55 0.01 . In: Burtis CA. Linearity The test is linear within a concentration range of 0.06 0.48:436-72.1 – 5.1 Rev. Reference information for the clinical laboratory. In: Kaplan LA. especially monoclonal IgM (Waldenström’s macroglobulinemia). 4. Data obtained in your laboratory may differ from these values. 6. Reference Intervals6 Serum/Plasma (fasting) Adults Children 4. 5. sex.3 – 5. review all operating parameters.Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Sacks DB.14 Total CV% 1. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Painter PC. Cope JY. 2.999x + 0. If any trends or sudden shifts in values are detected. The lowest detectable level represents the lowest measurable level of glucose that can be distinguished from zero. Barthelmai W.1 mmol/L during an oral glucose tolerance test (OGTT).04 0. Czok R.04 0. plasma and serum samples.3 mmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Ascorbate : Interference less than 3% up to 20 mg/dL ascorbate Icterus: Interference less than 10% up to 12 mg/dL or 205. Method Comparison Patient serum samples were used to compare this Glucose OSR6140 assay on the AU600 against another commercially available glucose assay. Smith JL. 8 Setting Sheet Footnotes # † * 1. User defined ¤ Analyser default value System Calibrator Cat. 3. 1999. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. 5th ed. eds.997 n = 119 Sample range = 0 – 43. 1998:131-37.6 – 45. In:Thomas L. Results of linear regression analysis were as follows: y = 0. 1999. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. sample type. Wisser H. Philadelphia:WB Saunders Company. Clinical chemistry theory. The results obtained by any individual laboratory may vary from the given mean value. BIBLIOGRAPHY Metabolite BLOSR6x40. Sacks DB. Zawta B. Ehret W. Dods RF. In: Burtis CA.6 mmol/L (60 – 100 mg/dL) 7 The generally accepted cut-off levels for the diagnosis of diabetes are : a) random plasma glucose of ≥ 11. 2000. Thomas L. Each laboratory should verify the transferability of the expected values to its own population.2 µmol/L bilirubin Haemolysis: Interference less than 10% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 65 mg/dL Intralipid In very rare cases gammopathy. clinical examinations and other findings. et al.9 mmol/L (74 – 106 mg/dL) 3. Carbohydrates. St Louis: Mosby.1 mmol/L. MacLaren NK. Bruns DE. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. eds. Frankfurt/Main: TH-Books Verlagsgesellschaft.766-85. 8.2:32pp. WHO/DIL/LAB/99. No.019 r = 0.46 SD 0.0 mmol/L or (c) 2-h postload glucose ≥ 11. diet and geographical location. OD L Reagent OD limit Fst. To work in mg/dL multiply by 18. H 45.6* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. H -0. ∇ ∇ ∇ Sec. # OD CONC † Factor/OD-L 21* 1-Point Cal. # # ο ∇ 5.0* Fst Fst 0 Lst Lst First H Last H 0. BSOSR6x40.: 66300 * Values set for working in SI units (mmol/L).5 0. AU400/AU640 Serum/Plasma Reagent ID: 040 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 340 Sub Fst. # # ο ∇ 3. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name GLU-S Sample type Ser ∇ On-board stability period 340 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. H Lst.6* Correlation factor % ∇ 45.1 0. OD H 0. L -0. No. No.5 ∇ Operation: Yes Test No ∇ ∇ # Test name GLU-S Sample type Ser Page 1/2 System Reagent: OSR6140 Reagent ID: 040 Application GLUCOSE STAT.1 -0.1 Dynamic range L 0. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name GLU-S ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 21* # Conc Factor/OD-H 35* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 35* # SERUM/PLASMA APPLICATION Test Name: Counts: GLU-S ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ Cal. Reagent 1 vol Reagent 2 vol μL μL μL 2 75 0 Dil. # # ο ∇ 2. 380 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.5 0. # # ο ∇ 7. No. vol Dil.0* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: GLU-S ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 6.01 2009-08 # User defined † System Calibrator Cat. L -0. To work in mg/dL multiply by 18. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ο ∇ 4.1 Lst.5 380 END + 10 Sample vol. None Selected 8.GLUCOSE STAT. vol 0 175 0 Max. Metabolite . point MB type factor Calibrator stability period 30 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat. vol Dil. AU600 Serum/Plasma Application System Reagent: OSR6140 Specific Test Parameters General LIH ISE Range Test Name: GLU-S ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 75 0 μL μL μL Dilution Dilution Dilution 0 175 0 μL μL μL Pri.: 66300 * Values set for working in SI units (mmol/L). No demographics 8. ∇ # # # # ο 5. 380 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. To work in mg/dL multiply by 18. AU680 <Point Cal. # # ο ∇ 3. ∇ 7.01 2009-08 . System Calibrator Cat.GLUCOSE STAT.6* 1 1 μL High B B 0 45. # # ο ∇ 7. 380 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.0* 0 0 Hour 0 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 30 Day 0 Calibration 30 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined.6 1 60 Range Operation: ∇ Yes Test Name: GLU-S ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 Last Last 10 % ∇ 1. Volume R1(R1-1) μL ∇ μL 1.0* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 140 0 μL μL μL Pri.1 -0.1 -0.5 μL Min. No. No. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm END ∇ + ∇ 0 340 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ + ∇ ++ ∇ ++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH GLU-S ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # GLU-S ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 4.6 60 0 0. Not within expected values mmol/L* Decimal Places Calibration Specific ISE GLU-S ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 24* 37* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 37* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: GLU-S ∇ < > Test Name: Use Serum Cal. # # ο ∇ 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x40. # OD CONC † Factor/OD-L 24* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal.OD Reagent OD Limit First Low Last Low Dilution 140 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6140 Reagent ID: 040 Application Operation Yes GLUCOSE STAT.5 45. # # ο ∇ 4. None Selected 8.5 0. AU2700/AU5400 Serum/Plasma Reagent ID: 040 Parameters General LIH GLU-S ∇ Dilution μL Max.OD -0. ∇ # # # # ο 6. # # ο ∇ 6.5 0. ∇ ∇ ∇ 0.1 R2(R2-1) μL Name Sec.: 66300 Values set for working in SI units (mmol/L).1 High High 0. ∇ # # # # ο 2. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. For No. # # ο ∇ 5. AU680/AU480 Serum/Plasma Application System Reagent: OSR6140 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0.6* Sec. ∇ # # # # ο 3. EN. Specimen Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. The results obtained by any individual laboratory may vary from the given mean value. Measurement of HDL-cholesterol is used in the early recognition of atherosclerosis risk. Once open. unopened. The antigen-antibody complexes formed block enzyme reactions when R2 is added. Determination of HDL-cholesterol is therefore essential for the interpretation of individual cholesterol determinations.67 mmol/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. protected from light. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.lipoprotein antibody CHE and CHO POD Antigen–Antibody complexes Cholest-4-en-3-one + Fatty acids + H2O2 Blue dye + F + 2H2O + - Contents.7 lU/mL 2. Test Principle Anti human-β-lipoprotein antibody in R1 binds to lipoproteins other than HDL (LDL.01 2009-08 Metabolite . Major preventative maintenance was performed on the analyser or a critical part was replaced.1 mL 4 x 107 mL 4 x 40 mL R1 R2 R1 R2 R1 R2 Summary1 Approximately 25% of total serum cholesterol is transported in the HDL fraction.20 mmol/L 0. up to the stated expiry date when stored at 2…8°C. Storage and Stability The reagents are stable. Quality Control HDL/LDL-Cholesterol Control Serum ODC0005 or other control materials with values determined by this method may be used. Reaction Principle LDL.3.5– dimethoxy – 4 fluoroaniline (F–DAOS) 4-Aminoantipyrine Preservative Detergent Variable 0.01 BLOSR6x87. VLDL and chylomicrons). Numerous clinical and epidemiological studies have demonstrated a strong inverse association between HDL-cholesterol and the incidence of coronary heart disease. 4 x 27 mL 4 x 9 mL 4 x 51. Serum and heparinised plasma (fasting and non-fasting): Stable for 7 days when stored at 2…8°C and 2 days when stored at 15…25°C. HDL-Cholesterol reagent OSR6587 for use on the AU2700 and AU5400 systems only.(2-hydroxy-3-sulfopropyl) . HDL-cholesterol is quantified by the presence of an enzyme chromogen system. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Low HDL-cholesterol is a risk factor independent of total cholesterol concentration and is highly predictive of the risk of coronary heart disease. The colour of R2 may turn to light green when stored on board the analyser. The calibrator is traceable to the US CDC (Centre for Disease Control) HDL-cholesterol reference method. 2 Calibration HDL-Cholesterol Calibrator ODC0011. reagents stored on board the instrument are stable for 30 days.HDL-CHOLESTEROL OSR6187 OSR6287 OSR6587 Intended Use Enzymatic colour test for the quantitative determination of HDL-cholesterol in human serum and plasma on Beckman Coulter analysers.0 lU/mL 30 mmol/L 0. This does not affect the performance of the reagent.β .4 lU/mL 1. Reagent Composition in the Test Final concentration of reactive ingredients: Anti human-β-lipoprotein antibody Cholesterol esterase (CHE) Cholesterol oxidase (CHO) Peroxidase (POD) Ascorbate oxidase Good’s buffer (pH 7. It has been proposed that the uptake and transport of cholesterol from peripheral tissue to the liver acts as a protective factor against the development of atherosclerotic plaques. Recalibrate the assay every 30 days and perform reagent blank every 7 days. and may also be used in the monitoring of individuals during treatment with lipid lowering drugs. or when the following occur: Change in reagent bottle or significant shift in control values. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument.3 mL 4 x 17. For in vitro diagnostic use only.0) N-Ethyl – N . Dispose of all waste material in accordance with local guidelines.VLDL and chylomicrons HDL-cholesterol + H2O + O2 H2O2 + 4 – AA + F–DAOS Anti human .8 lU/mL 4. Ehret W.993 n = 200 Sample range = 0. The lowest detectable level represents the lowest measurable level of HDL-cholesterol that can be distinguished from zero.62 0. No. n = 60 Within Run Total Mean mmol/L SD CV% SD 0.3 mmol/L (1000 mg/dL). review all operating parameters. Heil W. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. Clinical laboratory diagnostics. Results of linear regression analysis were as follows: y = 1. evaluation.080 r = 0. th 4. clinical examinations and other findings.4. Calculation The Beckman Coulter analysers automatically compute the HDL-cholesterol concentration of each sample.018 2. repeat assay and multiply result by dilution factor. 4 Limitations When triglyceride in a sample exceeds 11. In: Thomas L. Effects of drugs on clinical laboratory tests.31 – 2.03 mmol/L (< 40 mg/dL) ≥ 1. Metabolite BLOSR6x87.013 1. 5 ed. To work in mg/dL multiply by 38. et al. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 10 days. WHO/DIL/LAB/99. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection.027 CV% 1.007 0. Use and assessment of clinical laboratory results.61 0.006 0.92 1. Data obtained in your laboratory may differ from these values. and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001.32 Sensitivity The lowest detectable level on an AU640 analyser was calculated as 0.08 0. Setting Sheet Footnotes # † * ‡ User defined ¤ Analyser default value HDL Cholesterol Calibrator Cat. 3. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. however there is poor correlation between lipemia and triglyceride concentration – see limitations section.285:2486-2497. sex. Riesen WF. National Cholesterol Education Program (NCEP) guidelines3 < 1. and if necessary determine its own reference interval according to good laboratory practice. ed.55 mmol/L (≥ 60 mg/dL) Low HDL-cholesterol (major risk factor for coronary heart disease) High HDL-cholesterol (“negative” risk factor for coronary heart disease) Expected values may vary with age.85 0.: ODC0011 Values set for working in SI units (mmol/L). results should always be assessed in conjunction with the patient's medical history. 1998:171-173.013 0. 2.212x + 0.69 0. Lipid metabolism. Töpfer G.05 .7. plasma and serum samples. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.54 mmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Ascorbate: Interference less than 3% up to 20 mg/dL ascorbate Bilirubin: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 900 mg/dL *Intralipid * No significant interference was observed from samples containing native triglycerides up to 11. dilute the sample with a saline solution.1 Rev. Each laboratory should verify the transferability of the expected values to its own population.3 mmol/L (1000 mg/dL).002 mmol/L.69 1. Linearity The test is linear within a concentration range of 0. National cholesterol education program expert panel. 2000.If any trends or sudden shifts in values are detected. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. AACC Press.65 mmol/L (2 -180 mg/dL).01 . For diagnostic purposes. Young DS. Perform reagent blank every 7 days BIBLIOGRAPHY 1. Schmitt Y. Zawta B. Wisser H. Refer to Young for further information on interfering substances.2:26pp. sample type.01 2009-08 EN. Frankfurt/Main: TH-Books Verlagsgesellschaft. diet and geographical location. Method Comparison Patient serum samples were used to compare this HDL-Cholesterol OSR6187 assay on the AU640 against another commercially available HDL-cholesterol assay.09 0. OSR6287 Specific Test Parameters General LIH ISE Range Test Name: HDL-c ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil. To work in mg/dL multiply by 38.05* H 4. AU400/AU640 Serum/Plasma Reagent ID: 087 Specific test parameters Test No Serum ∇ Sample vol. # # ο ∇ 3.1 Last L -0. # # ο ∇ 4.05* Correlation factor H A B Rate Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. # # ο ∇ 5.7 Perform reagent blank every 7 days # † * ‡ User defined HDL Cholesterol Calibrator Cat.: ODC0011 Values set for working in SI units (mmol/L). No. Reagent 1 vol Reagent 2 vol μL μL μL Fst. H ∇ ∇ ∇ Main 600 Sub 2 180 60 Dil. # # ο ∇ 6. To work in mg/dL multiply by 38. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. 700 ∇ Min.65* Correlation Factor: A 1 B 0 On-board stability period: 30 4.65* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: HDL-c ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. point MB type factor Calibrator stability period 30‡ Select the function using the Function key or the Mouse # † * ‡ BSOSR6x87. OD H 0. No. H Lst. OD L Reagent OD limit Fst.1 Lst.01 2009-08 User defined ¤ Analyser default value HDL Cholesterol Calibrator Cat.1 First H 0.7 Perform reagent blank every 7 days Metabolite .1 Dynamic Range: L 0. AU600 Serum/Plasma Application System Reagent: OSR6187. vol Dil. L -0. None Selected 8. # # ο ∇ 2.5 Dynamic range L 0. No. # # ο ∇ 7.1 ∇ Operation: Yes ∇ ∇ # Test name HDL-c Sample type Ser Page 1/2 System Reagent: OSR6187. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name HDL-c Sample type Ser ∇ 600 END + First 0 First 0 Pri. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name HDL-c ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 5* # Conc Factor/OD-H 8* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 8* # SERUM/PLASMA APPLICATION Test Name: Counts: HDL-c ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 30‡ Advanced Calibration: # ∇ Cal.1 0.: ODC0011 Values set for working in SI units (mmol/L).HDL CHOLESTEROL. vol 0 0 0 Max. ∇ ∇ ∇ Sec.5 Last H 0. OSR6287 Reagent ID: 087 Application HDL CHOLESTEROL. Linearity Fst No lag time % Sec 0 0 Lst Lst 700 END + 27 10 2 180 60 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key. vol Dil. L -0. # OD CONC † Factor/OD-L 5* 1-Point Cal. 1 0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # L mmol/L* H Month # # # # # # Panic Value Low # High # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. # OD CONC † Factor/OD-L 5* Counts: # ∇ ∇ Factor Range Low High Slope Check 5* 8* Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 30‡ Advanced Calibration: # ∇ None ∇ 1-Point Cal. OSR6287. # # ο ∇ 7.1 Dynamic Range: L 0.1 Last L -0.65* 0 0 30 Day # +++++ +++++ +++++ Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. ∇ # # # # ο 3. For No. # # ο ∇ 6.5 High High 0.1 -0. OSR6587 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt.65* Correlation Factor: A 1 B 0 On-board stability period: 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Test Name: HDL-C ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.05* H 4. ∇ # # # # ο 6. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. OSR6587 Reagent ID: 087 Application Operation Yes HDL CHOLESTEROL.: ODC0011 * Values set for working in SI units (mmol/L). No demographics 8.HDL CHOLESTEROL. Not within expected values mmol/L* Decimal Places Calibration Specific ISE HDL-C ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum ∇ ο Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 8* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: HDL-C ∇ < > Test Name: Use Serum Cal. 700 ∇ Last Last 27 10 4.01 2009-08 . of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x87. ∇ # # # # ο 5. AU680/AU480 Serum/Plasma Application System Reagent: OSR6187. # # ο ∇ 5.OD -0. AU2700/AU5400 Serum/Plasma Reagent ID: 087 Parameters General LIH HDL-C ∇ ∇ Dilution μL Max.6 144 48 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.05* 1 1 μL High B B 0 48 Dilution 0 1. # # ο ∇ 4. 700 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. # # ο ∇ 3. ‡ Perform reagent blank every 7 days ф AU680 <Point Cal. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 10 Onboard Stability Period LIH Influence Check: Lipemia Icterus Hemolysis Parameters General LIH HDL-C ∇ < > ISE HbA1c Test Name: Noneф 600 ∇nm END ∇ + ∇ 0 0 % ∇ ∇ ∇ ∇ Sec. Volume R1(R1-1) μL ∇ μL 1. ∇ 7.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit < > ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6187. OSR6287. To work in mg/dL multiply by 38.1 μL Min.5 Last H 0.6 1 144 Range Operation: ∇ Yes Test Name: HDL-C ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 7 Day 0 Calibration 30 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined † HDL Cholesterol Calibrator Cat.1 First H 0. 600 END + First 0 First 0 Common Rgt. ∇ # # # # ο 4. No. No. # # ο ∇ 2.7. None Selected 8. ∇ # # # # ο 2. hyperalimentation. S45. 8 7 Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.35 mmol/L 50 mmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: Irritant. S37. Recalibrate the assay every 30 days. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. Storage and Stability The reagents are stable. Reaction principle 7 H3PO4 + 12 (Mo7O24) + 72 H 6+ 7 H3PO4(MoO3)12 + 36 H2O Contents. seek medical advice immediately (show the label where possible). and redistribution of phosphate that occurs in tumour lysis. S60: In case of contact with eyes.g. low PTH or resistance to PTH and vitamin D toxicity. The use of a surfactant eliminates the need to prepare a protein free filtrate. Hypophosphataemia (phosphate depletion) is relatively common in hospitalised patients and is found in up to 30% of surgical patients. No. because it is a substrate for oxidative phosphorylation. Serum phosphate concentrations are dependent on diet and variation in the secretion of hormones such as PTH. Calibration Use System Calibrator Cat. malabsorption. increased excretion such as occurs in secondary PTH excess. plasma and urine on Beckman Coulter analysers. Once open. unopened.. or when the following occur: Change in reagent lot or significant shift in control values.3. Hyperphosphataemia is caused by increased intake such as occurs in intravenous therapy and phosphate enemas. No. Intracellularly phosphate occurs primarily as organic phosphate however a small but extremely important fraction exists as inorganic phosphate which. The inorganic phosphorous values of both calibrators are traceable to a Beckman Coulter Master Calibrator. post renal transplant and re-feeding starved patients. About 85% of extracellular phosphate occurs in the Pi form as hydroxyapatite thereby playing an important role in bone structure. and from redistribution of phosphate e. The absorbance at 340/380 nm is directly proportional to the inorganic phosphorous concentration in the sample. EN. approximately 15% bound to protein and the remainder in complexed and free forms.01 BLOSR6x22.4 In plasma and serum the majority of phosphate exists in the inorganic form (Pi). ODC0025 for urine application. Major preventative maintenance was performed on the analyser or a critical part was replaced. reagents stored on board the instrument are stable for 30 days. Specimen Serum and heparinised plasma: Stable in serum for 4 days when stored at 2…8°C and 1 day when stored at 15…25°C.6 Inorganic phosphorous reacts with molybdate to form a heteropolyacid complex. Refer to Safety Data Sheets for further information.8°C. up to the stated expiry date when stored at 2. Urine: Acidified with 6M HCl.2. 66300 for serum application and Urine Calibrator Cat. Wear suitable gloves. Strongly haemolysed samples should be avoided. 4 x 15 mL 4 x 15 mL 4 x 40 mL 4 x 40 mL R1 R2 R1 R2 Summary1. recovery from diabetic ketoacidosis and respitatory alkalosis.8°C. For in vitro diagnostic use only. Safety Phrases: S26. reduced excretion such as occurs in acute and chronic renal failure. Test Principle5. rinse immediately with plenty of water and seek medical advice. Reagent Composition in the Test Final concentration of reactive ingredients: Sulphuric acid Ammoniumheptamolybdate Glycine Preservative 200 mmol/L 0... In case of accident or if you feel unwell. use of oral phosphate binders and primary PTH excess. rhabdomyolysis and heat stroke. Hypophosphataemia is caused by a decreased intake or absorption of phosphate such as occurs in Vit D deficiency.INORGANIC PHOSPHOROUS OSR6122 OSR6222 Intended Use Photometric UV test for the quantitative determination of inorganic phosphorous in human serum. participates in reactions concerned with generation of metabolic energy. Dispose of all waste material in accordance with local guidelines. Store at 2. This material and its container must be disposed of as hazardous waste. R36/38 Irritating to eyes and skin.. Collect timed 24-hour specimen using standard laboratory procedures.01 2009-08 Metabolite . results should always be assessed in conjunction with the patient's medical history.32 – 6.81 – 1.26 mmol/L (4. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.51 87.61 0.63 0. No. The lowest detectable level using urine settings on an AU2700 analyser was estimated at 0. Results of linear regression analysis were as follows: y = 0. ODC0025 1:10 with purified H2O.04 The following data was obtained on an AU640 using 3 urine pools analysed over 20 days. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. User defined ¤ Analyser default value System Calibrator Cat.Quality Control Controls Cat.23 CV% 2.02 0.0 – 7.01 1. Linearity The test is linear within a concentration range of 0. 397 and 398 or other control materials with values determined by this Beckman Coulter system may be used for the urine application. For diagnostic purposes.07 mmol/L Interfering Substances Results of serum studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 3. The lowest detectable level represents the lowest measurable level of Inorganic phosphorous that can be distinguished from zero. Metabolite BLOSR6x22. n = 80 Within Run Total Mean mmol/L SD CV% SD 9. No. If any trends or sudden shifts in values are detected. To work in mg/dL multiply by 3.9 – 42.5 mg/dL) Children 1.36 0. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed.0 mg/dL) Urine On non-restricted diet 12. Calculation The Beckman Coulter analysers automatically compute the inorganic phosphorous concentration of each sample. No.64 0. 9 Setting Sheet Footnotes ‡ # † * Dilute samples and Urine Calibrator Cat. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.71 1.936x + 0.03 0.968x – 0.0 mmol/d (0.99 1. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used for the serum application.54 0.23 0.01 0.41 mmol/L Patient urine samples were used to compare this Inorganic phosphorous assay on the AU2700 against another commercially available inorganic phosphorous assay.13 1. Data obtained in your laboratory may differ from these values. sex.71 0.02 3. Each laboratory should verify the transferability of the expected values to its own population.10 mmol/L. may cause unreliable results. diet and geographical location. review all operating parameters.4 – 1.1.30 Sensitivity The lowest detectable level using serum settings on an AU600 analyser was estimated at 0. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. n = 60 Within Run Total Mean mmol/L SD CV% SD 0. The results obtained by any individual laboratory may vary from the given mean value. Reference Intervals2 Serum Adults 0.48 mmol/L.170 r = 0.55 1. Results of linear regression analysis were as follows: y = 0.96 0.01 2009-08 EN.29 – 2.41 0. Refer to Young for further information on interfering substances.55 1.42 – 53.44 – 6. especially monoclonal IgM (Waldenström’s macroglobulinemia). No.35 0. The test is linear within a concentration range of 0 – 113 mmol/L (0 – 350 mg/dL) for urine.5 – 4.000 n = 118 Sample range = 0.45 mmol/L (2. Method Comparison Patient serum samples were used to compare this Inorganic phosphorous assay on the AU600 against another commercially available inorganic phosphorous assay.01 1.01 .28 32.96 0. Biorad Liquichek Urine Chemistry Controls Cat.62 0.33 1. clinical examinations and other findings.: 66300/ Urine Calibrator Cat. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.3 g/day) Expected values may vary with age.5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 800 mg/dL Intralipid Results of urine studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin In very rare cases gammopathy.: ODC0025 Values set for working in SI units (mmol/L). No.14 CV% 1. and if necessary determine its own reference interval according to good laboratory practice.055 r = 1.999 n = 100 Sample range = 3.40 mmol/L (1 – 20 mg/dL) for serum. sample type. ed. Pennsylvania: NCCLS. Urinalysis and collection. 7. 9. Use and assessment of clinical laboratory results. transportation. Fraser D.BIBLIOGRAPHY 1. Phosphate. Walker SW. 6.1 Rev. AACC Press. In: Thomas L. Ashwood ER. Schmitt Y. 1999. 8. Töpfer G. WHO/DIL/LAB/99. Determination of serum-phosphate without deproteinization by ultraviolet spectrophotometry of the phosphomolybdic acid complex. Jones G. Clin Chem 1972. Scand J Clin Lab Invest 1980. Endres DB. Try K. 4. Effects of drugs on clinical laboratory tests. eds. NCCLS. EN. Clinical laboratory diagnostics. 1998:241-247. Ertingshausen G. Beckett GJ.2:39pp.01 BLOSR6x22. NCCLS Document GP16-A2. Kooh SW.01 2009-08 Metabolite . et al. 6th ed.Oxford: Blackwell Science. Wisser H. 2000. Radde IC. Philadelphia: WB Saunders Company. Philadelphia:WB Saunders Company. Rae PWH. Mineral and bone metabolism. In: Tietz NW.1998:75pp. Ehret W. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. plasma and serum samples. 5th ed. Thomas L. 3. eds. 2. Daly JA. Direct method for determining inorganic phosphate in serum with the “CentrifiChem”. Zawta B. Rude RK. approved guideline. 1987:706pp. Young DS. and preservation of urine specimens.1406-1441. Gamst O. Fundamentals of clinical chemistry. Calcium and phosphate metabolism. ed. Tietz textbook of clinical chemistry. Frankfurt/Main: TH-Books Verlagsgesellschaft.18(3):263-5. In: Burtis CA. 5. Heil W. Lecture notes on clinical biochemisty.40(5):483-6. 2nd ed. 2001. Smith AF. . Point MB type factor Calibrator stability period 30 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat.1 First H 0. To work in mg/dL multiply by 3. 380 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. OSR6222 Specific Test Parameters General LIH ISE Range Test Name: PHOS ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil.INORGANIC PHOSPHOROUS.32* H 6.5 ∇ Operation: Yes Test No ∇ ∇ # Test name PHOS Sample type Ser Page ½ System Reagent: OSR6122. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. No. H Lst. # # ο ∇ 4. # # ο ∇ 5. No.1 BSOSR6x22. # OD CONC † Factor/OD-L 8* 1-Point Cal.: 66300 * Values set for working in SI units (mmol/L). AU600 Serum/Plasma Application System Reagent: OSR6122. L -0.1 Lst. AU400/AU640 Serum/Plasma Reagent ID: 022 Specific test parameters Serum ∇ Sample vol. None Selected 8. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name PHOS ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 8* # Conc Factor/OD-H 13* ∇ SERUM/PLASMA APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 13* # Test Name: Counts: PHOS ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ Cal.1 Last L -0.: 66300 * Values set for working in SI units (mmol/L).32* Correlation factor 6. L -0.01 2009-08 # User defined † System Calibrator Cat. ∇ ∇ ∇ Sec.1 Dynamic range L 0. OD H 0. Reagent 1 vol Reagent 2 vol μL μL μL Fst. Vol 0 120 120 Max.1 0. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # L # Test name PHOS Sample type Ser ∇ Level L # % Sec 0 0 Lst Lst 380 END + 27 10 3 30 30 μL μL μL Dilution Dilution Dilution 0 120 120 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period 340 END + First 0 First 0 Pri. No. # # ο ∇ 3. # # ο ∇ 2.1 Last H 0. # # ο ∇ 7. H ∇ ∇ ∇ Main 340 Sub 3 30 30 Dil.5 Dynamic Range: L 0.40* Correlation Factor: A 1 B 0 On-board stability period: 30 H A B Rate Min. Vol Dil. OSR6222 Reagent ID: 022 Application INORGANIC PHOSPHOROUS.40* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # # # # # # # Age Y Y Y Y Y Y Range Page 2/2 Level H # Test Name: PHOS ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. OD L Reagent OD limit Fst. Linearity Fst No lag time Select using Space key. Vol Dil.1 Metabolite . To work in mg/dL multiply by 3. # # ο ∇ 6. OSR6222 Reagent ID: 022 Application Operation Yes INORGANIC PHOSPHOROUS. # # ο ∇ 3.1 -0.40* 0 0 Hour 25 Dilution 100 2. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. No demographics 8. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ 30 Day # ∇ +++++ ∇ +++++ ∇ ++++ ∇ 340 END + First 0 First 0 Pri. Not within expected values Decimal Places Calibration Specific Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration Type Serum Counts: ∇ Factor Range Low High 8* 13* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 13* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: PHOS ∇ < > Use Serum Cal.32* 1 1 μL High B B 0 6. # # ο ∇ 5. ∇ # # # # ο 5.INORGANIC PHOSPHOROUS. ∇ # # # # ο 3. ∇ ∇ ∇ Sec. # # ο ∇ 4. # # ο ∇ 7. None Selected 8.32* H 6.1 0.1 First H 0. # # ο ∇ 6.1 Last L -0.1 High High 0. For No. ∇ 7. ∇ # # # # ο 6.: 66300 Values set for working in SI units (mmol/L). Volume R1(R1-1) μL ∇ μL 2. No. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 30 Day 0 Calibration 30 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined System Calibrator Cat. # # ο ∇ 2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General ISE PHOS ∇ < > Y=AX+B Test Name: mmol/L* Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.5 Dynamic Range: L 0.5 1 25 Range Operation: ∇ Yes Test Name: PHOS ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec. OSR6222 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt. To work in mg/dL multiply by 3.1 AU680 <Point Cal. No. 380 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.OD -0.1 Last H 0. 380 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. ∇ # # # # ο 2.5 25 25 μL μL μL Dilution Dilution Dilution 0 100 100 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. # OD CONC † Factor/OD-L 8* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal.40* Correlation Factor: A 1 B 0 On-board stability period: 30 Specific Test Parameters General LIH ISE Serum ∇ LIH PHOS ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # PHOS ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.OD Reagent OD Limit First Low Last Low Dilution 100 0 OD Limit < > ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6122. AU2700/AU5400 Serum/Plasma Reagent ID: 022 Parameters General LIH PHOS ∇ ∇ Dilution μL Max.01 2009-08 . of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x22.5 μL Min. AU680/AU480 Serum/Plasma Application System Reagent: OSR6122. ∇ # # # # ο 4. 5 Wave Method Reaction Point 1 Point 2 ∇ ∇ ∇ Main 340 Sub 380 END + 27 10 Fst. OSR6222 Specific test parameters Urine ∇ 10 Max OD H -0.1 Lst. No. No. # # ο ∇ 6. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.1 # User defined † Urine Calibrator Cat.: ODC0025 * Values set for working in SI units (mmol/L). or select from list displayed by Guide key Sample type Uri ∇ Level L # Age Y Y Y Y Y Y H # # # # # # M→ M→ M→ M→ M→ M→ Page 2/2 Level H # Range Test Name: PHOS ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. AU400/AU640 Urine Reagent ID: 022 System Reagent: OSR6122. point MB type factor Calibrator stability period ‡ # † * BSOSR6x22.: ODC0025 Values set for working in SI units (mmol/L). # # ο ∇ 4.5 ∇ Operation: Yes Test No ∇ ∇ # Test name PHOS Sample type Uri Page 1/2 Reagent ID: 022 Application Manual Dilution Standard Mode Urine Application INORGANIC PHOSPHOROUS.1 Dynamic range L 0* Correlation factor % ∇ 113* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Test No ∇ # ∇ L # # # # # # M M M M M M # # # # # # # Test name PHOS Urine ∇ # # # # # # # Age Y Y Y Y Y Y Select using Space key. OSR6222 Specific Test Parameters General LIH ISE Range Test Name: PHOS ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 30 30 μL μL μL Dilution Dilution Dilution 0 120 120 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: On-board stability period 340 END + First 0 First 0 Pri.1 0. # OD CONC † Factor/OD-L 120* 1-Point Cal. 380 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. OD L Reagent OD limit Fst. Reagent 1 vol Reagent 2 vol μL μL μL 2‡ 30 30 Dil. # # ο ∇ 5.INORGANIC PHOSPHOROUS. L -0. L -0. AU600 System Reagent: OSR6122. No. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range URINE APPLICATION Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name PHOS Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 230* # Test Name: Counts: PHOS ∇ < > Type ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 120* # Conc Factor/OD-H 230* ∇ Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ Cal.1 0.1 -0. # # ο ∇ 2. ODC0025 1:10 with purified H2 0. No.1 Metabolite .1 0* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. User defined ¤ Analyser default value Urine Calibrator Cat.01 2009-08 30 Select the function using the Function key or the Mouse Dilute samples and Urine Calibrator Cat. H Lst. vol Dil. vol 0 120 120 Max. None Selected 8. vol Dil. To work in mg/dL multiply by 3. # # ο ∇ 3. To work in mg/dL multiply by 3. # # ο ∇ 7. OD H 0. ∇ ∇ ∇ Sec. H Sample vol. H 113* Fst Fst 0 0 Lst Lst First H Last H 0. ∇ 7. # # ο ∇ 7. To work in mg/dL multiply by 3.OD -0. ∇ # # # # ο 5.5 μL Min. ∇ # # # # ο 3. AU680/AU480 Urine Application System Reagent: OSR6122. 380 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Urine ∇ LIH PHOS ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # PHOS ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.OD Reagent OD Limit First Low Last Low Dilution 100 0 OD Limit < > ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6122. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ 340 END + First 0 First 0 Sec.1 -0. AU2700/AU5400 Urine Reagent ID: 022 Parameters General LIH PHOS ∇ ∇ Dilution μL Max. ∇ # # # # ο 4. ∇ ∇ ∇ 0* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. No. # OD CONC † Factor/OD-L 120* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. ∇ # # # # ο 2.1 0.1 0. ∇ # # # # ο 6. None Selected 8.5 1.INORGANIC PHOSPHOROUS. Volume R1(R1-1) μL ∇ μL 1.1 R2(R2-1) μL Name Sec. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal.01 2009-08 . No demographics 8. # # ο ∇ 2.7 25 25 μL μL μL Dilution Dilution Dilution 0 100 100 μL μL μL Pri.: ODC0025 Values set for working in SI units (mmol/L). # # ο ∇ 3. Not within expected values mmol/L* Decimal Places Calibration Specific ISE PHOS ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ Factor Range Low High 120* 230* ∇ # ο ∇ Calibration Specific General ISE Type Urine ∇ Counts: Factor/OD-H 230* # Process: CONC ∇ Test Name: PHOS ∇ < > Test Name: Use Serum Cal. # # ο ∇ 6.1 High High 0.7 10 25 Range Operation: ∇ Yes Test Name: PHOS ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 0 113* 0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # URINE APPLICATION Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. # # ο ∇ 5.1 AU680 <Point Cal.1 -0. No. 380 Onboard Stability Period Last Last 27 10 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0* 1 1 30 Day μL High B B 0 113* 0 0 Hour 25 Dilution 100 Sample Volume Pre-Dilution Rate Rgt. OSR6222 Reagent ID: 022 Application Operation Yes INORGANIC PHOSPHOROUS. # # ο ∇ 4. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x22. OSR6222 Specific Test Parameters General LIH ISE Urine ∇ 10 Max OD H -0. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 30 Day 0 Calibration 30 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: # Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined Urine Calibrator Cat. For No. For in vitro diagnostic use only. Safety data sheet available for professional user on request. Major preventative maintenance was performed on the analyser or a critical part was replaced. 4 x 15 mL 4 x 15 mL 4 x 30 mL 4 x 30 mL R1 R2 R1 R2 Summary1.5.7 mmol/L 0. haemoglobin and myoglobin. The increase in absorbance is directly proportional to the amount of iron present. unopened. It is a constituent of the oxygen-carrying chromoproteins. acute leukemia.6 The method utilises TPTZ [2. The remaining body iron is present in the flavoproteins. 7 Stable in serum and plasma for 3 weeks when stored at 2…8°C and 7 days when stored at 15…25°C. Serum iron concentration is decreased in many but not all patients with iron deficiency anemia.2. Quality Control Control Cat. The ferrous ions then react with TPTZ to form a blue coloured complex which can be measured bichromatically at 600/800 nm. Once open.IRON OSR6186 OSR6286 Intended Use Photometric colour test for the quantitative determination of iron in human serum and plasma on Beckman Coulter analysers. No. Iron levels may also be increased in acute hepatitis. immunisation. In an acidic medium. late pregnancy.4. This does not affect the performance of the reagent. Greater than normal concentrations of serum iron occur in iron-overload disorders such as haemochromatosis and in acute iron poisoning following oral or parenteral iron administration. such as cytochrome oxidase and peroxidases. reagents stored on board the instrument are stable for 60 days. Remove serum from red cells immediately to avoid haemolysis. Test Principle4. thalassemia or oral contraception. Reaction Principle Transferrin 2(Fe ) 2 Fe Fe 2+ 3+ 3+ Buffer 2(Fe ) + Apo-transferrin 2 Fe 2+ 3+ + Ascorbic Acid + 2 H2O + Dehydroascorbic Acid + 2 H3O 2+ + + TPTZ Iron-complex (blue coloured complex) Contents. the iron-sulphur proteins. Specimen Serum and heparinised plasma. menstruation and nephrosis.01 BLOSR6x86. and myocardial infarction. Serum iron concentration diminishes markedly in patients who are beginning to respond to specific therapy for anemias of other causes e. malignancy.6-Tri-(2-pyridyl)-5-triazine] as the chromogen. Some discoloration may be observed in R1 as the reagent ages.3 Iron participates in a variety of vital processes in the body varying from cellular oxidative mechanisms to the transport and delivery of oxygen to body cells. since iron values can decrease by 30% during the course of the day. 66300. kwashiorkor.7) L-ascorbic acid 2. treatment of pernicious anemia with Vit B12. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. as well as various enzymes. as well as storage iron-ferritin and transport iron-transferrin. No. oxalate or citrate plasma. lead poisoning. up to the stated expiry date when stored at 2…8°C. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. Dispose of all waste material in accordance with local guidelines. Measured serum iron concentration is principally the Fe (III) bound to serum transferrin and does not include the iron contained in serum as free haemoglobin. acute or recent haemorrhage. The paediatric application is suitable for use with small volume serum/plasma samples Calibration System Calibrator Cat. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples EN. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. Lipemic samples should be avoided. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument.4.6-Tri(2-pyridyl)-5-triazine Preservative 215 mmol/L 4.01 2009-08 Metabolite .5 mmol/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. Hydrochloric acid and sodium ascorbate reduce the ferric ions to the ferrous state. Storage and Stability The reagents are stable. 8 Samples should be taken in the morning from patients in a fasting state. transferrin-bound iron dissociates into free ferric ions and apo-transferrin. Reagent Composition in the Test Final concentration of reactive ingredients: Glycine buffer (pH 1. The calibrator iron value provided in the calibrator package insert is traceable to a Beckman Coulter Master Calibrator. in acute or chronic inflammatory disorders such as acute infection. Do not use EDTA.g. Haemolysed samples may react with the reagent to produce spuriously low results and such specimens should not be used. 7. MillerJ.66 0. 9.9 – 41. In: Kaplan LA.999 n = 96 Sample range = 1. NCCLS Document HI7-A. Direct measurement of serum iron and binding capacity.F. Metabolite BLOSR6x86.1995:374-375. total iron-binding capacity and percent transferrin saturation. 2000. eds. ed. approved standard.: 66300 Values set for working in SI units (µmol/L). Reference information for the clinical laboratory. Painter PC. 1996:714pp. Henry JB. If any trends or sudden shifts in values are detected.6 µmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 1 g/L haemoglobin ® Lipemia: Interference less than 10% up to 100 mg/dL Intralipid Copper: Interference less than 10% up to 1 mg/dL or 0. diet and geographical location. Tietz textbook of clinical chemistry. Cope JY. Setting Sheet Footnotes # † * User defined ¤ Analyser default value System Calibrator Cat. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Reference Intervals9. Perrotta G.4 mmol/L triglyceride In very rare cases gammopathy.304 r = 0.9 µmol/L (40 – 100 µg/dL) Child 9. extremely high concentrations of monoclonal immunoglobulins. Klee GG. 87: 442.12:47-57.23 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 0.02 0. Effects of drugs on clinical laboratory tests. Each laboratory should verify the transferability of the expected values to its own population. Data obtained in your laboratory may differ from these values. Ashwood ER. 1996:188-190. Pennsylvania: NCCLS.77 1. Clin Chem 1991.68 0.1820pp. In: Burtis CA. Diehl H. Clinical guide to laboratory tests. Philadelphia: WB Saunders Company. 11 Limitations In rare instances. In: Burtis CA. Clinical chemistry theory. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days.002x – 0. sample type. may cause turbidity in the reaction 12 cuvette and elevate direct colorimetric iron assays.5 – 32.2 – 17.90 – 44. 3.585. Smith JL. For diagnostic purposes. Ashwood ER. Tietz textbook of clinical chemistry. Pesce AJ.1 Rev. To work in µg/dL multiply by 5.3 µmol/L. Ogama J. 8. may cause unreliable results. 1999. Iron and total iron binding capacity. Schade A. Reinhart R. Guillemette M.10 1. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. analysis. Clinical diagnosis and management by laboratory methods.01 .4. 1999. Wisser H.2:36pp. Bakker AJ.34 0. Heil W.7 – 32. Refer to Young for further information on interfering substances. rd BIBLIOGRAPHY 1.19 0. th 11.10 Male 12. 5 ed.are tested and each time calibration is performed. 2. Clin Chem 1966. St Louis: Mosby. WHO/DIL/LAB/99. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Use of anticoagulants in Diagnostic laboratory investigations and stability of blood. eds.30 CV% 2.65 1. 4. AACC Press. due to monoclonal gammopathies. Proc Soc Exp Biol Med 1954. The results obtained by any individual laboratory may vary from the given mean value.5 µmol/L (50 – 120 µg/dL) Expected values may vary with age. Philadelphia:WB Saunders Company. clinical examinations and other findings. The lowest detectable level represents the lowest measurable level of iron that can be distinguished from zero. especially monoclonal IgM (Waldenström’s macroglobulinemia). Fairbanks VF. Philadelphia:WB Saunders Company.0 – 21. Tietz NW. 3 ed. plasma and serum samples. ed. Results of linear regression analysis were as follows: y = 1.09 1. Dec 1998. In: Henry JB. 6. Linearity The test is linear within a concentration range of 2 – 179 µmol/L (10 – 1000 µg/dL). Influence of monoclonal immunoglobulins in direct determinations of iron in serum. Young DS. nd In:GF Smith 2 ed. results should always be assessed in conjunction with the patient's medical history. et al. Goodwin JF. Zawta B. Biochemical aspects of hematology. Woo J. Philadelphia: WB Saunders Company.157 mmol/L copper Globulin: Interference less than 10% up to 2 g/dL or 20 g/L Triglyceride: Interference less than 10% up to 300 mg/dL or 3. Determination of serum iron. The Iron Reagents: Bathophenanthroline Bathophenanthroline-Disulfonic acid 2. and correlation.01 2009-08 EN.1698-1703. n = 60 Within Run Total Mean µmol/L SD CV% SD 9. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.37:690-4. Calculation The Beckman Coulter analysers automatically compute the iron concentration of each sample.2 µmol/L ( 60 – 180 µg/dL) Serum (Children) Newborn 17. Töpfer G. 5. 12.50 105.59 0. Ohio: Chem Co 1960. Ehret W.20 28. Metabolic intermediates and inorganic ions. 10. Murphy B. ed. Serum (Adults) Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. review all operating parameters. Schmitt Y. sex.2 µmol/L ( 70 – 180 µg/dL) Female 10.6-Tripyridyl-s-triazine Phenyl-2-pyridyl Ketoxime. No.8 µmol/L (100 – 250 µg/dL) Infant 7.54 0. NCCLS. and if necessary determine its own reference interval according to good laboratory practice. Method Comparison Patient serum samples were used to compare this Iron OSR6186 assay on the AU600 against another commercially available iron assay. eds. SmithG. OSR6286 Reagent ID: 086 Application IRON.585 Metabolite . L -0. OSR6286 Specific Test Parameters General LIH ISE Range Test Name: IRON ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 20 50 50 μL μL μL Dilution Dilution Dilution 0 175 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. No.IRON. To work in µg/dL multiply by 5. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat. # # ο ∇ 2. # # ο ∇ 6. Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name IRON ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 680* # Conc Factor/OD-H 1038* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 1038* # SERUM/PLASMA APPLICATION Test Name: Counts: IRON ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 Advanced Calibration: # ∇ Cal. # # ο ∇ 3.585 BSOSR6x86. OD L Reagent OD limit Fst. AU400/AU640 Serum/Plasma Reagent ID: 086 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 600 Sub Fst. vol 0 175 10 Max. vol Dil. 800 ∇ Last Last 12 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. L -0.: 66300 * Values set for working in SI units (µmol/L). No. H 179* Fst Fst 0 0 Lst Lst First H Last H 0. H -0.01 2009-08 # User defined † System Calibrator Cat.2 2* B 60 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. Reagent 1 vol Reagent 2 vol μL μL μL 20 50 50 Dil.2 Dynamic range L 2* Correlation factor % ∇ 179* 1 0 ¤ 60 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: IRON ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. To work in µg/dL multiply by 5. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name IRON Sample type Ser ∇ On-board stability period 600 END + First 0 First 0 Pri. # # ο ∇ 7.2 Lst.2 -0.2 0. vol Dil. H Lst. # # ο ∇ 4. # OD CONC † Factor/OD-L 680* 1-Point Cal.2 Wave Method Reaction Point 1 Point 2 800 END + 12 10 Sample vol. OD H 0. ∇ ∇ ∇ Sec. AU600 Serum/Plasma Application System Reagent: OSR6186. None Selected 8. # # ο ∇ 5.2 ∇ Operation: Yes Test No ∇ ∇ # Test name IRON Sample type Ser Page 1/2 System Reagent: OSR6186. No.2 0.: 66300 * Values set for working in SI units (µmol/L). Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ο ∇ 3. # # ο ∇ 2.OD -0.2 -0. No. ∇ # # # # ο 4.01 2009-08 .2 High High 0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 600 ∇nm END ∇ + ∇ 0 0 % ∇ 600 END + First 0 First 0 Sec. None Selected 8. No demographics 8.: 66300 Values set for working in SI units (µmol/L). # OD CONC † Factor/OD-L 716* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation None ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 Advanced Calibration: # ∇ # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 1-Point Cal. ∇ 7.2 0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x86. Volume R1(R1-1) μL ∇ μL 12 1 30 Range Operation: ∇ Yes Test Name: IRON ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 Last Last 12 10 12 30 30 0. AU2700/AU5400 Serum/Plasma Reagent ID: 086 Parameters General LIH IRON ∇ Dilution μL Max. ∇ # # # # ο 3. # # ο ∇ 6. ∇ # # # # ο 2. OSR6286 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0. ∇ # # # # ο 6. OSR6286 Reagent ID: 086 Application Operation Yes IRON. # # ο ∇ 4.2 μL Min. # # ο ∇ 5.2 R2(R2-1) μL Name Sec. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal.OD Reagent OD Limit First Low Last Low Dilution 101 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6186.IRON.585 AU680 <Point Cal. Point: ο with CONC-0 Slope Check: ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined. 800 ∇ Last Last 12 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 60 Day # ∇ + ∇ +++++ ∇ + ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH IRON ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # IRON ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.2 179* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 101 10 μL μL μL Pri. To work in µg/dL multiply by 5. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 2* 1 1 μL High B B 0 179* 0 0 Hour 30 Dilution 10 Sample Volume Pre-Dilution Rate Rgt.2 -0. Not within expected values µmol/L* Decimal Places Calibration Specific ISE IRON ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 716* 1074* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 1074* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: Test Name: IRON ∇ < > Use Serum Cal. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. No.2 0. For No. System Calibrator Cat. # # ο ∇ 7. AU680/AU480 Serum/Plasma Application System Reagent: OSR6186. ∇ ∇ ∇ 2* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. ∇ # # # # ο 5. To work in µg/dL multiply by 5.: 66300 * Values set for working in SI units (µmol/L). ∇ ∇ ∇ Sec. OSR6286 Reagent ID: 086 Application IRON. vol Dil. AU400/AU640 Paediatric Reagent ID: 086 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 600 Sub Fst. vol Dil.585 BSOSR6x86. H Lst.2 Wave Method Reaction Point 1 Point 2 800 END + 12 10 Sample vol.: 66300 * Values set for working in SI units (µmol/L). point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat. 800 ∇ Last Last 12 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. L -0. H -0. AU600 Paediatric Application System Reagent: OSR6186.2 ∇ Operation: Yes Test No ∇ ∇ # Test name IRONP Sample type Ser Page 1/2 System Reagent: OSR6186.2 Lst. # # ο ∇ 3. Reagent 1 vol Reagent 2 vol μL μL μL 20 50 50 Dil. vol 10 165 10 Max. L -0.2 -0.2 0. # OD CONC † Factor/OD-L 680* 1-Point Cal. OD H 0.2 0. OSR6286 Specific Test Parameters General LIH ISE Range Test Name: IRONP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 20 50 50 μL μL μL Dilution Dilution Dilution 10 165 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. # # ο ∇ 2. # # ο ∇ 5. # # ο ∇ 4.585 Metabolite .01 2009-08 # User defined † System Calibrator Cat. # # ο ∇ 6.2 Dynamic range L 2* Correlation factor % ∇ 179* 1 0 ¤ 60 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: IRONP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. No. Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name IRONP ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 680* # Conc Factor/OD-H 1038* ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 1038* # Test Name: Counts: IRONP ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal.IRON. None Selected 8. To work in µg/dL multiply by 5. No.2 2* B 60 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. H 179* Fst Fst 0 0 Lst Lst First H Last H 0. No. # # ο ∇ 7. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name IRONP Sample type Ser ∇ On-board stability period 600 END + First 0 First 0 Pri. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. OD L Reagent OD limit Fst. # # ο ∇ 7.2 0.2 -0. ∇ # # # # ο 3. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. OSR6286 Reagent ID: 086 Application Operation Yes IRON. ∇ # # # # ο 5. System Calibrator Cat. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 2* 1 1 μL High B B 0 179* 0 0 Hour 30 Dilution 10 Sample Volume Pre-Dilution Rate Rgt.01 2009-08 . Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. Point: ο with CONC-0 Slope Check: ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined.2 0. # # ο ∇ 5. ∇ # # # # ο 2. 800 ∇ Last Last 12 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 60 Day # ∇ + ∇ +++++ ∇ + ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH IRONP ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # IRONP ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. None Selected 8.OD Reagent OD Limit First Low Last Low Dilution 91 10 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6186. ∇ 7.IRON. Volume R1(R1-1) μL ∇ μL 12 1 30 Range Operation: ∇ Yes Test Name: IRONP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 Last Last 12 10 12 30 30 0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 600 ∇nm END ∇ + ∇ 0 0 % ∇ 600 END + First 0 First 0 Sec. No.: 66300 Values set for working in SI units (µmol/L). # # ο ∇ 3.2 μL Min. AU2700/AU5400 Paediatric Reagent ID: 086 Parameters General LIH IRONP ∇ Dilution μL Max. To work in µg/dL multiply by 5.2 High High 0.585 AU680 <Point Cal. Not within expected values µmol/L* Decimal Places Calibration Specific ISE IRONP ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 716* 1074* ∇ # ο ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 1074* # Process: CONC ∇ Test Name: IRONP ∇ < > Test Name: Use Serum Cal.2 R2(R2-1) μL Name Sec.2 179* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 10 91 10 μL μL μL Pri. ∇ # # # # ο 4. For No.2 -0. No. AU680/AU480 Paediatric Application System Reagent: OSR6186. ∇ ∇ ∇ 2* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. # OD CONC † Factor/OD-L 716* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation None ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 Advanced Calibration: # ∇ # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 1-Point Cal. OSR6286 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0. # # ο ∇ 2. No demographics 8.OD -0. # # ο ∇ 4. # # ο ∇ 6. ∇ # # # # ο 6. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x86. reagents stored on board the instrument are stable for 30 days. A coloured product is produced by the reaction of peroxidase (POD).1 mmol/L ≥ 0. Storage and Stability The reagents are stable. Icteric and haemolysed samples should be avoided. brain. myocardial infarction.2. shock. Lactate dehydrogenase catalyses the reduction of pyruvate to lactate.01 BLOSR6x93. Cerebrospinal Fluid: CSF collected into plain collection devices or sodium fluoride/potassium oxalate tubes. Once open. Keep the sample on ice and separate plasma from cells within 15 minutes of collection. Do not use serum. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Examples of metabolic disorders include diabetes mellitus. A slight pink colouration of the working reagent will not influence performance. For in vitro diagnostic use only. pyruvate dehydrogenase deficiency. 4 -aminoantipyrine and a hydrogen donor (TOOS). ischemia and in certain inborn errors of metabolism eg. mitochondrial myopathies and biotinidase deficiency. Sample Stability: Analyse fresh otherwise stable stored at 2…8°C for up to 24 hours. The colour intensity is proportional to the concentration of lactate in the sample. It is derived predominantly from white skeletal muscle.8.3 L-lactate is the end product of anaerobic glycolysis. Calibration System Calibrator Cat.2 kU/L ≥ 1 kU/L 50 mmol/L 0. blood loss and pulmonary oedema (2) metabolic or drug/toxin related disorders. up to the stated expiry date when stored at 2…8°C. increased lactate levels in CSF in the absence of increased blood/plasma lactate concentration have been reported in cases of bacterial meningitis. Glycolysis resulting from physical exercise gives rise to an increased lactate concentration in the bloodstream. flush waste-pipes with water after the disposal of undiluted reagent. hydrogen peroxide. movement of the hand or arm should be avoided.3 mmol/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. Therefore.01 2009-08 Metabolite . epinephrine and acetaminophen. Recalibrate the assay every 30 days or when the following occur: Change in reagent lot or significant shift in control values. Lactate levels in CSF will generally mirror those in blood/plasma. skin.LACTATE OSR6193 Intended Use Enzymatic colour test for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter analysers. There are two major clinical settings in which lactic acidosis occurs (1) conditions associated with hypoxia eg. renal medulla and erythrocytes. 66300.9 Plasma or cerebrospinal fluid. However. Specimen1. Analyse the sample immediately. Reaction Principle L-Lactate + O2 H2O2 + 4–AA + H donor LOD POD Pyruvate + H2O2 Chromogen + 2H2O Contents. congestive heart failure. To avoid the possible build-up of azide compounds. The calibrator is traceable to a primary standard which is gravimetrically prepared using reagent grade L-lactate. hepatic disease and neoplasia. The coloured product is measured photometrically. In particular. unopened. Test Principle4. Sample Stability: Stable for 14 days when stored at 2…8°C and 8 hours when stored at 15…25°C. Plasma: Use plasma from blood collected into sodium fluoride-potassium oxalate tubes. cerebral hypoxia.7. Congenital metabolic disorders include type I glycogen storage disease. Major preventative maintenance was performed on the analyser or a critical part was replaced EN. 4 x 10 mL 4x R1 Buffer R1 Lyo Summary1. The reagent can still be used providing the reagent blank is within specification. the patient should be at rest before taking the sample. Reagent Preparation R1: Dissolve the contents of one vial of R1 Lyo completely with the contents of one vial of R1 buffer. Reagent Composition in the Test Final concentration of reactive ingredients: Lactate oxidase Peroxidase Good’s Buffer (pH 7. Dispose of all waste material in accordance with local guidelines. Note whether the sample is venous or arterial.6. ethanol.5 L-lactate is oxidised to pyruvate and hydrogen peroxide by lactate oxidase (LOD).0) 4-aminoantipyrine TOOS* * N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3-methylaniline Preservative ≥ 0. No. Mix gently by inversion and place on board the instrument. Examples of drugs/toxins which give rise to elevated lactate are methanol. adult Expected values may vary with age.32 mmol/L (2 – 120 mg/dL). User defined ¤ Analyser default value System Calibrator Cat. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used.01 2009-08 EN.33 mmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference using an artificially manufactured matrix were as follows: Icterus: Interference less than 10% up to 16 mg/dL or 274 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin Ascorbate: Interference less than 10% up to 10 mg/dL ascorbate ® Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances. Trinder P. ed. 62: 3-11.007 0.034 0.231 Total CV% 1. clinical examinations and other findings. Sauberbich HE: Selected Methods for Determination of Ascorbic Acid in Animal Cells. Measurement of lactate in cerebrospinal fluid in investigation of inherited metabolic disease. Washington D.01 BIBLIOGRAPHY . Clinical guide to laboratory tests. Precision The following data was obtained on an AU640 using 3 pools analysed over 20 days. Ann Clin Biochem 1969. Results of linear regression analysis were as follows: y = 1. Plasma ascorbate concentrations at tissue saturation are reported to be 1 – 1. n = 80 Within Run Mean mmol/L SD CV% SD 1. 7. however.1 – 4.20 – 7. Metabolite BLOSR6x93. Westgard JO.43:158-161. Clin Chem 1994. 1999:787pp. >10 days old CSF. although ascorbate is generally cleared via urinary excretion within 4 hours of ingestion. Preece MA. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. 2000.5 – 2.090 13. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. 2. 1979. Determination of glucose in blood using glucose oxidase with an alternative oxygen acceptor.4 mmol/L (10 – 40 mg/dL) 1.23 mmol/L Patient CSF samples were used to compare this Lactate OSR6193 assay on the AU400 against another commercially available lactate assay. Each laboratory should verify the transferability of the expected values to its own population.50 0. Gray G. In: Thomas L. The lowest detectable level represents the lowest measurable level of lactate that can be distinguished from zero.8 2. An improved colour reagent for the determination of blood glucose by the oxidase system. Philadelphia. good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. 3rd ed. Data obtained in your laboratory may differ from these values. Sedor F. Omaye ST. sample type. Tietz NW.Quality Control Controls Cat. Analyst 1972. Linearity The test is linear within a concentration range of 0. If any trends or sudden shifts in values are detected. Trinder P.7 mmol/L (10 – 60 mg/dL) 1.40:1327-1330. 5th ed. and if necessary determine its own reference interval according to good laboratory practice. 1st ed. Philadelphia: WB Saunders Company. Turnbull JD. 1999:382pp. Results of linear regression analysis were as follows: y = 1. Each laboratory should establish its own control frequency.6 0. 10 Limitations11 Ascorbate interference may be observed at concentrations greater than 10 mg/dL. Studies conducted at Beckman Coulter show that there is no observed interference from ascorbate at this concentration. Barham D.. Method Comparison Patient plasma samples were used to compare this Lactate OSR6193 assay on the AU640 against another commercially available lactate assay. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.059x – 0. Frankfurt/Main: TH-Books Verlagsgesellschaft. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Ashwood ER. diet and geographical location.1 – 2.113 0.8 mg/dL) 1.8 0.01 Burtis CA. Henry JB.021 4.5 – 19. To work in mg/dL multiply by 9.4 mmol/L (10 – 22 mg/dL) Plasma CSF. The results obtained by any individual laboratory may vary from the given mean value.15 0.6:24-27. Effects of drugs on clinical laboratory tests. 8. Clin Chem 1997. ed.5 mg/dL. Lahmeyer BL.1 – 6. Green A.999 n = 103 Sample range = 0.8 0. Clinical laboratory diagnostics.97:142-145. Hutchesson A. Astles R. sex. Williams CP. 3 – 10 days old CSF. Tissues and Fluids. Setting Sheet Footnotes # † * 1. AACC Press.C. Lactate. Use of the Du Pont “automatic clinical analyzer” in direct determination of lactic acid in plasma stabilized with sodium fluoride.160pp.46 – 13. neonate CSF. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.1995. 19th ed.118 r = 0. WB Saunders Co. In: Methods of Enzymeology.999 n = 56 Sample range = 1.22 – 13. 4.18:1334-1338. 1998. Clinical diagnosis and management by laboratory methods. results should always be assessed in conjunction with the patient's medical history. 10. Tietz textbook of clinical chemistry. Calculation The Beckman Coulter analysers automatically compute the lactate concentration of each sample.1 1. Use and assessment of clinical laboratory results. Clin Chem 1972. No.156 r = 0.: 66300 Values set for working in SI units (mmol/L). review all operating parameters. Thomas L. Birnbaum ML. 3rd ed.1 – 2.2 mmol/L (4. 5.7 Sensitivity The lowest detectable level on an AU640 analyser was calculated at 0. 9. No. Stability of plasma lactate in vitro in the presence of antiglycolytic agents. 11. Young DS. 3. Reference Intervals6 0. For diagnostic purposes. 6.35 0.001 mmol/L. Philadelphia: WB Saunders Company.8 mmol/L (10 – 25 mg/dL) 1.049x – 0. AU400/AU640 Plasma/CSF Reagent ID: 093 System Reagent: OSR6193 Specific test parameters Test No Serum ∇ Sample vol. point MB type factor Calibrator stability period 30 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat No: 66300.1 Lst. vol 0 0 0 Max. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name LAC Sample type Ser ∇ 540 FIXED + First 1 First Last Last 15 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L -0.2 Last L -0.5 0.1 Last H 0. 1 Sample Pre-dil.2* ∇ PLASMA/CSF APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 12.2 Dynamic Range: L 0.01 2009-08 # User defined † System Calibrator Cat No: 66300 * Values set for working in SI units mmol/L. vol Dil. To work in (mg/dL) multiply by 9.32* Correlation Factor: A 1 B 0 On-board stability period: 30 Wave Method Reaction Point 1 Point 2 13.22* Correlation factor H A B Rate Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key. # # ο ∇ 6.1* 1-Point Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. H Lst. # # ο ∇ 3. # OD CONC † Factor/OD-L 8.2 0. # # ο ∇ 7.1 Reagent OD limit Fst.01 Metabolite . L -0. * Values set for working in SI units mmol/L. # # ο ∇ 4. vol Dil.1 Dynamic range L 0. AU600 Plasma/CSF Application System Reagent: OSR6193 Specific Test Parameters General LIH ISE Range Test Name: LAC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 200 0 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.2 ∇ # Test name LAC Sample type Ser Page 1/2 Reagent ID: 093 Application LACTATE.2* # Test Name: Counts: LAC ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ Cal. To work in (mg/dL) multiply by 9. # # ο ∇ 5.1 H 2.1* # Conc Factor/OD-H 12. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name LAC ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 8.5 Reagent OD limit: First L -0.1 First H 0. 700 ∇ 700 FIXED + 15 Min. Reagent 1 vol Reagent 2 vol μL μL μL Fst.32* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: LAC ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. None Selected 8. H ∇ ∇ ∇ Main 540 Sub 2 200 0 Dil.LACTATE.22* H 13. # # ο ∇ 2. No. OD L -0.01 BSOSR6x93. Linearity Fst No lag time % Sec ∇ ∇ ∇ Fst Fst Lst Lst Sec. OD H ∇ Operation: Yes ∇ 2. L -0. ∇ # # # # ο 6. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x93. None Selected 8. ∇ # # # # ο 3. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # L mmol/L* H Month # # # # # # Panic Value Low # High # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.6 160 0 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check % ∇ ISE LAC ∇ < > HbA1c Parameters General LIH Test Name: % ∇ Pre-Dilution Rate: 1 Min OD Max OD L -0.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.2 Last L -0. # # ο ∇ 7. 700 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.1* Counts: # ∇ ∇ Factor Range Low High Slope Check 8. ∇ ∇ ∇ Sec.1 -0. For No.2* Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 30 Advanced Calibration: # ∇ None ∇ 1-Point Cal. # # ο ∇ 4. 700 ∇ 540 FIXED + First 1 First Noneф 540 ∇nm FIXED ∇ + ∇ 1 Last Last 15 Onboard Stability Period LIH Influence Check Lipemia Iceterus Hemolysis Last Last 15 13. Not within expected values mmol/L* Decimal Places Calibration Specific ISE LAC ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum ∇ ο PLASMA/CSF APPLICATION Calibration Specific General ISE Type Serum ∇ ∇ Counts: Factor/OD-H 12. AU680/AU480 Plasma/CSF Application System Reagent: OSR6193 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt. # # ο ∇ 2. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 30 Day 0 Calibration 30 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. † System Calibrator Cat No: 66300 * Values set for working in SI units mmol/L.01 ф AU680 <Point Cal.01 2009-08 . # # ο ∇ 3.6 1 160 Range Operation: ∇ Yes Test Name: LAC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec.22* 1 1 μL High B B 0 0 Dilution 0 1.2 Dynamic Range: L 0.5 0. ∇ # # # # ο 4.32* 0 0 30 Day # +++++ Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.5 Reagent OD limit: First L -0.1 H 2.LACTATE. ∇ # # # # ο 5.2 0. # # ο ∇ 5. ∇ 7.1 First H 0.1 -0. To work in (mg/dL) multiply by 9. AU2700/AU5400 Plasma/CSF Reagent ID: 093 Parameters General LIH LAC ∇ ∇ Dilution μL -0. No.1* 12. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. Volume R1(R1-1) μL ∇ μL 1.2 < > ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6193 Reagent ID: 093 Application Operation Yes LACTATE. # # ο ∇ 6.2* # Process: Test Name: LAC ∇ < > Test Name: Use Serum Cal. # OD CONC † Factor/OD-L 8.22* H 13.1 High High Max. ∇ # # # # ο 2. No demographics 8.1 Last H 0.OD μL Min.32* Correlation Factor: A 1 B 0 On-board stability period: 30 +++ +++++ Specific Test Parameters General LIH ISE Serum ∇ # Range Test Name: LAC ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Storage and Stability The reagents are stable. Reaction Principle R2 Phase 2 LDL-cholesterol + 2 H2O + 2 O2 CHE and CHO Deprotecting Reagent POD 2 Cholest-4-en-3-one + 2 Fatty acids + 2 H2O2 2 H2O2 + 4–AA + HDAOS Final concentration of reactive ingredients: Cholesterol esterase Cholesterol oxidase Peroxidase Sodium azide Good’s Buffer (pH 6.3 LDL-cholesterol (LDL C) constitutes the largest portion of the LDL molecule. Test Principle4 A protecting agent in R1 protects LDL from enzymatic reactions.2. LDL-cholesterol has the strongest association with coronary mortality of all lipid and lipoprotein variables (GRIPS study). Specimen5 Serum and heparinised plasma: Stable for 7 days when stored at 2…8°C and 1 day when stored at 15…25°C. Once open. LDL-cholesterol plays a causal role in the development of coronary heart disease (CHD).7 IU/mL 4. LDL-cholesterol evaluation provides early recognition of atherosclerosis risk and may be used to determine the response to lipid-lowering drug therapy. S60: Wear suitable protective clothing. When R2 is added. This material and its container must be disposed of as hazardous waste.02 2009-11 Metabolite . LDL can now be quantified by the CHO/PAP system.8) 4-aminoantipyrine Catalase HDAOS Detergents Blue Dye + OH + 3 H2O + - Contents. The colour of R1 may turn to light green when stored on board the analyser. VLDL. 4 x 27 mL 4x 9 mL 4 x 51. This does not affect the performance of the reagent. High levels of LDL-cholesterol are associated with increased cardiovascular risk and familial hyperlipidaemia. The calibrator is traceable to the US CDC (Centre for Disease Control) LDL-cholesterol reference method.7 IU/mL 3. For in vitro diagnostic use only. Hydrogen peroxide (POD) produced by this reaction is decomposed by catalase in R1. Reduced levels of LDL-cholesterol may be found in malabsorption and malnutrition. To avoid the possible build-up of azide compounds.1 % 25 mmol/L 0. Major preventative maintenance was performed on the analyser or a critical part was replaced. protected from light. The 2001 update of these guidelines (NCEP-ATP III) put further emphasis on better risk identification and more aggressive cholesterol-lowering treatment. Recalibrate the assay every 30 days and perform reagent blank every 7 days. R22 Harmful if swallowed. or when the following occur: Change in reagent bottle or significant shift in control values. Calibration LDL-Cholesterol Calibrator ODC0012.1 mL R1 R2 R1 R2 Summary1.47 mmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: R2 reagent: Harmful. Safety Phrases: S36. with numerous clinical and epidemiological studies demonstrating its atherogenic properties. Reagent Composition in the Test 3. contains sodium azide. These recommendations defined LDL-cholesterol as the primary target of therapy.01 BLOSR6x83. EN. with a combination of raised LDL-cholesterol and elevated triglyceride levels constituting an especially high risk. reagents stored on board the instrument are stable for 30 days.LDL-CHOLESTEROL OSR6183 OSR6283 Intended Use Enzymatic colour test for the quantitative determination of LDL-cholesterol in human serum and plasma on Beckman Coulter AU analysers. up to the stated expiry date when stored at 2…8°C.8 mmol/L 743 IU/mL 0. Dispose of all waste material in accordance with local guidelines.3 mL 4 x 17. All non-LDL lipoproteins (HDL. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. flush waste-pipes with water after the disposal of undiluted reagent. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. CM) are broken down by reaction with cholesterol esterase (CHE) and cholesterol oxidase (CHO). formed via the action of lipoprotein lipase on VLDL. the protecting reagent is released from LDL and catalase inactivated by sodium azide. unopened. Refer to Safety Data Sheets for further information. In 1988 the National cholesterol Education Program Adult Treatment Panel (NCEP-ATP) developed recommendations for the diagnosis and treatment of patients with hypercholesterolemia.9 IU/mL 0. and if necessary determine its own reference interval according to good laboratory practice. 5. Naito HK.1 Rev. Carry over from this LDL-cholesterol reagent to Lipase reagent may result in elevated lipase values.70 Within Run SD 0. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. et al. Nagel D.012 mmol/L.3 mmol/L triglyceride In very rare cases gammopathy. Metabolite BLOSR6x83. Strong JP. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.1995. Scott MG et al.02 2009-11 EN.3 mmol/L (1000 mg/dL). National cholesterol education program. Perform reagent blank every 7 days. Pascual-Usandizaga P. NIH Publication No. To work in mg/dL multiply by 38. 3. BIBLIOGRAPHY 1.07 CV% 2.1 – 4. Töpfer G. Elster H.129(2):221-230. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 10 days.285:2486-2497. 2. Values set for working in SI units (mmol/L). For diagnostic purposes. Executive summary of the third report of the national cholesterol education program (NCEP) expert panel 7.2:26pp.57 2.g. especially monoclonal IgM (Waldenström’s macroglobulinemia). can interfere with this reagent. 41(1):132-133. AACC Press. Clin Chem 2000. review all operating parameters.04 0.461 – 4. Atherogenesis: current topics on etiology and risk factors.966 n = 134 Sample range = 1. dilute the sample with a saline solution. on detection. and treatment of high blood cholesterol in adults (Adult Treatment Panel III). The results obtained by any individual laboratory may vary from the given mean value.46(8 Pt 1):1121-31. diet and geographical location. Ehret W. 7 Limitations When triglyceride in a sample exceeds 11.328 r = 0. Risk factors for myocardial infarction in a cohort of 5790 men. Ten year follow-up results from the Goettingen Risk.1 mmol/L (130 – 159 mg/dL) 4. Please refer to Contamination Parameters. Expert panel on detection. Clin Lab 1999. sample type.6 – 3. National Cholesterol Education Program (NCEP) guidelines6 < 2. Enzymatic selective protection method.34 2. Analytical and clinical evaluation of two homogeneous assays for LDL-cholesterol in hyperlipidemic patients. de La Viuda-Unzueta JM. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Azcarate-Ania MN. clinical examinations and other findings. may cause unreliable results. Setting Sheet Footnotes # † * ‡ User defined ¤ Analyser default value LDL-Cholesterol Calibrator Cat. Cremer P.9 mmol/L (190 mg/dL) Optimal Near Optimal / Above Optimal Borderline High High Very High Expected values may vary with age. evaluation. Young DS. Miki Y. et al.68 Sensitivity The lowest detectable level on an AU640 analyser was estimated at 0.4 – 4.3 mmol/L (10 . as contained in some solutions for intravenous infusions (e. 8 Samples from patients with Type III Hyperlipoproteinemia give discrepant results to the reference method (bias + 30%). Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood.06 0. ® Artificial lipid mixtures. Incidence and prevalance study (GRIPS).04 0. 5th ed. n = 60 Mean mmol/L 1. Zawta B. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Guimon-Bardesi A.26 1. WHO/DIL/LAB/99.45:398-401. Clin Chem 1995.26 . Esteban-Salan M. sex. Effects of drugs on clinical laboratory tests. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed.04 0.10 Total CV% 2.Quality Control HDL/LDL-Cholesterol Control Serum ODC0005 or other control materials with values determined by this method may be used. Schmitt Y. No. 93-3095. Data obtained in your laboratory may differ from these values. evaluation and treatment of high blood cholesterol in adults (adult treatment panel II). 1. Intralipid ).01 . ODC0012. Results of linear regression analysis were as follows: y = 0.9 mmol/L (160 – 189 mg/dL) ≥ 4. Wisser H.36 1. Muller – Berninger R.76 SD 0. Each laboratory should verify the transferability of the expected values to its own population. Amoroto-Del-Rio E.10. The lowest detectable level represents the lowest measurable level of LDL-cholesterol that can be distinguished from zero. 8. Refer to Young for further information on interfering substances. If any trends or sudden shifts in values are detected.7. A homogeneous assay for the selective measurement of LDL-cholesterol in serum.400 mg/dL). Plasma and Serum Samples. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.6 mmol/L (100 mg/dL) 2.054 mmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin Ascorbate: Interference less than 3% up to 20 mg/dL ascorbate Triglyceride: Interference less than 10% up to 11. Linearity The test is linear within a concentration range of 0. 4. repeat assay and multiply result by dilution factor.71 2.3 mmol/L (100 – 129 mg/dL) 3. Heil W.912x + 0. Mann H. 2000. results should always be assessed in conjunction with the patient's medical history. Atherosclerosis 1997. National cholesterol education program expert panel. Labrot B. JAMA 2001.63 3. Samples from patients receiving these lipid mixtures should not be analysed for LDL-cholesterol using this assay. Calculation The Beckman Coulter analysers automatically compute the LDL-cholesterol concentration of each sample. 6. Method Comparison Patient serum samples were used to compare this OSR6183 LDL-cholesterol assay on the AU600 against another commercially available LDL-cholesterol assay. No. OSR6283 Specific Test Parameters General LIH ISE Range Test Name: LDL-c ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil. OD L Reagent OD limit Fst.1 0.5 First H 0.: ODC0012 Values set for working in SI units (mmol/L) To work in mg/dL multiply by 38.: ODC0012 Values set for working in SI units (mmol/L) To work in mg/dL multiply by 38. # # ο ∇ 7. None Selected 8.5 Dynamic range L 0. # OD CONC † Factor/OD-L 12* 1-Point Cal. AU600 Serum/Plasma Application System Reagent: OSR6183. # # ο ∇ 4.3* 1 0 ¤ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key. No.1 10. 700 ∇ Min. Linearity Fst No lag time % Sec 0 0 Lst Lst 700 END + 27 10 2 180 60 μL μL μL H A B Rate Dilution Dilution Dilution 0 0 0 μL μL μL 0. vol Dil. vol ∇ Operation: Yes # Test name LDL-c Sample type Ser Page 1/2 System Reagent: OSR6183. H Lst. # # ο ∇ 5.5 Last H 0. # # ο ∇ 6. # # ο ∇ 3. No. L -0. OSR6283 Reagent ID: 083 Application LDL CHOLESTEROL.1 Last L -0.01 2009-08 User defined ¤ Analyser default value LDL Cholesterol Calibrator Cat. point MB type factor Calibrator stability period 30‡ Select the function using the Function key or the Mouse # † * ‡ BSOSR6x83. AU400/AU640 Serum/Plasma Reagent ID: 083 Specific test parameters Test No ∇ 0 0 0 μL μL μL Fst.3* Correlation Factor: A 1 B 0 On-board stability period: 30 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: LDL-c ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. H Max. OD H ∇ Serum ∇ Sample vol. Reagent 1 vol Reagent 2 vol Main ∇ ∇ ∇ 600 Sub 2 180 60 Dil. vol Dil.26* H 10.1 Dynamic Range: L 0.5 Lst. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name LDL-c ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process # Conc ∇ Factor/OD-L 12* Factor/OD-H 19* Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 19* # SERUM/PLASMA APPLICATION Test Name: Counts: LDL-c ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30‡ ∇ Advanced Calibration: # ∇ Cal.7 Perform reagent blank every 7 days Metabolite .26* Correlation factor Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name LDL-c Sample type Ser ∇ 600 END + First 0 First 0 Pri. ∇ ∇ ∇ Sec. # † * ‡ User defined LDL Cholesterol Calibrator Cat. # # ο ∇ 2.LDL CHOLESTEROL.7 Perform reagent blank every 7 days. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. L -0. 5 High High 0.5 Last H 0. # # ο ∇ 7. ∇ # # # # ο 4. AU680/AU480 Serum/Plasma Application System Reagent: OSR6183. AU2700/AU5400 Serum/Plasma Reagent ID: 083 Parameters General LIH LDL-C ∇ ∇ Dilution μL Max. # # ο ∇ 3. Point: ο with CONC-0 Slope Check: Advanced Calibration Operation Interval (RB/ACAL) # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 7 Day 0 Calibration 30 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ‡ ф User defined LDL Cholesterol Calibrator Cat.: ODC0012 Values set for working in mmol/L. ∇ 7.1 0. # OD CONC † Factor/OD-L 12* Counts: # ∇ ∇ Factor Range Low High Slope Check 12* 19* Allowance Range Check ο Reagent Blank ο Calibration Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 30 ‡ ∇ Advanced Calibration: # None ∇ 1-Point Cal. 700 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. # # ο ∇ 5. Not within expected values mmol/L* Decimal Places Calibration Specific ISE Test Name: LDL-C ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum ∇ ο Calibration Specific General ISE ψ Counts: Factor/OD-H 19* # Process: CONC ∇ Type Serum ∇ SERUM/PLASMA APPLICATION Test Name: LDL-C ∇ < > Use Serum Cal. ∇ # # # # ο 5. ∇ # # # # ο 3. No.7 Perform reagent blank every 7 days AU680 <Point Cal. # # ο ∇ 4.3* 0 0 30 Day # ∇ ++++ ∇ +++++ ∇ +++++ ∇ Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. To work in SI units ( mgldL) multiply by 38. ∇ # # # # ο 6. OSR6283 Reagent ID: 083 Application Operation Yes LDL CHOLESTEROL. For No. 700 ∇ Last Last 27 10 10.OD -0. None Selected 8.LDL CHOLESTEROL. Volume R1(R1-1) μL ∇ μL 1.6 144 48 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit < > ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6183. No.1 Last L -0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 600 ∇nm END ∇ + ∇ 0 0 % ∇ ∇ ∇ ∇ Sec. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.5 First H 0.1 μL Min.1 Dynamic Range: L 0.3* Correlation Factor: A 1 B 0 On-board stability period: 30 Specific Test Parameters General LIH ISE Serum ∇ LIH LDL-C ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # LDL-C ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. ∇ # # # # ο 2.6 1 144 Range Operation: ∇ Yes Test Name: LDL-C ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec. OSR6283 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt.5 -0. # # ο ∇ 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x83.01 2009-08 . 600 END + First 0 First 0 Common Rgt.26* 1 1 μL High B B 0 48 Dilution 0 1.26* H 10. No demographics 8. # # ο ∇ 6. Reagent Composition in the Test Final concentration of reactive ingredients: ∈-Amino-n Caproic Acid Tris Glycoletherdiamine-N.. hypoparathyroidism.. Safety data sheet available for professional user on request. forced diuresis. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used for the serum/plasma application. flush waste-pipes with water after the disposal of undiluted reagent. No. The best-defined manifestation of magnesium deficiency is impairment of neuromuscular function e. cellular respiration and transmembranous calcium transport. For in vitro diagnostic use only. oxalate or citrate plasma. Collect timed 24 hour specimen using standard laboratory procedures. Reaction Principle Mg 2+ + Xylidyl blue pH 11. Hypomagnesemia is observed in cases of diabetes. chronic alcoholism.N’ tetraacetic acid Xylidyl blue Preservative 450 mmol/L 100 mmol/L 0. No. and electrocardiographic changes. up to the stated expiry date when stored at 2…8°C. reagent stored on board the instrument is stable for 14 days. To avoid the possible build-up of azide compounds.4. Reagent Preparation The reagent is ready for use and can be placed directly on board the instrument. tetany.N. 1 Magnesium in serum is stable for 7 days when stored at 15…25°C. 7 6 Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Calcium interference is eliminated by glycoletherdiamine-N. Magnesium is mainly regulated by the rate of renal magnesium excretion. Store at 2. convulsions.8°C. Urine: Acidified with 6M HCl. Do not use EDTA. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed.01 BLOSR6x89. Dispose of all waste material in accordance with local guidelines. Once open.18 mmol/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. and plays an important role in glycolysis. 4 x 40 mL R1 Summary1.01 2009-08 Metabolite .N. hyperthyroidism. which along with calcium is subject to the effects of parathyroid hormone. dehydration. The magnesium values of both calibrators are traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 909b Level 2. Test Principle3. 397 and 398 or other control materials with values determined by this Beckman Coulter system may be used for the urine application. Increasing calcium reabsorption thus leads to competitive inhibition of magnesium absorption. No. Biorad Liquichek Urine Chemistry Controls Cat. Haemolysed samples should be avoided due to the higher magnesium concentration in erythrocytes. Major preventative maintenance was performed on the analyser or a critical part was replaced. severe diabetic acidosis and Addison’s Disease.N`-tetraacetic acid (GEDTA).12 mmol/L 0. Specimen Serum or heparinised plasma. 66300 for serum/plasma application and Urine Calibrator Cat. The colour produced is measured bichromatically at 520/800 nm and is proportional to the magnesium concentration in the sample.N`.MAGNESIUM OSR6189 Intended Use Photometric colour test for the quantitative determination of magnesium in human serum. unopened. Quality Control Controls Cat. plasma and urine on Beckman Coulter analysers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low) and hypermagnesemia (abnormally high). malabsorption and acute pancreatitis. either as an integral part of a metalloenzyme or as an activator. EN. Recalibrate the assay every 7 days.2 Magnesium is an essential factor in many important enzymatic reactions. Calibration Use System Calibrator Cat. No. Increased serum magnesium levels have been found in cases of renal failure. ODC0025 for urine application.4 Purple complex Contents. Storage and Stability The reagent is stable.N’. hypocalcemia. or when the following occur: Change in reagent lot or significant shift in control values.5 The Magnesium reagent utilises a direct method in which magnesium ions form a coloured complex with xylidyl blue in a strongly basic solution.g. Separate serum from red blood cells immediately. hyperirritability. 40 Sensitivity The lowest detectable level in serum on an AU640 analyser was estimated at 0. Use and assessment of clinical laboratory results. 5.03 mmol/L (1. approved guideline. transportation. Mann CK.999 n = 120 Sample range = 0.02 mmol/L. Results of linear regression analysis were as follows: y = 0. Microdosage du magnésium dans divers milieux biologiques. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.01 1. Clin Chim Acta 1962.81 0.2 – 9. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.01 1.The results obtained by any individual laboratory may vary from the given mean value.23 – 1. Philadelphia:WB Saunders Company.71 0.01 3.8 – 2. 1987:521-524.43.10 7. The lowest detectable level in urine on the AU2700 was estimated at 0.5 mg/dL) Urine Adults 3 – 5 mmol/24 h (73 – 122 mg/24 h) Expected values may vary with age. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.990x + 0. ed. n = 80 Within Run Total Mean mmol/L SD CV% SD 0. Clinical chemistry theory. Jacob RA.02 0.5 – 22.97 mmol/L Patient urine samples were used to compare this Magnesium OSR6189 assay on the AU2700 against another commercially available magnesium assay.76 0. No.4-dimethylcarboxanilido) naphthalene-1’(2-hydroxybenzene-5-sulfonate).53 mmol/L Interfering Substances Results of serum studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 28 mg/dL or 479 µmol/L bilirubin Calcium: Interference less than 3% up to 30 mg/dL or 7.073 r = 1. 2001. NCCLS. n = 60 Within Run Total Mean mmol/L SD CV% SD 0. 2000. Mann CK. Pennsylvania: NCCLS.01 .6 mg/dL) Women 0. For diagnostic purposes.15 0. diet and geographical location. 2.75 0. 7. Trace Elements.3 mmol/L (0.77 – 1.27 CV% 1. In: Kaplan LA. AACC Press.994x – 0. Calculation The Beckman Coulter analysers automatically compute the magnesium concentration of each sample.0 mg/dL) for serum and plasma. 3.04 The following data was obtained on an AU640 using 3 urine pools analysed over 20 days. Fundamentals of clinical chemistry. Yoe JH. Spectrophotometric determination of magnesium with sodium 1-Azo-2-hydroxy-3-(2.90 0.5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 500 mg/dL Intralipid Results of urine studies conducted to evaluate the susceptibility of the method to interference were as follows: Calcium: Interference less than 10% up to 40 mg/dL or 10 mmol/L calcium Refer to Young for further information on interfering substances. 1996:551pp. Bohuon C. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.9 – 2. Anal Chem 1956. Reference Intervals1 Serum Men 0. sex. Yoe JH.01 2009-08 EN. analysis.04 3.73 – 1.02 0. 8 Setting Sheet Footnotes # † * 1. Pesce AJ. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 10 days. 4.003 r = 0.73 3. Kazmierczak SC.71 0. results should always be assessed in conjunction with the patient's medical history. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. User defined ¤ Analyser default value System Calibrator Cat. Data obtained in your laboratory may differ from these values.80 0. review all operating parameters.03 0. Magnesium.01 1. Frankfurt/Main: TH-Books Verlagsgesellschaft mbH. sample type. Urinalysis and collection.06 mmol/L (1. To work in mg/dL multiply by 2. 2nd ed.2 – 3. 8. Magnesium (Mg). St Louis: Mosby. ed. Young DS. BIBLIOGRAPHY Metabolite BLOSR6x89. and preservation of urine specimens. Linearity The test is linear within a concentration range of 0.24 CV% 4. Method Comparison Patient serum samples were used to compare this Magnesium OSR6189 assay on the AU640 against another commercially available magnesium assay.03 0.: 66300/ Urine Calibrator Cat. eds. Spectrophotometric determination of magnesium with 1-Azo-2-hydroxy-3-(2.96 2.5 mg/dL) for urine. clinical examinations and other findings. If any trends or sudden shifts in values are detected. NCCLS Document GP16-A2. and if necessary determine its own reference interval according to good laboratory practice. In: Thomas L.09 0. No. The lowest detectable level represents the lowest measurable level of magnesium that can be distinguished from zero.7:811-817. Each laboratory should verify the transferability of the expected values to its own population. Clinical laboratory diagnostics.01 mmol/L.06 0. 5th ed.25 mmol/L (0. Results of linear regression analysis were as follows: y = 0. Dörner K.78 0. Effects of drugs on clinical laboratory tests.:ODC0025 Values set for working in SI units (mmol/L).15 1.16:155-160. 1998:339-340.000 n = 79 Sample range = 0. In: Tietz NW.4-dimethylcarboxanilido) naphthalene-1’-(2-hydroxybenzene).01 0.36 – 6.29 1.28:202-205. and correlation. The test is linear within a concentration range of 0.5 mmol/L calcium Haemolysis: Interference less than 10% up to 1. Anal Chim Acta 1957.5 – 8. 6. AU600 Serum/Plasma Application System Reagent: OSR6189 Specific Test Parameters General LIH ISE Range Test Name: MG ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 200 0 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.9 0. # OD CONC † Factor/OD-L 3* 1-Point Cal.: 66300 * Values set for working in SI units (mmol/L).5 ∇ Operation: Yes Test No ∇ ∇ # Test name MG Sample type Ser Page 1/2 System Reagent: OSR6189 Reagent ID: 089 Application MAGNESIUM. H 0. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name MG ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 3* # Conc Factor/OD-H 5* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 5* # SERUM/PLASMA APPLICATION Test Name: Counts: MG ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 7 ∇ Advanced Calibration: # ∇ Cal. No. ∇ ∇ ∇ Sec. # # ο ∇ 7.43 Metabolite . 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.3* 1 0 ¤ 14 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: MG ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. OD L Reagent OD limit Fst. # # ο ∇ 4.2* Correlation factor % ∇ 3. point MB type factor Calibrator stability period 7 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ο ∇ 5. H 3.MAGNESIUM. vol Dil. OD H 1. To work in mg/dL multiply by 2.2* B 14 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil.: 66300 * Values set for working in SI units (mmol/L). AU400/AU640 Serum/Plasma Reagent ID: 089 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 520 Sub Fst. No. To work in mg/dL multiply by 2. # # ο ∇ 3.43 BSOSR6x89.3* Fst Fst 0 Lst Lst First H Last H 1. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name MG Sample type Ser ∇ On-board stability period 520 END + First 0 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min.5 1. None Selected 8. H Lst. Reagent 1 vol Reagent 2 vol μL μL μL 2 200 0 Dil.9 0. L 0. # # ο ∇ 6.9 Dynamic range L 0.5 1. vol 0 0 0 Max. # # ο ∇ 2. vol Dil.9 Lst. No.5 800 END + 27 Sample vol.01 2009-08 # User defined † System Calibrator Cat. L 0. 2* 1 1 μL High B B 0 3.5 μL Min.9 High High 1.43 ф AU680 <Point Cal. For No. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 7 Day 0 Calibration 7 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. ∇ # # # # ο 6. ∇ 7. Volume R1(R1-1) μL ∇ μL 1.6 160 0 1. ∇ # # # # ο 3. ∇ # # # # ο 4. Not within expected values mmol/L* Decimal Places Calibration Specific ISE MG ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 3* 5* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 5* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: MG ∇ < > Test Name: Use Serum Cal.5 3. AU680/AU480 Serum/Plasma Application System Reagent: OSR6189 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H 0.9 0.6 1 160 Range Operation: ∇ Yes Test Name: MG ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 14 Last Last 10 % ∇ 1. # # ο ∇ 3. # # ο ∇ 6. ∇ ∇ ∇ 0.3* 0 0 Hour 0 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. # # ο ∇ 7.: 66300 * Values set for working in SI units (mmol/L).MAGNESIUM. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. No demographics 8. † System Calibrator Cat. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.3* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 10 0 μL μL μL Pri.9 R2(R2-1) μL Name Sec. ∇ # # # # ο 2. # # ο ∇ 4.OD Reagent OD Limit First Low Last Low Dilution 10 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6189 Reagent ID: 089 Application Operation Yes MAGNESIUM.5 1. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. AU2700/AU5400 Serum/Plasma Reagent ID: 089 Parameters General LIH MG ∇ Dilution μL Max.OD 0. No. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. # # ο ∇ 2. # OD CONC † Factor/OD-L 3* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 7 ∇ Advanced Calibration: # None ∇ 1-Point Cal. None Selected 8.5 1.01 2009-08 . of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x89.9 0. No. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 520 ∇nm END ∇ + ∇ 0 520 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 14 Day # ∇ +++++ ∇ ++++ ∇ ++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH MG ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # MG ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. To work in mg/dL multiply by 2. # # ο ∇ 5. ∇ # # # # ο 5.2* Sec. # # ο ∇ 5. Reagent 1 vol Reagent 2 vol μL μL μL 1 200 0 Dil.5 1.25* Fst Fst 0 Lst Lst First H Last H 1. AU400/AU640 Urine Reagent ID: 089 Specific test parameters Urine ∇ 1 Max OD H Main ∇ ∇ ∇ 520 Sub Fst. # # ο ∇ 2.2* Correlation factor % ∇ 9. AU600 Urine Application System Reagent: OSR6189 Specific Test Parameters General LIH ISE Range Test Name: MG ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 1 200 0 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.5 800 END + 27 Sample vol. L 0. None Selected 8. No. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # URINE APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name MG ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 5* # Conc Factor/OD-H 11* ∇ Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 11* # Test Name: Counts: MG ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 7 ∇ Advanced Calibration: # ∇ Cal. # # ο ∇ 4. OD H 1. # # ο ∇ 6. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. ∇ ∇ ∇ Sec. No. vol 0 0 0 Max. H 0. vol Dil. H 9.9 Dynamic range L 0. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. No.5 ∇ Operation: Yes Test No ∇ ∇ # Test name MG Sample type Uri Page 1/2 System Reagent: OSR6189 Reagent ID: 089 Application MAGNESIUM. To work in mg/dL multiply by 2. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name MG Sample type Uri ∇ On-board stability period 520 END + First 0 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. vol Dil.5 1.MAGNESIUM. To work in mg/dL multiply by 2. # OD CONC † Factor/OD-L 5* 1-Point Cal. L 0.01 2009-08 .: ODC0025 * Values set for working in SI units (mmol/L). H Lst. # # ο ∇ 7.9 Lst.43 Metabolite BSOSR6x89.2* B 14 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. # # ο ∇ 3.9 0. OD L Reagent OD limit Fst.25* 1 0 ¤ 14 Specific Test Parameters General LIH ISE Urine ∇ # Range Page 2/2 Level L # Level H # Test Name: MG ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.43 # User defined † Urine Calibrator Cat.: ODC0025 * Values set for working in SI units (mmol/L).9 0. point MB type factor Calibrator stability period 7 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Urine Calibrator Cat. # # ο ∇ 6.0 1 200 Range Operation: ∇ Yes Test Name: MG ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 14 % ∇ 1. To work in mg/dL multiply by 2. No. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 7 Day 0 Calibration 7 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined.01 2009-08 .2* 1 1 14 Day μL High B B 0 9. ∇ # # # # ο 5. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ ∇ ∇ 0.25* 0 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. 800 Onboard Stability Period Last Last 10 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.OD 0.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6189 Reagent ID: 089 Application Operation Yes MAGNESIUM. AU2700/AU5400 Urine Reagent ID: 089 Parameters General LIH MG ∇ Dilution μL Max.5 1.2* Sec.9 High High 1. None Selected 8.5 μL Min. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x89. Volume R1(R1-1) μL ∇ μL 1. # # ο ∇ 3. No demographics 8. # OD CONC † Factor/OD-L 5* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 7 ∇ Advanced Calibration: # None ∇ 1-Point Cal.: ODC0025 Values set for working in SI units (mmol/L).5 1. For No. ∇ 7. ∇ # # # # ο 3.9 0.25* 0 0 Hour 0 Dilution 0 Sample Volume Pre-Dilution Rate Rgt.9 R2(R2-1) μL Name Sec. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 520 ∇nm END ∇ + ∇ 0 520 END + First 0 First Last Last 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Urine ∇ LIH MG ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # MG ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.9 0. # # ο ∇ 2.5 9. # # ο ∇ 7. ∇ # # # # ο 4.MAGNESIUM. # # ο ∇ 5. ∇ # # # # ο 6. # # ο ∇ 4.43 AU680 <Point Cal. Urine Calibrator Cat. ∇ # # # # ο 2. Not within expected values mmol/L* Decimal Places Calibration Specific ISE MG ∇ < Low # # # # # # # # # URINE APPLICATION High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ Factor Range Low High 5* 11* ∇ # ο ∇ Calibration Specific General ISE Type Urine ∇ Counts: Factor/OD-H 11* # Process: CONC ∇ Test Name: MG ∇ < > Test Name: Use Serum Cal. Calibration Type: AB ∇ Formula: Y=AX+B Cal. AU680/AU480 Urine Application System Reagent: OSR6189 Specific Test Parameters General LIH ISE Urine ∇ 1 Max OD H 0.0 200 0 1. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. It is also useful in interpreting the significance of the total protein concentration to have more specific knowledge of individual fractions such as albumins and globulins. up to the stated expiry date when stored at 2…25°C. Wear suitable protective clothing. gloves and eye/face protection. contains sodium hydroxide. reagents stored on board the instrument are stable for 30 days. S61: In case of contact with eyes. 4 x 25 mL 4 x 25 mL 4 x 48 mL 4 x 48 mL R1 R2 R1 R2 Summary1 The total serum protein is the sum of all circulating proteins and is a major component of blood. Dispose of all waste material in accordance with local guidelines. This material and its container must be disposed of as hazardous waste. The absorbance of the complex at 540/660 nm is directly proportional to the concentration of protein in the sample. Values obtained for the controls should fall within specified limits as defined by the user. may cause long-term adverse effects in the aquatic environment.S36/37/39. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. R34 Causes burns. Once open. Safety Phrases: S26 . Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values.TOTAL PROTEIN OSR6132 OSR6232 Intended Use Photometric colour test for the quantitative determination of total protein in human serum and plasma on Beckman Coulter analysers. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheets for analyser-specific assay instructions. S45. Specimen Serum. Consequently each laboratory should set a calibration frequency in the instrument parameters appropriate to their usage pattern. R2 Reagent: Irritant. Each laboratory should establish its own control frequency.01 BLOSR6x32. or bone marrow as well as other metabolic and nutritional disorders. EDTA or heparinised plasma.01 2009-08 Metabolite . 66300. 3 Stable in serum and plasma for 4 weeks when stored at 2…8°C and 6 days when stored at 15…25°C. S60. If any trends or sudden shifts in values are detected. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. kidney. Good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Refer to Safety Data Sheets for further information. Storage and Stability The reagents are stable. Quality Control Controls Cat. Calibration System Calibrator Cat. Refer to special instructions/safety data sheets. review all operating parameters. Test Principle2 Cupric ions in an alkaline solution react with proteins and polypeptides containing at least two peptide bonds to produce a violet coloured complex. rinse immediately with plenty of water and seek medical advice. EN. No. Reaction Principle Protein + Cu 2+ OH ¯ Blue violet complex Contents. Both conditions can be distinguished by additional performance of serum protein electrophoresis and the determination of haematocrit. In case of accident or if you feel unwell. For in vitro diagnostic use only. Avoid release to the environment. The calibrator total protein value is traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 927c. Absorption of atmospheric CO2 by the reagent on board the analyser can impair calibration stability. A deviation of serum total protein from the reference interval indicates the presence of dysproteinemia or a disorder in water balance.8 mmol/L 30 mmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: R1 Reagent: Corrosive. Major preventative maintenance was performed on the analyser or a critical part was replaced. seek medical advice immediately (show the label where possible). Harmful to aquatic organisms. R36/38. Measurements of total protein are used in the diagnosis and treatment of a variety of diseases involving the liver. R52/53: Irritating to eyes and skin. No. unopened. Reagent Composition in the Test Final concentration of reactive ingredients: Sodium hydroxide Potassium sodium tartrate Copper sulphate Potassium iodide 200 mmol/L 32 mmol/L 18. This effect will vary depending upon the rate of use. Total Protein. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. sample type. 16:40-48.34 0. Reference Intervals1 Serum/plasma Adults Children (1 . plasma and serum samples. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 20 days.57 73.84 0. Use and assessment of clinical laboratory results. 1998:644-647. 4. sex.77 g/L.26 SD 0.18 0. The lowest detectable level represents the lowest measurable level of total protein that can be distinguished from zero. Amer J Clin Path 1946.50 0.0 g/dL) 41 – 63 g/L (4. Frankfurt/Main: TH-Books Verlagsgesellschaft.70 0. Wisser H.01 . Use of anticoagulants in diagnostic laboratory investigations and stability of blood. Clinical laboratory diagnostics. Results of linear regression analysis were as follows: y = 1.24 – 118.3 g/dL) Expected values may vary with age.30 0. Weichselbaum TE. Heil W.7 – 8. Each laboratory should verify the transferability of the expected values to its own population. 4 Setting Sheet Footnotes # † * ‡ 1.33 110. Data obtained in your laboratory may differ from these values. BIBLIOGRAPHY Metabolite BLOSR6x32.999 n = 125 Sample range = 33. n = 80 Mean g/L 35. Depends on usage pattern in the laboratory Thomas L. Effects of drugs on clinical laboratory tests. Ehret W. clinical examinations and other findings. 2000.80 Within Run SD 0.0 g/dL). An accurate and rapid method for the determination of proteins in small amounts of blood serum and plasma. Zawta B.51 0. User defined ¤ Analyser default value System Calibrator Cat. results should always be assessed in conjunction with the patient's medical history.3 g/dL) 57 – 80 g/L (5.71 Total CV% 0.26 g/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 24 mg/dL or 410 µmol/L bilirubin Haemolysis: Interference less than 10% up to 3 g/L haemoglobin ® Lipemia: Interference less than 10% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances. WHO/DIL/LAB/99. To work in g/dL divide by 10. Linearity The test is linear within a concentration range of 30 – 120 g/L (3.30 d) 66 – 83 g/L (6. ed.2:40pp.25 0. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter Systems.64 Sensitivity The lowest detectable level in serum on an AU400 analyser was estimated at 0. No.29 CV% 0. AACC. Young DS.: 66300 Values set for working in SI units (g/L).18 y) New-borns (1 .Calculation The Beckman Coulter analysers automatically compute the total protein concentration of each sample. 2. In: Thomas L. 5th ed. et al.0 – 12.003x – 1.1 Rev. Töpfer G. 3.6 – 8. AACC Press.091 r = 0.01 2009-08 EN.1 – 6. Method Comparison Patient serum samples were used to compare this Total Protein OSR6132 assay on the AU640 against another commercially available total protein assay. Schmitt Y. and if necessary determine its own reference interval according to good laboratory practice. For diagnostic purposes. diet and geographical location. H 120* Fst Fst 0 0 Lst Lst First H Last H 0. H Lst. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. L -0. To work in g/dL divide by 10.1 0. Metabolite . OSR6232 Reagent ID: 032 Application TOTAL PROTEIN. Vol 0 150 0 Max. No. H -0. # # ο ∇ 2.1 ∇ Operation: Yes Test No ∇ ∇ # Test name TP Sample type Ser Page ½ System Reagent: OSR6132. 660 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. To work in g/dL divide by 10.5 Dynamic range L 30* Correlation factor % ∇ 120* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: TP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Point MB type factor Calibrator stability period ‡ Select the function using the Function key or the Mouse # † * ‡ BSOSR6x32.5 30* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. L -0. OD H 0. # OD CONC † Factor/OD-L 147* 1-Point Cal. AU600 Serum/Plasma Application System Reagent: OSR6132. Depends on usage pattern in the laboratory. None Selected 8. Vol Dil.TOTAL PROTEIN. OSR6232 Specific Test Parameters General LIH ISE Range Test Name: TP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 6 50 50 μL μL μL Dilution Dilution Dilution 0 150 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.5 -0. # # ο ∇ 7. No. Depends on usage pattern in the laboratory. # # ο ∇ 5. # # ο ∇ 6. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name TP ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 147* # Conc Factor/OD-H 237* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 237* # SERUM/PLASMA APPLICATION Test Name: Counts: TP ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ‡ ∇ Advanced Calibration: # ∇ Cal. Vol Dil. Reagent 1 vol Reagent 2 vol μL μL μL 6 50 50 Dil. AU640 Serum/Plasma Reagent ID: 032 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 540 Sub Fst.1 0.1 Wave Method Reaction Point 1 Point 2 660 END + 27 10 Sample vol.5 Lst. or select from list displayed by Guide key Test No ∇ ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name TP Sample type Ser ∇ On-board stability period 540 END + First 0 First 0 Pri. No. # # ο ∇ 4.01 2009-08 User defined ¤ Analyser default value System Calibrator Cat.: 66300 Values set for working in SI units (g/L).: 66300 Values set for working in SI units (g/L). # † * ‡ User defined System Calibrator Cat. # # ο ∇ 3. OD L Reagent OD limit Fst. ∇ ∇ ∇ Sec. TOTAL PROTEIN. OSR6232 Reagent ID: 032 Specific Test Parameters General LIH ISE Range ∇ 1 Max OD H -0. Metabolite BSOSR6x32. No. # # ο ∇ 5.5 -0. # # ο ∇ 7.01 2009-08 . # Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: TP AB ∇ ∇ Formula: OD < > Y=AX+B CONC † ∇ Type Serum Counts: Factor/OD-L 150* # ∇ Process: CONC ∇ Factor/OD-H 244* SERUM/PLASMA APPLICATION Test Name: TP ∇ < > Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ ‡ ∇ Advanced Calibration: # Cal. # # ο ∇ 6. # # ο ∇ 3. Point: ο with CONC-0 Slope Check: 1-Point Cal. # OD CONC † Factor/OD-L 122* 1-Point Cal.1 0.: 66300 Values set for working in SI units (g/L). To work in g/dL divide by 10. # # ο ∇ 7. System Calibrator Cat. None Selected 8. AU400 Serum/Plasma Application System Reagent: OSR6132. # # ο ∇ 4. No.: 66300 Values set for working in SI units (g/L). # # ο ∇ 4. Out of Range L # # # # # # # # Unit: g/L* H # # # # # # # # Decimal places: # Panic Value: # # Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 195* # Process: CONC ∇ Calibration Specific General ISE Test Name: Calibration Type: Cal.1 120* 0 6 50 50 μL μL μL ∇ ∇ ∇ Last Last % ∇ 27 10 Sec. None Selected 8. 660 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 540 END + First 0 First 0 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Range ∇ Level L: Month # # # # # # L # # Age H Year # # # # # # H # < > Serum ∇ # Test Name: TP Range Specific Test Parameters General LIH ISE Test Name: TP ∇ < > Type: Type: Level H: Month # # # # # # Serum # ∇ Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 30* B 30 0 H 120* First H Last H 0. ∇ ∇ ∇ Sec. # # ο ∇ 3. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic Value: H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2.1 Pri. AU2700/AU5400 Serum/Plasma Reagent ID: 032 System Reagent: OSR6132.1 0. Depends on usage pattern in the laboratory.5 -0. # # ο ∇ 2.5 30* First H Last H H B 30 0. No. No. OSR6232 Specific Test Parameters General LIH ISE Range Test Name: TP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 5 33 33 μL μL μL Dilution Dilution Dilution 0 90 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: A 1 On-board stability period: 540 END + First 0 First 0 Pri. Depends on usage pattern in the laboratory # † * ‡ User defined System Calibrator Cat. # # ο ∇ 5. # # ο ∇ 6. Point: MB Type Factor: ο With CONC-0 Slope Check: None ∇ Advanced Calibration: Calibration Stability Period: ‡ # ∇ MB Type Factor: Calibration Stability Period: # † * ‡ User defined. Sample: Reagents: Volume R1 Volume R2 Volume ∇ Operation: Yes Test Name: TP Application TOTAL PROTEIN. ∇ 660 μL μL μL Dilution Dilution Dilution 0 140 10 < > Type: ∇ ∇ Serum Operation: Yes Serum ∇ 1 Max OD H -0. To work in g/dL divide by 10. For No. ∇ # # # # ο 3. To work in g/dL divide by 10.1 Sample Volume Pre-Dilution Rate Rgt. Not within expected values Month # # # # # # Low # # # # # # # # Unit g/L* Decimal Places # SERUM/PLASMA APPLICATION Parameters Calibrators General ∇ # ∇ None ∇ Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation # ∇ # ∇ Interval (RB/ACAL) ο Use Serum Cal.01 2009-08 . No.5 -0. ∇ # # # # ο 5. Volume R1(R1-1) 5 1 33 0 μL OD Limit μL ∇ μL Dilution 90 μL Min.TOTAL PROTEIN. ∇ # # # # ο 2. ∇ 7.5 High High 0.OD -0. ∇ # # # # ο 4. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 30 Day # ∇ +++++ ∇ +++ ∇ +++ ∇ Noneф 540 ∇nm END ∇ + ∇ 0 0 % ∇ Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General Range Serum ∇ Panic Value Low # High # LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: TP ∇ < > Type: High # High # # # # # # # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: TP ∇ < > Type Serum Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Y=AX+B ∇ Factor Range Low High 122* 195* Counts: <Point Cal. OSR6232 Parameters General Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: TP ∇ < > Type: Operation Yes Dilution Max. 0 Hour ф 660 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 30* 1 1 High B B 120* 0 0 Common Rgt.1 0. Depends on usage pattern in the laboratory AU680 Metabolite BSOSR6x32. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank ‡ Day ‡ Calibration ‡ Day ‡ Hour Hour MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 # † * ‡ ф User defined System Calibrator Cat.OD Reagent OD Limit First Low Last Low R2(R2-1) 33 μL Dilution 10 μL Name Sec. ∇ # # # # ο 6.: 66300 Values set for working in SI units (g/L). AU680/AU480 Serum/Plasma Reagent ID: 032 Application Range ∇ System Reagent: OSR6132. No demographics 8. . 6 µkat/L) Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents.5 kU/L (8. Specimen1 Serum and EDTA or heparinised plasma. which is read at 660/800nm.5 This Triglyceride procedure is based on a series of coupled enzymatic reactions. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument.5 mL R1 R2 R1 R2 Summary1..TRIGLYCERIDE OSR60118 OSR61118 Intended Use Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter analysers. Strongly icteric samples should be avoided. diabetes mellitus. Once open. Plasma using anticoagulants such as fluoride. The increase in absorbance at 660/800nm is proportional to the triglyceride content of the sample. The formed H2O2 reacts with 4-aminophenazone and N.98 kU/L (16.2 Measurements of triglyceride are used in the diagnosis and treatment of patients with acute and chronic pancreatitis. 9 Stable in serum and plasma for 7 days when stored at 2. up to the stated expiry date when stored at 2…8°C.5) 2+ Mg MADB 4-Aminoantipyrine ATP Preservative 50 mmol/L 4.01 2009-08 Metabolite . Test Principle3. or various endocrine disorders. Dispose of all waste material in accordance with local guidelines. unopened. Major preventative maintenance was performed on the analyser or a critical part was replaced. citrate and oxalate should be avoided.3 µkat/L) 0.6 mmol/L 0. 4 x 20 mL 4x 5 mL 4 x 50 mL 4 x 12. No.48 kU/L (24. The glycerol-3-phosphate is oxidised by molecular oxygen in the presence of GPO (glycerol phosphate oxidase) to produce hydrogen peroxide (H2O2) and dihydroxyacetone phosphate. or when the following occur: Change in reagent lot number or significant shift in control values. Recalibrate the assay every 30 days.N-bis(4-sulfobutyl)-3. flush waste-pipes with water after the disposal of undiluted reagent.5 kU/L (25 µkat/L) 0. To avoid the possible build-up of azide compounds. and other diseases involving lipid metabolism. extrahepatic biliary obstruction.4 mmol/L Lipases Glycerol kinase Peroxidase Ascorbate oxidase Glycerol-3-phosphate oxidase 1.6 µkat/L) 1.. Reaction Principle Triglycerides + 3 H2O Glycerol + ATP Glycerol-3-phosphate + O2 H2O2 + 4-AAP + MADB Lipase 2+ Glycerol + 3 Fatty acids Glycerol-3-phosphate + ADP Dihydroxyacetone phosphate + H2O2 Blue Dye + OH + 3 H2O - GK.3 µkat/L) 1. The triglycerides in the sample are hydrolysed by a combination of microbial lipases to give glycerol and fatty acids. Calibration System Calibrator Cat. Reagent Composition in the Test Final concentration of reactive ingredients: PIPES buffer (pH 7. 66300. For in vitro diagnostic use only. The glycerol is phosphorylated by adenosine triphosphate (ATP) in the presence of glycerol kinase (GK) to produce glycerol-3-phosphate.8°C and 2 days when stored at 15…25°C.5 mmol/L 1. nephrosis. EN. Clinically. and in the assessment of risk factors for atherosclerosis and coronary artery disease. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.01 BLOSR6x118. triglyceride assays are used to help classify various genetic and metabolic lipoprotein disorders.48 kU/L (24.4. The paediatric application is suitable for use with small volume serum/plasma samples. Storage and Stability The reagents are stable. disodium salt (MADB) in the presence of peroxidase (POD) to produce a chromophore. Mg GPO POD Contents. reagents stored on board the instrument are stable for 30 days. The calibrator triglyceride value provided in the calibrator package insert is traceable to the Isotope Dilution Mass Spectrometry Reference Method.25 mmol/L 0. Avoid using vacuum tubes with glycerol-coated stoppers.5-dimethylaniline. Riesen WF.04 10. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. sample type.01 2009-08 EN. No. diet and geographical location. BIBLIOGRAPHY Metabolite BLOSR6x118.25 mmol/L (150 – 199 mg/dL) High 2. Shephard MD. 5th ed. Van Denmark PJ. 2. 2000.15 CV% 1. Ann Clin Biochem.79 0.11 mmol/L (10 mg/dL) from the triglyceride value obtained. In order to identify grossly lipemic samples exhibiting this phenomenon. Clinical laboratory diagnostics. Frankfurt/Main: TH-Books Verlagsgesellschaft.285: 2486-2497. 98:1063-1068. User defined ¤ Analyser default value System Calibrator Cat. AACC Press.06 0. Zawta B. Philadelphia: WB Saunders Company.1 – 11. 7 Limitations Note: Triglycerides GPO enzymatic methodologies are subject to a strong negative interference from patient samples with extremely elevated 8 triglyceride levels. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. 3. Evaluation. If any trends or sudden shifts in values are detected.20 0. for example diabetes or liver disorders.1 Rev. results can be erroneously reported as being within the linear range of the assay. and the results multiplied by 5. Trinder P. Heil W. refer to Setting Sheet for specific instrument details. Use and assessment of clinical laboratory results. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.65 mmol/L (500 mg/dL) Expected values may vary with age.01 1.28 0. To work in mg/dL multiply by 88. 36:325-329.88:250-255. clinical examinations and other findings. J Bacteriol 1969. National Cholesterol Education Program Expert Panel.08 0. ed. Alpha-glycerophosphate oxidase in streptococcus faecium F 24. 6:24-27.03 0. @ or &). 5. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. Whiting MJ.01 . Precision The following data was obtained on an AU640 using 3 serum pools analysed over 20 days. WG. results should always be assessed in conjunction with the patient's medical history.2: 44pp. Reference Intervals6 Normal < 1. 6. Grossly lipemic samples under rare circumstances may evade the Data Check Parameters and should routinely be diluted 1 part sample to 4 parts saline prior to analysis.46 Sensitivity The lowest detectable level in serum on an AU640 analyser was estimated at 0. Lipid metabolism.005 r = 1. and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Executive summary of the third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection. The results obtained by any individual laboratory may vary from the given mean value. JAMA 2001. Koditschek LK. Jacobs NJ. ed. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.60 – 10. In: Thomas L.3 mmol/L (10 – 1000 mg/dL). ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. 8.85 mmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Ascorbate: Interference less than 5% up to 20 mg/dL ascorbate Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin Refer to Young for further information on interfering substances.76 1. Umbreit WW. While these samples are extremely lipemic in appearance and typically have triglyceride levels exceeding 20 mmol/L. 4.Quality Control Controls Cat. Effects of drugs on clinical laboratory tests. Guder. Calculation The Beckman Coulter analysers automatically compute the triglyceride concentration of each sample. sex. The lowest detectable level represents the lowest measurable level of triglyceride that can be distinguished from zero. plasma and serum samples. Results of linear regression analysis were as follows: y = 0.47 0. 1969. n = 80 Within Run Total Mean mmol/L SD CV% SD 0.03 1.966x – 0. Clin Chem 1990.5 Tietz NW. Prozone settings must be applied when using the Triglyceride reagent. Young DS. Clinical guide to laboratory tests. 7. WHO/DIL/LAB/99. review all operating parameters. For diagnostic purposes. 1995: 610-611. Setting Sheet Footnotes # † * 1. Falsely low estimation of triglycerides in lipemic plasma by the enzymatic triglyceride method with modified Trinder’s chromogen. subtract 0.000 n = 101 Sample range = 0. This correction is mainly applicable to healthy individuals.64 mmol/L (200 – 499 mg/dL) Very high ≥ 5. et al. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. 1998:169-171.01 mmol/L. No. 9. Data Check Parameters are provided. the analysis result will be flagged (F.70 mmol/L (150 mg/dL) Borderline high 1.01 4. Ehret W. Linearity The test is linear within a concentration range of 0. and if necessary determine its own reference interval according to good laboratory practice. Arch Biochem Biophys 1960. Data obtained in your laboratory may differ from these values.70 – 2.26 – 5. Each laboratory should verify the transferability of the expected values to its own population. Wisser H. but for some diseases.: 66300 Values set for working in SI units (mmol/L). Z. a higher concentration of free glycerol may occur. Method Comparison Patient serum samples were used to compare this Triglyceride OSR61118 assay on the AU640 against another commercially available triglyceride assay. AACC. Schmitt Y. Töpfer G. 3rd ed. 1 If compensating for free glycerol.72 0. If the reaction kinetics of a test exhibit the characteristics of one of these elevated triglyceride samples. 0500 9. L -0.0000 0 0 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 10 22 27 1. L -0. No. Vol Dil. To work in mg/dL multiply by 88. ∇ ∇ ∇ Sec.01 2009-08 .0000 0.1* Correlation factor Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Calibration Specific General ISE Serum # Factor/OD-H 19* Process: CONC ∇ ∇ Test Name: Counts: TRIG ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal.5 # User defined ¤ Analyser default value † System Calibrator Cat. or select from list displayed by Guide key Calibration Specific Test No AB ∇ Y=AX+B OD # Test name TRIG ∇ ∇ Conc † Count Process Factor/OD-L 12* # Conc Factor/OD-H 19* ∇ % Sec % ∇ On-board stability period 0 0 Lst Lst 660 Sub Fst.1 Lst.1 0. OD H 0.1000 0 22 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # User defined † System Calibrator Cat. Vol Dil. AU600 Serum/Plasma Application System Reagent: OSR60118. No. Linearity Fst No lag time Select using Space key.0000 0 0 NO 0 0.: 66300 * Values set for working in SI units (mmol/L).1 Dynamic range L 0. OSR61118 Specific Test Parameters General LIH ISE Range Test Name: TRIG ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 100 25 μL μL μL Dilution Dilution Dilution 0 90 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 660 END + First 0 First 0 Pri.0000 0. 800 ∇ Min. Reagent 1 vol Reagent 2 vol 2 100 25 Dil.0000 0.3 11. Point: ο with CONC-0 Slope Check: Select the function using the Function key or the Mouse Data Check Parameters Test No # Logic check-1 Name YES TRIG ∇ Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0. To work in mg/dL multiply by 88.3 0.0500 9.: 66300 * Values set for working in SI units (mmol/L). Point MB type factor Calibrator stability period 30 1-Point Cal. No. AU400/AU640 Serum/Plasma Reagent ID: 118 Specific Test Parameters Test No Serum 1 Max OD H Main Fst Fst Sample Pre-dil.1* B 30 0 H 11.0000 0. H Lst.5 Metabolite BSOSR6x118. OD L Reagent OD limit Fst.TRIGLYCERIDE. H H A B Rate -0.3* 1 0 ¤ 30 ∇ Operation: Yes ∇ # Test name TRIG ∇ Sample type Ser ∇ Page ½ System Reagent: OSR60118.3* First H Last H 0.3 0. # OD CONC † Factor/OD-L 12* Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. OSR61118 Reagent ID: 118 Application TRIGLYCERIDE. Vol 0 90 10 μL μL μL Max.3 Wave Method Reaction Point 1 Point 2 800 END + 27 10 ∇ ∇ ∇ Sample vol.1000 0 22 MB Type Factor: Calibration Stability Period: SERUM/PLASMA APPLICATION Data Check Parameters Serum ∇ Test Name: TRIG ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: < > Type: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 10 22 27 1.1 -0. 3 0.1 R2(R2-1) 17 μL Dilution 10 Name Sec. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ SERUM/PLASMA APPLICATION Data Check Parameters Serum ∇ Test Name: TRIG ∇ < > Type: <Point Cal.TRIGLYCERIDE. AU2700/AU5400 Serum/Plasma Reagent ID: 118 Parameters General LIH TRIG ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61118.01 2009-08 .3 11. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check None 660 ∇nm END ∇ + ∇ 0 0 % ∇ 660 END + First 0 First 0 Sec.3 Sample Volume Pre-Dilution Rate Rgt. No.1 High High 0.3 0. 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. # OD CONC † Factor/OD-L 10* Counts: # ∇ ∇ Factor Range Low High Slope Check 10* 17* Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. For No. To work in mg/dL multiply by 88.940 9.3* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 57 10 μL μL μL Pri. 800 Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L ∇ Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Calibration Specific General ISE Type: Serum ISE TRIG ∇ < > Y=AX+B Type Test Name: Counts: # Factor/OD-H 17* Process: CONC ∇ Test Name: TRIG ∇ < > ∇ Parameters Calibrators General Calibration Specific Calibration Parameters STAT Table Calibration Calibration Type: AB ∇ Formula: Y=AX+B ∇ Serum ∇ ο Use Serum Cal. No.: 66300 * Values set for working in SI units (mmol/L).1 -0. Volume R1(R1-1) Dilution 57 μL Min. ∇ ∇ ∇ 0. Cal.1000 0 22 Pattern1 Metabolite BSOSR6x118.0000 0. OSR66118 Specific Test Parameters General LIH ISE Operation Yes ∇ Range Serum 1 Max.3* 0 0 Hour < > Type: ∇ ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 Last Last 27 10 1.1 -0.9400 9. † System Calibrator Cat.100 0 22 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: # User defined. AU680 Serum/Plasma Application System Reagent: OSR61118.1* 1 1 μL High B B 0 11.6 1 66 μL ∇ μL Dilution 0 OD Limit μL Test Name: TRIG ∇ Operation: Yes Max OD H -0.6 66 17 0.0000 0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 30 Day 0 Calibration 30 Day 0 ∇ ο with Conc-0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters TRIG ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: 11 17 27 0.5 √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: 11 17 27 0.1* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.OD Reagent OD Limit First Low Last Low 1. OSR66118 Reagent ID: 118 Application TRIGLYCERIDE.OD -0. OD -0.1* 1 1 High B B 11. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 30 Day 0 Calibration 30 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 Parameters Misc CheckedTests Type: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: Serum ∇ Contamination Parameters Data Check Parameters Test Name: TRIG ∇ < > Logic Check -2 Check Point-1: Check Point Interval: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: 10 22 27 1.: 66300 * Values set for working in SI units (mmol/L). To work in mg/dL multiply by 88.0000 0.01 2009-08 Metabolite .6 1 66 0 μL OD Limit μL ∇ μL Dilution 57 μL Min.OD Reagent OD Limit First Low Last Low R2(R2-1) 17 μL Dilution 10 μL Sec. For No. ο Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: TRIG ∇ < > Type Serum Y=AX+B None ∇ Counts: # ∇ ∇ Factor Range Low High Slope Check 10* 17* Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal. No.3* 0 0 Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 660 ∇nm END ∇ + ∇ 0 0 % ∇ Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters Calibrators General ∇ Use Serum Cal.3 0. 0 Hour 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. OSR66118 Parameters General Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: TRIG ∇ < > Type: Operation Yes ∇ Dilution Max.0500 9.5 BSOSR6x118. Volume R1(R1-1) 1.1 High High 0.1 -0.3 Sample Volume Pre-Dilution Rate Rgt.1000 0 22 Pattern1 Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ # User defined. † System Calibrator Cat. AU480 Serum/Plasma Reagent ID: 118 Application Range System Reagent: OSR61118.TRIGLYCERIDE. 1* B 30 0 H 11.01 2009-08 . Point MB type factor Calibrator stability period 30 1-Point Cal.0500 9. OSR61118 Specific Test Parameters General LIH ISE Range Test Name: TRIGP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 100 25 μL μL μL Dilution Dilution Dilution 10 80 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 660 END + First 0 First 0 Pri. # OD CONC † Factor/OD-L 12* Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: # 30 Test No ∇ Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.0000 0.1 0.3* 1 0 ¤ 30 2 100 25 Dil.0500 9. L -0. AU600 Paediatric Application System Reagent: OSR60118. Vol Dil.3 11.0000 0.3 0. AU400/AU640 Paediatric Reagent ID: 118 Specific Test Parameters Test No Serum 1 Max OD H Main Fst Fst Sample Pre-dil.: 66300 * Values set for working in SI units (mmol/L). OSR61118 Reagent ID: 118 Application TRIGLYCERIDE.1000 0 22 MB Type Factor: Calibration Stability Period: PAEDIATRIC APPLICATION Data Check Parameters Serum ∇ Test Name: TRIGP ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: < > Type: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 10 22 27 1.: 66300 * Values set for working in SI units (mmol/L). L -0.0000 0. ∇ ∇ ∇ Sec.5 # User defined ¤ Analyser default value † System Calibrator Cat.1 Dynamic range L 0. No. H -0.3 0. Point: ο with CONC-0 Slope Check: None Select the function using the Function key or the Mouse Data Check Parameters # Name YES TRIGP ∇ Logic check-1 Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0.1000 0 22 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # User defined † System Calibrator Cat. or select from list displayed by Guide key Calibration Specific Test No AB ∇ Y=AX+B ∇ Conc † OD # Test name TRIGP ∇ Count Process Factor/OD-L 12* # Conc Factor/OD-H 19* ∇ % Sec % ∇ On-board stability period 0 0 Lst Lst H A B Rate 660 Sub Fst.5 Metabolite BSOSR6x118.1 Lst. Vol Dil.0000 0. No. Reagent 1 vol Reagent 2 vol 0.0000 0 0 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 10 22 27 1. OD L Reagent OD limit Fst. To work in mg/dL multiply by 88.0000 0 0 NO 0 0. To work in mg/dL multiply by 88.3* First H Last H 0. OD H ∇ Operation: Yes ∇ # Test name TRIGP ∇ Sample type Ser Page ∇ ½ System Reagent: OSR60118.1 -0. No. 800 ∇ Min. Vol 10 80 10 μL μL μL Max.TRIGLYCERIDE. H Lst.3 Wave Method Reaction Point 1 Point 2 800 END + 27 10 ∇ ∇ ∇ Sample vol. Linearity Fst No lag time Select using Space key.1* Correlation factor Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ A 1 On-board stability period: Calibration Specific General ISE Serum # Factor/OD-H 19* Process: CONC ∇ ∇ Test Name: TRIGP ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Counts: Cal. 6 66 17 0.3* 0 μL μL μL Dilution Dilution Dilution 10 47 10 μL μL μL Pri.100 0 22 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: # User defined. 800 Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L ∇ Last L Dynamic Range: L Correlation Factor: % ∇ A 1 On-board stability period: Calibration Specific General ISE Type: Serum ISE TRIGP Y=AX+B ∇ < > Type Test Name: Process: CONC ∇ Factor/OD-H 17* Test Name: TRIGP ∇ < > ∇ Parameters Calibrators General Calibration Specific Calibration Parameters STAT Table Calibration Calibration Type: AB ∇ Formula: Y=AX+B ∇ Counts: # Serum ∇ ο Use Serum Cal.0000 0. For No.1* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. OSR66118 Reagent ID: 118 Application TRIGLYCERIDE. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 30 Day 0 Calibration 30 Day 0 ∇ ο with Conc-0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters TRIGP ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: 11 17 27 0.3* 0 0 Hour < > Type: ∇ ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 1.OD Reagent OD Limit First Low Last Low 1. 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. OSR66118 Specific Test Parameters General LIH ISE Operation Yes ∇ Range Serum 1 Max. To work in mg/dL multiply by 88. Volume R1(R1-1) Dilution 47 μL Min. ∇ ∇ ∇ 0.3 11.3 Sample Volume Pre-Dilution Rate Rgt.1 R2(R2-1) 17 μL Dilution 10 Name Sec.01 2009-08 .3 0.1 High High 0.940 9.: 66300 * Values set for working in SI units (mmol/L).1 -0.OD -0.9400 9. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # ∇ Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ PAEDIATRIC APPLICATION Data Check Parameters Serum ∇ Test Name: TRIGP ∇ < > Type: <Point Cal.0000 0. Cal. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check None 660 ∇nm END ∇ + ∇ 0 0 % ∇ 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 660 END + First 0 First 0 Sec. No.6 1 66 μL ∇ μL Dilution 10 OD Limit μL Test Name: TRIGP ∇ Operation: Yes Max OD H -0. # OD CONC † Factor/OD-L 10* Counts: # ∇ ∇ Factor Range Low High Slope Check 10* 17* Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. AU680 Paediatric Application System Reagent: OSR61118.1* 1 1 μL High B B 0 11. AU2700/AU5400 Paediatric Reagent ID: 118 Parameters General LIH TRIGP ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61118.3 0. † System Calibrator Cat.TRIGLYCERIDE.1 -0.5 √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: 11 17 27 0.1000 0 22 Pattern1 Metabolite BSOSR6x118. No. 1 High High 0. OSR66118 Parameters General Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: TRIGP ∇ < > Type: Operation Yes ∇ Dilution Max. No.3 0. To work in mg/dL multiply by 88.OD -0.0500 9.3 Min. Volume R1(R1-1) 1.: 66300 * Values set for working in SI units (mmol/L). ο Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: TRIGP ∇ < > Type Y=AX+B None ∇ Counts: # ∇ ∇ Factor Range Low High Slope Check 10* 17* Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal.1000 0 22 Pattern1 Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ # User defined.01 2009-08 Metabolite .0000 0. AU480 Paediatric Reagent ID: 118 Application Range System Reagent: OSR61118.OD Reagent OD Limit First Low Last Low Sample Volume Pre-Dilution Rate Rgt. For No.6 1 66 10 μL OD Limit μL ∇ μL Dilution 47 μL R2(R2-1) 17 μL Dilution 10 μL Sec.1 -0.3* 0 0 Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 660 ∇nm END ∇ + ∇ 0 0 % ∇ Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters Calibrators General Serum ∇ Use Serum Cal.5 BSOSR6x118. 0 Hour 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour ο with Conc-0 Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 30 Day 0 Calibration 30 Day 0 MB Type Factor: 1-Point Calibration Point ∇ Parameters Misc CheckedTests Type: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: Serum ∇ Contamination Parameters Data Check Parameters Test Name: TRIGP ∇ < > Logic Check -2 Check Point-1: Check Point Interval: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: 10 22 27 1.TRIGLYCERIDE. † System Calibrator Cat.1* 1 1 High B B 11. Summary1. contains hydroxylammonium chloride.UIBC OSR6124 4 x 27 mL 4 x 3 mL 4 x 6 mL 4 x 2 mL R1 R1a R2 R2a Intended Use Photometric colour test for the quantitative determination of unsaturated iron binding capacity (UIBC) in human serum and plasma on Beckman Coulter analysers. Common causes for an increase in TIBC include iron deficiency anemia. oxalate or citrate plasma.e. or when the following occur: Change in reagent bottle or significant shift in control values. 5 Samples should be taken in the morning from patients in a fasting state. R40: Limited evidence of a carcinogenic effect. unopened. in iron poisoning. They are thus not available for the colour reaction with NitrosoPSAP. Calibration System Calibrator Cat. This is the unsaturated iron binding capacity (UIBC). 2+ Contents. No. Mix by gentle inversion before placing on board the instrument. Refer to special instructions/safety data sheets.3 Iron participates in a variety of vital processes in the body varying from cellular oxidative mechanisms to the transport and delivery of oxygen to body cells. Haemolysed samples should be avoided. S60. Storage and Stability The reagents are stable. R2: Contains hydroxylammonium chloride. principally transferrin. S61: Avoid contact with skin. nephrosis. such as cytochrome oxidase and peroxidases.2.9 µmol/L 176 µmol/L 36 mmol/L 175 mmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: R1: Harmful. R2: The entire contents of bottle R2a must be transferred into the entire volume of R2. Test Principle Fe from reagent 1 reacts with Nitroso-PSAP from reagent 2 to form an intense green complex. If sample is added a part or all of the iron ions bind specifically with transferrin at unsaturated iron binding sites at alkaline pH. Reagent Preparation R1: The entire contents of bottle R1a must be transferred into the entire volume of R1.01 2009-08 Metabolite . reagents stored on board the instrument are stable for 30 days. Wear suitable protective clothing and gloves. oral contraception and viral hepatitis. malignancy. Irritant to eyes. Major preventative maintenance was performed on the analyser or a critical part was replaced. as well as various enzymes. and transport iron-transferrin. as well as storage ironferritin. R43: May cause sensitisation by skin contact. serum transferrin has considerable reserve iron-binding capacity. Measured serum iron concentration is principally the Fe(III) bound to serum transferrin and does not include the iron contained in serum as free haemoglobin. flush waste-pipes with water after the disposal of undiluted reagent. Reagent Composition in the Test Final concentration of reactive ingredients: Tris Buffer (pH 8. the iron-sulphur proteins. 66300. For in vitro diagnostic use only. Refer to Safety Data Sheets for further information. Specimen Serum and heparinised plasma. To avoid the possible build-up of azide compounds. The remaining body iron is present in the flavoproteins. Do not use EDTA. Avoid release to the environment. Once prepared. This is called the serum unsaturated or latent iron-binding capacity. kwashiorkor and thalassemia. rinse immediately with plenty of water and seek medical advise. R36/R40 Limited evidence of a carcinogenic effect. Mix by gentle inversion before placing on board the instrument. haemoglobin and myoglobin. S26. UIBC measurements can be used in conjunction with serum iron concentration to obtain the total-iron binding capacity (TIBC) i. S36/37. Remove serum from red cells immediately to avoid haemolysis. since iron values can decrease by 30% during the course of the day.01 BLOSR6x24. the maximum concentration of iron that serum proteins. Since normally only about one-third of the iron-binding sites of transferrin are occupied by Fe(III). Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. up to the stated expiry date when stored at 2…8°C. The difference between the resulting changes in the measured absorbances with or without samples is equivalent to the iron quantity bound to transferrin.1) Iron Nitroso-PSAP Hydroxylammonium chloride Thiourea Preservative 180 mmol/L 6. 4 Stable in serum and plasma for 3 weeks when stored at 2…8°C and 7 days when stored at 15…25°C. renal disease. contains thiourea. Recalibrate the assay every 14 days. It is a constituent of the oxygen-carrying chromoproteins. late pregnancy. Wear eye/face protection in case of contact with eyes. TIBC is decreased in chronic infections. can bind. EN. Safety Phrases: S24. The calibrator value is traceable to a Beckman Coulter Master Calibrator. This material and its container must be disposed of as hazardous waste. R1a: Irritant. May produce an allergic reaction. Dispose of all waste material in accordance with local guidelines. Zawta B.58 0.8 – 53. Heil W.06 0. For diagnostic purposes. No. diet and geographical location. eds. Effects of drugs on clinical laboratory tests. 3rd ed. results should always be assessed in conjunction with the patient's medical history.WHO/DIL/LAB/99. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.295 r = 0. sex.93 1. Töpfer G.17 0. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.585. et al. plasma and serum samples. Use of anticoagulants in diagnostic laboratory investigations and stability of blood.39 1. review all operating parameters. Reference Intervals6 Adults 27. Klee GG. Woo J. If any trends or sudden shifts in values are detected. Clinical diagnosis and management by laboratory methods. Pesce AJ. Precision The following data was obtained on an AU2700 using 3 serum pools analysed over 20 days. Philadelphia: WB Saunders Company. ed. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. 2000. 1996:714pp.8 – 80. 7. Biochemical aspects of hematology.47 0. No. 5. 1996:188-190. Clinical guide to laboratory tests. ed. Ehret W.1698-1703.2:36pp. Metabolic intermediates and inorganic ions.55 62. Each laboratory should verify the transferability of the expected values to its own population.35 0.09 0. To work in µg/dL multiply by 5. In: Burtis CA. and correlation. Clinical chemistry theory. Schmitt Y. Tietz textbook of clinical chemistry. Data on file at Beckman Coulter. Philadelphia:WB Saunders Company.38 1. Calculation The Beckman Coulter analysers automatically compute the UIBC concentration of each sample.56 1. Perrotta G. 6.20-56. BIBLIOGRAPHY Metabolite BLOSR6x24.46 µmol/L.68 Sensitivity The lowest detectable level on an AU2700 analyser was estimated at 1.04 CV% 1. Philadelphia: WB Saunders Company. Young DS. clinical examinations and other findings. 3. The results obtained by any individual laboratory may vary from the given mean value. sample type. Data obtained in your laboratory may differ from these values. In: Kaplan LA.7 µmol/L (155 – 300 µg/dL) Expected values may vary with age. Method Comparison Patient serum samples were used to compare this UIBC OSR6124 assay on the AU2700 against another commercially available UIBC assay. eds. Wisser H. Tietz NW. 5th ed. Henry JB.01 .997 n = 117 Sample range = 14. Fairbanks VF. and if necessary determine its own reference interval according to good laboratory practice. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Results of linear regression analysis were as follows: y = 0.Quality Control Controls Cat.6 µmol/L (55 – 450 µg/dL). The lowest detectable level represents the lowest measurable level of UIBC that can be distinguished from zero.1 Rev.01 2009-08 EN. analysis. 2. AACC Press.: 66300 Values set for working in SI units (µmol/L). In: Henry JB. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Ashwood ER. Iron and total iron binding capacity.46 35. 1999. St Louis: Mosby.59 1.1995:376-377. User defined ¤ Analyser default value System Calibrator Cat. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed.66 µmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances. 4. Linearity The test is linear within a concentration range of 9. n = 80 Within Run Total Mean µmol/L SD CV% SD 29. 7 Setting Sheet Footnotes # † * 1.867x + 3. 6* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L # Age Y Y Y Y Y Y Level H # Test Name: UIBC ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. point MB type factor Calibrator stability period 14 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat No: 66300 * Values set for working in SI units (µmol/L).1 Last H 0. vol Dil.3 Last L -0. AU400/AU640 Serum/Plasma Reagent ID: 024 Specific test parameters Test No Serum Sample vol. H 10 150 30 Dil. None Selected 8. Linearity Fst No lag time % Sec 0 0 Lst Lst END 27 10 ∇ ∇ ∇ 10 150 30 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key. # # ο ∇ 6. OD H 0. AU600 Serum/Plasma Application System Reagent: OSR6124 Specific Test Parameters General LIH ISE Range Test Name: UIBC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil.585 BSOSR6x24.85* Correlation factor H A B Rate Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.85* H 80.6* Correlation Factor: A 1 B 0 On-board stability period: 30 80. To work In µg/dL multiply by 5. vol 0 0 0 μL μL μL Max. To work In µg/dL multiply by 5.1 Lst. ∇ ∇ ∇ Sec. H Lst. L -0. # # ο ∇ 4.3 0. No. None ∇ Min. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. OD L Reagent OD limit Fst. # # ο ∇ 5. # OD CONC † Factor/OD-L 340* 1-Point Cal.3 Dynamic Range: L 9. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name UIBC ∇ Sample type Ser ∇ 800 END First 0 First 0 Pri. # # ο ∇ 3.01 2009-08 # User defined † System Calibrator Cat No: 66300 * Values set for working in SI units (µmol/L). Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name UIBC ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 340* # Conc Factor/OD-H 510* ∇ Calibration Specific General ISE Serum # Factor/OD-H 510* Process: CONC ∇ ∇ SERUM/PLASMA APPLICATION Test Name: Counts: UIBC ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 14 ∇ Advanced Calibration: # ∇ Cal. L -0. vol Dil.1 Dynamic range L 9.585 Metabolite .UIBC. # # ο ∇ 7. # # ο ∇ 2.1 First H 0.3 ∇ Operation: Yes ∇ # Test name UIBC ∇ Sample type Ser ∇ Page 1/2 System Reagent: OSR6124 Reagent ID: 024 Application UIBC. Reagent 1 vol Reagent 2 vol Main 800 Sub Fst. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. None Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 9. ∇ # # # # ο 6.1 First H 0. # # ο ∇ 5. AU680 Serum/Plasma Application System Reagent: OSR6124 Specific Test Parameters General LIH ISE Operation Yes ∇ Range Serum Dilution Max. Not within expected values µmol/L* Decimal Places Calibration Specific ISE UIBC ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration Calibration Specific General ISE Type Serum Counts: Factor/OD-H 510* # Process: CONC ∇ ∇ SERUM/PLASMA APPLICATION Test Name: UIBC ∇ < > > Y=AX+B Type Serum Counts: ∇ # ο ∇ Use Serum Cal.1 Last H 0. ∇ 7. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal.85* 1 1 24 μL Dilution 0 μL High B B 0 8 120 24 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.1 High High 0. ∇ # # # # ο 2. # # ο ∇ 3. AU2700/AU5400 Serum/Plasma Reagent ID: 024 Parameters General LIH UIBC ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6124 Reagent ID: 024 Application UIBC. # # ο ∇ 6.6* Correlation Factor: A 1 B 0 On-board stability period: 30 Specific Test Parameters General LIH ISE Serum LIH UIBC ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # UIBC ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.UIBC. No.3 0. # # ο ∇ 2.1 -0. † System Calibrator Cat No: 66300 * Values set for working in SI units (µmol/L).3 Dynamic Range: L 9. # # ο ∇ 4.85* H 80. ∇ # # # # ο 3. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. None Selected 8.01 2009-08 . No demographics 8.OD Reagent OD Limit First Low Last Low Sample Volume Pre-Dilution Rate Rgt. To work In µg/dL multiply by 5. None ∇ Last Last 27 10 80. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis None 800 ∇nm END ∇ ∇ 0 0 % ∇ ∇ ∇ ∇ Sec.585 Hour Hour Metabolite BSOSR6x24. ∇ # # # # ο 4.3 Dilution 0 μL Min. For No.OD -0.6* 0 0 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.3 Last L -0. # # ο ∇ 7. ∇ # # # # ο 5. # OD CONC † Factor/OD-L 340* ∇ Factor Range Low High 340* 510* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 14 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. Volume R1(R1-1) 8 1 120 μL ∇ μL 0 OD Limit μL Test Name: UIBC ∇ Operation: Yes < > Type: ∇ ∇ Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) Name Sec. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 14 Day 0 Calibration 14 Day 0 <Point Cal. 800 END First 0 First 0 Common Rgt. principally transferrin. malignancy.01 2009-08 Metabolite . Once prepared.e. For in vitro diagnostic use only.01 BLOSR6x205. Common causes for an increase in TIBC include iron deficiency anemia. up to the stated expiry date when stored at 2…8°C. 4 Stable in serum and plasma for 3 weeks when stored at 2…8°C and 7 days when stored at 15…25°C. late pregnancy.3 Iron participates in a variety of vital processes in the body varying from cellular oxidative mechanisms to the transport and delivery of oxygen to body cells. R2: The entire contents of bottle R2a must be transferred into the entire volume of R2. Refer to Safety Data Sheets for further information. nephrosis. 2+ Contents. since iron values can decrease by 30% during the course of the day. Safety Phrases: S24. Reagent Composition in the Test Final concentration of reactive ingredients: Tris Buffer (pH 8. Exercise the normal precautions required for handling all laboratory reagents. Measured serum iron concentration is principally the Fe(III) bound to serum transferrin and does not include the iron contained in serum as free haemoglobin. unopened. Since normally only about one-third of the iron-binding sites of transferrin are occupied by Fe(III). Avoid contact with skin. TIBC is decreased in chronic infections. 66300. To avoid the possible build-up of azide compounds.9 µmol/L 176 µmol/L 36 mmol/L Precautions and Warnings Hazard Warnings and Risk Phrases: R1a: Irritant.UIBC OSR61205 4 x 27 mL 4 x 3 mL 4 x 6 mL 4 x 2 mL R1 R1a R2 R2a Intended Use Photometric colour test for the quantitative determination of unsaturated iron binding capacity (UIBC) in human serum and plasma on Beckman Coulter analysers. R43: May cause sensitisation by skin contact. Mix by gentle inversion before placing on board the instrument. Specimen Serum and heparinised plasma. as well as various enzymes. Remove serum from red cells immediately to avoid haemolysis.2. Storage and Stability The reagents are stable. kwashiorkor and thalassemia. This material and its container must be disposed of as hazardous waste. the iron-sulphur proteins. The remaining body iron is present in the flavoproteins. contains hydroxylammonium chloride. such as cytochrome oxidase and peroxidases.S37. They are thus not available for the colour reaction with NitrosoPSAP. Dispose of all waste material in accordance with local guidelines. The calibrator value is traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 937. Haemolysed samples should be avoided. flush waste-pipes with water after the disposal of undiluted reagent. can bind. reagents stored on board the instrument are stable for 30 days. serum transferrin has considerable reserve iron-binding capacity. No. or when the following occur: Change in reagent bottle or significant shift in control values. in iron poisoning. oxalate or citrate plasma. and transport iron-transferrin. Recalibrate the assay every 14 days. UIBC measurements can be used in conjunction with serum iron concentration to obtain the total-iron binding capacity (TIBC) i. haemoglobin and myoglobin. Calibration System Calibrator Cat. 5 Samples should be taken in the morning from patients in a fasting state.S60. Do not use EDTA. Summary1. oral contraception and viral hepatitis. R2: Contains hydroxylammonium chloride. renal disease. Mix by gentle inversion before placing on board the instrument. Test Principle Fe from reagent 1 reacts with Nitroso-PSAP from reagent 2 to form an intense green complex. the maximum concentration of iron that serum proteins. This is the unsaturated iron binding capacity (UIBC). May produce an allergic reaction. It is a constituent of the oxygen-carrying chromoproteins. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Reagent Preparation R1: The entire contents of bottle R1a must be transferred into the entire volume of R1.1) Iron Nitroso-PSAP Hydroxylammonium chloride Preservative 180 mmol/L 6. This is called the serum unsaturated or latent iron-binding capacity. EN. as well as storage ironferritin. The difference between the resulting changes in the measured absorbances with or without samples is equivalent to the iron quantity bound to transferrin. If sample is added a part or all of the iron ions bind specifically with transferrin at unsaturated iron binding sites at alkaline pH. Major preventative maintenance was performed on the analyser or a critical part was replaced. Wear suitable gloves. 1698-1703.: 66300 Values set for working in SI units (µmol/L). Metabolic intermediates and inorganic ions. 4. eds. eds. Data obtained in your laboratory may differ from these values.956 r = 0. analysis. results should always be assessed in conjunction with the patient's medical history. Wisser H. 1996:714pp. Woo J.1995:376-377.1 Rev. Zawta B. No. St Louis: Mosby. Fairbanks VF. Reference Intervals6 Adults 27.54 0. 7. Data on file at Beckman Coulter Biomedical Ltd. ed. Method Comparison Patient serum samples were used to compare this UIBC OSR61205 assay on the AU640 against another commercially available UIBC assay.8 – 63. ed. plasma and serum samples. No.68 72.992 n = 115 Sample range = 11. and correlation. BIBLIOGRAPHY Metabolite BLOSR6x205. sample type. and if necessary determine its own reference interval according to good laboratory practice.01 Sensitivity The lowest detectable level on an AU2700 analyser was estimated at 2. Philadelphia:WB Saunders Company. clinical examinations and other findings.Quality Control Controls Cat. diet and geographical location. Ashwood ER. Iron and total iron binding capacity. Linearity The test is linear within a concentration range of 10 – 100 µmol/L (55 – 550 µg/dL). Philadelphia: WB Saunders Company.56 0.57 0. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Pesce AJ. In: Kaplan LA. To work in µg/dL multiply by 5. et al. The lowest detectable level represents the lowest measurable level of UIBC that can be distinguished from zero.39 1.30 µmol/L. 3. Henry JB. review all operating parameters.01 . 2. Each laboratory should verify the transferability of the expected values to its own population.65 0.21 – 75. 5. 2000. Clinical diagnosis and management by laboratory methods. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.93 1.73 CV% 3. sex.82 35.585. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed.47 0. Results of linear regression analysis were as follows: y = 0. Ehret W.WHO/DIL/LAB/99. 5th ed. The results obtained by any individual laboratory may vary from the given mean value. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. Clinical chemistry theory. 7 Setting Sheet Footnotes # † * 1. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. 3rd ed. Calculation The Beckman Coulter analysers automatically compute the UIBC concentration of each sample. n = 80 Within Run Total Mean µmol/L SD CV% SD 24. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. Philadelphia: WB Saunders Company. Precision The following data was obtained on an AU2700 using 3 serum pools analysed over 20 days. If any trends or sudden shifts in values are detected. For diagnostic purposes.10 0. 1996:188-190.6 µmol/L (155 – 355 µg/dL) Expected values may vary with age.01 2009-08 EN. In: Burtis CA. 6. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.35 1.54 2. 1999. Heil W. In: Henry JB. Perrotta G. Schmitt Y.63 µmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 6% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 2 g/L haemoglobin ® Lipemia: Interference less than 5% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances. AACC Press. Klee GG. Tietz NW. Young DS.2:36pp.19 0. Clinical guide to laboratory tests. Töpfer G. User defined ¤ Analyser default value System Calibrator Cat. Biochemical aspects of hematology.988x + 1. Effects of drugs on clinical laboratory tests. Tietz textbook of clinical chemistry. 0* Correlation factor % ∇ 100. # OD CONC † Factor/OD-L 420* 1-Point Cal.1 Lst. Reagent 1 vol Reagent 2 vol μL μL μL 10 150 30 Dil. # # ο ∇ 5.3 Wave Method Reaction Point 1 Point 2 Sample vol. H 100* Fst Fst 0 0 Lst Lst END 27 10 First H Last H 0. # # ο ∇ 3. OD L Reagent OD limit Fst. AU400/AU640 Serum/Plasma Reagent ID: 205 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 800 Sub Fst. point MB type factor Calibrator stability period 14 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat No: 66300 * Values set for working in SI units (µmol/L).585 BSOSR6x205. Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name UIBC ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 420* # Conc Factor/OD-H 700* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 700* # SERUM/PLASMA APPLICATION Test Name: Counts: UIBC ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 14 ∇ Advanced Calibration: # ∇ Cal.1 10* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. No. OD H 0.3 0. To work In µg/dL multiply by 5. None ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min.UIBC. AU600 Serum/Plasma Application System Reagent: OSR61205 Specific Test Parameters General LIH ISE Range Test Name: UIBC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 10 150 30 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. None Selected 8. L -0. vol Dil.01 2009-08 # User defined † System Calibrator Cat No: 66300 * Values set for working in SI units (µmol/L). # # ο ∇ 6. # # ο ∇ 4. vol Dil.3 0. # # ο ∇ 7.1 Dynamic range L 10. To work In µg/dL multiply by 5.585 Metabolite . H Lst. H -0. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ο ∇ 2. L -0.3 ∇ Operation: Yes Test No ∇ ∇ # Test name UIBC Sample type Ser Page 1/2 System Reagent: OSR61205 Reagent ID: 205 Application UIBC. vol 0 0 0 Max. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name UIBC Sample type Ser ∇ On-board stability period 800 END First 0 First 0 Pri.0* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: UIBC ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 -0. ∇ ∇ ∇ Sec. 3 100* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. ∇ # # # # ο 2.UIBC.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61205 Reagent ID: 205 Application Operation Yes UIBC. Volume R1(R1-1) μL ∇ μL 8 1 120 Range Operation: ∇ Yes Test Name: UIBC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 Last Last 27 10 8 120 24 0. To work In µg/dL multiply by 5. ∇ # # # # ο 6.3 μL Min. For No. # # ο ∇ 4. No. # OD CONC † Factor/OD-L 420* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 14 ∇ Advanced Calibration: # None ∇ 1-Point Cal.3 0.1 -0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.585 AU680 <Point Cal. # # ο ∇ 3.01 2009-08 . Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A 10* 1 1 μL High B B 0 100* 0 0 Hour 24 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 14 Day 0 Calibration 14 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined. ∇ # # # # ο 5. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x205. ∇ 7. # # ο ∇ 6. None ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH UIBC ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # UIBC ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. System Calibrator Cat No: 66300 Values set for working in SI units (µmol/L).1 High High 0. None Selected 8. ∇ ∇ ∇ 10* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. # # ο ∇ 7. No demographics 8. # # ο ∇ 5. ∇ # # # # ο 3. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. Not within expected values µmol/L* Decimal Places Calibration Specific ISE UIBC ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 420* 700* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 700* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: UIBC ∇ < > Test Name: Use Serum Cal. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 800 ∇nm END ∇ ∇ 0 0 % ∇ 800 END First 0 First 0 Sec. AU680/AU480 Serum/Plasma Application System Reagent: OSR61205 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0.1 R2(R2-1) μL Name Sec.1 -0.OD -0. # # ο ∇ 2. AU2700/AU5400 Serum/Plasma Reagent ID: 205 Parameters General LIH UIBC ∇ Dilution μL Max. ∇ # # # # ο 4.3 0. resulting in increased rediffusion of urea in the distal tubules and increased creatinine secretion. For in vitro diagnostic use only. Reaction Principle Urea + 2 H2O 2-Oxoglutarate + 2 NH4 + 2 NADH + Urease 2 NH4 + CO3 + 2- GLDH 2 L-Glutamate + 2 NAD + 2 H2O + Contents. Haemolysed and strongly icteric samples should be avoided..UREA OSR6134 OSR6234 OSR6534 Intended Use Kinetic UV test for the quantitative determination of urea in human serum.. up to the stated expiry date when stored at 2…8°C. Urea synthesis is therefore dependant on daily protein intake and endogenous protein metabolism. Serum urea and serum creatinine determinations are frequently performed together in the differential diagnosis of kidney function. Rediffusion in the distal tubule depends on the urinary flow and is regulated by antidiuretic hormone. polycystic kidney. During diuresis. exsiccosis or thirst.8 mmol/L ≥ 17. urea synthesis rate. Once open. Plasma urea concentration is determined by renal perfusion. unopened. Prerenal elevation of urea occurs in cardiac decompensation. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument Storage and Stability The reagents are stable. which may occur in oliguric heart failure. tubular necrosis and nephrosclerosis. flush waste-pipes with water after the disposal of undiluted reagent. During antidiuresis. with 40 – 60% diffusing back into the blood. in particular those relating to the gastrointestinal system. Urea reagent OSR6534 for use on the AU680. chronic nephritis.26 mmol/L 10 mmol/L 2. chronic renal failure and prerenal azotaemia. Specimen Serum and EDTA or lithium heparinised plasma. Safety data sheet available for professional user on request. The ammonia produced in the first reaction + combines with 2-oxoglutarate and NADH in the presence of glutamate-dehydrogenase (GLDH) to yield glutamate and NAD . In end-stage renal failure. Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer NADH Tetra-Sodium diphosphate EDTA 2-Oxoglutarate Urease ADP GLDH Preservative 100 mmol/L ≥ 0. Post renal elevation of urea may be caused by obstruction of the urinary tract. the tubular urine flow is decreased. there is minimal rediffusion of urea into the blood. irrespective of the flow rate in the proximal tubule. 5 Urine: 24-hour collection without preservatives is recommended. In dialysis patients the urea concentration is representative of protein degradation and is also an indicator of metabolic status. Urea levels may be elevated due to renal causes such as acute glomerulonephritis.2 Urea is synthesised in the liver as the final product of protein and amino acid metabolism.65 mmol/L ≥ 9. Test Principle3 Urea is hydrolysed in the presence of water and urease to produce ammonia and carbon dioxide. The decrease in NADH absorbance per unit time is proportional to the urea concentration.and post renal kidney failure. Dispose of all waste material in accordance with local guidelines. a large quantity of urea is excreted in the urine and plasma urea concentration is low. and glomerular filtration rate (GFR) and may be increased in acute renal failure. reagents stored on board the instrument are stable for 30 days. Most of the urea produced during these metabolic processes is eliminated by glomerular filtration. plasma and urine on Beckman Coulter analysers.01 BLOSR6x34. In pre.76 kU/L ≥ 2. 4 Stable in urine for 7 days when stored at 2…8°C and 2 days when stored at 15…25°C. increased protein catabolism and water depletion. the urotoxic signs. urea rediffuses in the tubules at an increased rate and plasma urea is increased. correlate well with urea concentration. Do not use ammonium heparinised plasma. AU2700 and AU5400 systems only.6 mmol/L ≥ 0. To avoid the possible build-up of azide compounds.16 kU/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents.01 2009-08 Metabolite . 1 EN. 4 x 25 mL 4 x 25 mL 4 x 53 mL 4 x 53 mL 4 x 103 mL 4 x 103 mL R1 R2 R1 R2 R1 R2 Summary1. 4 Stable in serum and plasma for 7 days when stored at 2.25°C. n = 80 Within Run Total Mean mmol/L SD CV% SD 78. Data obtained in your laboratory may differ from these values.97 0.21 Sensitivity The lowest detectable level using serum settings on an AU600 analyser was calculated as 0.44 mmol/L Patient urine samples were used to compare this Urea OSR6134 assay on the AU2700 against another commercially available urea assay.80 1.8 – 7. No. 1 Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. No. The results obtained by any individual laboratory may vary from the given mean value. Reference Intervals Serum/Plasma Adult (Global) 2.55 mmol/L Interfering Substances Results of serum studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 20 mg/dL or 342 µmol/L bilirubin Haemolysis: Interference less than 10% up to 2. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Results of linear regression analysis were as follows: y = 0. Limitations Metabolite BLOSR6x34.4 – 4. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.91 0. Biorad Liquichek Urine Chemistry Controls Cat.10 1.206 r = 0.05 2.4 mg/dL) 7 250 – 570 mmol/day (15.81 1.38 mmol/L. If any trends or sudden shifts in values are detected.25 2.Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Calibration Use System Calibrator Cat.5 g/L haemoglobin ® Lipemia: Interference less than 3% up to 500 mg/dL Intralipid Results of urine studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin 8 Refer to Young for further information on interfering substances.999 n = 116 Sample range = 1.41 3. Method Comparison Patient serum samples were used to compare this Urea OSR6134 assay on the AU600 against another commercially available urea assay. The urea values of both calibrators are traceable to the National Institute of Standards and Technology (NIST) Reference Material (SRM) 909b Level 1.2.28 0.8 – 6. Each laboratory should verify the transferability of the expected values to its own population.200 mg/day) Urine Expected values may vary with age.10 14.34 0. 66300 for serum/plasma application and Urine Calibrator Cat. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. sex. sample type.02 2. Linearity The test is linear within a concentration range of 0.70 4.8 – 50 mmol/L (5 – 300 mg/dL) for serum and plasma. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used for the serum/plasma application. results should always be assessed in conjunction with the patient's medical history. and if necessary determine its own reference interval according to good laboratory practice.976x . ODC0025 for urine application. Results of linear regression analysis were as follows: y = 0. Quality Control Controls Cat. The lowest detectable level represents the lowest measurable level of urea that can be distinguished from zero.42 CV% 3.81 0.2 mmol/L (17 – 43 mg/dL) 6 1.01 . review all operating parameters.38 2. No.01 CV% 3.928x . The test is linear within a concentration range of 10 – 750 mmol/L (60 – 4500 mg/dL) for urine.50 0. diet and geographical location.40 0. clinical examinations and other findings. It is calculated as three standard deviations of 20 replicates of an analyte free sample.91 The following data was obtained on an AU640 using 3 urine pools analysed over 20 days.05 – 683.03 0.4 – 25. The paediatric application is suitable for use with small volume serum/plasma samples. 397 and 398 or other control materials with values determined by this Beckman Coulter system may be used for the urine application.09 3. For diagnostic purposes.38 – 39.4 mmol/L (10.06 9.999 n = 125 Sample range = 46.71 0. Major preventative maintenance was performed on the analyser or a critical part was replaced.01 2009-08 EN.88 9.0.23 37.71 mmol/L. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 20 days.68 436.144 r = 0.000 – 34.44 283. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. n = 80 Within Run Total Mean mmol/L SD CV% SD 1. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed.8 mg/dL) Newborn Infant/child 1. The lowest detectable level using urine settings on the AU2700 was estimated as 5.8 – 38. Calculation The Beckman Coulter analysers automatically compute the urea concentration of each sample.97 2. No.3 mmol/L (8. Schmitt Y. Effects of drugs on clinical laboratory tests. 8. and preservation of urine specimens. Young DS. Tietz textbook of clinical chemistry. 7. 4. Pesce AJ. St. 2001. No.Highly lipemic samples may exceed the reaction absorbance and will be flagged with a “@”. 3.01 BLOSR6x34. Philadelphia:WB Saunders Company. Newman DJ. BIBLIOGRAPHY EN. approved guideline. Klin Wochenschr 1965. Clinical chemistry theory. Reference information for the clinical laboratory.ODC0025 Values set for working in SI units (mmol/L). eds. Frankfurt/Main: TH-Books Verlagsgesellschaft. AACC Press. Urea. 5th ed. 2nd ed. Philadelphia: WB Saunders Company. ODC0025 1:10 with purified H2 0. Dilute samples and Urine Calibrator Cat. Ehret W. Wisser H.1239-1241. 2000. analysis and correlation. Kazmierczak. Use and assessment of clinical laboratory results. No.01 2009-08 Metabolite .: 66300/ Urine Calibrator Cat. Thomas L. 1996:500pp. Urea and blood urea nitrogen (BUN). Painter PC. Tietz textbook of clinical chemistry. Setting Sheet Footnotes ‡ # † * Ω 1. Töpfer G. NCCLS. To work in mg/dL multiply by 6. Clinical laboratory diagnostics. Price CP. 5.1 Rev. Zawta B. Renal function and nitrogen metabolites. eds. Depends on usage pattern in the laboratory. Pennsylvania: NCCLS.43:174-75. Ashwood ER. 49pp. Urinalysis and collection. Smith JL. In: Burtis CA. ed. In: Kaplan LA. Talke H. Heil W. Louis: Mosby. In: Burtis CA. 1998:374. WHO/DIL/LAB/99. transportation. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. et al. 1838pp. Cope JY. Enzymatische harnstoffbestimmung in blut und serum im optischen test nach Warburg. No. 1999. plasma and serum samples. eds. Ashwood ER. NCCLS Document GP16-A2. 1999. In: Thomas L. 6.377. User defined ¤ Analyser default value System Calibrator Cat. 2. Such samples should be diluted and re-run.2:44pp. Schubert GE. . Vol Dil. Point MB type factor Calibrator stability period Ω Select the function using the Function key or the Mouse # User defined ¤ Analyser default value Ω Depends on usage pattern in the laboratory † System Calibrator Cat. # # ∇ 4.UREA.5 50 50 µL µL µL Dilution Dilution Dilution 0 40 10 µL µL µL Pri. # OD CONC † Factor/OD-L 82* 1-Point Cal.5 2. OD L 1. H Lst. Vol Dil. OSR6234 Specific Test Parameters General LIH ISE Range Test Name: UREA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2. None Selected 8.5 # Test name UREA ∇ Sample type Ser ∇ Page ½ System Reagent: OSR6134.8* B 30 Linearity Fst No lag time NO 25 % Sec % ∇ 0 Sample Pre-dil. H 50* Fst Fst 12 Lst Lst First H Last H 2. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 Fst.: 66300 Values set for working in SI units (mmol/L).02 2010-06 # † * Ω User defined System Calibrator Cat. # # ∇ 3. # # ∇ 7. OD H Min. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. L 1.5 2.8* Correlation factor H A B Rate ∇ Operation: Yes ∇ Test No 2. # # ∇ 2. AU600 Serum/Plasma Application System Reagent: OSR6134.: 66300 * Values set for working in SI units (mmol/L). OSR6234 Reagent ID: 034 Application UREA. No.5 1.0 Reagent OD limit Fst. L 1. AU400/AU640 Serum/Plasma Reagent ID: 034 Specific test parameters Serum 1 1.0 1. To work in mg/dL multiply by 6. H Sample vol. ∇ ∇ ∇ Sec. No.5 2.5 Dynamic range L 0. Vol 0 40 10 µL µL µL Max. Reagent 1 vol Reagent 2 vol 2.5 Main 340 Sub 660 RATE 18 ∇ ∇ ∇ Max OD H 2. # # ∇ 6. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name UREA ∇ Sample type Ser ∇ On-board stability period 340 RATE First 12 First 25 YES Last Last 18 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 % ∇ 50* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L # Age Y Y Y Y Y Y Level H # Test Name: UREA ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 Lst.5 50 50 Dil. # # ∇ 5.5 0. To work in mg/dL multiply by 6 BSOSR6x34. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name UREA ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 82* # Conc Factor/OD-H 152* ∇ Calibration Specific General ISE Serum # Factor/OD-H 152* Process: CONC ∇ ∇ SERUM/PLASMA APPLICATION Test Name: Counts: UREA ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None Ω ∇ Advanced Calibration: # ∇ Cal. No. Depends on usage pattern in the laboratory Metabolite . # # # # ∇ 5.UREA. No.5 1.OD Reagent OD Limit First Low Last Low 0 µL OD Limit 2. For No. # # # # ∇ 4. # # # # ∇ 3. # # # # ∇ 6. To work in mg/dL multiply by 6. OSR6234. # # # # ∇ 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration ∇ with Conc-0 Ω Ω Day Day 0 0 Hour Hour Metabolite BSOSR6x34. No. # # ∇ 7. # # ∇ 2. # # ∇ 4.5 1. Not within expected values mmol/L* Decimal Places Calibration Specific ISE UREA ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ # ∇ Calibration Specific General ISE Type Serum Counts: Factor/OD-H 192* # Process: CONC ∇ ∇ SERUM/PLASMA APPLICATION Test Name: UREA ∇ < > Use Serum Cal. AU2700/AU5400 Serum/Plasma Reagent ID: 034 Parameters General LIH UREA Dilution 1. Point: with CONC-0 Slope Check: # Interval (RB/ACAL) Lot Calibration ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1.: 66300 * Values set for working in SI units (mmol/L). OSR6534 Reagent ID: 034 Application Operation Yes ∇ UREA.5 2.5 R2(R2-1) ф 660 40 µL Dilution 10 Name Sec.5 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ ∇ 12 340 RATE First 12 First 25 YES Last Last 18 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum LIH UREA ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # UREA ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Ω Depends on usage pattern in the laboratory Ф AU680 <Point Cal. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.0 1.5 50* B 30 Last Last 18 25 YES % ∇ Sample Volume Pre-Dilution Rate Rgt. ∇ ∇ ∇ 0.5 ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6134. No demographics 8. Volume R1(R1-1) 2 1 40 µL ∇ µL Test Name: UREA ∇ Yes < > Type: ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 2 40 40 µL µL µL Dilution Dilution Dilution 0 30 10 µL µL µL Pri. # # ∇ 3. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. † System Calibrator Cat.5 2. None Selected 8.8* 1 1 µL High B B 0 50* 0 0 Hour Range ∇ Operation: Max OD H 2.5 High High Max.0 1.02 2010-06 . # # # # ∇ 7. # # ∇ 5. OSR6234. # # ∇ 6. OSR6534 Specific Test Parameters General LIH ISE Serum 1 1.8* Sec. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. # OD CONC † Factor/OD-L 106* ∇ Factor Range Low High 82* 152* Slope Check Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None Ω ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal.5 2.OD Dilution 30 µL Min. AU680/AU480 Serum/Plasma Application System Reagent: OSR6134. ∇ ∇ ∇ Sec.5 # Test name UREA ∇ Sample type Uri ∇ Page 1/2 Application Manual Dilution Standard Mode Urine Application Reagent ID: 034 UREA.UREA. vol Dil. ODC0025 1:10 with purified H2 0. L 1. AU600 System Reagent: OSR6134. OD H Min.: ODC0025 Values set for working in SI units (mmol/L).0 Reagent OD limit Fst. No. User defined ¤ Analyser default value Ω Depends on usage pattern in the laboratory Urine Calibrator Cat. OSR6234 Specific Test Parameters General LIH ISE Range Test Name: UREA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 50 50 µL µL µL Dilution Dilution Dilution 0 40 10 µL µL µL Pri. Depends on usage pattern in the laboratory Metabolite . point MB type factor Calibrator stability period ‡ # † * BSOSR6x34. or select from list displayed by Guide key Sample type Uri ∇ Level L # Age Y Y Y Y Y Y H # # # # # # M→ M→ M→ M→ M→ M→ Page 2/2 Level H # Range Test Name: UREA ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 2. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 2.5 Dynamic range L 10 Correlation factor H A B Rate ∇ Operation: Yes ∇ Test No 2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: On-board stability period 340 RATE First 12 First 25 YES Last Last 18 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 % ∇ 750* 1 0 □ 30 Specific Test Parameters General LIH ISE Test No # L # # # # # # M M M M M M # # # # # # ∇ # Test name UREA ∇ Urine # # # # # # # Age Y Y Y Y Y Y ∇ Select using Space key. No. # # ∇ 2. # # ∇ 3. # OD CONC † Factor/OD-L 1000* 1-Point Cal. L 1. OD L 1.: ODC0025 Values set for working in SI units (mmol/L).5 1.5 Main 340 Sub 660 RATE 18 ∇ ∇ ∇ Max OD H 2. H Lst.0 1. OSR6234 Specific test parameters Urine 10 1. # # ∇ 7.5 2. H Sample vol. To work in mg/dL multiply by 6. AU400/AU640 Urine Reagent ID: 034 System Reagent: OSR6134.02 2010-06 Ω Select the function using the Function key or the Mouse Dilute samples and Urine Calibrator Cat. # # ∇ 4. None Selected 8.5 Fst. # # ∇ 6. Reagent 1 vol Reagent 2 vol 2‡ 50 50 Dil. # # ∇ 5. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range URINE APPLICATION Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name UREA Calibration Specific General ISE Urine # Factor/OD-H 2100* Process: CONC ∇ ∇ Test Name: Counts: UREA ∇ < > Type ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 1000* # Conc Factor/OD-H 2100* ∇ Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None Ω ∇ Advanced Calibration: # ∇ Cal. To work in mg/dL multiply by 6. No. vol Dil.5 Lst. vol 0 40 10 µL µL µL Max. H 750* Fst Fst 12 Lst Lst First H Last H 2. # † * Ω User defined Urine Calibrator Cat. No.5 10 B 30 Linearity Fst No lag time NO 25 % Sec % ∇ 0 Sample Pre-dil. # # ∇ 5.6 40 40 µL µL µL Dilution Dilution Dilution 0 30 10 µL µL µL Pri. Volume R1(R1-1) 1.5 R2(R2-1) ф 660 Onboard Stability Period Last Last 18 40 µL Dilution 10 Name Sec. Point: with CONC-0 Slope Check: # Interval (RB/ACAL) Lot Calibration ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ω Ф User defined. Urine Calibrator Cat.0 1. # # # # ∇ 5.02 2010-06 . No. OSR6234. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ ∇ 12 340 RATE First 12 First 25 YES Last Last 18 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Urine LIH UREA ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # UREA ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. OSR6234. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. ∇ ∇ ∇ 10 Sec. # OD CONC † Factor/OD-L 1000* ∇ Factor Range Low High 1000* 2100* Slope Check Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None Ω ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. For No.UREA. AU2700/AU5400 Urine Reagent ID: 034 Parameters General LIH UREA Dilution 1.OD Reagent OD Limit First Low Last Low 0 µL OD Limit 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration ∇ with Conc-0 Ω Ω Day Day 0 0 Hour Hour Metabolite BSOSR6x34. Not within expected values mmol/L* Decimal Places Calibration Specific ISE UREA ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ # ∇ Calibration Specific General ISE Type Urine Counts: Factor/OD-H 2100* # Process: CONC ∇ ∇ Test Name: UREA ∇ < > Use Serum Cal. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 10* 1 1 30 Day µL High B B 0 750* 0 0 Hour Range ∇ Operation: Max OD H 2. # # # # ∇ 6. # # ∇ 4. # # # # ∇ 7.5 1. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. # # ∇ 6.0 1. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # URINE APPLICATION Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. # # # # ∇ 3. No demographics 8.5 2. No.5 High High Max.5 ∇ Type: Urine < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6134. # # # # ∇ 2.: ODC0025 Values set for working in SI units (mmol/L).5 2. AU680/AU480 Urine Application System Reagent: OSR6134. OSR6534 Reagent ID: 034 Application Operation Yes ∇ UREA.5 750* B 30 25 YES % ∇ Sample Volume Pre-Dilution Rate Rgt.OD Dilution 30 µL Min.5 2.5 2. OSR6534 Specific Test Parameters General LIH ISE Urine 10 1. # # ∇ 2.6 10 40 µL ∇ µL Test Name: UREA ∇ Yes < > Type: ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 1. None Selected 8. To work in mg/dL multiply by 6.5 1. Depends on usage pattern in the laboratory AU680 <Point Cal. # # ∇ 7. # # # # ∇ 4. # # ∇ 3. # # ∇ 2. vol Dil. OSR6234 Specific Test Parameters General LIH ISE Range Test Name: UREAP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2. L 1.0 Reagent OD limit Fst. # # ∇ 6. ∇ ∇ ∇ Sec. L 1. Reagent 1 vol Reagent 2 vol 2.5 Fst. To work in mg/dL multiply by 6.02 2010-06 # † * Ω User defined System Calibrator Cat. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name UREAP ∇ Sample type Ser ∇ On-board stability period 340 RATE First 12 First 25 YES Last Last 18 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 % ∇ 50* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L # Age Y Y Y Y Y Y Level H # Test Name: UREAP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.8* B 30 Linearity Fst No lag time NO 25 % Sec % ∇ 0 Sample Pre-dil. vol Dil. # # ∇ 3.5 0.5 2.UREA.8* Correlation factor H A B Rate ∇ Operation: Yes ∇ Test No 2. H Sample vol. OSR6234 Reagent ID: 034 Application UREA. None Selected 8. # # ∇ 5. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.: 66300 Values set for working in SI units (mmol/L). 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. To work in mg/dL multiply by 6. OD H Min. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name UREAP ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 90* # Conc Factor/OD-H 140* ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Serum # Factor/OD-H 140* Process: CONC ∇ ∇ Test Name: Counts: UREAP ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None Ω ∇ Advanced Calibration: # ∇ Cal.5 Main 340 Sub 660 RATE 18 ∇ ∇ ∇ Max OD H 2. # # ∇ 4. Depends on usage pattern in the laboratory Metabolite .5 2. No. vol 10 30 10 µL µL µL Max. OD L 1.5 50 50 µL µL µL Dilution Dilution Dilution 10 30 10 µL µL µL Pri. # OD CONC † Factor/OD-L 90* 1-Point Cal.5 Lst. No.5 50 50 Dil. BSOSR6x34.5 2.0 1. # # ∇ 7. H Lst. No.5 # Test name UREAP ∇ Sample type Ser ∇ Page 1/2 System Reagent: OSR6134. AU600 Paediatric Application System Reagent: OSR6134.: 66300 * Values set for working in SI units (mmol/L).5 1. AU400/AU640 Paediatric Reagent ID: 034 Specific test parameters Serum 1 1.5 Dynamic range L 0. H 50* Fst Fst 12 Lst Lst First H Last H 2. point MB type factor Calibrator stability period Ω Select the function using the Function key or the Mouse # User defined ¤ Analyser default value Ω Depends on usage pattern in the laboratory † System Calibrator Cat. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.5 2. To work in mg/dL multiply by 6. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal.0 1. No.8* Sec.5 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration ∇ with Conc-0 Ω Ω Day Day 0 0 Hour Hour Metabolite BSOSR6x34. Volume R1(R1-1) 2 1 40 µL ∇ µL Test Name: UREAP ∇ Yes < > Type: ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 2 40 40 µL µL µL Dilution Dilution Dilution 10 20 10 µL µL µL Pri.UREA. # # ∇ 5. Depends on usage pattern in the laboratory AU680 <Point Cal. Not within expected values mmol/L* Decimal Places Calibration Specific ISE UREAP ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ # ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum Counts: Factor/OD-H 140* # Process: CONC ∇ ∇ Test Name: UREAP ∇ < > Use Serum Cal. # # # # ∇ 4.5 R2(R2-1) ф 660 40 µL Dilution 10 Name Sec. # # # # ∇ 6. # # ∇ 4. # # # # ∇ 5.5 50* B 30 Last Last 18 25 YES % ∇ Sample Volume Pre-Dilution Rate Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ ∇ 12 340 RATE First 12 First 25 YES Last Last 18 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum LIH UREAP ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # UREAP ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.: 66300 Values set for working in SI units (mmol/L). System Calibrator Cat.5 2.OD Reagent OD Limit First Low Last Low 10 µL OD Limit 2. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. OSR6534 Specific Test Parameters General LIH ISE Serum 1 1. Point: with CONC-0 Slope Check: # Interval (RB/ACAL) Lot Calibration ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ω Ф User defined.5 High High Max. # OD CONC † Factor/OD-L 90* ∇ Factor Range Low High 90* 140* Slope Check Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None Ω ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. # # # # ∇ 7. # # # # ∇ 2. No demographics 8. ∇ ∇ ∇ 0.0 1. None Selected 8.5 1. # # ∇ 2.5 2. For No.02 2010-06 . # # ∇ 3. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. AU2700/AU5400 Paediatric Reagent ID: 034 Parameters General LIH UREAP Dilution 1.OD Dilution 20 µL Min. OSR6534 Reagent ID: 034 Application Operation Yes ∇ UREA. AU680/AU480 Paediatric Application System Reagent: OSR6134. # # ∇ 6. # # # # ∇ 3. No. # # ∇ 7. OSR6234.5 1. OSR6234.8* 1 1 µL High B B 0 50* 0 0 Hour Range ∇ Operation: Max OD H 2.5 ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6134. Specimen Serum and EDTA or lithium heparinised plasma. Safety data sheet available for professional user on request.. tubular necrosis and nephrosclerosis. in particular those relating to the gastrointestinal system. with 40-60% diffusing back into the blood. Plasma urea concentration is determined by renal perfusion.UREA STAT OSR6141 OSR6541 Intended Use Kinetic UV test for the quantitative determination of urea in human serum. Reagent Preparation To prepare the working reagent. there is minimal rediffusion of urea into the blood. Urea synthesis is therefore dependant on daily protein intake and endogenous protein metabolism. Rediffusion in the distal tubule depends on the urinary flow and is regulated by antidiuretic hormone.16 kU/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. which may occur in oliguric heart failure. Do not use ammonium heparinised plasma. Reaction Principle Urea + 2 H2O 2-Oxoglutarate + 2 NH4 + 2 NADH Final concentration of reactive ingredients: Tris buffer NADH Tetra-Sodium diphosphate EDTA 2-Oxoglutarate Urease ADP GLDH Preservative + Urease GLDH 2 NH4 + CO3 + 2- 2 L-Glutamate + 2 NAD + 2 H2O + Contents.65 mmol/L ≥ 9. Reagent Composition in the Test 100 mmol/L ≥ 0. reagent stored on board the instrument is stable for 21 days. chronic renal failure and prerenal azotaemia. resulting in increased rediffusion of urea in the distal tubules and increased creatinine secretion. Storage and Stability The reagent components are stable. the tubular urine flow is decreased. In dialysis patients the urea concentration is representative of protein degradation and is also an indicator of metabolic status. For in vitro diagnostic use only.and post renal kidney failure. Serum urea and serum creatinine determinations are frequently performed together in the differential diagnosis of kidney function. exsiccosis or thirst. flush wastepipes with water after the disposal of undiluted reagent.01 BLOSR6x41. 4 Stable in serum and plasma for 7 days when stored at 2. urea synthesis rate. a large quantity of urea is excreted in the urine and plasma urea concentration is low.6 mmol/L ≥ 0. Mix gently by inversion and place on board the instrument. During antidiuresis. 1 Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. In pre. Most of the urea produced during these metabolic processes is eliminated by glomerular filtration. The decrease in NADH absorbance per unit time is proportional to the urea concentration. Post renal elevation of urea may be caused by obstruction of the urinary tract.. Once prepared. slowly add the contents of the bottle labelled R1-2 to the bottle labelled R1. In end-stage renal failure the urotoxic signs. 5 Urine: 24-hour collection without preservatives is recommended. increased protein catabolism and water depletion. Prerenal elevation of urea occurs in cardiac decompensation. During diuresis. To avoid the possible build-up of azide compounds.25°C. Urea levels may be elevated due to renal causes such as acute glomerulonephritis.76 kU/L ≥ 2.2 Urea is synthesised in the liver as the final product of protein and amino acid metabolism. The ammonia produced in the first reaction combines + with 2-oxoglutarate and NADH in the presence of glutamate-dehydrogenase (GLDH) to yield glutamate and NAD .26mmol/L 10 mmol/L 2. and glomerular filtration rate (GFR) and may be increased in acute renal failure. unopened. Dispose of all waste material in accordance with local guidelines. AU2700 and AU5400 systems only.02 2010-06 Metabolite . 4 x 25 mL 4 x 25 mL 4 x 50 mL 4 x 50 mL R1 R1-2 R1 R1-2 Summary1. EN. irrespective of the flow rate in the proximal tubule. urea rediffuses in the tubules at an increased rate and plasma urea is increased.8 mmol/L ≥ 17. 4 Stable in urine for 7 days at 2…8°C and 2 days when stored at 15…25°C. plasma and urine on Beckman Coulter analysers. polycystic kidney. up to the stated expiry date when stored at 2…8°C. Test Principle3 Urea is hydrolysed in the presence of water and urease to produce ammonia and carbon dioxide. chronic nephritis. correlate well with urea concentration. Urea reagent OSR6541 for use on the AU680. 25 1. The lowest detectable level represents the lowest measurable level of urea that can be distinguished from zero. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.06 3.18 11.38 – 39. results should always be assessed in conjunction with the patient's medical history. review all operating parameters.56 The following data was obtained on an AU640 using 3 urine pools analysed over 20 days. Metabolite BLOSR6x41.23 mmol/L.02 2010-06 EN.64 Sensitivity The lowest detectable level using serum settings on an AU600 analyser was calculated as 0. Method Comparison Patient serum samples were used to compare this Urea OSR6141 assay on the AU600 against another commercially available urea assay. sample type.107 r = 0. If any trends or sudden shifts in values are detected.92 mmol/L. Biorad Liquichek Urine Chemistry Controls Cat.46 276 3. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. Data obtained in your laboratory may differ from these values. 397 and 398 or other control materials with values determined by this Beckman Coulter system may be used for the urine application.8 – 7. The results obtained by any individual laboratory may vary from the given mean value.70 3. The urea values of both calibrators are traceable to the National Institute of Standards and Technology (NIST) Reference Material (SRM) 909b Level 1.999 n = 147 Sample range = 19. Linearity The test is linear within a concentration range of 0.970x + 3.80 0.02 402 3. The test is linear within a concentration range of 10 – 750 mmol/L (60 – 4500 mg/dL) for urine. The lowest detectable level using urine settings on the AU2700 was estimated as 2. ODC0025 for urine application. n = 80 Within Run Total Mean mmol/L SD CV% SD 4.29 – 739. No.99 3. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.0.7 1. diet and geographical location. Results of linear regression analysis were as follows: y = 0.80 0.Calibration Use System Calibrator Cat.09 1. Calculation The Beckman Coulter analysers automatically compute the urea concentration of each sample. Precision The following data was obtained on an AU600 using 2 serum controls analysed over 20 days.46 1. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed.92 0.50 2.90 0.925x .162 r = 0. No.000 – 34. 66300 for serum/plasma application and Urine Calibrator Cat. For diagnostic purposes. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.01 . Quality Control Controls Cat. No.20 CV% 3.12 25. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values.999 n = 116 Sample range = 1.18 mmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 5 g/L haemoglobin ® Lipemia: Interference less than 3% up to 500 mg/dL Intralipid Results of urine studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin Refer to Young for further information on interfering substances.200 mg/day) Expected values may vary with age. n = 80 Within Run Total Mean mmol/L SD CV% SD 93. and if necessary determine its own reference interval according to good laboratory practice.97 14. Each laboratory should verify the transferability of the expected values to its own population. No.44 mmol/L Patient urine samples were used to compare this Urea OSR6x41 assay on the AU2700 against another commercially available urea assay. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.64 0. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Major preventative maintenance was performed on the analyser or a critical part was replaced. clinical examinations and other findings. Reference Intervals Serum/Plasma Adult 6 Urine 1 2. Such samples should be diluted and re-run. Results of linear regression analysis were as follows: y = 0.65 CV% 2.93 2. sex. 7 Limitations Highly lipemic samples may exceed the reaction absorbance and will be flagged with a “@”.2 mmol/L (17 – 43 mg/dL) 250 – 570 mmol/day (15.8 – 50 mmol/L (5 – 300 mg/dL) for serum and plasma. Depends on usage pattern in the laboratory. NCCLS Document GP16-A2. Schmitt Y. Talke H. transportation.01 LOSR6x41. Urinalysis and collection. In: Burtis CA. WHO/DIL/LAB/99. 2000. Schubert GE. 2001.2:44pp.1239-1241.1 Rev. 1998:374-377. Kazmierczak. Wisser H. Urea. BIBLIOGRAPHY EN. 4. Louis: Mosby. Ashwood ER. 1996:500pp. 6. et al. Töpfer G. Philadelphia:WB Saunders Company. 3. Ehret W.Setting Sheet Footnotes # † * ± 1. Newman DJ.02 2010-06 Metabolite . Use of anticoagulants in diagnostic laboratory investigations and stability of blood. Heil W. 5th ed.Tietz textbook of clinical chemistry. No. Clinical chemistry theory. plasma and serum samples. NCCLS. User defined ¤ Analyser default value System Calibrator Cat. 2nd ed. Pennsylvania: NCCLS. Urea and blood urea nitrogen (BUN). Klin Wochenschr 1965. Zawta B. St. analysis and correlation. Young DS. Frankfurt/Main: TH-Books Verlagsgesellschaft. 5. In: Kaplan LA. 2. AACC. Pesce AJ. Renal function and nitrogen metabolites. Price CP. eds. In:Thomas L.: 66300 Values set for working in SI units (mmol/L). and preservation of urine specimens. 7. Clinical laboratory diagnostics. 1999. Thomas L. Enzymatische harnstoffbestimmung in blut und serum im optischen test nach Warburg.Use and assessment of clinical laboratory results. To work in mg/dL multiply by 6. Effects of drugs on clinical laboratory tests. eds. approved guideline. AACC Press. ed.43:174-75. . OD L 0. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name UREAS ∇ Sample type Ser ∇ On-board stability period 340 RATE First 2 First 25 YES Last Last 6 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min.8* B 21 Linearity Fst No lag time NO 25 % Sec % ∇ 0 Sample Pre-dil.5 Fst. To work in mg/dL multiply by 6. Reagent 1 vol Reagent 2 vol 2.0 # Test name UREAS ∇ Sample type Ser ∇ Page 1/2 System Reagent: OSR6141 Reagent ID: 041 Application UREA . vol Dil. L 1. Depends on usage pattern in the Laboratory Metabolite . No.2 0. point MB type factor Calibrator stability period # † * Ω BSOSR6x41. ∇ ∇ ∇ Sec. AU400/AU640 Serum/Plasma Reagent ID: 041 Specific test parameters Serum 1 0. # # ∇ 3. H Lst. L 1.7 1.0 2. # # ∇ 5.UREA . Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 100 0 µL µL µL Dilution Dilution Dilution 0 50 0 µL µL µL Pri. No. OD H ∇ Operation: Yes ∇ Test No 2.5 100 0 Dil.8* Correlation factor % ∇ 50* 1 0 ¤ 21 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L # Age Y Y Y Y Y Y Level H # Test Name: UREAS ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.0 Main 340 Sub 380 RATE 6 ∇ ∇ ∇ Max OD H 2.2 Dynamic range L 0.STAT.: 66300 Values set for working in SI units (mmol/L).2 Lst. None Selected 8. # # ∇ 4. # OD CONC † Factor/OD-L 100* 1-Point Cal. AU600 Serum/Plasma Application System Reagent: OSR6141 Specific Test Parameters General LIH ISE Range Test Name: UREAS ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2.0 2.7 Reagent OD limit Fst. # # ∇ 2. H 50* Fst Fst 2 Lst Lst First H Last H 2. # # ∇ 6. vol Dil. H Sample vol.2 1. vol 0 50 0 µL µL µL Max.5 2.02 2010-06 Ω Select the function using the Function key or the Mouse User defined ¤ Analyser default value System Calibrator Cat. 380 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. To work in mg/dL multiply by 6. # # ∇ 7. Depends on usage pattern in the Laboratory # † * Ω User defined System Calibrator Cat. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name UREAS ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 100* # Conc Factor/OD-H 183* ∇ Calibration Specific General ISE Serum # Factor/OD-H 183* Process: CONC ∇ ∇ SERUM/PLASMA APPLICATION Test Name: Counts: UREAS ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None Ω ∇ Advanced Calibration: # ∇ Cal.: 66300 Values set for working in SI units (mmol/L). No.STAT. No.0 ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6141. # # # # ∇ 3. No demographics 8. To work in mg/dL multiply by 6. AU680/AU480 Serum/Plasma Application System Reagent: OSR6141. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1.7 1. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration ∇ with Conc-0 Ω Ω Day Day 0 0 Hour Hour Metabolite BSOSR6x41.OD Dilution 40 µL Min. # # # # ∇ 2. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal.2 1. # OD CONC † Factor/OD-L 100* ∇ Factor Range Low High 100* 183* Slope Check Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None Ω ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. ∇ ∇ ∇ 0. # # ∇ 5. AU680 Depends on usage pattern in the Laboratory <Point Cal.UREA . AU2700/AU5400 Serum/Plasma Reagent ID: 041 Parameters General LIH UREAS Dilution 0. Not within expected values mmol/L* Decimal Places Calibration Specific ISE UREAS ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ # ∇ Calibration Specific General ISE Type Serum Counts: Factor/OD-H 183* # Process: CONC ∇ ∇ SERUM/PLASMA APPLICATION Test Name: UREAS ∇ < > Use Serum Cal. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. Point: with CONC-0 Slope Check: # Interval (RB/ACAL) Lot Calibration ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф Ω User defined.7 1. # # # # ∇ 6. No. # # # # ∇ 5.8* 1 1 µL High B B 0 50* 0 0 Hour Range ∇ Operation: Max OD H 2. # # ∇ 4.STAT.02 2010-06 . # # # # ∇ 7. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.2 R2(R2-1) ф 660 0 µL Dilution 0 Name Sec.5 2.OD Reagent OD Limit First Low Last Low 0 µL OD Limit 2. OSR6541 (AU680) Reagent ID: 041 Application Operation Yes ∇ UREA-STAT. Volume R1(R1-1) 2 1 80 µL ∇ µL Test Name: UREAS ∇ Yes < > Type: ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 2 80 0 µL µL µL Dilution Dilution Dilution 0 40 0 µL µL µL Pri.8* Sec. # # ∇ 6.: 66300 Values set for working in SI units (mmol/L). For No. # # ∇ 2.2 High High Max. # # ∇ 7.0 2.2 1.0 50* B 21 Last Last 6 25 YES % ∇ Sample Volume Pre-Dilution Rate Rgt. None Selected 8. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ ∇ 2 340 RATE First 2 First 25 YES Last Last 6 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 21 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum LIH UREAS ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # UREAS ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.0 2. OSR6541 Specific Test Parameters General LIH ISE Serum 1 0.5 2. # # ∇ 3. # # # # ∇ 4. System Calibrator Cat. L 1. # # ∇ 7. # # ∇ 3. vol 0 50 0 µL µL µL Max.UREA . OD H Min. H Sample vol.7 1. H Lst. OD L 0. ODC0025 1:10 with purified H2O User defined ¤ Analyser default value Urine System Calibrator Cat.3 Dynamic range L 10* Correlation factor H A B Rate ∇ Operation: Yes ∇ Test No 2. vol Dil. No.3 1.3 10* B 21 Linearity Fst No lag time YES 25 % Sec % ∇ 0 Sample Pre-dil. H 750* Fst Fst 2 Lst Lst First H Last H 2. No. To work in mg/dL multiply by 6.: ODC0025 * Values set for working in SI units (mmol/L). ∇ ∇ ∇ Sec. # # ∇ 5.3 Lst. Reagent 1 vol Reagent 2 vol 2‡ 100 0 Dil. # # ∇ 2.: ODC0025 Values set for working in SI units (mmol/L). No.5 Main 340 Sub 660 RATE 6 ∇ ∇ ∇ Max OD H 2.5 2. point MB type factor Calibrator stability period ‡ # † * BSOSR6x41. or select from list displayed by Guide key Sample type Uri ∇ Level L # Age Y Y Y Y Y Y H # # # # # # M→ M→ M→ M→ M→ M→ Page 2/2 Level H # Range Test Name: UREAS ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. No.STAT. # # ∇ 4.02 2010-06 Ω Select the function using the Function key or the Mouse Dilute samples and Urine Calibrator Cat.STAT.5 Fst. vol Dil.5 2.5 # Test name UREAS ∇ Sample type Uri ∇ Page 1/2 Application Application Reagent ID: 041 System Reagent: OSR6141 UREA .5 2. None Selected 8. To work in mg/dL multiply by 6 # User defined † Urine System Calibrator Cat. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.7 Reagent OD limit Fst. Ω Depends on usage pattern in the Laboratory Metabolite . AU600 Manual Dilution Standard Mode URINE Specific Test Parameters General LIH ISE Range Test Name: UREAS ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 100 0 µL µL µL Dilution Dilution Dilution 0 50 0 µL µL µL Pri. # # ∇ 6. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: On-board stability period 340 RATE First 2 First 25 YES Last Last 6 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 % ∇ 750* 1 0 ¤ 21 Specific Test Parameters General LIH ISE Test No # L # # # # # # M M M M M M # # # # # # ∇ # Test name UREAS ∇ Urine # # # # # # # Age Y Y Y Y Y Y ∇ Select using Space key. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # URINE APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name UREAS ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 1000* # Conc Factor/OD-H 2100* ∇ Calibration Specific General ISE Urine # Factor/OD-H 2100* Process: CONC ∇ ∇ Test Name: Counts: UREAS ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None Ω ∇ Advanced Calibration: # ∇ Cal. L 1. AU400/AU640 URINE Reagent ID: 041 System Reagent: OSR6141 Specific test parameters Urine 10 0. # OD CONC † Factor/OD-L 1000* 1-Point Cal. # # ∇ 5.5 2.: ODC0025 * Values set for working in SI units (mmol/L).STAT. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.OD Dilution 40 µL Min. # # ∇ 4. ∇ ∇ ∇ 10* Sec. OSR6541 Specific Test Parameters General LIH ISE Urine 10 0.5 2. OSR6541 (AU680) Reagent ID: 041 Application Operation Yes ∇ UREA-STAT.3 High High Max. # OD CONC † Factor/OD-L 1000* ∇ Factor Range Low High 1000* 2100* Slope Check Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None Ω ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. # # ∇ 6. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 10* 1 1 21 Day µL High B B 0 750* 0 0 Hour Range ∇ Operation: Max OD H 2. No. Point: with CONC-0 Slope Check: # Interval (RB/ACAL) Lot Calibration ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined.5 2. AU680/AU480 Urine Application System Reagent: OSR6141. # # ∇ 3. # # # # ∇ 4. No demographics 8. # # ∇ 2. No. For No.02 2010-06 . Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. None Selected 8. # # # # ∇ 6.5 2. Volume R1(R1-1) 1. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm RATE ∇ ∇ 2 340 RATE First 2 First 25 YES Last Last 6 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Urine LIH UREAS ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # UREAS ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.6 80 0 µL µL µL Dilution Dilution Dilution 0 40 0 µL µL µL Pri. # # # # ∇ 5.6 10 80 µL ∇ µL Test Name: UREAS ∇ Yes < > Type: ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 1.5 ∇ Type: Urine < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6141. Not within expected values mmol/L* Decimal Places Calibration Specific ISE UREAS ∇ Test Name: < Low # # # # # # # # # URINE APPLICATION High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ # ∇ Calibration Specific General ISE Type Urine Counts: Factor/OD-H 2100* # Process: CONC ∇ ∇ Test Name: UREAS ∇ < > Use Serum Cal.7 1. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration ∇ with Conc-0 Ω Ω Day Day 0 0 Hour Hour Metabolite BSOSR6x41.3 1.UREA .3 1.5 750* B 21 25 YES % ∇ Sample Volume Pre-Dilution Rate Rgt. # # # # ∇ 3. # # # # ∇ 7. # # ∇ 7. † Urine System Calibrator Cat. AU2700/AU5400 Urine Reagent ID: 041 Parameters General LIH UREAS Dilution 0.3 R2(R2-1) ф 660 Onboard Stability Period Last Last 6 0 µL Dilution 0 Name Sec. # # # # ∇ 2. To work in mg/dL multiply by 6. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal.7 1. Ф AU680 Ω Depends on usage pattern in the Laboratory <Point Cal.OD Reagent OD Limit First Low Last Low 0 µL OD Limit 2. In the vast majority of affected cases. The amount of dye formed is proportional to the uric acid concentration in the sample. Hazard Warnings and Risk Phrases: Risk Phrases R43: May cause sensitisation by skin contact. flush waste-pipes with water after the disposal of undiluted reagent. disodium salt (MADB) and 4-aminophenazone in the presence of peroxidase to produce a chromophore. starvation and chemotherapy. Secondary hyperuricaemia is associated with numerous conditions including renal insufficiency. Primary hyperuricaemia is associated with gout. associated with increased uric acid excretion in the urine. The formed H2O2 reacts with N.URIC ACID OSR6098 OSR6198 OSR6298 Intended Use Enzymatic colour test for the quantitative determination of uric acid in human serum.S26. polycythemia vera. Hypouricaemia may result from decreased uric acid production. Fanconi syndrome. type I glycogen storage disease. unopened. providing an indication of whether patients should be treated with uricosuric drugs to enhance renal excretion.15 μkat/L) ≥ 1.N-bis(4-sulfobutyl)-3. Refer to safety data sheet for further information. Dispose of all waste material in accordance with local guidelines. Quantitation of urinary uric acid excretion may assist in the selection of appropriate treatment for hyperuricaemia. and is eliminated via the kidney. Kelley Seegmiller syndrome and increased phosphoribosyl pyrophosphate synthase activity. Wear suitable gloves.2 Uric Acid is the major product of purine catabolism in humans.56 kU/L (26 μkat/L) Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. For in vitro diagnostic use only.01 BLOSR6x98. Once open. rinse immediately with plenty of water and seek medical advice. up to the stated expiry date when stored at 2…8°C. severe burns and hypereosinophilic syndrome.9 kU/L (98 μkat/L) ≥ 0. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. S60: This material and its container must be disposed of as hazardous waste. The Trinder reaction is utilised to measure H2O2. Lesch-Nyhan syndrome. hereditary purine nucleoside phosphorylase deficiency and allopurinol therapy. Reaction principle Uric acid + O2 + 2 H2O 2 H2O2 + MADB + 4-Aminophenazone Uricase Allantoin + CO2 + H2O2 Blue dye + OH + 3 H2O + - Peroxidase Contents. Secondary hyperuricaemia may be caused by increased nutritional purine uptake. Reagent Composition in the Test Final concentration of active ingredients: Phosphate Buffer (pH 7.5) MADB 4-Aminophenazone Peroxidase Uricase Ascorbate Oxidase Preservative 42 mmol/L 0. myeloproliferative diseases.3 mL 4 x 17. lead intoxication. Primary hyperuricaemia is also known as the idiopathic or familial form. reduced tubular secretion of uric acid is responsible for the elevation in uric acid levels. Safety Phrases S24.5 mL 4 x 42.5-dimethylaniline. diabetes mellitus.01 2009-08 Metabolite . EN.25 kU/L (4. Hypouricaemia may also be due to increased renal uric acid excretion. Most uric acid formation occurs in the liver. To avoid the possible build-up of azide compounds. or allopurinol to supress purine synthesis. haemolytic diseases.S37: Avoid contact with skin. hypouricaemia may result from treatment with uricosuric agents and ingestion of X-ray contrast media. 4 x 12 mL 4 x 5 mL 4 x 30 mL 4 x 12. Test Principle3 Uric acid is converted by uricase to allantoin and hydrogen peroxide.30 mmol/L ≥ 5. a purine-rich diet. psoriasis. which is read biochromatically at 660/800nm. In case of contact with eyes.7 mL R1 R2 R1 R2 R1 R2 Summary1. excess alcohol consumption. Hyperuricaemia is divided into primary and secondary classifications.15 mmol/L 0. reagents stored on board the instrument are stable for 30 days. involving either overproduction or reduced elimination. which may occur in malignant diseases. AIDS. In addition. such as occurs in hereditary xanthinuria. Approximately 1% of patients with primary hyperuricaemia have an enzymatic defect in purine metabolism which results in overproduction of uric acid. Storage and Stability The reagents are stable. plasma and urine on Beckman Coulter analysers. with the body uric acid pool determined by the balance between synthesis and elimination. fasting. No. The results obtained by any individual laboratory may vary from the given mean value.73 28.11 2. The lowest detectable level represents the lowest measurable level of uric acid that can be distinguished from zero. 66300 for serum/plasma application and Urine Calibrator Cat. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Linearity The test is linear within a concentration range of 89 – 1785 µmol/L (1. ODC0025 for urine application.2 mg/dL) Female 154. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.4 µmol/L (3.61 5604. The lowest detectable level using urine settings on an AU640 analyser was estimated at 10 µmol/L.653 µmol/L r = 0. Calculation The Beckman Coulter analysers automatically compute the uric acid concentration of each sample.06 1.6 – 6. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used for the serum/plasma application.0 µmol/L (2. results should always be assessed in conjunction with the patient's medical history.5 – 7.90 0. Serum Specific performance characteristics Data contained within this section are representative of performance on Beckman Coulter systems. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.0 mg/dL) Urine. 24h Average diet 1488 – 4463 µmol/d (250 – 750 mg/d) Expected values may vary with age.999 n = 116 Sample range = 94 – 1531 µmol/L Interfering Substances Results of studies conducted on serum samples to evaluate the susceptibility of the method to interference were as follows: Ascorbate: Interference less than 5% up to 20 mg/dL ascorbate. Interference less than 10% up to 20 mg/dL or 342 µmol/L conjugated bilirubin.16 3660.5 – 30 mg/dL) for serum and plasma.24 93. For diagnostic purposes.91 1. review all operating parameters.76 r = 1. The uric acid values of both calibrators are traceable to the Isotope Dilution Mass Spectrometry Reference Method (IDMS).57 1.498 Urine Samples: y = 0.95 1.06 9. sex.5 Serum and EDTA or heparinised plasma.800 µmol/L (2 – 400 mg/dL) for urine.67 CV% 1. diet and geographical location. 397 and 398 or other control materials with values determined by this Beckman Coulter system may be used for the urine application. add a sufficient volume of sodium hydroxide to bring the pH between 8 and 9. Test Procedure Refer to the appropriate User’s Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.94 388. (AU480 Interference less than 10% up to 1000 mg/dL Intralipid. No. Stable in serum and plasma for 7 days when stored at 2…8°C and 3 days when stored at 15…25°C. or when the following occur: Change in reagent lot number or significant shift in control values.12 Sensitivity The lowest detectable level using serum settings on an AU2700 analyser was estimated at 2 µmol/L. Biorad Liquichek Urine Chemistry Controls Cat. The test is linear within a concentration range of 119 – 23.982x + 80. Major preventative maintenance was performed on the analyser or a critical part was replaced.23 6.01 2009-08 EN. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 20 days. If any trends or sudden shifts in values are detected. Data obtained in your laboratory may differ from these values. Results of linear regression analysis were as follows: Serum Samples: y = 0. ) Metabolite BLOSR6x98. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. To prevent urate precipitation in urine specimens after collection.000 n = 151 Sample range = 142 – 20.71 2.Specimen4.01 . No. n = 80 Within Run Total Mean µmol/L SD CV% SD 171. and if necessary determine its own reference interval according to good laboratory practice. Quality Control Controls Cat.50 CV% 1.86 The following data was obtained on an AU640 using 3 urine pools analysed over 20 days.3 – 428. Recalibrate the assay every 30 days.55 9. Calibration Use System Calibrator Cat. ® ® Lipemia: Interference less than 5% up to 1000 mg/dL Intralipid.48 Within Run SD 14.57 98.44 2.44 Total CV% 1. Urine: Stable in urine for 4 days when stored at 15…25°C. Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L unconjugated bilirubin.63 71. n = 80 Mean µmol/L 1360.84 1.66 1.48 1362.02 1. sample type.7 – 357.76 SD 22. clinical examinations and other findings. Haemolysis: Interference less than 5% up to 5 g/L haemoglobin.39 57. Each laboratory should verify the transferability of the expected values to its own population. No. EDTA plasma will give a 5 – 10% lower recovery compared to serum or heparinised plasma.964x – 12. Reference Intervals6 Male 208. Method Comparison Patient samples were used to compare this uric acid assay on the AU640 against another commercially available uric acid assay. Töpfer G.97:142-5.Results of studies conducted on urine samples to evaluate the susceptibility of the method to interference were as follows: Ascorbate: Interference less than 5% up to 50 mg/dL ascorbate. Labor und Diagnose. CCPress. Ehret W. Ashwood ER. In: Thomas L. Ashwood ER.1245-50. Philadelphia: WB Saunders Company. In: Burtis CA. Effects of Drugs on CLINICAL Laboratory Tests. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. An improved colour reagent for the determination of blood glucose by the oxidase system. eds. Painter PC. User defined ¤ Analyser default value System Calibrator Cat. Trinder P. 2.1838pp. Barham D. 7 Refer to Young for further information on interfering substances. Frankfurt/Main: TH-Books Verlagsgesellschaft. eds. Reference information for the clinical laboratory. WHO/DIL/LAB/99.2: 44pp & 49pp. 3. 6. Cope JY.5. Tietz textbook of clinical chemistry. Thomas L. 5. Price CP. Data on file at OLMEI. Young DS. Schmitt Y. 4. Zawta B. Smith JL. Wisser H. BIBLIOGRAPHY EN. plasma and serum samples. Setting Sheet Footnotes # † * 1. No. Renal function and nitrogen metabolites. To work in mg/dL divide by 59. In: Burtis CA. 7. et al. especially IgM (Waldenström’s macroglobulinemia). 2005:280-289. 1999.1 Rev.01 BLOSR6x98. AACC. Newman DJ. Indikation und Bewertung von Laborbefunden für die medizinische Diagnostik. Uric acid. In very rare cases gammopathy. Philadelphia: WB Saunders Company. 5th ed. Hrsg.: 66300 Values set for working in SI units (µmol/L). 1999.01 2009-08 Metabolite . Analyst 1972. Heil W. 2000. Tietz textbook of clinical chemistry. may cause unreliable results. . # # ο ∇ 7. AU600 Serum/Plasma Application System Reagent: OSR6098. No. # # ο ∇ 6.3 0.3 0.1 Dynamic range L 89* Correlation factor % ∇ 1785* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: UA ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 Metabolite . OD L Reagent OD limit Fst. # # ο ∇ 3.1 Lst. AU400/AU640 Serum/Plasma Reagent ID: 098 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 660 Sub Fst.3 Wave Method Reaction Point 1 Point 2 800 END + 27 10 Sample vol. 800 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. # OD CONC † Factor/OD-L 2800* 1-Point Cal. Reagent 1 vol Reagent 2 vol μL μL μL 7 60 25 Dil. Vol Dil.5 BSOSR6x98. H -0.01 2009-08 # User defined † System Calibrator Cat.1 -0. To work in mg/dL divide by 59. # # ο ∇ 4. None Selected 8.3 ∇ Operation: Yes Test No ∇ ∇ # Test name UA Sample type Ser Page ½ System Reagent: OSR6098. OSR6198. Vol Dil. # # ο ∇ 5. OSR6298 Specific Test Parameters General LIH ISE Range Test Name: UA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 7 60 25 μL μL μL Dilution Dilution Dilution 0 90 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. ∇ ∇ ∇ Sec. or select from list displayed by Guide key Test No ∇ ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name UA Sample type Ser ∇ On-board stability period 660 END + First 0 First 0 Pri. Vol 0 90 10 Max.: 66300 * Values set for working in SI units (µmol/L) . To work in mg/dL divide by 59. Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name UA ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 2800* # Conc Factor/OD-H 5200* ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 5200* # SERUM/PLASMA APPLICATION Test Name: Counts: UA ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ Cal.1 89* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. L -0. # # ο ∇ 2. No. Point MB type factor Calibrator stability period 30 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat.: 66300 * Values set for working in SI units (µmol/L). L -0. OD H 0. H 1785* Fst Fst 0 0 Lst Lst First H Last H 0. OSR6198. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.URIC ACID. H Lst. No. OSR6298 Reagent ID: 098 Application URIC ACID. ∇ # # # # ο 4. For No. System Calibrator Cat. 800 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH UA ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # UA ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.6 1 48 Range Operation: ∇ Yes Test Name: UA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 Last Last 27 10 5. OSR6198. # # ο ∇ 6. # # ο ∇ 3. # # ο ∇ 2. No demographics 8. Values set for working in SI units (µmol/L) .3 0.3 1785* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 72 10 μL μL μL Pri. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 30 Day 0 Calibration 30 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined.3 μL Min.1 -0. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 89* 1 1 μL High B B 0 1785* 0 0 Hour 20 Dilution 10 Sample Volume Pre-Dilution Rate Rgt. ∇ ∇ ∇ 89* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. ∇ # # # # ο 6.3 0.01 2009-08 . ∇ # # # # ο 2. # # ο ∇ 7. Volume R1(R1-1) μL ∇ μL 5.URIC ACID. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x98.OD Reagent OD Limit First Low Last Low Dilution 72 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6098. # # ο ∇ 5. ∇ # # # # ο 5. None Selected 8.: 66300. No.OD -0. No. To work in mg/dL divide by 59. Not within expected values µmol/L* Decimal Places Calibration Specific ISE UA ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 2800* 5200* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 5200* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: UA ∇ < > Test Name: Use Serum Cal. ∇ 7. OSR6298 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. # # ο ∇ 4. ∇ # # # # ο 3.6 48 20 0. AU680/AU480 Serum/Plasma Application System Reagent: OSR6098.5 AU680 <Point Cal.1 -0. OSR6198. OSR6298 Reagent ID: 098 Application Operation Yes URIC ACID. AU2700/AU5400 Serum/Plasma Reagent ID: 098 Parameters General LIH UA ∇ Dilution μL Max. # OD CONC † Factor/OD-L 2800* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal.1 High High 0. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 660 ∇nm END ∇ + ∇ 0 0 % ∇ 660 END + First 0 First 0 Sec.1 R2(R2-1) μL Name Sec. URIC ACID. None Selected 8. No. point MB type factor Calibrator stability period 30 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Urine Calibrator Cat. # # ο ∇ 2. Out of Range L # # # # # # # # Panic value Unit: µmol/L* Decimal places: # H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H L # # # # # # # # L # H # # # # # # # # H # Panic Value: # # Select the function using the Function key or the Mouse Calibration specific Test No # Test name UA ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 12250* # Conc Factor/OD-H 22750* ∇ URINE APPLICATION Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 22750* # Test Name: Counts: UA ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 30 ∇ Advanced Calibration: # ∇ Cal. To work in mg/dL divide by 59. H Lst. # # ο ∇ 4.1 Dynamic range L 119* Correlation factor Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ 30 Specific Test Parameters General LIH ISE Urine ∇ # # # # # # Age Y Y Y Y Y Y # Range Test Name: UA ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 7.3 23800* 1 0 ¤ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: On-board stability period 660 END + First 0 First 0 Pri. vol Dil. ∇ ∇ ∇ Sec. OSR6298 Specific test parameters Reagent ID: 098 Application URIC ACID. # # ο ∇ 5.1 -0. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. OD H ∇ Urine ∇ 1 Max OD H Main ∇ ∇ ∇ 660 Sub Fst.3 Wave Method Reaction Point 1 Point 2 800 END + 27 10 H A B Rate ∇ Operation: Yes Sample vol. OSR6198. # # ο ∇ 3.: ODC0025 * Values set for working in SI units (µmol/L). vol 0 90 10 # Test name UA Sample type Uri Page 1/2 System Reagent: OSR6098.5 # User defined † Urine Calibrator Cat. L -0. Linearity Fst No lag time Select using Space key. L -0.1 Lst. # # ο ∇ 6.01 2009-08 . To work in mg/dL divide by 59. No. 800 ∇ Min.5 Metabolite BSOSR6x98. OD L Reagent OD limit Fst. H -0. OSR6198. vol Dil.3 0. AU400/AU640 Urine Reagent ID: 098 Test No ∇ Max.: ODC0025 * Values set for working in SI units (µmol/L) . No.1 119* Sample Pre-dil. or select from list displayed by Guide key Test No ∇ ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # L # Test name UA Sample type Uri ∇ Level L # Page 2/2 Level H # % Sec B 30 % ∇ 0 H 23800* Fst Fst 0 0 Lst Lst First H Last H 0. # OD CONC † Factor/OD-L 12250* 1-Point Cal. AU600 Urine Application System Reagent: OSR6098. OSR6298 Specific Test Parameters General LIH ISE Range Test Name: UA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 1.5 60 25 Dil.5 60 25 μL μL μL Dilution Dilution Dilution 0 90 10 μL μL μL 0.3 0. Reagent 1 vol Reagent 2 vol μL μL μL 1. # OD CONC † Factor/OD-L 12250* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 30 Advanced Calibration: # ∇ None ∇ 1-Point Cal. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 660 ∇nm END ∇ + ∇ 0 0 % ∇ 660 END + First 0 First 0 Sec.1 High High 0. OSR6298 Specific Test Parameters General LIH ISE Urine ∇ 1 Max OD H -0.OD Reagent OD Limit First Low Last Low Dilution 72 0 OD Limit < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6098. ∇ # # # # ο 6. ∇ # # # # ο 5. # # ο ∇ 7. ∇ 7.1 -0.3 1. OSR6298 Reagent ID: 098 Application Operation Yes URIC ACID. Volume R1(R1-1) μL ∇ μL 1. ∇ # # # # ο 3. # # ο ∇ 4. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. Not within expected values µmol/L* Decimal Places Calibration Specific ISE UA ∇ < Low # # # # # # # # # URINE APPLICATION High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ Factor Range Low High 12250* 22750* ∇ # ο ∇ Calibration Specific General ISE Type Urine ∇ Counts: Factor/OD-H 22750* # Process: CONC ∇ Test Name: UA ∇ < > Test Name: Use Serum Cal.3 μL Min. For No. To work in mg/dL divide by 59. # # ο ∇ 3.OD -0. OSR6198. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. ∇ ∇ ∇ 119* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. # # ο ∇ 5. ∇ # # # # ο 4.1 -0. # # ο ∇ 2. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 30 Day 0 Calibration 30 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined.3 0.URIC ACID. OSR6198.2 48 20 μL μL μL Dilution Dilution Dilution 0 72 10 μL μL μL Pri. AU680/AU480 Urine Application System Reagent: OSR6098. 800 Onboard Stability Period Last Last 27 10 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 119* 1 1 30 Day μL High B B 0 23800* 0 0 Hour 20 Dilution 10 Sample Volume Pre-Dilution Rate Rgt. None Selected 8. No. # # ο ∇ 6.3 0. ∇ # # # # ο 2. No demographics 8. Urine Calibrator Cat. No.: ODC0025 Values set for working in SI units (µmol/L) .2 1 48 Range Operation: ∇ Yes Test Name: UA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 30 0 23800* 0. 800 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Urine ∇ LIH UA ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # UA ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 R2(R2-1) μL Name Sec. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Metabolite BSOSR6x98. AU2700/AU5400 Urine Reagent ID: 098 Parameters General LIH UA ∇ Dilution μL Max.5 AU680 <Point Cal.01 2009-08 . 5 mmol/L Sodium Oxalate 1. Storage and Stability 1. Urine samples contaminated by haemoglobin will result in a falsely elevated value. This material and its container must be disposed of as hazardous waste.5. otherwise stable stored at 4°C for up to 72 hours. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Where such samples are suspected it is recommended that the sample be concentrated and further analysed via 1 electrophoresis. EN. A blue-purple complex is formed with a maximum absorbance at 600 nm. 7 Sample Stability: Analyse fresh otherwise stable stored at 2.. Refer to Safety Data Sheets for further information. In the case of CSF samples care should be taken to avoid blood contamination during collection. contains a mixture of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one. Discrepancies may arise when analysing total urine protein in samples from patients who have been treated with polypeptide-based plasma 8 substitutes.01 2009-08 Metabolite . 4.0 mmol/L Methanol 0. Determination of increased intrathecal synthesis of immunoglobulins is important in the diagnosis of demyelinating diseases such as multiple sclerosis. 2. S60. Reagent Preparation R1 is ready for use and can be placed directly on board the instrument. nephritis. The Calibrator is ready for use. CSF: Beckman Coulter recommends that CSF samples be collected in plain collection devices. Protect R1 from direct sunlight.2.8 % w/v Calibrator Human Serum Albumin Also contains preservatives 0. The absorbance of this complex is directly proportional to the protein concentration in the sample. Test Principle1. The polypeptides from the plasma substitute may be excreted into the urine and result in an elevated total urine protein result. The assay is based on the shift in absorption that occurs when the pyrogallol red-molybdate complex binds basic amino groups of protein molecules. Increased permeability of the blood brain barrier may result from conditions such as brain tumour. Increased levels of urinary protein may also be present following strenuous exercise or in the following conditions: monoclonal gammopathies. Contents. The measurement of total protein in CSF is important in detecting increased permeability of the blood/brain barrier to plasma proteins or to detect increased intrathecal production of immunoglobulins. this product should be handled as a potentially infectious material.01 BLOSR6x70. intracerebral haemmorhage or by inflammation caused by bacterial or viral meningitis. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. S37. The opened calibrator is stable until the expiration date on the label. provided that the stopper and cap are replaced immediately after each use to avoid contamination and the calibrator is stored at 2…8°C.3 Pyrogallol red is combined with molybdate to form a red complex with a maximum absorbance at 470nm. diabetic nephropathy or urinary tract infections. reagent stored on board the instrument is stable for 90 days.50 g/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. For in vitro diagnostic use only. These diseases are often characterised by proteinuria of which there are four main types: (a) increased glomerular permeability (glomerular proteinuria) (b) defective tubular reabsorption (tubular proteinuria) (c) increased concentration of low molecular weight protein (overload proteinuria) (d) abnormal secretion of protein into the urinary tract (postrenal proteinuria). To avoid the possible build-up of azide compounds.. The unopened reagent and calibrator are stable until the expiration date printed on the label when stored at 2…8°C. Safety Phrases: S24.6 Urine: A 24 hour or 12 hour urine specimen with no preservative is preferred. cardiac and thyroid function. As with all dye based methods. Bence-Jones Protein) may result in the underestimation of protein. Specimen Urine or cerebrospinal fluid.8°C for up to 48 hours. Avoid contact with skin. Wear suitable protective clothing and gloves. Once open. Reagent Composition in the Test Final concentration of reactive ingredients: R1 Pyrogallol Red 47 µmol/L Sodium Molybdate 320 µmol/L Succinic Acid 50 mmol/L Sodium Benzoate 3. Biological materials of human origin contained in the calibrator were tested for anti-HCV. Hazard Warnings and Risk Phrases: Calibrator: Irritant. Dispose of all waste material in accordance with local guidelines.e. 4 Sample Stability: Analyse fresh. 4 x 19 mL 1 x 3 mL R1 Calibrator Summary1 Measurement of total protein in urine is important in the diagnosis and treatment of diseases associated with renal.URINARY/CSF PROTEIN OSR6170 Intended Use Photometric colour test for the quantitative determination of total protein in human urine and cerebrospinal fluid (CSF) on Beckman Coulter analysers. analysis of urine samples containing immunoglobulin light chains (i. Where such samples are suspected it is recommended that the sample be concentrated and further analysed via electrophoresis. May cause sensitisation by skin contact. flush waste-pipes with water after the disposal of calibrator. encephalitis or poliomyelitis. R43. 15 0. For value assigned to the calibrator please refer to bottle label. and AU2700/AU5400 show that the following substances interfere with this Urinary/CSF Protein procedure by < 10%: Substance Ammonia Ascorbate Bilirubin Citric Acid Creatinine 2+ Cu 3+ Fe Gentamycin Glucose Oxalic Acid Tartaric Acid Tobramycin Uric Acid 10 Level Tested (mmol/L) 139 1. clinical examinations and other findings.8 0. Calculation The Beckman Coulter analysers automatically compute the total protein concentration of each sample.00 g/L.01 – 1.53 0.01 – 2.7 0. Major preventative maintenance was performed on the analyser or a critical part was replaced. Calibration Use Calibrator provided in the kit. If any trends or sudden shifts in values are detected. Results of linear regression analysis were as follows: y = 0.1 0.998 n = 108 Sample range = 0.006 1. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.08 g/day at rest Value may increase to up to 0. Reference Intervals Urine 0.1 277 7. 1 Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Linearity The test is linear within a concentration range of 0.9 1. Setting Sheet Footnotes # † * User defined ¤ Analyser default value Urinary/CSF Protein Calibrator supplied with the kit Values set for working in SI units (g/L). Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values.04 0. Metabolite BLOSR6x70.45 g/L CSF (Adults) 1 0.15 – 1. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte-free sample. The lowest detectable level represents the lowest measurable level of total protein that can be distinguished from zero.05 – 0. results should always be assessed in conjunction with the patient's medical history. and if necessary determine its own reference interval according to good laboratory practice. Quality Control Control material with values determined by this Beckman Coulter system may be used. Data obtained in your laboratory may differ from these values. For diagnostic purposes. review all operating parameters.7 Sensitivity The lowest detectable level on an AU640 analyser was estimated at 0. Precision 9 Estimates of precision based on NCCLS recommendations are consistent with typical performance.957x + 0. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.026 1. sex. Method Comparison Patient urine samples were used to compare this Urinary/CSF Protein OSR6170 assay on the AU640 against another commercially available urinary/CSF protein assay. AU600/AU640.01 . The calibrator is traceable to a primary standard which is prepared gravimetrically using reagent grade human serum albumin.30 g/L CSF (newborn <1month) Expected values may vary with age. 1 0.30 g/day following exercise.007 g/L.04 18 Refer to Young for further information on interfering substances.52 0.15 – 0.Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.3 10 26 1.01 2009-08 EN. The following data was obtained on an AU640 using 3 urine pools analysed over 20 days. n=80 Within run Total Mean g/L SD CV% SD CV% 0.2 0. Each laboratory should verify the transferability of the expected values to its own population.003 1. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.6 1.8 13 Level Tested (g/L) 0. The results obtained by any individual laboratory may vary from the given mean value. diet and geographical location.7 0.007 4.011 0.010 1.009 r = 0.99 g/L Interfering Substances Results of studies conducted on the AU400. sample type. To work in traditional units (mg/dL) multiply by 100. St. nd 6. 1994. Pesce. AJ. NCCLS document EP5-A.1999. Effects of drugs on clinical laboratory tests. NCCLS document GP16-A2.second edition. Planella T. Tietz NW. analysis and correlation. 5. Tokuda K. 1997. Young DS. 1995:518-520. approved guideline . Homs R. transportation and preservation of urine specimens. eds. Philadelphia: WB Saunders Company. Louis: Mosby-Year Book. NCCLS. Kitano S. Tietz NW. 2. Ohsawa S. Bunseki Kagaku 1983. 2 ed. rd 7.01 BLOSR6x70. nd EN. Clinical guide to laboratory tests. AACC. Clin Chem 1986. AACC Press. Clin Chem 1998. Effects of preanalytical variables on clinical laboratory tests. NCCLS. Ohkubo A. Mori I. rd 4. 9. Fujita Y. Yamanaka M. Cortes M. Urinalysis and collection. 1996:484-504. approved guideline.44:359-360. 2000. th 10. Watanabe N. Color reaction between pyrogallol red molybdenum (VI) complex and protein. Urinary protein as measured with pyrogallol red-molybdate complex manually and in Hitachi 726 automated analyser. Young DS. Pena C. 3. 8. AACC Press.BIBLIOGRAPHY 1. Philadelphia: WB Saunders Company. Martinez-Bru C. Textbook of clinical chemistry. 3 ed. Kamei S. Evaluation of precision performance of clinical chemistry devices. In: Kaplan LA. Effect of plasma replacement therapy on determinations of urine protein concentration [Letter]. 5 ed. 2001.32:379-386. First MR.32:1551-1544. 3 ed. Clinical chemistry: theory. Renal Function.Makino K.01 2009-08 Metabolite . 2 ed. . L 0. 800 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key.05 Last H 0. vol 0 0 0 Max.2 Dynamic Range: L 0. OD H 0. 0 Sample Pre-dil. L 0.2 Last L 0. OD L Reagent OD limit Fst. AU600 Urine/CSF Application System Reagent: OSR6170 Specific Test Parameters General LIH ISE Range Test Name: UCSFP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 190 0 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.05 Lst. None Selected 8. # # ο ∇ 6. No.2 ∇ Operation: Yes Test No ∇ ∇ # Test name UCSFP Sample type Uri Page 1/2 System Reagent: OSR6170 Reagent ID: 070 Application URINARY/CSF PROTEIN. # # ο ∇ 2. vol Dil. To work in traditional units (mg/dL) multiply by 100 BSOSR6x70.05 First H 0. # # ο ∇ 4. H Lst. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name UCSFP Sample type Uri ∇ 600 END + First 0 First Last Last 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L 0. AU400/AU640 Urine/CSF Reagent ID: 070 Specific test parameters Urine ∇ Sample vol. Reagent 1 vol Reagent 2 vol μL μL μL Fst. # OD CONC † Factor/OD-L 4* 1-Point Cal.00* Correlation Factor: A 1 B 0 On-board stability period: 90 Wave Method Reaction Point 1 Point 2 800 END + 10 H A B Rate Min. # # ο ∇ 3. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Urinary/CSF Protein Calibrator supplied with kit * Values set for working in g/L. Out of Range L # # # # # # # # Unit: g/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name UCSFP ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 4* # Conc Factor/OD-H 9* ∇ URINE/CSF APPLICATION Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 9* # Test Name: Counts: UCSFP ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal.01* Correlation factor 2.URINARY/CSF PROTEIN. # # ο ∇ 7. vol Dil.00* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Urine ∇ # Range Page 2/2 Level L # Level H # Test Name: UCSFP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.01* H 2. To work in traditional units (mg/dL) multiply by 100 Metabolite .01 2009-08 # User defined † Urinary/CSF Protein Calibrator supplied with kit * Values set for working in g/L.05 Dynamic range L 0. # # ο ∇ 5. H ∇ ∇ ∇ Main 600 Sub 2 190 0 Dil. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.2 0. Linearity Fst No lag time % Sec ∇ ∇ ∇ Fst Fst Lst Lst Sec. OD L Reagent OD limit Fst. Point: MB Type Factor: ο with CONC-0 Slope Check: None ∇ Advanced Calibration: Calibration Stability Period: 999 Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.05 First H 0. AU600 Automated Pre-Dilution URINARY/CSF PROTEIN. None Selected 8.2 Dynamic Range: L 0. point MB type factor Calibrator stability period # ∇ 999 # User defined. Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L 0.2 10 190 0 Dil.01* H 2.2 0. # Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: OD < > Y=AX+B ∇ CONC † Counts: # Type Urine ∇ Process: CONC ∇ Factor/OD-L 4* Factor/OD-H 9* Test No # Conc ∇ Factor/OD-H 9* # Test name UCSFP ∇ AB ∇ Y=AX+B ∇ Count Process Calibration Type: OD Conc † Factor/OD-L 4* 1-Point Cal. H 0.2 Last L 0. UCSFP Reagent ID: 070 Application Urine/CSF Application System Reagent: OSR6170 Specific test parameters Uri ∇ Max. vol Dil.01* Correlation factor 600 END + First 0 First Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Sample Pre-dil. To work in traditional units (mg/dL) multiply by 100 Metabolite BSOSR6x70. # # ο ∇ 6. L 0.URINARY/CSF PROTEIN. # # ο ∇ 3. vol 0 0 0 μL μL μL Main 600 Sub ∇ ∇ ∇ Wave Method Reaction Point 1 Point 2 H A B Rate 2. # # ο ∇ 5. # # ο ∇ 4.05 Lst. # # ο ∇ 7.6 152 0 μL μL μL ∇ ∇ ∇ Last Last % ∇ 10 Sec.00* Correlation Factor: A 1 B 0 On-board stability period: 90 Linearity Fst No lag time 90 Specific Test Parameters General LIH ISE Range ∇ Level L: Month # # # # # # L # Age H Year # # # # # # H # Unit: # < > Type: Level H: Month # # # # # # Test Name: UCSFP % Sec % ∇ On-board stability period Select using Space key. No.05 Dynamic range L 0. H Lst. # # ο ∇ 2. L 0. vol Dil.05 Last H 0. OD H Page 1/2 Test No # Test name UCSFP ∇ Sample type Sample vol. To work in traditional units (mg/dL) multiply by 100 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Urinary/CSF Protein Calibrator supplied with kit * Values set for working in g/L. or select from list displayed by Guide key Uri ∇ Level L # Level H # Page 2/2 Test No # Test name UCSFP ∇ Sample type Urine # ∇ # ∇ L M→ M→ M→ M→ M→ M→ H Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Panic Value: L # # # # # # # # L # H # # # # # # # # H # # # # # # # Age Y Y Y Y Y Y # # # # # # M M M M M M # # # # # # Age Y Y Y Y Y Y # # # # # # Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. AU2700/AU5400 Urine/CSF System Reagent: OSR6170 Reagent ID: 070 Specific Test Parameters General LIH ISE Range ∇ 1. Reagent 1 vol Reagent 2 vol Fst.01 2009-08 .00* 1 0 5 Fst Fst 0 Lst Lst 800 END + 10 Min. † Urinary/CSF Protein Calibrator supplied with kit * Values set for working in g/L. Out of Range L # # # # # # # # g/L* H # # # # # # # # Decimal places: # Panic value Select the function using the Function key or the Mouse URINE/CSF APPLICATION Calibration specific Calibration Specific General ISE Test Name: UCSFP AB ∇ ∇ Formula: Cal. ∇ 800 μL μL μL Dilution Dilution Dilution 0 0 0 < > Type: ∇ ∇ Urine Operation: Yes Test Name: Sample: Reagents: Volume R1 Volume R2 Volume Pri. ∇ # # # # ο 4.01 2009-08 .05 High High 0.01* 1 1 High B B 2. 90 Day 0 Hour ф 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.OD 0. AU680/AU480 Urine/CSF Reagent ID: 070 Application Range ∇ System Reagent: OSR6170 Parameters General Urine ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: UCSFP ∇ < > Type: Operation Yes Dilution Max.URINARY/CSF PROTEIN. No demographics 8. ∇ 7. To work in traditional units (mg/dL) multiply by 100 AU680 Metabolite BSOSR6x70. Not within expected values Month # # # # # # Low # # # # # # # # Unit g/L* Decimal Places # Parameters Calibrators General ∇ # ∇ None ∇ Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation # ∇ # ∇ Interval (RB/ACAL) ο Use Serum Cal.6 1 152 0 μL OD Limit μL ∇ μL Dilution 0 μL Min.00* 0 0 Common Rgt. Calibration Specific Calibration Parameters STAT Table Calibration ISE URINE/CSF APPLICATION URINE/CSF APPLICATION Test Name: UCSFP ∇ < > Type Urine Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Y=AX+B ∇ Factor Range Low High 4* 9* Counts: <Point Cal. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 600 ∇nm END ∇ + ∇ 0 Onboard Stability Period Last Last 10 % ∇ Parameters General Range Urine ∇ Panic Value Low # High # LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: UCSFP ∇ < > Type: High # High # # # # # # # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.2 Sample Volume Pre-Dilution Rate Rgt. ∇ # # # # ο 6.2 0.OD Reagent OD Limit First Low Last Low R2(R2-1) 0 μL Dilution 0 μL Name Sec. ∇ # # # # ο 3.05 0. Volume R1(R1-1) 1. ∇ # # # # ο 2. For No. ∇ # # # # ο 5. Urinary/CSF Protein Calibrator supplied with kit Values set for working in g/L. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 Hour Hour MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 # † * ф User defined. . It binds and inactivates a large number of basic and lipophilic compounds including progesterone and related hormones as well as the progesterone antagonist RU486. Refer to Safety Data Sheets for further information.6) Goat anti-human α-1 acidglycoprotein antiserum Preservative 81 mmol/L Variable Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. plasma levels show a 3-4 fold increase in most conditions associated with inflammation and tissue necrosis. but granulocytes and monocytes may also contribute significantly to plasma levels in sepsis. Storage and Stability The reagents are stable. human α-1 acidglycoprotein reacts specifically with the anti-human α-1 acidglycoprotein antibodies to yield insoluble aggregates. For in vitro diagnostic use only. Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer (pH 7. reagents stored on board the instrument are stable for 90 days. It also binds and reduces the bioavailability of many drugs including cocaine and benzodiazepine. Calibration Monitor. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. The results obtained by any individual laboratory may vary from the given mean value. on the Beckman Coulter analyser. Major preventative maintenance was performed on the analyser or a critical part was replaced. S60. the resulting curve should be visually reviewed.01 BLOSR6x62. up to the stated expiry date when stored at 2…8°C. review all operating parameters. 4 x 20 mL 4 x 4.5 mL R1 R2 Summary1 α-1 acidglycoprotein (also known as orosomucoid) contains a high percentage of carbohydrate and a large number of sialic acid residues giving it a very high net negative charge and high solubility in water. This material and its container must be disposed of as hazardous waste. contains sodium azide. Dispose of all waste material in accordance with local guidelines. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Specimen Serum or heparinised plasma. Safety Phrases: S36. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution. 2 Stable in serum and plasma for 5 months when stored at 2…25°C. Levels are also increased by glucocorticoid effects. No. for acceptability using the software options Routine. It may be one of the most reliable indicators of clinical activity of ulcerative colitis. If any trends or sudden shifts in values are detected. unopened. either endogenous (e. The calibrator α-1 acidglycoprotein values are traceable to IFCC (International Federation of Clinical Chemistry) standard CRM 470. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Following calibration. Contents. α-1 acidglycoprotein is synthesised primarily by the hepatic parenchymal cells. α-1 acidglycoprotein is an acute phase reactant. Plasma levels are decreased by oestrogens and due to nephrotic syndrome and protein losing enteropathies. Wear suitable protective clothing. Calculation The Beckman Coulter analysers automatically compute the α-1 acidglycoprotein concentration of each sample. Calibration Curve. Harmful if swallowed. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.01 2009-08 Specific Protein . Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument.g. EN. ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. Once open. Calibration Serum Protein Multi-Calibrator 2 Cat. flush waste-pipes with water after the disposal of undiluted reagent. The absorbance of these aggregates is proportional to the α-1 acidglycoprotein concentration in the sample. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Quality Control ITA Control Sera ODC0014.α-1 ACIDGLYCOPROTEIN OSR6162 Intended Use Immuno-turbidimetric test for the quantitative determination of α-1 acidglycoprotein in human serum and plasma on Beckman Coulter analysers. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. To avoid the possible build-up of azide compounds. ODR3023. R22. Cushing's syndrome) or exogenous as in prednisolone or dexamethasone therapy. Reference Intervals3 Serum Adult 0. Use of Anticoagulants in Diagnostic Laborator Investigations and Stability of Blood. The lowest detectable level represents the lowest measurable level of α-1 acidglycoprotein that can be distinguished from zero. Heil W. Zawta B. may produce atypical results. No.5 – 1. 4 Limitations Samples with extremely abnormal optical characteristics.2 g/L (50 – 120 mg/dL) Expected values may vary with age. Schmitt Y. 5th ed. Plasma and Serum Samples.23 0.1 Rev. Setting Sheet Footnotes # † * 1.836x + 0. eds. especially turbidity. Dati F. diet and geographical location. To work in mg/dL multiply by 100.991 n = 130 Sample range = 0. sex. Johnson AM. 485-486. Effects of drugs on clinical laboratory tests.03 1. Baudner S.2:21pp. Samples with very high α-1 acidglycoprotein concentrations (> 5 g/L) can generate false low results without appropriate "Z" flags due to excess antigen in the sample.: ODR3023 Values set for working in SI units (g/L).01 2.02 2. For diagnostic purposes.27 0.01 2009-08 EN. and if necessary determine its own reference interval according to good laboratory practice. 3.2 – 2. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. BIBLIOGRAPHY Specific Protein BLOSR6x62. Proteins. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP International reference material CRM 470.11 Sensitivity The lowest detectable level on an AU600 analyser was calculated as 0. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems. WHO/DIL/LAB/99.03 1. Silverman LM.57 0. Each laboratory should verify the transferability of the expected values to its own population. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. User defined ¤ Analyser default value Serum Protein Multi-Calibrator 2 Cat.05 0. sample type. In: Burtis CA. Rohlfs EM.01 1. n = 60 Within Run Total Mean g/L SD CV% SD 0. Data obtained in your laboratory may differ from these values. 1999. Results of linear regression analysis were as follows: y = 0.20:145-152. Töpfer G. J Lab Med 1996. 2. Method Comparison Patient serum samples were used to compare this α-1 Acidglycoprotein OSR6162 assay on the AU640 against another commercially available α-1 acidglycoprotein assay. et al. AACC Press. Philadelphia:WB Saunders Company. results should always be assessed in conjunction with the patient's medical history.047 g/L. Linearity The test is linear within a concentration range of 0. Wisser H. 4. Ashwood ER.18 2.44 g/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin ® Lipemia: Interference less than 5% up to 1000 mg/dL Intralipid.10 0. Tietz textbook of clinical chemistry.92 2.0 g/L (20 – 200 mg/dL).03 CV% 4.35 – 2. clinical examinations and other findings. Ehret W. Refer to Young for further information on interfering substances.63 0. 2000.105 r = 0.01 . Young DS. 1 -0.5 1.5 2.: ODR3023 * Values set for working in SI units (g/L).1 -0.1 # Conc Factor/OD-H 2. # # # # # OD CONC † † † † † Factor/OD-L -0.5 1.2* Correlation factor % ∇ 2* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: AAG ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Reagent 1 vol Reagent 2 vol μL μL μL 2 200 45 Dil. Vol Dil. # # ο ∇ 5. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator 2 Cat.1 -0. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. H -0.1 -0.1 0.5 Wave Method Reaction Point 1 Point 2 NONE END + 27 10 Sample vol. AU600 Serum/Plasma Application System Reagent: OSR6162 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 660 Sub Fst.5 # SERUM/PLASMA APPLICATION Test Name: Counts: AAG ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.5 2. OD H 1.1 -0. To work in mg/dL multiply by 100. L -0. None Selected 8.1 1-Point Cal.1 -0.1 -0. # # ο ∇ 3.: ODR3023 * Values set for working in SI units (g/L). # # ο ∇ 2. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name AAG Sample type Ser ∇ On-board stability period 660 END + First 0 First 0 Pri. No. BSOSR6x62. None ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min.5 2. # # ο ∇ 7.1 Lst.01 2009-08 # User defined † Serum Protein Multi-Calibrator 2 Cat. H 2* Fst Fst 0 0 Lst Lst First H Last H 1.2* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil.5 2.5 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2.1 -0.1 -0. Specific Protein . # # ο ∇ 4. Vol 0 0 0 Max. ∇ ∇ ∇ Sec. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name AAG ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0. No.5 2.5 2. L -0. To work in mg/dL multiply by 100. Vol Dil.1 Dynamic range L 0.5 ∇ Operation: Yes Test No ∇ ∇ # Test name AAG Sample type Ser Page Range Test Name: AAG ∇ < > Type: ½ Sample: Reagents: Volume R1 Volume R2 Volume 2 200 45 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.α-1-ACIDGLYCOPROTEIN. H Lst. OD L Reagent OD limit Fst.5 2. No. # # ο ∇ 6. AU400/AU640 Serum/Plasma Application Reagent ID: 062 Specific test parameters System Reagent: OSR6162 Reagent ID: 062 α-1-ACIDGLYCOPROTEIN.5 2. 6 160 36 First H Last H H 2* 1.5 2. # # ο ∇ 6. None Selected 8.: ODR3023 Values set for working in SI units (g/L). Serum Protein Multi-Calibrator 2 Cat.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Reagent ID: 062 Operation Yes Parameters General Specific Test Parameters Calculated Test Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H R2(R2-1) 36 μL Name Sec.1 -0. Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A 0.2* B 90 0 Last Last 27 10 1.1 2. AU680 <Point Cal.5 1.1 -0.1 -0.5 -0. For No.5 -0. # # ο ∇ 2. ∇ # # # # ο 2. ∇ # # # # ο 5. ∇ ∇ ∇ Sec. No demographics 8. # # ο ∇ 4. ∇ # # # # ο 4.5 2. # # ο ∇ 7.α-1-ACIDGLYCOPROTEIN.5 1.2* 1 1 μL High B B 0 2* 0 0 Hour Dilution 10 μL ∇ μL Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.5 ∇ OD Range Low High -0.5 2.1 -0.1 2.1 0.1 2.5 -0. Not within expected values Decimal Places Calibration Specific ISE AAG ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum Counts: ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: # Process: CONC ∇ Test Name: Use Serum Cal. Volume R1(R1-1) 1. # # # # # OD CONC † † † † † Factor/OD-L -0.5 μL μL μL Dilution Dilution Dilution 0 0 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.1 Factor/OD-H 2.1 High High 1.5 -0.1 -0. AU2700/AU5400 α-1-ACIDGLYCOPROTEIN. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined. AU680/AU480 Serum/Plasma Application Reagent ID: 062 Serum/Plasma Application System Reagent: OSR6162 System Reagent: OSR6162 LIH AAG ∇ Dilution μL Max. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x62.1 2. No. ∇ # # # # ο 6. None ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ # Range Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Test Name: AAG ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ 1-Point Cal.1 2. ∇ 7.5 2. SERUM/PLASMA APPLICATION Test Name: AAG ∇ < > Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) + ∇ Cal.5 μL Min.OD -0.1 -0. # # ο ∇ 5. # # ο ∇ 3. ∇ # # # # ο 3. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # g/L* Month # # # # # # Month # # # # # # Panic Value Low # High # L g/L* H Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General LIH AAG ∇ < > ISE HbA1c Test Name: Noneф 660 ∇nm END ∇ + ∇ 0 0 % ∇ 660 END + First 0 First 0 Pri.01 2009-08 .6 1 160 Test Name: AAG ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume -0. To work in mg/dL multiply by 100. No. It forms tetrahedral complexes with the active sites of serine proteases thus blocking their enzyme activity. For in vitro diagnostic use only. flush waste-pipes with water after the disposal of undiluted reagent. Harmful if swallowed. Quality Control ITA Control Sera ODC0014. Wear suitable protective clothing. No. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Refer to Safety Data Sheets for further information. Specimen Serum and heparinised plasma. contains sodium azide. Calibration Curve. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed.proteinase inhibitor or α1-Pi) it inhibits the serine proteases trypsin. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. for acceptability using the software options Routine. Physiologically it is most important as an inhibitor of leukocyte elastase.01 BLOSR6x63. chymotrypsin as well as pancreatric and especially granulocytic elastase. Once open. Safety Phrases: S36. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. CRP can be measured to distinguish such cases. Contents. If any trends or sudden shifts in values are detected. in monocytes and macrophages) nearly all plasma α-1 antitrypsin is synthesised by the hepatic parenchymal cells. Major preventative maintenance was performed on the analyser or a critical part was replaced. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. The results obtained by any individual laboratory may vary from the given mean value. 3 Stable in serum and plasma for 5 months when stored at 2…8°C and 3 months when stored at 15…25°C.01 2009-08 Specific Protein . reagents stored on board the instrument are stable for 90 days. ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. This material and its container must be disposed of as hazardous waste. the resulting curve should be visually reviewed. Following calibration. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution. cirrhosis and hepatocellular carcinoma. 4 x 20 mL 4 x 6. Calibration Monitor. In α-1 antitrypsin deficiency. Although there is some local tissue synthesis (e. which is released in the process of phagocytosis by polymorphonuclear leukocytes. human α-1 antitrypsin reacts specifically with the anti-human α-1 antitrypsin antibodies to yield insoluble aggregates. To avoid the possible build-up of azide compounds.α-1 ANTITRYPSIN OSR6163 Intended Use Immuno-turbidimetric test for the quantitative determination of α-1 antitrypsin in human serum and plasma on Beckman Coulter analysers. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. severe neonatal hepatitis. R22. a glycoprotein with a molecular mass of 51 kDa is present in approximately equal concentrations in plasma and interstitial fluid. Low levels of α-1 antitrypsin are found in neonatal respiratory distress syndrome. unopened. EN. Storage and Stability The reagents are stable.6) Goat anti-human α-1 antitrypsin antibodies Preservative 75 mmol/L Variable Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. levels can fall within the reference interval because of its acute phase function in cases of inflammation. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Dispose of all waste material in accordance with local guidelines. The absorbance of these aggregates is proportional to the α-1 antitrypsin concentration in the sample. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. review all operating parameters. Elevated levels are also seen in late pregnancy and during oestrogen therapy because the synthesis of α-1 antitrypsin is stimulated by oestrogens. The calibrator α-1 antitrypsin values are traceable to IFCC (International Federation of Clinical Chemistry) standard CRM 470.2 α-1 antitrypsin. on the Beckman Coulter analyser. Also referred to as serine protease inhibitor (α1. preterminal disease of the pancreas and in severe protein losing enteropathies. Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer (pH 7.5 mL R1 R2 Summary1.g. up to the stated expiry date when stored at 2…8°C. S60. A hereditary deficiency of α-1 antitrypsin is associated with pulmonary emphysema and diseases of the liver including neonatal cholestasis (hepatitis). ODR3023. Calibration Serum Protein Multi-Calibrator 2 Cat. Increased levels of α-1 antitrypsin are common as it is an acute phase reactant whose plasma concentrations rise several fold in the case of acute or chronic inflammation. J Lab Med 1996. sex. Setting Sheet Footnotes # † * 1. Zawta B. sample type. 4.01 g/L. In: Burtis CA.98 2. diet and geographical location. Schmitt Y. Linearity The test is linear within a concentration range of 0. For diagnostic purposes. Young DS. The lowest detectable level represents the lowest measurable level of α-1 antitrypsin that can be distinguished from zero.81 0.01 2009-08 EN. Dati F.98 0. et al. clinical examinations and other findings. 3.029 0. BIBLIOGRAPHY Specific Protein BLOSR6x63. WHO/DIL/LAB/99.992 n = 140 Sample range = 0. Töpfer G. Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood.: ODR3023 Values set for working in SI units (g/L).63 – 4.2:23pp.9 – 2.0 g/L (90 – 200 mg/dL) Expected values may vary with age. 5th ed.059 4. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. Johnson AM. User defined ¤ Analyser default value Serum Protein Multi-Calibrator 2 Cat.24 1. Plasma and Serum Samples. To work in mg/dL multiply by 100.1 Rev. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP International reference material CRM 470. eds. Heil W. Rohlfs EM. 1998:654-656. Philadelphia:WB Saunders Company. results should always be assessed in conjunction with the patient's medical history. Results of linear regression analysis were as follows: y = 0. 5 Limitations Samples with extremely abnormal optical characteristics. Frankfurt/Main: TH-Books Verlagsgesellschaft. Use and assessment of clinical laboratory results. Proteins. Silverman LM. Ehret W.0 g/L (30 – 500 mg/dL).42 0.Calculation The Beckman Coulter analysers automatically compute the α-1 antitrypsin concentration of each sample. Thomas L.094 CV% 2. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. In: Thomas L. 5.12 Sensitivity The lowest detectable level on an AU600 analyser was calculated as 0.170 r = 0.834x + 0.01 . AACC Press. Baudner S. 1999. Method Comparison Patient serum samples were used to compare this α-1 Antitrypsin OSR6163 assay on the AU640 against another commercially available α-1 antitrypsin assay. Wisser H. No.40 0.036 0. Samples with very high α-1 antitrypsin concentrations (> 16 g/L) can generate false low results without appropriate "Z" flags due to excess antigen in the sample.20:145-152. especially turbidity. n = 60 Within Run Total Mean g/L SD CV% SD 0. and if necessary determine its own reference interval according to good laboratory practice.96 0. Ashwood ER. ed. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Tietz textbook of clinical chemistry. may produce atypical results. Data obtained in your laboratory may differ from these values. Effects of drugs on clinical laboratory tests.486-490.43 0. 2000.006 1.38 g/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin ® Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances. Reference Intervals4 Serum Adult 0. a1-Antitrypsin (a1-AT). 2. Each laboratory should verify the transferability of the expected values to its own population.3 – 5. Clinical laboratory diagnostics.009 2. 1 -0. AU600 Serum/Plasma Application System Reagent: OSR6163 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 600 Sub Fst.3* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil.5 2. Specific Protein .α-1-ANTITRYPSIN. OD L Reagent OD limit Fst.5 1. # # ο ∇ 7. BSOSR6x63. None ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. OD H 1.1 Dynamic range L 0. H 5* Fst Fst 0 0 Lst Lst First H Last H 1. # # ο ∇ 4.1 0. No. No. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator 2 Cat.1 -0.: ODR3023 * Values set for working in SI units (g/L). Vol Dil.1 -0.: ODR3023 * Values set for working in SI units (g/L).1 -0. # # ο ∇ 5.1 1-Point Cal.5 2.1 # Conc Factor/OD-H 2.1 -0. To work in mg/dL multiply by 100. # # ο ∇ 3. H -0. ∇ ∇ ∇ Sec. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name AAT ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0. AU400/AU640 Serum/Plasma Application Reagent ID: 063 Specific test parameters System Reagent: OSR6163 Reagent ID: 063 α-1-ANTITRYPSIN. H Lst.3* Correlation factor % ∇ 5* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: AAT ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 ∇ Operation: Yes Test No ∇ ∇ # Test name AAT Sample type Ser Page Range Test Name: AAT ∇ < > Type: ½ Sample: Reagents: Volume R1 Volume R2 Volume 2 200 65 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.5 # SERUM/PLASMA APPLICATION Test Name: Counts: AAT ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 1.5 Wave Method Reaction Point 1 Point 2 NONE END + 27 10 Sample vol. No. # # ο ∇ 6.5 2. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name AAT Sample type Ser ∇ On-board stability period 600 END + First 0 First 0 Pri.1 Lst.5 2. Vol Dil.5 2. To work in mg/dL multiply by 100.1 -0.5 2. L -0. Vol 0 0 0 Max.1 -0.1 -0. None Selected 8. # # # # # OD CONC † † † † † Factor/OD-L -0. # # ο ∇ 2.01 2009-08 # User defined † Serum Protein Multi-Calibrator 2 Cat. L -0.1 -0.5 2.5 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2. Reagent 1 vol Reagent 2 vol μL μL μL 2 200 65 Dil.5 2. 1 -0.1 -0.1 R2(R2-1) μL Name Sec.5 ∇ OD Range Low High -0. None ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH AAT ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # AAT ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Volume R1(R1-1) μL ∇ μL 1.5 -0.α-1-ANTITRYPSIN. Not within expected values g/L* Decimal Places Calibration Specific ISE AAT ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum Counts: ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: AAT ∇ < > Test Name: Use Serum Cal. AU680 <Point Cal. Serum Protein Multi-Calibrator 2 Cat. ∇ # # # # ο 5.1 -0.1 -0.6 160 52 1. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal.5 1. ∇ # # # # ο 2.5 2. ∇ # # # # ο 6. ∇ ∇ ∇ 0. # # ο ∇ 4. # # ο ∇ 2.5 2.5 1. Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A 0. No. ∇ # # # # ο 3.1 -0. # # ο ∇ 5.01 2009-08 . ∇ 7.1 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 600 ∇nm END ∇ + ∇ 0 0 % ∇ 600 END + First 0 First 0 Sec.5 2. ∇ # # # # ο 4.3* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L g/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.1 2. # # ο ∇ 7. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined.3* 1 1 μL High B B 0 5* 0 0 Hour 52 Dilution 10 Sample Volume Pre-Dilution Rate Rgt. None Selected 8.1 2. AU2700/AU5400 Serum/Plasma Application Reagent ID: 063 Parameters General LIH AAT ∇ Dilution μL Max.6 1 160 Range Operation: ∇ Yes Test Name: AAT ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 Last Last 27 10 1.5 + ∇ 1-Point Cal. # # # # # CONC † † † † † Factor/OD-L -0. # # ο ∇ 6.5 -0. For No.5 5* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 0 10 μL μL μL Pri.OD -0.: ODR3023 Values set for working in SI units (g/L).OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6163 Reagent ID: 063 α-1-ANTITRYPSIN.5 -0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x63.1 High High 1. No.5 -0.1 Factor/OD-H 2.5 2.5 μL Min. No demographics 8. To work in mg/dL multiply by 100.1 2.1 -0. AU680/AU480 Serum/Plasma Application Operation Yes System Reagent: OSR6163 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0. # # ο ∇ 3.1 2. No. the most abundant form of Apo B. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. very low-density lipoprotein (VLDL). Major preventative maintenance was performed on the analyser or a critical part was replaced. Contents. For in vitro diagnostic use only.3 Lipids are transported throughout the body by complex structures called lipoproteins. at least five major apolipoproteins have been described and have been labelled A through E. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Storage and Stability The reagents are stable. Over the past several decades.01 BLOSR6x42. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.2. for acceptability using the software options . The calibrator Apo A1 values are traceable to the WHO International Reference Material. The principle apolipoproteins of HDL are the A apolipoproteins. unopened. Apo B plays an essential role in the delivery of cholesterol to the tissues. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.4) Sodium chloride Polyethylene glycol 6000 Goat anti-Apo A1 antibodies Preservative 8 mmol/L 106 mmol/L 3. intermediate density lipoprotein (IDL). Calibration Monitor.8°C and 1 day when stored at 15…25°C. Calculation The Beckman Coulter analysers automatically compute the Apo A1 concentration of each sample.. IDL and LDL. Apo B100 is present in all atherogenic lipoprotein fractions VLDL. Quality Control Controls Cat.. Following calibration. low-density lipoprotein (LDL) and high-density lipoprotein (HDL).14 g/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. review all operating parameters. Apo A1 reacts specifically with anti-human Apo A1 antibodies to yield insoluble aggregates. constituting nearly 90% of the protein mass. the resulting curve should be visually reviewed. No. 4 x 13 mL 4 x 13 mL R1 R2 Summary1. flush waste-pipes with water after the disposal of undiluted reagent. Specimen4 Serum: Stable for 8 days when stored at 2. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. Lipoproteins are classified into five major density classes: chylomicrons. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. No. Calibration Apo A1 & B Calibrators Cat. The results obtained by any individual laboratory may vary from the given mean value. Reagent Composition in the Test Final concentration of reactive ingredients: TRIS buffer (pH 7. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. To avoid the possible build-up of azide compounds.5 % w/v ≈ 0.APO A1 OSR6142 Intended Use Immuno-turbidimetric test for the quantitative determination of Apo A1 (Apolipoprotein A1) in human serum on Beckman Coulter analysers. decreased serum levels of high-density lipoprotein (HDL) and increased levels of low-density lipoprotein (LDL) have been associated with increased risk of coronary artery disease. Associated with these lipoproteins. ODR3022 for 5 point calibration. Apo A1 & B Calibrators Cat. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. Dispose of all waste material in accordance with local guidelines. SP1-01. Once open. on the Beckman Coulter analyser.01 2009-08 Specific Protein . Calibration Curve. Apo A1 has a role in the removal of excess cholesterol from the tissues and reduced levels of Apo A1 have been observed in patients with coronary heart disease.Routine. ODR3005 for 3 point calibration. Apo A1 measurements are frequently used in characterising patients with genetic disorders that lead to low HDL cholesterol concentrations. Elevated levels of ApoB100 are associated with an increased risk of coronary artery disease. up to the stated expiry date when stored at 2…8°C. EN. The absorbance of these aggregates is proportional to the Apo A1 concentration in the sample. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution. If any trends or sudden shifts in values are detected. reagents stored on board the instrument are stable for 90 days. Warnick GR.04 1. 4.05 – 2. Heil W. User defined ¤ Analyser default value Apo A1 & B Calibrator Cat. To work in mg/dL multiply by 100. 5 Limitations Samples with extremely abnormal optical characteristics. Riesen WF. 5th ed. 2. may produce atypical results.01 0. results should always be assessed in conjunction with the patient's medical history. Use of anticoagulants in diagnostic laboratory investigations and stability of blood.80 0. Durrington PN. ODR3022 and set Cal Type as 13 . Ehret W.34 2. Use and assessment of clinical laboratory results. 2000. Dominiczak MH. especially turbidity. Handbook of lipoprotein testing. ed.5AB When using 5 point calibration choose Apo A1 & B Calibrator Cat No. BIBLIOGRAPHY Specific Protein BLOSR6x42.87 0. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days.05 g/L (105 – 205 mg/dL) Expected values may vary with age. Bhatnagar D.: ODR3005 for 3 point Calibration When using 5 point calibration choose Apo A1 & B Calibrator Cat No. eds.1 Rev.02 Sensitivity The lowest detectable level in serum on an AU600 analyser was estimated at 0. et al. Method Comparison Patient serum samples were used to compare this Apo A1 OSR6142 assay on the AU600 against another commercially available Apo A1 assay.05 – 1.01 0. Schmitt Y.887x – 0. Philadelphia:WB Saunders Company. sample type. and if necessary determine its own reference interval according to good laboratory practice. The lowest detectable level represents the lowest measurable level of Apo A1 that can be distinguished from zero.002 g/L. sex. clinical examinations and other findings. In: Tietz NW.40 – 2.45 2. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. In: Rifai N. Zawta B.78 0.01 . Young DS. WHO/DIL/LAB/99. 1997:177-198.04 CV% 1. Linearity The test is linear within a concentration range of 0.02 0. 5. No. ed. 1998:172-173.990 n = 80 Sample range = 0.591 – 2. Data obtained in your laboratory may differ from these values. lipoproteins. Lipids.01 1. Each laboratory should verify the transferability of the expected values to its own population. For diagnostic purposes.75 g/L (105 – 175 mg/dL) Female 1. Stein EA. Washington: AACC Press.01 2009-08 EN. Wisser H. Töpfer G. Lipid metabolism. Measurement and clinical significance of apolipoproteins A-1 and B.2:23pp. n = 60 Within Run Total Mean g/L SD CV% SD 0. Fundamentals of clinical chemistry. Effects of Drugs on Clinical Laboratory Tests.081 r = 0. 3.319 g/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 900 mg/dL Intralipid Refer to Young for further information on interfering substances. In: Thomas L. Frankfurt/Main: TH-Books Verlagsgesellschaft.61 0. ODR3022 and set Cal Type as 5AB Values set for working in SI units (g/L). Results of linear regression analysis were as follows: y = 0. Setting Sheet Footnotes # † ‡ ‡ * 1. 1987:454-456. plasma and serum samples.50 g/L (40 – 250 mg/dL).02 1. AACC.96 0. AACC Press. Clinical laboratory diagnostics. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.Reference Intervals2 Male 1. and apolipoproteins. diet and geographical location. To work in mg/dL multiply by 100 # † ‡ * User defined APO A1 & B Calibrator Cat. Reagent 1 vol Reagent 2 vol μL μL μL Fst. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # SERUM APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name Apo A1 ∇ 3AB‡ ∇ POLYGONAL OD ∇ Conc † † † Count Process Factor/OD-L -0. AU600 Serum Application System Reagent: OSR6142 Specific Test Parameters General LIH ISE Range Test Name: Apo A1 ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil. 800 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.5 Last L -0.1 -0. H ∇ ∇ ∇ Main 540 Sub 2 65 65 Dil. L -0. ∇ ∇ ∇ Sec. ODR3022 and set Cal Type as 5AB Values set for working in SI units (g/L). L -0. point MB type factor Calibrator stability period # † ‡ * BSOSR6x42. OD L Reagent OD limit Fst.: ODR3005 for 3 point Calibration When using 5 point calibration choose Apo A1 & B Calibrator Cat.1 -0.5 1. # # ο ∇ 3.50* Correlation Factor: A 1 B 0 On-board stability period: 90 H A B Rate Min.1 Lst.1 Dynamic range L 0. vol Dil. # # ο ∇ 2.5 Dynamic Range: L 0.01 2009-08 999 Select the function using the Function key or the Mouse User defined ¤ Analyser default value APO A1 & B Calibrator Cat. To work in mg/dL multiply by 100 Specific Protein . No. # # ο ∇ 4. No. AU400/AU640 Serum Reagent ID: 042 Specific test parameters Serum ∇ Sample vol. ODR3022 and set Cal Type as 13-5AB Values set for working in SI units (g/L). No. H Lst.1 # Conc Factor/OD-H 2. vol Dil. OD H 1.Apo A1.5 ∇ Operation: Yes Test No ∇ ∇ # Test name Apo A1 Sample type Ser Page 1/2 System Reagent: OSR6142 Reagent ID: 042 Application Apo A1. # # ο ∇ 5.1 1-Point Cal.5 2.: ODR3005 for 3 point Calibration When using 5 point calibration choose Apo A1 & B Calibrator Cat. Linearity Fst No lag time % Sec 0 0 Lst Lst 800 END + 27 10 2 65 65 μL μL μL Dilution Dilution Dilution 0 130 20 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name Apo A1 Sample type Ser ∇ 540 END + First 0 First 0 Pri.5 2.1 -0. None Selected 8. No.5 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2. No.5 2.1 First H 1. # # ο ∇ 6. # # ο ∇ 7.5 # Test Name: Counts: Apo A1 ∇ < > Type Calibration Type: 3AB‡ ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.1 -0. vol 0 130 20 Max. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 11‡ Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.1 Last H 1.40* H 2.40* Correlation factor 2.5 2. # # # OD CONC † † † Factor/OD-L -0.50* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: Apo A1 ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. OD Reagent OD Limit First Low Last Low Dilution 104 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6142 Reagent ID: 042 Application Operation Yes APO A1. ∇ 7.5 -0.1 -0.1 -0.: ODR3005 for 3 point Calibration When using 5 point calibration choose Apo A1 & B Calibrator Cat.5 μL Min.1 Factor/OD-H 2.5 ∇ OD Range Low High -0. No.1 High High 1. ∇ # # # # ο 3.1 -0. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 3AB‡ ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † ‡ * ф User defined. Calibration Type: 3AB‡ ∇ Formula: POLYGONAL ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 Advanced Calibration: # ∇ Cal.50* 0 0 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 540 ∇nm END ∇ + ∇ 0 0 % ∇ ∇ ∇ ∇ Sec.1 First H 1. No.5 Dynamic Range: L 0. # # ο ∇ 3.5 + ∇ 1-Point Cal. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x42. # # ο ∇ 6. AU680/AU480 Serum Application System Reagent: OSR6142 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt.6 52 52 μL μL μL Dilution Dilution Dilution 0 104 16 μL μL μL Pri.5 1. To work in mg/dL multiply by 100 AU680 <Point Cal. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L g/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 2. Not within expected values g/L* Decimal Places Calibration Specific ISE APO A1 ∇ < Low # # # # # # # # # SERUM APPLICATION High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum Counts: ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: # Process: CONC ∇ Test Name: APO A1 ∇ < > Test Name: Use Serum Cal. # # # CONC † † † Factor/OD-L -0. # # ο ∇ 4. For No.40* 1 1 μL High B B 0 52 Dilution 16 1.40* H 2. # # ο ∇ 5. No demographics 8.6 1 52 Range Operation: ∇ Yes Test Name: APO A1 ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec. # # ο ∇ 7. No. 540 END + First 0 First 0 Common Rgt. None Selected 8.5 Last L -0. AU2700/AU5400 Serum Reagent ID: 042 Parameters General LIH APO A1 ∇ Dilution μL Max.5 -0.OD -0. ∇ # # # # ο 6.1 2.1 2.1 Last H 1. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. ∇ # # # # ο 4. Volume R1(R1-1) μL ∇ μL 1. APO A1 & B Calibrator Cat. 800 ∇ Last Last 27 10 2.50* Correlation Factor: A 1 B 0 On-board stability period: 90 Specific Test Parameters General LIH ISE Serum ∇ LIH APO A1 ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # APO A1 ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2.5 2.1 2.5 2. ODR3022 and set Cal Type as 5AB Values set for working in SI units (g/L).01 2009-08 . ∇ # # # # ο 5.APO AI. The results obtained by any individual laboratory may vary from the given mean value. review all operating parameters. To avoid the possible build-up of azide compounds. For in vitro diagnostic use only. Over the past several decades.01 BLOSR6x43. the most abundant form of Apo B. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.6 mmol/L 125 mmol/L 4 % w/v ≈ 1. 4 x 13 mL 4 x 7 mL R1 R2 Summary1. ODR3005 for 3 point calibration. Elevated levels of Apo B100 are associated with an increased risk of coronary artery disease. If any trends or sudden shifts in values are detected. very low-density lipoprotein (VLDL). ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution. Dispose of all waste material in accordance with local guidelines. flush waste-pipes with water after the disposal of undiluted reagent. Apo A1 measurements are frequently used in characterising patients with genetic disorders that lead to low HDL cholesterol concentrations. ODR3022 for 5 point calibration. SP3-07. Calibration Monitor. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. decreased serum levels of high-density lipoprotein (HDL) and increased levels of low-density lipoprotein (LDL) have been associated with increased risk of coronary artery disease. Major preventative maintenance was performed on the analyser or a critical part was replaced. Quality Control Controls Cat. Once open. Reagent Composition in the Test Final concentration of reactive ingredients: TRIS buffer (pH 7. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Specimen Test Procedure Serum: Stable for 8 days when stored at 2. Apo B plays an essential role in the delivery of cholesterol to the tissues. Apo B100 is present in all atherogenic lipoprotein fractions VLDL. Apo A1 has a role in the removal of excess cholesterol from the tissues and reduced levels of Apo A1 have been observed in patients with coronary heart disease. low-density lipoprotein (LDL) and high-density lipoprotein (HDL). on the Beckman Coulter analyser. The absorbance of these aggregates is proportional to the Apo B concentration in the sample.2. The principle apolipoproteins of HDL are the A apolipoproteins. Following calibration.8°C and 1 day when stored at 15…25°C. constituting nearly 90% of the protein mass. Calibration Curve. Apo A1 & B Calibrators Cat.Apo B OSR6143 Intended Use Immuno-turbidimetric test for the quantitative determination of Apo B (Apolipoprotein B) in human serum on Beckman Coulter analysers. IDL and LDL. No. intermediate density lipoprotein (IDL). Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. at least five major apolipoproteins have been described and have been labelled A through E. Lipemic samples should be avoided. No. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Lipoproteins are classified into five major density classes: chylomicrons.. Associated with these lipoproteins. EN. The calibrator Apo B values are traceable to the WHO International Reference Material. Apo B reacts specifically with anti-human Apo B antibodies to yield insoluble aggregates. up to the stated expiry date when stored at 2…8°C.4) Sodium chloride Polyethylene glycol 6000 Goat anti-Apo B antibodies Preservative 8.93 g/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. Contents.01 2009-08 Specific Protein . No. for acceptability using the software options Routine. unopened. the resulting curve should be visually reviewed. 4 Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. reagents stored on board the instrument are stable for 90 days.3 Lipids are transported throughout the body by complex structures called lipoproteins. Storage and Stability The reagents are stable. Calibration Apo A1 & B Calibrators Cat.. Calculation The Beckman Coulter analysers automatically compute the Apo B concentration of each sample. Clinical laboratory diagnostics. 1997:177-198.01 .01 r = 0.71 0. Results of linear regression analysis were as follows: y = 0.01 0. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.03 CV% 1.68 g/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 200 mg/dL Intralipid Refer to Young for further information on interfering substances. lipoproteins. Wisser H. Handbook of lipoprotein testing. et al.5AB When using 5 point calibration choose Apo A1 & B Calibrator Cat No. and if necessary determine its own reference interval according to good laboratory practice. To work in mg/dL multiply by 100.33 Sensitivity The lowest detectable level in serum on an AU600 analyser was estimated at 0.89 0.40 – 2. 4. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. Schmitt Y. BIBLIOGRAPHY Specific Protein BLOSR6x43.01 2009-08 EN. 1987:454-456. sample type. Heil W. Effects of Drugs on Clinical Laboratory Tests.01 0. ed.55 – 1. Setting Sheet Footnotes # † ‡ ‡ * 1. No. 3. 2000. 1998:172-173. 2. ODR3022 and set Cal Type as 5AB Values set for working in SI units (g/L). In: Thomas L. Each laboratory should verify the transferability of the expected values to its own population. Töpfer G. Riesen WF.992 n = 80 Sample range = 0. Ehret W.951x . may produce atypical results. Zawta B. diet and geographical location.16 0. The lowest detectable level represents the lowest measurable level of Apo B that can be distinguished from zero.Reference Intervals2 Male 0. Philadelphia:WB Saunders Company.1 Rev.007 g/L. WHO/DIL/LAB/99. sex. plasma and serum samples.2:23pp. n = 60 Within Run Total Mean g/L SD CV% SD 0. Bhatnagar D. AACC Press.27 1. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. AACC. Fundamentals of clinical chemistry. Dominiczak MH. Method Comparison Patient serum samples were used to compare this Apo B OSR6143 assay on the AU600 against another commercially available Apo B assay. 5th ed.40 g/L (60 – 140 mg/dL) Female 0. ODR3022 and set Cal Type as 13 . In: Rifai N. User defined ¤ Analyser default value Apo A1 & B Calibrator Calibrator Cat.92 1. Young DS. especially turbidity. Frankfurt/Main: TH-Books Verlagsgesellschaft.0.61 0. Use and assessment of clinical laboratory results. Stein EA. Durrington PN. Warnick GR. results should always be assessed in conjunction with the patient's medical history.: ODR3005 for 3 point Calibration When using 5 point calibration choose Apo A1 & B Calibrator Cat No. In: Tietz NW.98 0. Data obtained in your laboratory may differ from these values. Lipid metabolism.60 – 1.01 1. ed.00 g/L (40 – 200 mg/dL).02 1. Linearity The test is linear within a concentration range of 0. eds. Measurement and clinical significance of apolipoproteins A-1 and B. 5 Limitations Samples with extremely abnormal optical characteristics. clinical examinations and other findings. For diagnostic purposes.49 0.01 1. Washington: AACC Press.48 – 1.30 g/L (55 – 130 mg/dL) Expected values may vary with age. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. Lipids. 5. and apolipoproteins. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 11‡ Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.1 -0.5 2. OD H 1.40* H 2.01 2009-08 999 Select the function using the Function key or the Mouse User defined ¤ Analyser default value APO A1 & B Calibrator Cat.00* Correlation Factor: A 1 B 0 On-board stability period: 90 H A B Rate Min.1 # Conc Factor/OD-H 2. # † ‡ * User defined APO A1 & B Calibrator Cat. # # ο ∇ 6. No.1 First H 1. H ∇ ∇ ∇ Main 340 Sub 2 65 35 Dil. L -0. # # # OD CONC † † † Factor/OD-L -0.40* Correlation factor 2. Specific Protein . # # ο ∇ 5.1 -0. To work in mg/dL multiply by 100.5 1. point MB type factor Calibrator stability period # † ‡ * BSOSR6x43. OD L Reagent OD limit Fst. vol 0 130 15 Max.5 Dynamic Range: L 0.5 2.1 Last H 1. AU600 Serum Application System Reagent: OSR6143 Specific Test Parameters General LIH ISE Range Test Name: Apo B ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name Apo B Sample type Ser ∇ 340 END + First 0 First 0 Pri.1 1-Point Cal. vol Dil.: ODR3005 for 3 point Calibration When using 5 point calibration choose Apo A1 & B Calibrator Cat No.5 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2. # # ο ∇ 7.: ODR3005 for 3 point Calibrator When using 5 point calibration choose Apo A1 & B Calibrator Cat No. # # ο ∇ 4. None Selected 8. Reagent 1 vol Reagent 2 vol μL μL μL Fst.1 -0. # # ο ∇ 3.1 Lst.5 Last L -0.5 2.Apo B. No. ODR3022 and set Cal Type as13-5AB Values set for working in SI units (g/L). No. ∇ ∇ ∇ Sec. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # SERUM APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name Apo B ∇ 3AB‡ ∇ POLYGONAL OD ∇ Conc † † † Count Process Factor/OD-L -0. To work in mg/dL multiply by 100.1 -0. H Lst. Linearity Fst No lag time % Sec 0 0 Lst Lst 800 END + 27 10 2 65 35 μL μL μL Dilution Dilution Dilution 0 130 15 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key.5 2.5 # Test Name: Counts: Apo B ∇ < > Type Calibration Type: 3AB‡ ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 Advanced Calibration: # ∇ Cal. AU400/AU640 Serum Reagent ID: 043 Specific test parameters Serum ∇ Sample vol.5 ∇ Operation: Yes Test No ∇ ∇ # Test name Apo B Sample type Ser Page 1/2 System Reagent: OSR6143 Reagent ID: 043 Application Apo B.1 Dynamic range L 0. # # ο ∇ 2. L -0. vol Dil. 800 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. ODR3022 and set Cal Type as 5AB Values set for working in SI units (g/L).00* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: Apo B ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. None Selected 8.01 2009-08 .5 2. # # # CONC † † † Factor/OD-L -0. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.1 High High 1.6 1 52 Range Operation: ∇ Yes Test Name: APO B ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec.5 + ∇ 1-Point Cal. ∇ 7. AU680 <Point Cal.5 1.5 -0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L g/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. No demographics 8. ODR3022 and set Cal Type as 5AB Values set for working in SI units (g/L). Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 3AB‡ ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † ‡ * Ф User defined APO A1 & B Calibrator Cat. No. ∇ # # # # ο 3.OD Reagent OD Limit First Low Last Low Dilution 104 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6143 Reagent ID: 043 Application Operation Yes Serum Application System Reagent: OSR6143 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt. Not within expected values g/L* Decimal Places Calibration Specific ISE APO B ∇ < Low # # # # # # # # # SERUM APPLICATION High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum Counts: ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: # Process: CONC ∇ Test Name: APO B ∇ < > Test Name: Use Serum Cal.1 Factor/OD-H 2.1 2.5 2.00* Correlation Factor: A 1 B 0 On-board stability period: 90 Specific Test Parameters General LIH ISE Serum ∇ LIH APO B ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # APO B ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. No. To work in mg/dL multiply by 100. # # ο ∇ 6.1 Last H 1.00* 0 0 90 Day # ∇ +++ ∇ +++++ ∇ +++++ ∇ Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.5 μL Min.OD -0.APO B.6 52 28 μL μL μL Dilution Dilution Dilution 0 104 12 μL μL μL Pri. ∇ # # # # ο 6. Calibration Type: 3AB‡ ∇ Formula: POLYGONAL ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 Advanced Calibration: # ∇ Cal.: ODR3005 for 3 point Calibration When using 5 point calibration choose Apo A1 & B Calibrator Cat No. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x43. Volume R1(R1-1) μL ∇ μL 1.5 -0.1 2. 340 END + First 0 First 0 Common Rgt.5 Dynamic Range: L 0.1 -0. AU680/AU480 Reagent ID: 043 Parameters General LIH APO B ∇ Dilution μL Max.40* H 2.5 Last L -0.1 -0.1 -0.40* 1 1 μL High B B 0 28 Dilution 12 1. ∇ # # # # ο 2. # # ο ∇ 3. ∇ # # # # ο 5. # # ο ∇ 2. AU2700/AU5400 Serum APO B. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ ∇ ∇ ∇ Sec.5 ∇ OD Range Low High -0.1 2. 800 ∇ Last Last 27 10 2. # # ο ∇ 5. # # ο ∇ 4.1 First H 1. ∇ # # # # ο 4. # # ο ∇ 7. In an infected individual streptolysin O acts as a protein antigen to which the patient mounts an antibody response. clinical examinations and other findings. For in vitro diagnostic use only. the resulting curve should be visually reviewed for acceptability. or any change in reagent colour. Reagent Composition in the Test Final concentration of reactive ingredients: Phosphate buffer (pH 7.01 BLOSR6x94.ASO OSR6194 Intended Use Immuno-turbidimetric test for the quantitative determination of ASO (Anti-Streptolysin O) antibodies in human serum on Beckman Coulter analysers. MC Cal A Cat No. gangrene. Reference Intervals1 Adults ≤ 200 IU/mL Children ≤ 150 IU/mL Expected values may vary with age. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Specimen Test Procedure Serum: Stable for 8 days when stored at 2…8 °C and 2 days when stored at 15…25 °C. Calibrator 4 may be used. For diagnostic purposes. The absorbance of these aggregates is proportional to the ASO concentration in the sample. septic scarlet fever. Do not use if there are visible signs of microbial growth. flush waste-pipes with water after the disposal of undiluted reagent. using the software options to access the Calibration Monitor.0) Streptolysin-O coated latex Preservative 35 mmol/L < 0. Major preventative maintenance was performed on the analyser or a critical part was replaced. Please refer to User Guide for further instructions. Anti-Streptolysin O antibodies react specifically with Streptolysin-O coated latex to yield insoluble aggregates. EN. ODR30037 for Mastercurve enabled systems only. Safety data sheet available for professional user on request. ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. Calibration This assay may be calibrated using multi-point calibration or single point calibration assay. and if necessary determine its own reference interval according to good laboratory practice. unopened. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Contents. sex. Storage and Stability The reagents are stable. reagents stored on board the instrument are stable for 60 days. Dispose of all waste material in accordance with local guidelines. acute glomerulonephritis. 3 Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. and lymphangitis. 4 x 51 mL 4 x 7 mL R1 R2 Summary1.2 % w/v Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. causing diseases such as acute rheumatic fever. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. In the absence of complications or re-infection. Following calibration. For multi-point calibration use Serum Protein Multi-Calibrator Cat.: ODR3021. Streptolysin O is a haemolysin produced by group A streptococci. No. R2 should be mixed by inversion 5 – 10 times before placing on board the instrument and at weekly intervals thereafter. st 4. sample type. AST.2 Group A streptococcus is one of the most common causes of human bacterial infections. If any trends or sudden shifts in values are detected. results should always be assessed in conjunction with the patient's medical history. Quality Control ITA Control Sera ODC0014.5 Calibrator ASO values are traceable to the WHO NIBSC 1 International standard for Anti. Each laboratory should verify the transferability of the expected values to its own population. on the Beckman Coulter analyser. diet and geographical location. sinusitis. turbidity of precipitate. The results obtained by any individual laboratory may vary from the given mean value. Once open. Reagent Preparation R1 is ready for use and can be placed directly on board the instrument. up to the stated expiry date when stored at 2…8 °C. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. acute pharyngitis. Test Principle When a sample is mixed with R1 buffer and R2 latex solution. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values.01 2009-08 Specific Protein . review all operating parameters. Calculation The Beckman Coulter analysers automatically compute the ASO concentration of each sample. No. the ASO titre will usually fall to pre-infection levels within 6 – 12 months. To avoid the possible build-up of azide compounds. Titres rise as early as 1 week and peak 3 – 6 weeks after infection.: ODR3021. pneumonia. For single point calibration Serum Protein Multi-Calibrator Cat. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice.Streptolysin O. Clinical laboratory diagnostics.24:271-79. 4. 3rd ed. especially turbidity. Protein standardization IV: value transfer procedure for the assignment of serum protein values from a reference preparation to a target material.21 7. The lowest detectable level represents the lowest measurable level of Anti-Streptolysin O that can be distinguished from zero.01 . Setting Sheet Footnotes # † User defined ¤ Analyser default value For multi-point calibration use Serum Protein Multi-Calibrator Cat. plasma and serum samples.2:22pp. Frankfurt/Main: TH-Books Verlagsgesellschaft.031x . International standard for anti-streptolysin-O. Wisser H. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 20 days. 3. Use and assessment of clinical laboratory results. Blirup-Jensen S.84 1.: ODR3021. Clinical guide to laboratory tests.01 2009-08 EN. Tietz NW.575 r = 0. No. ed. ODR30037 * Values set for working in IU/mL BIBLIOGRAPHY 1. Streptococcus pyogenes infection. 5. 6. Linearity The test is linear within a concentration range of 100 – 1000 lU/mL. 2000. WHO/DIL/LAB/99. n = 80 Within Run Total Mean IU/mL SD CV% SD 152 2.77 318 3. In:Thomas L. et al. Zawta B. Hewitt LF. Heil W.49 2. Method Comparison Patient serum samples were used to compare this ASO OSR6194 assay on the AU2700 against another commercially available ASO method. Results of linear regression analysis were as follows: y = 1.90 CV% 2. Bull Wld Hlth Org 1961.18 16. Philadelphia: WB Saunders Company. Töpfer G.74 644 7. 4). 6 Limitations Samples with extremely abnormal optical characteristics. No. Young DS.992 n = 102 Sample range = 106 – 941 IU/mL Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin ® Lipemia: Interference less than 5% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances.63 Sensitivity The lowest detectable level in serum on an AU400 analyser was calculated as 7 IU/mL. Effects of Drugs on Clinical Laboratory Tests. Set the factor range at 0 to 99999. Bentzon MW.61 1. ₪ MC Cal A Cat. Data obtained in your laboratory may differ from these values. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. ed.43 2. Specific Protein BLOSR6x94.65 3.1 Rev.50 1. No. AACC. For single-point calibration use Serum Protein Multi-Calibrator ODR3021 (Cal. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Larsen M.16. Spaun J. 2.Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.9 when using calibration type “AB”. Ehret W. Thomas L.39:1110-1122. Olesen Larsen S.Clin Chem Lab Med 2001. AACC Press. 5th ed. 1998:1201-1203. with calibration type “AB”. Schmitt Y. Johnson AM.1995:919pp. may produce atypical results. # # ∇ 7.5 2.02 2009-11 # User defined ₪ MC Cal A ODC30037 † For multi-point calibration use Serum Protein Multi-Calibrator Cat. Point: With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. None Selected 8.1 # Conc Factor/OD-H 2. AU600 Serum Application System Reagent: OSR6194 Specific Test Parameters General LIH ISE Range Test Name: ASO ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2.0 182 25 Dil.5 1. Out of Range L # # # # # # # # Unit: IU/mL* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Age Y Y Y Y Y Y L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name ASO ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0.1 Reagent OD limit Fst.5 ∇ SERUM APPLICATION Calibration Specific General ISE Serum # Factor/OD-H 2. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name ASO ∇ Sample type Ser ∇ Level L # Page 2/2 Level H # % Sec % ∇ 0 Sample Pre-dil.ASO.5 2. vol 0 0 0 µL µL µL Max. # # # # # OD CONC † † † † † Factor/OD-L -0.5 Sample vol.5 Process: CONC ∇ ∇ Test Name: Counts: ASO ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.5 Main 600 Sub ∇ ∇ ∇ Fst. L -0.5 2.: ODR3021 For single-point calibration use Serum Protein Multi-Calibrator ODR3021 (Cal.0 182 25 µL µL µL Dilution Dilution Dilution 0 0 0 µL µL µL Pri. No.1 1-Point Cal. # # ∇ 4.1 -0. Reagent 1 vol Reagent 2 vol 2. # # ∇ 5. No. with calibration type “AB” *Set the factor range at 0 to 99999. No.5 2. ∇ ∇ ∇ Sec. vol Dil.1 -0. OD L -0.1 -0.1 -0.1 100* B 60 Linearity Fst No lag time Select using Space key. H Lst. with calibration type “AB” * Set the factor range at 0 to 99999.1 -0. # # ∇ 6.5 2. 4). AU400/AU640 Serum Reagent ID: 094 Specific test parameters Serum 1 -0.1 Lst.5 2. vol Dil. L -0.5 2.: ODR3021 For single-point calibration use Serum Protein Multi-Calibrator ODR3021 (Cal. No.1 -0.5 1. No.5 ∇ Operation: Yes ∇ Test No # Test name ASO ∇ Sample type Ser ∇ Page 1/2 System Reagent: OSR6194 Reagent ID: 094 Application ASO.9 when using calibration type “AB” * Values set for working in IU/mL Specific Protein .1 -0. OD H 2.5 1.1 Dynamic range L 100* Correlation factor % ∇ 1000* 1 0 ¤ 60 Specific Test Parameters General LIH ISE Serum # # # # # # # Age Y Y Y Y Y Y ∇ Range Test Name: ASO ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. H 1000* Fst Fst 11 Lst Lst FIXED + 16 First H Last H 1.9 when using calibration type “AB” * Values set for working in IU/mL BSOSR6x94. None ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: On-board stability period 600 FIXED + First 11 First Last Last 16 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † For multi-point calibration use Serum Protein Multi-Calibrator Cat.5 2.1 -0. # # ∇ 3.1 -0. H Max OD H 2. 4). # # ∇ 2.1 -0. 5 2. No.OD Reagent OD Limit First Low Last Low 1. # # ∇ 5. # # # # ∇ 7. 20 µL Dilution 0 Range ∇ Operation: Max OD H 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check % ∇ Parameters General LIH ASO ∇ < > ISE HbA1c Test Name: Noneф 600 ∇nm FIXED ∇ + ∇ 11 600 FIXED + First 11 First Last Last 16 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: High B B 60 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 0 % ∇ 1000* 0 0 Hour Specific Test Parameters General LIH ISE Serum # ∇ Range Test Name: ASO ∇ < > Type: Level L: # Level H: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.OD Dilution 0 µL 0 µL OD Limit 2. # # # # # CONC † † † † † Factor/OD-L -0.1 -0.6 146 20 µL µL µL Dilution Dilution Dilution 0 0 µL µL µL Pri. None Selected 8.1 Factor/OD-H 2. # # # # ∇ 4.1 -0.5 -0. # # # # ∇ 5. OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.5 1.5 Allowance Range Check -0.5 1.5 2. # # # # ∇ 3.5 1.1 -0.5 ∇ Type: Serum < > ∇ ISE HbA1c Range Specific Test Parameters Calculated Test Application System Reagent: OSR6194 Reagent ID: 094 ASO. # # ∇ 3. # # # # ∇ 6.1 2.6 1 146 µL ∇ µL Test Name: ASO ∇ Yes < > Type: ∇ Test Name: Operation Yes ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 1.1 -0.5 Counts: # ∇ ∇ OD Range Low High Slope Check -0. with calibration type “AB” * Set the factor range at 0 to 99999.1 2. 4). Volume R1(R1-1) Min. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # Lot Calibration ∇ Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined † For multi-point calibration use Serum Protein Multi-Calibrator Cat.5 1000* B 60 Last Last 16 µL Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 100* 1 1 Sample Volume Pre-Dilution Rate Rgt. # # ∇ 6. # # ∇ 7.5 -0.02 2009-11 .5 Reagent Blank -0. For No. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L IU/mL* H SERUM APPLICATION Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. # # ∇ 2.1 High High Max.: ODR3021 For single-point calibration use Serum Protein Multi-Calibrator ODR3021 (Cal.5 2.5 Calibration Advanced Calibration Operation Interval (RB/ACAL) Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration <Point Cal.1 -0.9 when using calibration type “AB” * Values set for working in IU/mL ф AU680 999 999 Day Day 0 0 Hour Hour Specific Protein BSOSR6x94.5 1.1 -0. No. AU2700/AU5400 Serum Reagent ID: 094 Parameters General LIH ASO Dilution -0.1 R2(R2-1) Name Sec. AU680/AU480 Serum Application System Reagent: OSR6194 Specific Test Parameters General LIH ISE Serum 1 -0. None ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.1 2. No demographics 8.1 -0.ASO.5 2.1 -0. Not within expected values IU/mL* Decimal Places Calibration Specific ISE ASO ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum ∇ Calibration Specific General ISE Type Serum Counts: # Process: CONC ∇ ∇ Test Name: ASO ∇ < > Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Use Serum Cal. ∇ ∇ ∇ 100* Sec. No.1 2. # # # # ∇ 2. # # ∇ 4. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point None ∇ with Conc-0 + ∇ 1-Point Cal.1 2. AU680/AU480 Mastercurve Reagent ID: 094 Range Serum Application System Reagent: OSR6194 Parameters General Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: ASO ∇ < > Type: Operation Yes ∇ Dilution -0.5 1.02 2009-11 User defined Values set for working in IU/mL MC Cal A ODR30037 AU680 Specific Protein . # # # # ∇ 6. For No. # # # # ∇ 5.5 Max.ASO. # # # # ∇ 4. µL Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A Last Last 16 % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General Range Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: ASO ∇ < > Type: High # High # # # # # # # # Panic Value Low # High # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1.1 -0.1865 Reagent Blank Calibration Hour Hour MB Type Factor: 1-Point Calibration Point None ∇ with Conc-0 # * ₪ ф BSOSR6x94. of Correction Points Master Curve> Calibrator OD Conc Point-1 # ₪ ∇ Point-2 ∇ 999 999 Day Day 0 0 Use Master Curve MC1 ∇ ∇ OD Range Low High Stability 0. # # # # ∇ 7. Volume R1(R1-1) 1.1 High High 1. # # # # ∇ 2. Not within expected values Month # # # # # # Low # # # # # # # # SERUM APPLICATION Unit IU/mL* Decimal Places # Parameters Calibrators General ∇ Use Serum Cal. Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: ASO ∇ < > Type Serum ∇ Yes # ∇ Calibration Type: 5MC ∇ Formula: POLYGONAL ∇ Counts: # ∇ <Calibrator Parameters> OD Range Calibrator OD Conc Low High Slope Check Point 1: 126* ∇ Point 2: 233* Allowance Range Check ∇ Point 3: 353* ∇ Point 4: 465* Reagent Blank ∇ Point 5: 570* Calibration ∇ Point 6: ∇ Point 7 Advanced Calibration ∇ Point 8 Operation ∇ Point 9 ∇ Point 10 Interval (RB/ACAL) ∇ ∇ Lot Calibration 1 <Point Cal.6 1 146 0 µL OD Limit µL ∇ µL Dilution 0 µL Min. # # # # ∇ 3. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 60 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Noneф 600 ∇nm FIXED ∇ + ∇ 11 Name Sec.OD Reagent OD Limit First Low Last Low R2(R2-1) 100* 1 1 0 Hour High B B 1000* 0 0 20 µL Dilution 0 Common Rgt. No demographics 8.5 Sample Volume Pre-Dilution Rate Rgt.OD 2.1 -0.0799 0. . 01 2009-08 Specific Protein . Test Principle When a sample is mixed with R1 buffer and R2 latex solution. all conditions with an increased proliferation rate of lymphocytic cells are associated with elevated serum concentrations e. For in vitro diagnostic use only. A reduction in GFR prolongs the half-life of β-2 microglobulin and serum concentrations increase exponentially. it is subject to free glomerular filtration and tubular reabsorption. Contents. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. chronic lymphocytic leukemias and other malignant nonHodgkin's lymphomas. ODR3023. infectious mononucleosis and transplant rejection. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. certain autoimmune diseases. reagents stored on board the instrument are stable for 90 days. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Since the lymphatic system is the main synthesis site of β-2 microglobulin. on the Beckman Coulter analyser.CMV. human β-2 microglobulin reacts specifically with anti-human β-2 microglobulin antibodies coated on the latex particles. due to bacterially induced interstitial nephritis and cadmium nephropathy. Reagent Preparation R1 is ready for use and can be placed directly on board the instrument. st The calibrator β-2 microglobulin values provided in the calibrator package insert are traceable to the WHO 1 International Standard 1985.EBV). Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed.8 kDa) protein found on the cell membrane of all nucleated cells including lymphocytes. If any trends or sudden shifts in values are detected. 3 Stable in serum and plasma for 3 days when stored at 2…25°C. Following calibration. Calibration Monitor. bacterial and viral infections (HIV. Calibration Curve. Once open. To avoid the possible build-up of azide compounds.g. Dispose of all waste material in accordance with local guidelines. ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. the resulting curve should be visually reviewed. up to the stated expiry date when stored at 2…8°C. Quality Control ITA Control Sera ODC0014. Changes in serum β-2 microglobulin levels or β-2 microglobulin excretion are caused by an increase in production. R2 should be mixed by inversion 5 – 10 times before placing on board the instrument and at weekly intervals thereafter. flush waste-pipes with water after the disposal of undiluted reagent. a change in glomerular filtration rate (GFR) or tubular reabsorption. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Production of β-2 microglobulin is also increased in all diseases that are associated with activation of the immune system e.β-2 MICROGLOBULIN OSR6151 Intended Use Immuno-turbidimetric test for the quantitative determination of β-2 microglobulin in human serum and plasma on Beckman Coulter analysers. Reagent Composition in the Test Final concentration of reactive ingredients: Phosphate buffer (pH 6.g. multiple myelomas. No. review all operating parameters.g.5) Latex particles coated with anti-human β-2 microglobulin Preservative 22 mmol/L Variable Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. 4 x 10 mL 4 x 8 mL R1 R2 Summary1. The protein is the light or β-chain of the class I human leukocyte antigen (HLA) and consists of a single polypeptide chain with one intrachain disulfide bridge. Calibration Serum Protein Multi-Calibrator 2 Cat.01 BLOSR6x51. EN. Major preventative maintenance was performed on the analyser or a critical part was replaced. Storage and Stability The reagents are stable. for acceptability using the software options Routine. The absorbance of these aggregates is proportional to the β-2 microglobulin concentration in the sample. Specimen Serum and EDTA or heparinised plasma. β-2 microglobulin is synthesised at a relatively constant rate and released into the body fluids during the process of natural cell regeneration. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Strongly lipemic samples should be avoided. to yield insoluble aggregates. The results obtained by any individual laboratory may vary from the given mean value. particularly in kidney transplant patients in whom rejection of the allograft will manifest as an increase in serum β-2 microglobulin due to tubulopathy.2 β-2 microglobulin is a low molecular weight (11. Excretion of β-2 microglobulin is increased in the case of tubular damage e. unopened. In healthy people. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Hodgkin's lymphomas. β-2 microglobulin is frequently used to test renal tubular function. 1 Rev. 4 Limitations Samples from patients with paraproteinemia may occasionally give spuriously elevated results. Method Comparison Patient serum samples were used to compare this β-2 Microglobulin OSR6151 assay on the AU600 against another commercially available β-2 microglobulin assay.980 n = 62 Sample range = 11. Wisser H. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.: ODR3023 Values set for working in mg/L. Heil W. Log (y) = 0. Thomas L. No. Silverman LM. Use of anticoagulants in diagnostic laboratory investigations and stability of blood.46 0.16 CV% 2. Clinical laboratory diagnostics. plasma and serum samples. AACC Press. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. 1998:685-688.24 mg/dL) (> 60 years) ≤ 3. 3.4 mg/L (0. Linearity The test is linear within a concentration range of 0.2:38pp. 5th ed. Reference Intervals1 (< 60 years) 0.0 mg/L (≤ 0. Grant GH. n = 60 Within Run Total Mean mg/L SD CV% SD 0.63 0. Data obtained in your laboratory may differ from these values. Effects of drugs on clinical laboratory tests. Young DS. especially turbidity.05 – 1.36 1.01 . Fundamentals of clinical chemistry. sex. results should always be assessed in conjunction with the patient's medical history. β2-microglobulin (β2-M).8 – 2.01 2009-08 EN. Frankfurt/Main: TH-Books Verlagsgesellschaft.01 6. The lowest detectable level represents the lowest measurable level of β-2 microglobulin that can be distinguished from zero. ed. Töpfer G. Results from such patients should be interpreted with care. Schmitt Y.3 mg/dL) Expected values may vary with age. Samples with extremely abnormal optical characteristics.08 – 0. Serum. Each laboratory should verify the transferability of the expected values to its own population.12 9. Philadelphia: WB Saunders Company. et al.Calculation The Beckman Coulter analysers automatically compute the β-2 microglobulin concentration of each sample. For diagnostic purposes.02 0.998log(x) – 0.072 r = 0. 4.02 2. Use and assessment of clinical laboratory results.5 – 16.64 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 0. diet and geographical location. and if necessary determine its own reference interval according to good laboratory practice. BIBLIOGRAPHY Specific Protein BLOSR6x51. ed. Samples with very high β-2 microglobulin concentrations (> 2000 mg/L) can generate false low results without appropriate “Z” flags due to excess antigen in the sample.89 1. such samples should be diluted prior to analysis.6 mg/dL). plasma Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. 2000. clinical examinations and other findings.10 1.0 – 56. Christenson RH. 1987:335pp.37 0. In: Teitz NW.0 mg/L (0. Setting Sheet Footnotes # † * 1. 2. Amino Acids and proteins. To work in mg/dL divide by 10. Zawta B.5 mg/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 500 mg/dL Intralipid Refer to Young for further information on interfering substances. WHO/DIL/LAB/99. sample type. Ehret W. Samples containing elevated levels of rheumatoid factor may cause positive interference in this assay. In: Thomas L.064 mg/L. User defined ¤ Analyser default value Serum Protein Multi-Calibrator 2 Cat. may produce atypical results.92 0.07 1.09 0. 5 Fst.5 1.5 ∇ # Test name B2M Sample type Ser Range Test Name: B2M ∇ < > Type: Page 1/2 Sample: Reagents: Volume R1 Volume R2 Volume 2 100 80 μL μL μL Dilution Dilution Dilution 0 65 15 μL μL μL Pri.5 2. AU600 Serum/Plasma Application System Reagent: OSR6151 Specific Test Parameters General LIH ISE Serum ∇ 1 -0.5 NONE FIXED + 21 Max OD H 2. # # ο ∇ 5.1 Main ∇ ∇ ∇ 570 Sub -0. Out of Range L # # # # # # # # Unit: mg/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name B2M ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0.5 2.5* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil.5 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2.1 -0. # # ο ∇ 3. # # ο ∇ 6.1 -0. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal.: ODR3023 * Values set for working in mg/L. vol Dil. # # # # # OD CONC † † † † † Factor/OD-L -0.5 2.0* Fst Fst 12 Lst Lst First H Last H 1.1 -0. To work in mg/dL divide by 10.1 -0. None Selected 8.1 Dynamic range L 0.5 1.: ODR3023 * Values set for working in mg/L.β-2-MICROGLOBULIN. No. H Lst.5 2. To work in mg/dL divide by 10. # # ο ∇ 7.5 2. ∇ ∇ ∇ Sec. H 16. No. OD L -0. Specific Protein .5 2.1 Reagent OD limit Fst. OD H ∇ Operation: Yes Test No ∇ 2.1 -0.5* Correlation factor % ∇ 16. L -0.1 Lst.1 -0.1 0.5 # SERUM/PLASMA APPLICATION Test Name: Counts: B2M ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 Advanced Calibration: # ∇ Cal. No. AU400/AU640 Serum/Plasma Application Reagent ID: 051 Specific test parameters System Reagent: OSR6151 Reagent ID: 051 β-2-MICROGLOBULIN. BSOSR6x51.0* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: B2M ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name B2M Sample type Ser ∇ On-board stability period 570 FIXED + First 12 First Last Last 21 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min.1 -0. L -0.5 2. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator 2 Cat.1 # Conc Factor/OD-H 2. vol Dil. vol 0 65 15 Max. None ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.01 2009-08 # User defined † Serum Protein Multi-Calibrator 2 Cat.1 -0.1 -0. Reagent 1 vol Reagent 2 vol μL μL μL 2 100 80 Dil.5 1.1 1-Point Cal. H Sample vol. # # ο ∇ 2. # # ο ∇ 4.5 2. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 Advanced Calibration: # ∇ Cal.5 -0.1 2. ∇ ∇ ∇ 0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x51.1 -0.1 2.: ODR3023 Values set for working in mg/L.β-2-MICROGLOBULIN.1 Factor/OD-H 2.1 -0. No. # # ο ∇ 6. ∇ 7.0* B 90 Last Last 21 % ∇ B2M ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 1. # # # # # CONC † † † † † Factor/OD-L -0. ∇ # # # # ο 5.5 -0. ∇ # # # # ο 2.1 2. Not within expected values mg/L* Decimal Places Calibration Specific ISE B2M ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum Counts: ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: B2M ∇ < > Test Name: Use Serum Cal. Volume R1(R1-1) μL ∇ μL 1. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mg/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. For No.5 -0. # # ο ∇ 5.1 -0.5* 1 1 μL High B B 0 16.5 2.1 High High Max. Serum Protein Multi-Calibrator 2 Cat.1 -0.1 -0.5* Sec. AU2700/AU5400 Serum/Plasma Application Reagent ID: 051 Parameters General LIH B2M ∇ Dilution μL -0. None Selected 8. No demographics 8.5 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm FIXED ∇ + ∇ 12 570 FIXED + First 12 First Last Last 21 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH B2M ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # B2M ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 2.5 2.5 ∇ OD Range Low High -0.5 + ∇ 1-Point Cal.5 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6151 Reagent ID: 051 β-2-MICROGLOBULIN.OD Reagent OD Limit First Low Last Low Dilution 52 0 OD Limit 2.5 -0.1 -0. AU680 <Point Cal. # # ο ∇ 3.5 1. AU680/AU480 Serum/Plasma Application Operation Yes System Reagent: OSR6151 Specific Test Parameters General LIH ISE Serum ∇ 1 -0. ∇ # # # # ο 4. No. To work in mg/dL divide by 10.0* 0 0 Hour 64 Dilution 12 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.6 80 64 μL μL μL Dilution Dilution Dilution 0 52 12 μL μL μL Pri. None ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.01 2009-08 . ∇ # # # # ο 6. Point: ο With CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined.1 -0. # # ο ∇ 7. ∇ # # # # ο 3. Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A 0.1 2.OD μL Min.6 1 80 Test Name: Max OD H 2.5 16.5 2.5 1. # # ο ∇ 4.5 1.1 -0.1 R2(R2-1) μL Name Sec. # # ο ∇ 2.5 1. Following calibration. Specimen Serum and EDTA or heparinised plasma.C3 OSR6159 Intended Use Immuno-turbidimetric test for the quantitative determination of C3 (Complement 3) in human serum and plasma on Beckman Coulter analysers. up to the stated expiry date when stored at 2…8 °C. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. The paediatric application is suitable for use with small volume serum/plasma samples.8 °C and 4 days when stored at 15…25 °C. ® The calibrator values are traceable to ERM – DA470 for C3c. human C3 reacts specifically with anti-human C3 antibodies to yield insoluble aggregates.2 The Complement system consists of about 20 plasma proteins as well as receptors on blood cells that play an important role in inflammation by facilitating phagocytosis through opsonisation. Once open. on the Beckman Coulter analyser. increasing vascular permeability and attracting phagocytes. Calibration Serum Protein Multi-Calibrator Cat. Please refer to User Guide for further instructions. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer (pH 7. review all operating parameters.01 2009-08 Specific Protein .01 BLOSR6x59. 3 Stable in serum and plasma for 8 days when stored at 2. measurement of both C3 and C4 can determine whether the classical or alternative pathway has been activated. using the software options to access the Calibration Monitor. Strongly lipemic samples should be avoided. EN.. For in vitro diagnostic use only.g. C4 levels fall only as a consequence of classical pathway activation. No. Major preventative maintenance was performed on the analyser or a critical part was replaced. SLE. ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. Contents. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. MC Cal A Cat No. Calculation The Beckman Coulter analysers automatically compute the C3 concentration of each sample. however this may be compensated for in part by the synthesis of acute phase reactants. Storage and Stability The reagents are stable. C3 comprises about 30% of the total plasma concentration of complement components and is consumed by activation of both the classical and alternative pathways. The results obtained by any individual laboratory may vary from the given mean value.2) Polyethylene glycol 6000 Goat anti-C3 antibodies Preservative 62 mmol/L 1. particularly those involving immune complex deposition e. 4 x 10 mL 4 x 8 mL R1 R2 Summary1. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. ODR30037 for Mastercurve enabled systems only. Safety data sheet available for professional user on request. ODR3021.. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution. mixed cryoglobulinaemia and some forms of vasculitis. therefore if hypocomplementemia is present. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. unopened.6% w/v Variable Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. reagents stored on board the instrument are stable for 90 days. To avoid the possible build-up of azide compounds. Activation or consumption of complement occurs in a number of disorders. lysing foreign cells. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Quality Control ITA Control Sera ODC0014. If any trends or sudden shifts in values are detected. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. the resulting curve should be visually reviewed for acceptability. flush waste-pipes with water after the disposal of undiluted reagent. Dispose of all waste material in accordance with local guidelines. The absorbance of these aggregates is proportional to the C3 concentration in the sample. Thomas L. plasma and serum samples. The complement system.75 0. The lowest detectable level represents the lowest measurable level of C3 that can be distinguished from zero. Each laboratory should verify the transferability of the expected values to its own population. Young DS. Zawta B. Ann Clin Biochem 1999.29 g/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 500 mg/dL Intralipid Refer to Young for further information on interfering substances. Data obtained in your laboratory may differ from these values.84 0.01 1. ODR30037 * Values set for working in SI units (g/L). Smith JL.011 g/L. clinical examinations and other findings.01 . Cope JY. BIBLIOGRAPHY 1. eds. 3. Schmitt Y. Philadelphia:WB Saunders Company. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.00 g/L (15 – 500 mg/dL). Ismail AA. Frankfurt/Main: TH-Books Verlagsgesellschaft.176 r = 0.38 1. Baudner S.64 0. may produce atypical results.9 – 1. To work in mg/dL multiply by 100. et al.01 2009-08 EN.1 Rev. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. Wisser H. Specific Protien BLOSR6x59. 4. sex.926 n = 80 Sample range = 0. 5. Tietz textbook of clinical chemistry. sample type. Autoantibodies and specific serum proteins in the diagnosis of rheumatological disorders.895x .01 0.24 0.37 1. Painter PC. No. Linearity The test is linear within a concentration range of 0.: ODR3021 ₪ MC Cal A Cat. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP international reference material CRM 470. Results of linear regression analysis were as follows: y = 0. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. n = 60 Within Run Total Mean g/L SD CV% SD 0.15 – 5. In:Thomas L.0. For diagnostic purposes.91 – 2. Heil W. ed. Setting Sheet Footnotes # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator Cat. Ehret W. No. diet and geographical location. Snowden N. Ashwood ER. AACC Press.36:565-578. Use and assessment of clinical laboratory results. 5th ed.Reference Intervals4. J Lab Med 1996. Reference information for the clinical laboratory.01 Sensitivity The lowest detectable level in serum on an AU600 analyser was estimated at 0.03 0. AACC. and if necessary determine its own reference interval according to good laboratory practice. 2. WHO/DIL/LAB/99.2:27pp. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.01 1. especially turbidity.05 CV% 1.1807pp.02 4. 1999.39 0. 1998:794-806.8 g/L (90 – 180 mg/dL) Expected values may vary with age. 6. Dati F. 2000. 6 Limitations Samples with extremely abnormal optical characteristics. results should always be assessed in conjunction with the patient's medical history. Method Comparison Patient serum samples were used to compare this C3 OSR6159 assay on the AU600 against another commercially available C3 assay.5 Adults and children 0. In: Burtis CA. Effects of Drugs on Clinical Laboratory Tests.68 0. Töpfer G.20:145-152. Clinical laboratory diagnostics. 5 2. Specific Protein . # # ο ∇ 5.1 -0. L -0.5 2. 800 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.5 Last L -0.: ODR3021 * Values set for working in SI units (g/L). H Lst. Vol 0 150 0 Max. # # ο ∇ 6.1 -0.1 -0.5 2.0* Correlation Factor: A 1 B 0 On-board stability period: 90 H A B Rate Min.1 -0. # # ο ∇ 3.5 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2.C3.1 Last H 1.1 -0.5 1.5 2.1 -0. Vol Dil. To work in mg/dL multiply by 100. To work in mg/dL multiply by 100.5 ∇ Operation: Yes Test No ∇ ∇ # Test name C3 Sample type Ser Page ½ System Reagent: OSR6159 Reagent ID: 059 Application C3. ∇ ∇ ∇ Sec.5 2.1 Lst.5 2. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name C3 ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0.1 -0. No.15* Correlation factor 5. H ∇ ∇ ∇ Main 380 Sub 2 50 40 Dil. # # ο ∇ 4. # # ο ∇ 7.5 # SERUM/PLASMA APPLICATION Test Name: Counts: C3 ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.1 -0.: ODR3021 * Values set for working in SI units (g/L).01 2009-08 # User defined † Serum Protein Multi-Calibrator Cat. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. None Selected 8. BSOSR6x59. AU600 Serum/Plasma Application System Reagent: OSR6159 Specific Test Parameters General LIH ISE Range Test Name: C3 ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil.15* H 5. No. Vol Dil.1 First H 1.1 Dynamic range L 0. # # ο ∇ 2. # # # # # OD CONC † † † † † Factor/OD-L -0. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator Cat.0* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: C3 ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 Dynamic Range: L 0. L -0. or select from list displayed by Guide key Test No ∇ ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name C3 Sample type Ser ∇ 380 END + First 0 First 0 Pri. No. OD H 1. Linearity Fst No lag time % Sec 0 0 Lst Lst 800 END + 27 10 2 50 40 μL μL μL Dilution Dilution Dilution 0 150 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key.1 1-Point Cal. AU400/AU640 Serum/Plasma Reagent ID: 059 Specific test parameters Serum ∇ Sample vol.1 # Conc Factor/OD-H 2. Reagent 1 vol Reagent 2 vol μL μL μL Fst.5 2.5 2. OD L Reagent OD limit Fst. Volume R1(R1-1) μL ∇ μL 1. ∇ # # # # ο 4.5 2.1 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 380 ∇nm END ∇ + ∇ 0 0 % ∇ ∇ ∇ ∇ Sec. ∇ # # # # ο 6. # # ο ∇ 2.5 Dynamic Range: L 0. AU680/AU480 Serum/Plasma Application System Reagent: OSR6159 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt.5 -0.5 ∇ OD Range Low High -0.5 2. AU680 <Point Cal.5 2.5 -0.5 + ∇ 1-Point Cal. ∇ # # # # ο 2. Serum Protein Multi-Calibrator Cat. ∇ 7.5 1. # # ο ∇ 4.5 2.1 2.1 Last H 1.0* Correlation Factor: A 1 B 0 On-board stability period: 90 Specific Test Parameters General LIH ISE Serum ∇ LIH C3 ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # C3 ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. 380 END + First 0 First 0 Common Rgt.15* 1 1 μL High B B 0 32 Dilution 10 1.01 2009-08 .1 2.OD -0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L g/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.1 First H 1. 800 ∇ Last Last 27 10 5. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x59. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal.1 -0. No. # # ο ∇ 7.1 -0.: ODR3021 Values set for working in SI units (g/L).1 -0.OD Reagent OD Limit First Low Last Low Dilution 110 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6159 Reagent ID: 059 Application Operation Yes C3.0* 0 0 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. Not within expected values g/L* Decimal Places Calibration Specific ISE C3 ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum Counts: ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: C3 ∇ < > Test Name: Use Serum Cal.6 40 32 μL μL μL Dilution Dilution Dilution 0 110 10 μL μL μL Pri. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. # # ο ∇ 6. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined. For No. # # ο ∇ 5.C3. ∇ # # # # ο 3.5 Last L -0.15* H 5.1 High High 1. No. ∇ # # # # ο 5.6 1 40 Range Operation: ∇ Yes Test Name: C3 ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec.1 2. AU2700/AU5400 Serum/Plasma Reagent ID: 059 Parameters General LIH C3 ∇ Dilution μL Max.1 -0.5 -0. # # ο ∇ 3. No demographics 8. None Selected 8. To work in mg/dL multiply by 100.5 μL Min.1 2.1 -0.1 Factor/OD-H 2.5 -0. # # # # # CONC † † † † † Factor/OD-L -0. 5 1. ∇ # # # # ο 5. For No. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Noneф 380 ∇nm END ∇ + ∇ 0 0 % ∇ Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General Range Serum ∇ Panic Value Low # High # LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: C3 ∇ < > Type: High # High # # # # # # # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. Not within expected values Month # # # # # # Low # # # # # # # # Unit g/L* Decimal Places # Parameters Calibrators General ∇ ο Use Serum Cal. AU680/AU480 Mastercurve Reagent ID: 059 Serum/Plasma Application Range Serum ∇ ∇ System Reagent: OSR6159 Parameters General LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: C3 ∇ < > Type: Operation Yes Dilution Max.C3. ∇ 7.0* 0 0 Common Rgt. ∇ # # # # ο 4.1 High High 1. Volume R1(R1-1) 1.6 1 40 0 μL OD Limit μL ∇ μL Dilution 110 μL Min.OD Reagent OD Limit First Low Last Low R2(R2-1) 32 μL Dilution 10 μL Name Sec.8196 Reagent Blank 999 Day 0 Calibration 999 Day 0 Hour Hour MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 # * ₪ ф BSOSR6x59.1 -0.01 2009-08 User defined Values set for working in SI units (g/L).5 Sample Volume Pre-Dilution Rate Rgt. Calibration Specific Calibration Parameters STAT Table Calibration ISE SERUM/PLASMA APPLICATION Test Name: C3 ∇ < > Type Serum ∇ Yes ∇ # ∇ Calibration Type: 5MC ∇ Formula: POLYGONAL ∇ Counts: # ∇ <Calibrator Parameters> OD Range Calibrator OD Conc Low High Slope Check Point 1: 0.55* Allowance Range Check ∇ Point 3: 2. To work in mg/dL multiply by 100.15* 1 1 High B B 5.3513 0.93* ∇ ο Calibration Point 6: ∇ Point 7 Advanced Calibration ∇ Point 8 Operation ∇ Point 9 ∇ Point 10 Interval (RB/ACAL) ∇ 1 <Point Cal.OD -0.41* ∇ Point 2: 1.69* ∇ Point 4: 3. ∇ # # # # ο 6. MC Cal A ODR30037 AU680 Specific Protein . ∇ # # # # ο 3.86* ∇ ο Reagent Blank Point 5: 4. No demographics 8. of Correction Points Master Curve> Calibrator OD Conc Point-1 # ₪ ∇ Point-2 ∇ Use Master Curve MC1 ∇ ∇ ο Lot Calibration OD Range Low High Stability 0. 0 Hour ф 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. ∇ # # # # ο 2. 5 2. AU600 Paediatric Application System Reagent: OSR6159 Specific Test Parameters General LIH ISE Range Test Name: C3P ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil.5 2.1 Dynamic range L 0.5 2. # # ο ∇ 5.1 -0. H Lst.5 2. Reagent 1 vol Reagent 2 vol μL μL μL Fst.5 1.5 Last L -0. # # ο ∇ 7.1 -0.0* 1 0 ¤ Specific Test Parameters General LIH ISE Serum ∇ # # # # # # # Age Y Y Y Y Y Y Range Page 2/2 Level H # Test Name: C3P ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 3. vol Dil. BSOSR6x59.5 Dynamic Range: L 0. Specific Protein . L -0. OD H ∇ Operation: Yes Test No ∇ ∇ # Test name C3P Sample type Ser Page 1/2 System Reagent: OSR6159 Reagent ID: 059 Application C3.5 ∇ ∇ ∇ Main 380 Sub 2 50 40 Dil. or select from list displayed by Guide key Test No ∇ # ∇ H # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ M M M M M M Age Y Y Y Y Y Y # # # # # # L # Test name C3P Sample type Ser ∇ Level L # % Sec 0 0 Lst Lst H A B Rate 800 END + 27 10 2 50 40 μL μL μL Dilution Dilution Dilution 10 140 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period 380 END + First 0 First 0 Pri.: ODR3021 * Values set for working in SI units (g/L). L -0.1 -0. vol 10 140 0 Max. ∇ ∇ ∇ Sec. No. H 1.1 -0.5 # Test Name: C3P ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.5 2.1 1-Point Cal. 800 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.1 -0.1 Last H 1.1 -0. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name C3P ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0.5 2. # # ο ∇ 2.1 First H 1.5 2.0* Correlation Factor: A 1 B 0 On-board stability period: 90 90 Min. Linearity Fst No lag time Select using Space key.15* H 5. To work in mg/dL multiply by 100. vol Dil.01 2009-08 # User defined † Serum Protein Multi-Calibrator Cat. To work in mg/dL multiply by 100. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator Cat. No.1 -0.15* Correlation factor 5.5 ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2. # # ο ∇ 6.1 -0.5 2. None Selected 8. AU400/AU640 Paediatric Reagent ID: 059 Specific test parameters Serum ∇ Sample vol.1 Lst.C3.1 # Conc Factor/OD-H 2. # # # # # OD CONC † † † † † Factor/OD-L -0.: ODR3021 * Values set for working in SI units (g/L). OD L Reagent OD limit Fst. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. No. # # ο ∇ 4. OD Reagent OD Limit First Low Last Low Dilution 100 10 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6159 Reagent ID: 059 Application Operation Yes C3.1 2.6 1 40 Range Operation: ∇ Yes Test Name: C3P ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec. # # # # # CONC † † † † † Factor/OD-L -0.: ODR3021 Values set for working in SI units (g/L).1 2. AU680/AU480 Paediatric Application System Reagent: OSR6159 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt.1 High High 1.15* 1 1 μL High B B 0 5.5 ∇ OD Range Low High -0.C3. Not within expected values Decimal Places Calibration Specific Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration Type Serum Counts: ∇ # ο ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ Process: CONC ∇ Test Name: C3P ∇ < > Use Serum Cal. # # ο ∇ 5. ∇ # # # # ο 4.6 40 32 μL μL μL Dilution Dilution Dilution 10 100 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. # # ο ∇ 4.5 + ∇ 1-Point Cal. 800 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.1 2.01 2009-08 .0* Correlation Factor: A 1 B 0 On-board stability period: 90 Specific Test Parameters General LIH ISE Serum ∇ LIH C3P ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # C3P ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. AU2700/AU5400 Paediatric Reagent ID: 059 Parameters General LIH C3P ∇ Dilution μL Max.5 2.5 μL Min.5 1.5 -0.1 -0. No demographics 8. Volume R1(R1-1) μL ∇ μL 1.1 -0. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.1 -0.5 -0. # # ο ∇ 3. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Counts: OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal.5 2.15* H 5. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 380 ∇nm END ∇ + ∇ 0 0 % ∇ 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 380 END + First 0 First 0 Pri. # # ο ∇ 2.5 Dynamic Range: L 0. ∇ 7.5 -0.1 Last H 1. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined. To work in mg/dL multiply by 100.1 -0.5 -0. AU680 <Point Cal. ∇ # # # # ο 5. # # ο ∇ 6. ∇ ∇ ∇ Sec. ∇ # # # # ο 6. ∇ # # # # ο 3.5 Last L -0. For No.0* 0 0 Hour 32 Dilution 10 1. None Selected 8.1 Factor/OD-H 2. ∇ # # # # ο 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x59. No.5 2. Serum Protein Multi-Calibrator Cat. # # ο ∇ 7. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General ISE C3P ∇ < > POLYGONAL Test Name: g/L* Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L g/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.5 2. No.1 2.1 First H 1.1 2.1 -0.OD -0. . The absorbance of these aggregates is proportional to the C4 concentration in the sample. MC Cal A Cat No. Please refer to User Guide for further instructions. review all operating parameters. Quality Control ITA Control Sera ODC0014. flush waste-pipes with water after the disposal of undiluted reagent. Storage and Stability The reagents are stable. For in vitro diagnostic use only.6% w/v Variable Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents.. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. the resulting curve should be visually reviewed for acceptability. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution. Safety data sheet available for professional user on request. The paediatric application is suitable for use with small volume serum/plasma samples. Calculation The Beckman Coulter analysers automatically compute the C4 concentration of each sample. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Following calibration. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed.g. ® The calibrator values are traceable to ERM – DA470. Strongly lipemic samples should be avoided. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. particularly those involving immune complex deposition e. up to the stated expiry date when stored at 2…8 °C. If any trends or sudden shifts in values are detected. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. reagents stored on board the instrument are stable for 90 days. therefore if hypocomplementemia is present. C4 levels fall only as a consequence of classical pathway activation. mixed cryoglobulinaemia and some forms of vasculitis. on the Beckman Coulter analyser.01 2009-08 Specific Protein . Specimen Serum and EDTA or heparinised plasma. Dispose of all waste material in accordance with local guidelines. EN. To avoid the possible build-up of azide compounds. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.2 The Complement system consists of about 20 plasma proteins as well as receptors on blood cells that play an important role in inflammation by facilitating phagocytosis through opsonisation. measurement of both C3 and C4 can determine whether the classical or alternative pathway has been activated.2) Polyethylene glycol 6000 Goat anti-C4 antibodies Preservative 62 mmol/L 1. No.C4 OSR6160 Intended Use Immuno-turbidimetric test for the quantitative determination of C4 (Complement 4) in human serum and plasma on Beckman Coulter analysers. unopened.8 °C and 2 days when stored at 15…25 °C.01 BLOSR6x60.. C3 comprises about 30% of the total plasma concentration of complement components and is consumed by activation of both the classical and alternative pathways. 4 x 10 mL 4 x 8 mL R1 R2 Summary1. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. ODR30037 for Mastercurve enabled systems only. Activation or consumption of complement occurs in a number of disorders. 3 Stable in serum and plasma for 8 days when stored at 2. increasing vascular permeability and attracting phagocytes. using the software options to access the Calibration Monitor. lysing foreign cells. Contents. ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. SLE. ODR3021. Calibration Serum Protein Multi-Calibrator Cat. human C4 reacts specifically with anti-human C4 antibodies to yield insoluble aggregates. Once open. however this may be compensated for in part by the synthesis of acute phase reactants. Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer (pH 7. The results obtained by any individual laboratory may vary from the given mean value. Major preventative maintenance was performed on the analyser or a critical part was replaced. 36 Sensitivity The lowest detectable level in serum on an AU600 analyser was estimated at 0.20:145-152. User defined ¤ Analyser default value Serum Protein Multi-Calibrator Cat. Results of linear regression analysis were as follows: y = 1. Use of anticoagulants in diagnostic laboratory investigations and stability of blood.: ODR3021 MC Cal A Cat. sex. n = 60 Within Run Total Mean g/L SD CV% SD 0.36:565-578. Frankfurt/Main: TH-Books Verlagsgesellschaft. Setting Sheet Footnotes # † ₪ * 1. results should always be assessed in conjunction with the patient's medical history. Ashwood ER. 2000. 1999. sample type. Philadelphia:WB Saunders Company. 6 Limitations Samples with extremely abnormal optical characteristics. Heil W. eds. Each laboratory should verify the transferability of the expected values to its own population. The lowest detectable level represents the lowest measurable level of C4 that can be distinguished from zero. Young DS. Schmitt Y. 2.84 0.00 0.48 1. Dati F.063x . Effects of Drugs on Clinical Laboratory Tests. especially turbidity. For diagnostic purposes. Clinical laboratory diagnostics.1807pp. Autoantibodies and specific serum proteins in the diagnosis of rheumatological disorders. AACC.08 – 1. 5th ed. In:Thomas L. In: Burtis CA. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.94 0. diet and geographical location. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP international reference material CRM 470. No.002 g/L. et al. No. 4. Töpfer G. clinical examinations and other findings.43 0. Zawta B. Cope JY. Use and assessment of clinical laboratory results. Smith JL. To work in mg/dL multiply by 100. 1998:794-806.01 g/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 500 mg/dL Intralipid Refer to Young for further information on interfering substances.4 g/L (10 – 40 mg/dL) Expected values may vary with age. may produce atypical results. Method Comparison Patient serum samples were used to compare this C4 OSR6160 assay on the AU600 against another commercially available C4 assay. and if necessary determine its own reference interval according to good laboratory practice.972 n = 81 Sample range = 0.5 Adults and Children 0.31 0. Tietz textbook of clinical chemistry.33 0. Reference information for the clinical laboratory.50 g/L (8 – 150 mg/dL). It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. J Lab Med 1996. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. Painter PC.16 0. Thomas L. ODR30037 Values set for working in SI units (g/L). Ismail AA.01 0.00 2. 5.1 – 0. Linearity The test is linear within a concentration range of 0. The complement system.00 1.1 Rev.05 r = 0. Snowden N. Baudner S.02 CV% 2.Reference Intervals4. AACC Press. WHO/DIL/LAB/99. BIBLIOGRAPHY Specific Protein BLOSR6x60. plasma and serum samples.00 0. Ehret W. 6.01 . Ann Clin Biochem 1999.01 2009-08 EN. 3.0.2:27pp. Wisser H.19 1. ed. Data obtained in your laboratory may differ from these values.08 – 1. 5 Dynamic Range: L 0. Linearity Fst No lag time % Sec 0 0 Lst Lst 800 END + 27 10 2 50 40 μL μL μL Dilution Dilution Dilution 0 150 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key. AU600 Serum/Plasma Application System Reagent: OSR6160 Specific Test Parameters General LIH ISE Range Test Name: C4 ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil.50* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: C4 ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 2. OD L Reagent OD limit Fst. No. H ∇ ∇ ∇ Main 340 Sub 2 50 40 Dil. # # # # # OD CONC † † † † † Factor/OD-L -0.1 Lst. # # ο ∇ 7. None Selected 8. # # ο ∇ 5.1 -0. # # ο ∇ 4.1 -0. OD H 1.50* Correlation Factor: A 1 B 0 On-board stability period: 90 H A B Rate Min.5 2. To work in mg/dL multiply by 100. BSOSR6x60. Vol Dil.08* H 1.: ODR3021 * Values set for working in SI units (g/L).5 2. or select from list displayed by Guide key Test No ∇ ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name C4 Sample type Ser ∇ 340 END + First 0 First 0 Pri.1 -0. To work in mg/dL multiply by 100. No.1 Last H 1.1 1-Point Cal.5 Last L -0. 800 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. H Lst.5 2.: ODR3021 * Values set for working in SI units (g/L).1 -0.5 2. ∇ ∇ ∇ Sec. No. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name C4 ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0.1 -0.01 2009-08 # User defined † Serum Protein Multi-Calibrator Cat. # # ο ∇ 6.1 First H 1.5 ∇ Operation: Yes Test No ∇ ∇ # Test name C4 Sample type Ser Page ½ System Reagent: OSR6160 Reagent ID: 060 Application C4. Vol 0 150 0 Max.1 Dynamic range L 0. L -0. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. AU400/AU640 Serum/Plasma Reagent ID: 060 Specific test parameters Serum ∇ Sample vol.5 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2.1 -0.C4.5 2.5 2.5 1. L -0.5 # SERUM/PLASMA APPLICATION Test Name: Counts: C4 ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. # # ο ∇ 2. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator Cat. Specific Protein . # # ο ∇ 3. Reagent 1 vol Reagent 2 vol μL μL μL Fst.5 2. Vol Dil.1 -0.1 -0.1 # Conc Factor/OD-H 2.08* Correlation factor 1. # # ο ∇ 5.1 -0.5 ∇ OD Range Low High -0.1 First H 1.5 + ∇ 1-Point Cal.5 2.1 2.5 μL Min. ∇ # # # # ο 4. # # ο ∇ 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ ∇ ∇ ∇ Sec.5 2.1 High High 1. ∇ # # # # ο 3.C4. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. ∇ # # # # ο 2.1 2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L g/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.08* 1 1 μL High B B 0 32 Dilution 10 1. # # # # # CONC † † † † † Factor/OD-L -0. # # ο ∇ 3.1 -0.08* H 1. ∇ # # # # ο 5. ∇ # # # # ο 6.1 Last H 1.5 Last L -0. No.1 -0.1 2. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 Advanced Calibration: # ∇ Cal.5 -0.5 2. For No.01 2009-08 .6 1 40 Range Operation: ∇ Yes Test Name: C4 ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec. AU680 <Point Cal.50* Correlation Factor: A 1 B 0 On-board stability period: 90 Specific Test Parameters General LIH ISE Serum ∇ LIH C4 ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # C4 ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 Dynamic Range: L 0.50* 0 0 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.OD Reagent OD Limit First Low Last Low Dilution 110 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6160 Reagent ID: 060 Application Operation Yes C4. No.1 2.OD -0. # # ο ∇ 4. To work in mg/dL multiply by 100.1 -0. Volume R1(R1-1) μL ∇ μL 1. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined. No demographics 8. 800 ∇ Last Last 27 10 1.6 40 32 μL μL μL Dilution Dilution Dilution 0 110 10 μL μL μL Pri.5 -0. Serum Protein Multi-Calibrator Cat. AU2700/AU5400 Serum/Plasma Reagent ID: 060 Parameters General LIH C4 ∇ Dilution μL Max.5 2. 340 END + First 0 First 0 Common Rgt. # # ο ∇ 7.1 Factor/OD-H 2.5 -0. ∇ 7.5 1.1 -0. AU680/AU480 Serum/Plasma Application System Reagent: OSR6160 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt.1 2. # # ο ∇ 6. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x60. None Selected 8. Not within expected values g/L* Decimal Places Calibration Specific ISE C4 ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum Counts: ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: C4 ∇ < > Test Name: Use Serum Cal.5 -0.: ODR3021 Values set for working in SI units (g/L). 3835 Reagent Blank 999 Day 0 Calibration 999 Day 0 Hour Hour MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 # * ₪ ф BSOSR6x60. Not within expected values Month # # # # # # Low # # # # # # # # Unit g/L* Decimal Places # Parameters Calibrators General ∇ ο Use Serum Cal.40* ∇ ο Calibration Point 6: ∇ Point 7 Advanced Calibration ∇ Point 8 Operation ∇ Point 9 ∇ Point 10 Interval (RB/ACAL) ∇ 1 <Point Cal.5 Sample Volume Pre-Dilution Rate Rgt.48* Allowance Range Check ∇ Point 3: # 0.78* ∇ Point 4: # 1. AU680/AU480 Mastercurve Reagent ID: 060 Serum/Plasma Application Range Serum ∇ ∇ System Reagent: OSR6160 Parameters General LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: C4 ∇ < > Type: Operation Yes Dilution Max.5 1. ∇ # # # # ο 3. ∇ # # # # ο 2.1 -0. ∇ # # # # ο 6.1 High High 1.11* ∇ ο Reagent Blank Point 5: # 1. To work in mg/dL multiply by 100.OD Reagent OD Limit First Low Last Low R2(R2-1) 32 μL Dilution 10 μL Name Sec. 0 Hour ф 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.15* ∇ Point 2: # 0.50* 0 0 Common Rgt.01 2009-08 User defined Values set for working in SI units (g/L). ∇ # # # # ο 4. ∇ # # # # ο 5. Calibration Specific Calibration Parameters STAT Table Calibration ISE SERUM/PLASMA APPLICATION Test Name: C4 ∇ < > Type Serum ∇ Yes ∇ # ∇ Calibration Type: 5MC ∇ Formula: POLYGONAL ∇ Counts: # ∇ <Calibrator Parameters> OD Range Calibrator OD Conc Low High Slope Check Point 1: # 0.OD -0. ∇ 7. For No.C4.1644 0. Volume R1(R1-1) 1. No demographics 8.6 1 40 0 μL OD Limit μL ∇ μL Dilution 110 μL Min. MC Cal A ODR30037 AU680 Specific Protein . Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General Range Serum ∇ Panic Value Low # High # LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: C4 ∇ < > Type: High # High # # # # # # # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.08* 1 1 High B B 1. of Correction Points Master Curve> Calibrator OD Conc Point-1 # ∇ ₪ Point-2 ∇ Use Master Curve MC1 ∇ ∇ ο Lot Calibration OD Range Low High Stability 0. ∇ ∇ ∇ Sec. # # # # # OD CONC † † † † † Factor/OD-L -0. L -0. AU400/AU640 Paediatric Reagent ID: 060 Specific test parameters Serum ∇ Sample vol. # # ο ∇ 3. # # ο ∇ 6. To work in mg/dL multiply by 100.5 2.08* H 1. No. H Lst. BSOSR6x60.1 -0. To work in mg/dL multiply by 100.1 -0.1 Lst. or select from list displayed by Guide key Test No ∇ # ∇ H # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ M M M M M M Age Y Y Y Y Y Y # # # # # # L # Test name C4P Sample type Ser ∇ Level L # % Sec 0 0 Lst Lst H A B Rate 800 END + 27 10 2 50 40 μL μL μL Dilution Dilution Dilution 10 140 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period 340 END + First 0 First 0 Pri.5 2.1 -0. L -0.1 First H 1. AU600 Paediatric Application System Reagent: OSR6160 Specific Test Parameters General LIH ISE Range Test Name: C4P ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil. # # ο ∇ 5.1 # Conc Factor/OD-H 2. Vol 10 140 0 Max. Linearity Fst No lag time Select using Space key.01 2009-08 # User defined † Serum Protein Multi-Calibrator Cat.1 Last H 1.1 Dynamic range L 0. Specific Protein . OD H ∇ Operation: Yes Test No ∇ ∇ # Test name C4P Sample type Ser Page ½ System Reagent: OSR6160 Reagent ID: 060 Application C4.5 2. # # ο ∇ 2.5 Dynamic Range: L 0.5 ∇ ∇ ∇ Main 340 Sub 2 50 40 Dil.5 ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2. None Selected 8.: ODR3021 * Values set for working in SI units (g/L).1 -0.1 -0. Reagent 1 vol Reagent 2 vol μL μL μL Fst. No. Vol Dil.1 -0. # # ο ∇ 7.08* Correlation factor 1.5 2.50* Correlation Factor: A 1 B 0 On-board stability period: 90 90 Min.50* 1 0 ¤ Specific Test Parameters General LIH ISE Serum ∇ # # # # # # # Age Y Y Y Y Y Y Range Page 2/2 Level H # Test Name: C4P ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.C4.5 2.1 1-Point Cal.5 # Test Name: C4P ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.1 -0.: ODR3021 * Values set for working in SI units (g/L). Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 Last L -0.5 2.5 2. # # ο ∇ 4. 800 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. H 1. OD L Reagent OD limit Fst. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator Cat. Vol Dil. No.5 2.1 -0.5 1. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name C4P ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0. Not within expected values Decimal Places Calibration Specific Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration Type Serum Counts: ∇ # ο ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ # Process: CONC ∇ Test Name: C4P ∇ < > Use Serum Cal. # # ο ∇ 5. To work in mg/dL multiply by 100.08* 1 1 μL High B B 0 1. No. ∇ # # # # ο 6. Volume R1(R1-1) μL ∇ μL 1.5 -0.1 2. ∇ 7.08* H 1.1 -0.1 -0. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.C4.5 + ∇ 1-Point Cal. No. For No. # # ο ∇ 7. # # ο ∇ 6.6 1 40 Range Operation: ∇ Yes Test Name: C4P ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec.5 2.50* Correlation Factor: A 1 B 0 On-board stability period: 90 Specific Test Parameters General LIH ISE Serum ∇ LIH C4P ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # C4P ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.6 40 32 μL μL μL Dilution Dilution Dilution 10 100 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.1 -0.5 ∇ OD Range Low High -0. ∇ # # # # ο 5. 800 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. ∇ # # # # ο 2. AU680/AU480 Paediatric Application System Reagent: OSR6160 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt.01 2009-08 .1 2. ∇ ∇ ∇ Sec. # # ο ∇ 2.5 μL Min. # # ο ∇ 3.5 2. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Counts: OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal.5 Last L -0.1 High High 1.OD Reagent OD Limit First Low Last Low Dilution 100 10 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6160 Reagent ID: 060 Application Operation Yes C4.1 Last H 1. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined. AU680 <Point Cal. # # # # # CONC † † † † † Factor/OD-L -0.5 2. No demographics 8.: ODR3021 Values set for working in SI units (g/L).1 2.5 -0.1 Factor/OD-H 2.1 2. AU2700/AU5400 Paediatric Reagent ID: 060 Parameters General LIH C4P ∇ Dilution μL Max.5 1. ∇ # # # # ο 4.1 -0. # # ο ∇ 4. Serum Protein Multi-Calibrator Cat. ∇ # # # # ο 3. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 340 END + First 0 First 0 Pri. None Selected 8.5 Dynamic Range: L 0.1 -0.OD -0.5 -0.5 -0.5 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x60.50* 0 0 Hour 32 Dilution 10 1. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General ISE C4P ∇ < > POLYGONAL Test Name: g/L* Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L g/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.1 First H 1.1 2. . Ceruloplasmin’s main clinical importance is in the diagnosis of Wilson’s disease. For diagnostic purposes.01 BLOSR6x64. Major preventative maintenance was performed on the analyser or a critical part was replaced. The calibrator values are traceable to the IFCC (International Federation of Clinical Chemistry) standard CRM 470. Increased ceruloplasmin levels are particularly notable in diseases of the reticuloendothelial system such as Hodgkin’s disease as well as during pregnancy or the use of contraceptive pills. diet and geographical location. reagents stored on board the instrument are stable for 90 days. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. No. It is a late acute phase reactant synthesised by the liver. The absorbance of these aggregates is proportional to the ceruloplasmin concentration in the sample. Reference Intervals4 Adults 200 – 600 mg/L (20 – 60 mg/dL) Expected values may vary with age. flush waste-pipes with water after the disposal of undiluted reagent. Safety data sheet available for professional user on request. 3 Stable in serum and plasma for 3 days when stored at 2. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. If any trends or sudden shifts in values are detected. Reagent Composition in the Test Final concentration of reactive ingredients: Solution of polymers in phosphate buffered saline Polyethylene glycol 6000 Rabbit anti-human ceruloplasmin antiserum Preservative (pH 7.CERULOPLASMIN OSR6164 Intended Use Immuno-turbidimetric test for the quantitative determination of ceruloplasmin in human serum and plasma on Beckman Coulter analysers. on the Beckman Coulter analyser. myocardial infarction.01 2009-08 Specific Protein . Once open. Acute phase reactant refers to proteins whose serum concentrations rise significantly during acute inflammation due to causes including surgery.4 – 7. and if necessary determine its own reference interval according to good laboratory practice. Storage and Stability The reagents are stable. ODR3023. EN. sex. up to the stated expiry date when stored at 2…8°C. Here plasma ceruloplasmin concentration is reduced while dialysable copper concentration is increased. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution.. Quality Control ITA Control Sera ODC0014. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed.6) 5% w/v Variable Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. 4 x 18 mL 4 x 5 mL R1 R2 Summary1. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Calculation The Beckman Coulter analysers automatically compute the ceruloplasmin concentration of each sample. Calibration Monitor. Calibration Serum Protein Multi-Calibrator 2 Cat. Specimen Serum and EDTA or heparinised plasma. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. To avoid the possible build-up of azide compounds. sample type.. particularly biliary cirrhosis. Following calibration. Contents. Calibration Curve. Dispose of all waste material in accordance with local guidelines. the resulting curve should be visually reviewed. ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. unopened. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Low plasma levels of ceruloplasmin are found in malnutrition. results should always be assessed in conjunction with the patient's medical history. human ceruloplasmin reacts specifically with the anti-human ceruloplasmin antibodies to yield insoluble aggregates. For in vitro diagnostic use only.8°C. for acceptability using the software options Routine. The results obtained by any individual laboratory may vary from the given mean value. infections and tumours. Each laboratory should verify the transferability of the expected values to its own population. malabsorption. review all operating parameters.2 Ceruloplasmin is the primary copper containing protein in plasma. nephrosis and severe liver disease. clinical examinations and other findings. These samples are characterised by having extremely elevated Cholesterol values (>10 mmol/L) and elevated Bilirubin. Johnson AM. may produce atypical results.020x – 3.94 2.27 22. AACC.80 CV% 2.10 0. Linearity The test is linear within a concentration range of 60 – 2000 mg/L (6 – 200 mg/dL). Clinical chemistry theory. Setting Sheet Footnotes # † * 1. The lowest detectable level represents the lowest measurable level of ceruloplasmin that can be distinguished from zero. Dati F. Philadelphia: WB Saunders Company.Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.30 1.90 934. Effects of Drugs on Clinical Laboratory Tests. correlation. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP international reference material CRM 470. 4. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Samples with extremely abnormal optical characteristics. Philadelphia:WB Saunders Company. Ceruloplasmin.490-492. To work in mg/dL divide by 10.50 17.44 2.01 2009-08 EN.10 0. In: Kaplan LA. eds. User defined ¤ Analyser default value System Calibrator Cat.10 1810. Silverman LM. Pesce AJ. analysis.01 . Ashwood ER. Data obtained in your laboratory may differ from these values. Such samples should be diluted 1 part sample to 4 parts deionised water prior to analysis and the result multiplied by 5.80 1. AACC Press. 5. 3rd ed.990 n = 50 Sample range = 90 – 510 mg/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid® Refer to Young for further information on interfering substances. 3. BIBLIOGRAPHY Specific Protein BLOSR6x64. St Louis: Mosby. ed. 1995:122pp. 1999. No. 1996:966pp. Method Comparison Patient serum samples were used to compare this Ceruloplasmin OSR6164 assay on the AU640 against another commercially available ceruloplasmin assay. 5th ed.: ODR3023 Values set for working in SI units (mg/L).36 4.10 11.94 84. especially turbidity. J Lab Med 1996. Young DS. n = 80 Within Run Total Mean mg/L SD CV% SD 120.20:145-152. Proteins. Results of Deming linear regression analysis were as follows: y = 1. 2000. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 20 days.68 Sensitivity The lowest detectable level on an AU640 analyser was calculated at 4 mg/L. eds. Tietz textbook of clinical chemistry. 5 Limitations Samples from patients with abnormal lipoprotein metabolism such as those seen in cholecystitis or obstructive liver disease may give artificially negative Ceruloplasmin results. Rohlfs EM. Baudner S. In: Burtis CA. Clinical guide to laboratory tests. Tietz NW. 2.5 r = 0. Kazmierczak SC. No. ∇ ∇ ∇ Sec.5 2.1 -0. To work in mg/dL divide by 10.5 Wave Method Reaction Point 1 Point 2 800 END + 27 10 Sample vol. vol Dil.5 2. 800 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. H -0.5 2. # # ο ∇ 6.1 -0.1 -0. Specific Protein .1 -0. vol 0 10 10 Max.5 1. No.5 2.5 ∇ Calibration Specific General ISE ∇ Process: CONC ∇ Factor/OD-H 2. L -0. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CER Sample type Ser ∇ On-board stability period 340 END + First 0 First 0 Pri.1 -0. H 2000* Fst Fst 0 0 Lst Lst First H Last H 1.CERULOPLASMIN.: ODR3023 * Values set for working in SI units (mg/L). Reagent 1 vol Reagent 2 vol μL μL μL 2 180 50 Dil.1 Dynamic range L 60* Correlation factor % ∇ 2000* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: CER ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 -0.5 2. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. AU400/AU640 Serum/Plasma Reagent ID: 064 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 340 Sub Fst. No.5 SERUM/PLASMA APPLICATION Test Name: Counts: # CER ∇ < > Type Serum Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.5 1. # # ο ∇ 5.5 2.5 2.1 -0. AU600 Serum/Plasma Application System Reagent: OSR6164 Specific Test Parameters General LIH ISE Range Test Name: CER ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 180 50 μL μL μL Dilution Dilution Dilution 0 10 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. vol Dil.1 Lst. # # ο ∇ 2.: ODR3023 * Values set for working in SI units (mg/L). L -0.1 1-Point Cal.1 # Conc Factor/OD-H 2. BSOSR6x64.1 -0. None Selected 8. # # ο ∇ 4.5 2.5 ∇ Operation: Yes Test No ∇ ∇ # Test name CER Sample type Ser Page 1/2 System Reagent: OSR6164 Reagent ID: 064 Application CERULOPLASMIN. # # ο ∇ 3.01 2008-08 # User defined † Serum Protein Multi-Calibrator 2 Cat. OD H 1. Out of Range L # # # # # # # # Unit: mg/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name CER ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0. # # # # # OD CONC † † † † † Factor/OD-L -0. # # ο ∇ 7.1 60* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil.1 -0. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator 2 Cat. H Lst. OD L Reagent OD limit Fst. To work in mg/dL divide by 10. CERULOPLASMIN. None Selected 8.5 2.1 R2(R2-1) μL Name Sec.5 + ∇ 1-Point Cal. No demographics 8.5 2000* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 10 10 μL μL μL Pri.1 -0.5 -0. # # ο ∇ 5. AU680 <Point Cal. ∇ 7. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 340 END + First 0 First 0 Sec. AU680/AU480 Serum/Plasma Application System Reagent: OSR6164 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0.5 μL Min.1 -0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x64.1 High High 1.1 -0. Serum Protein Multi-Calibrator 2 Cat.1 -0.01 2008-08 . For No.5 1. # # ο ∇ 6. ∇ # # # # ο 4. # # ο ∇ 4. # # ο ∇ 2.5 2. # # ο ∇ 7. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Test Name: Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mg/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. 800 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH CER ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # CER ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. ∇ # # # # ο 5. AU2700/AU5400 Serum/Plasma Reagent ID: 064 Parameters General LIH CER ∇ Dilution μL Max.OD -0.OD Reagent OD Limit First Low Last Low Dilution 10 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6164 Reagent ID: 064 Application Operation Yes CERULOPLASMIN.1 Factor/OD-H 2. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined.1 -0. # # # # # CONC † † † † † Factor/OD-L -0.1 2. Volume R1(R1-1) μL ∇ μL 2 1 180 Range Operation: ∇ Yes Test Name: CER ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 Last Last 27 10 2 180 50 1.1 -0. ∇ # # # # ο 3. No.5 -0.1 2. ∇ # # # # ο 6. ∇ # # # # ο 2. Not within expected values mg/L* Decimal Places Calibration Specific ISE CER ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum Counts: ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: CER ∇ < > Use Serum Cal. ∇ ∇ ∇ 60* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.1 2.1 2. To work in mg/dL divide by 10.5 1.1 2.5 -0. # # ο ∇ 3. No. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 60* 1 1 μL High B B 0 2000* 0 0 Hour 50 Dilution 10 Sample Volume Pre-Dilution Rate Rgt.5 -0.5 2.: ODR3023 Values set for working in SI units (mg/L).5 2.5 ∇ OD Range Low High -0. 5) Sodium chloride Polyethylene glycol 6000 Goat anti-CRP antibodies Preservative 80 mmol/L 125 mmol/L 1. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. tissue necrosis and malignancy. and even then only by comparison with previous values. Following calibration. flush waste-pipes with water after the disposal of undiluted reagent. the resulting curve should be visually reviewed. Safety data sheet available for professional user on request. ODR3021. Normal CRP levels do not exclude the presence of minor degrees of acute. Because the increase is non-specific. Warning – this preparation contains a substance not yet tested completely. In many cases the changes in plasma CRP level precede changes in the clinical symptoms. Dispose of all waste material in accordance with local guidelines. For in vitro diagnostic use only. To avoid the possible build-up of azide compounds. No. and trauma. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. If any trends or sudden shifts in values are detected. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Calibration Serum Protein Multi-Calibrator Cat. on the Beckman Coulter analyser. Storage and Stability The reagents are stable. The degree of elevation of CRP reflects the mass or activity of the inflammed tissue and in acute inflammation or infection correlates well with disease activity. it cannot be interpretated without a complete clinical history. 3 Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.5 % w/v ≈ 0. review all operating parameters. for acceptability using the software options to access Calibration Monitor.. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. localised inflammation or some chronic diseases such as SLE and ulcerative colitis. up to the stated expiry date when stored at 2…8 °C. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. The absorbance of these aggregates is proportional to the CRP concentration in the sample.01 BLOSR6x47. Major preventative maintenance was performed on the analyser or a critical part was replaced. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution. Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer (pH 7. CRP reacts specifically with anti-human CRP antibodies to yield insoluble aggregates. myocardial infarction. CRP exhibits dramatic increases in concentration following acute or chronic inflammation that may accompany bacterial infections . unopened. The increase occurs within 24 – 48 hours and the level may be 2000 times normal. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values.. Calculation The Beckman Coulter analysers automatically compute the CRP concentration of each sample.CRP OSR6147 Intended Use Immuno-turbidimetric test for the quantitative determination of C-reactive protein (CRP) in human serum and plasma on Beckman Coulter analysers. Contents. Once open. ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. Quality Control ITA Control Sera ODC0014.the most potent stimulus to CRP production.8 °C and 11 days when stored at 15…25 °C. The results obtained by any individual laboratory may vary from the given mean value. Specimen Test Procedure Serum and heparinised plasma: Stable in serum and plasma for 2 months when stored at 2. 4 x 14 mL 4 x 6 mL R1 R2 Summary1.2 C-reactive protein (CRP) is an acute phase protein synthesised by the liver in response to the release of inflammatory cytokines such as interleukin-6.01 2009-08 Specific Protein . Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. A persistently raised CRP level generally indicates that therapy is ineffective. EN. autoimmune or immune complex disease.6 g/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. The calibrator CRP values are traceable to IFCC (International Federation of Clinical Chemistry) standard CRM 470. reagents stored on board the instrument are stable for 90 days. 20:145-152. Philadelphia:WB Saunders Company. 5. especially monoclonal IgM (Waldenström’s Macroglobulinemia). ed. Results of linear regression analysis were as follows: y = 0. Zawta B. In: Thomas L. Christenson RH. Baudner S.1 Rev. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Dati F. No.02 SD 0.49 1. Heil W.994 n = 79 Sample range = 10 – 212 mg/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances.31 2. Setting Sheet Footnotes # † * 1. 1987:334pp. Effects of drugs on clinical laboratory tests.56 168. et al.65 2. sex.57 mg/L. No. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.939x – 0. Schmitt Y. AACC Press. For diagnostic purposes. 5th ed. Ehret W.81 2. In very rare cases gammopathy. Use and assessment of clinical laboratory results. Frankfurt/Main: TH-Books Verlagsgesellschaft. plasma and serum samples. In: Tietz NW. Fundamentals of clinical chemistry. Method Comparison Patient serum samples were used to compare this CRP OSR6147 assay on the AU600 against another commercially available CRP assay. diet and geographical location. refer to Setting Sheet for specific instrument details. 5 Limitations This product is not suitable for cardiovascular risk assessment or diagnostic evaluation of neonates. 3.29 2. Linearity The test is linear within a concentration range of 5 – 300 mg/L Prozone settings must be applied when using the CRP reagent.55 1. 4. Wisser H. Samples with very high CRP concentrations (> 750 mg/L) can generate false low results without appropriate "Z" flags due to excess antigen in the sample. may produce atypical results. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 20 days. These samples are characterised by having extremely elevated Cholesterol values (> 10 mmol/L) and elevated Bilirubin.29 Sensitivity The lowest detectable level on an AU640 analyser was estimated at 1. 1998:700-706. Data obtained in your laboratory may differ from these values. J Lab Med 1996. 2000.817 r = 0. Clinical laboratory diagnostics. may cause unreliable results. sample type. clinical examinations and other findings.01 2009-08 EN. Young DS.Reference Intervals4 Serum-adult Upper limit is 5 mg/L Expected values may vary with age.2:28pp. Each laboratory should verify the transferability of the expected values to its own population.99 2. User defined ¤ Analyser default value Serum Protein Multi-Calibrator Cat.24 1.71 CV% 2. ed.: OSR6199 is available for this purpose.07 Within Run SD 0. WHO/DIL/LAB/99. Such samples should be diluted 1 part sample to 4 parts deionised water prior to analysis and the result multiplied by 5.01 . Samples with extremely abnormal optical characteristics. Samples from patients with abnormal lipoprotein metabolism such as those seen in cholecystitis or obstructive liver disease may give artificially elevated CRP results. n = 80 Mean mg/L 10. results should always be assessed in conjunction with the patient's medical history.90 89.17 Total CV% 5. Silverman LM. and if necessary determine its own reference interval according to good laboratory practice. The CRP Latex reagent Cat.: ODR3021 Values set for working in mg/L Whicher J. Grant GH. especially turbidity. Amino acids and proteins. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP international reference material CRM 470. BIBLIOGRAPHY Specific Protein BLOSR6x47. 2. Töpfer G. The lowest detectable level represents the lowest measurable level of CRP that can be distinguished from zero. C-reactive protein (CRP). # # # # # # OD CONC † † † † † † Factor/OD-L -0.1 -0.5 2.: ODR3021 * Values set for working in mg/L # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator Cat.1 -0. No. L -0. Reagent 1 vol Reagent 2 vol 18 70 30 Dil.5 2.5 2. Linearity Fst No lag time Select using Space key.1 -0.0000 0 0 NO 0 0. Vol Dil. OD L -0.0000 0.5 1.0 0.1 Reagent OD limit Fst.5 300* 1 1* ¤ 90 ∇ # Test name CRP Sample type Ser Page 1/2 System Reagent: OSR6147 Reagent ID: 047 Application CRP. AU600 Serum/Plasma Application System Reagent: OSR6147 Specific Test Parameters General LIH ISE Range Test Name: CRP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 18 70 30 μL μL μL Dilution Dilution Dilution 0 170 10 μL μL μL Pri.0000 0.1 -0.0 0. L -0.1 -0. or select from list displayed by Guide key Calibration Specific Test No ∇ ∇ Count Process # Conc ∇ 6AB ∇ POLYGONAL OD # Test name CRP % Sec % ∇ On-board stability period 11 Lst Lst 340 Sub -0.5 2.1 Main Fst Fst Sample Pre-dil.4 2.5 1. H Lst. Vol 0 170 10 μL μL μL Max.01 2009-08 .1 Factor/OD-H 2. Vol Dil.5 Wave Method Reaction Point 1 Point 2 800 FIXED + 27 ∇ ∇ ∇ Max OD H 2. No.: ODR3021 * Values set for working in mg/L Specific Protein BSOSR6x47. AU400/AU640 Serum/Plasma Reagent ID: 047 Specific Test Parameters Serum ∇ 1 -0.3 10 11 MB Type Factor: Calibration Stability Period: SERUM/PLASMA APPLICATION Data Check Parameters Serum ∇ Logic Check -3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Test Name: CRP ∇ < > Type: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 11 14 18 0. OD H ∇ Operation: Yes Test No ∇ 2.0000 0 0 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 11 14 18 0. Point: ο with CONC-0 Slope Check: Select the function using the Function key or the Mouse Data Check Parameters # Logic check-1 Name YES CRP ∇ Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0.3 10 11 Logic Check –2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # User defined † Serum Protein Multi-Calibrator Cat.1 Cal type 14 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 # ∇ Point 7 ∇ 1-point cal.5 2.1 -0. H H A B Rate Sample vol. 800 ∇ Min.5 ∇ Advanced Calibration: ∇ Test No 999 # # Test Name: Counts: CRP ∇ < > Type Calibration Type: 6AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + Cal.1 Lst.1 5* B 90 1* H 300* First H Last H 1.5 2.5 Fst. No.5 2.1 -0.4 2.5 1.5 1-Point Cal.1 -0. Point MB type factor Calibrator stability period 999 Conc † † † † † † Factor/OD-L -0.1 -0.1 -0.5 2.5 2.1 Dynamic range L 5* Correlation factor Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 340 FIXED + First 11 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2.CRP.1 -0. ∇ ∇ ∇ Sec.5 2. 1 -0.1 Factor/OD-H 2.OD Reagent OD Limit First Low Last Low Dilution 170 0 OD Limit 2.1 -0.5 1.OD μL Min. Test Name: Counts: # Process: CONC ∇ CRP ∇ < > Calibration Type: 6AB ∇ Formula: POLYGONAL ∇ OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 Advanced Calibration: # Cal.: ODR3021 Values set for working in mg/L AU680 √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: Specific Protein BSOSR6x47.1 -0.1 R2(R2-1) μL Name Sec.1 -0.5 2.5 2.5 ο Reagent Blank -0.5 Allowance Range Check -0.5 Advanced Calibration Operation Interval (RB/ACAL) # ∇ # ∇ Calibration Type: 6AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: # † ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ SERUM/PLASMA APPLICATION Data Check Parameters Type: ∇ Serum Test Name: CRP ∇ < > <Point Cal. Serum Protein Multi-Calibrator Cat.1 2. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 5* 1 1 μL High B B 0 300* 0 1* Hour 30 Dilution 10 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. No.4 2.5 + ∇ 1-Point Cal.5 300* B 90 Last Last 27 % ∇ CRP ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 1* Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 15 47 20 μL μL μL Dilution Dilution Dilution 0 110 10 μL μL μL Pri.5 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6147 Reagent ID: 047 Application Operation Yes CRP.1 -0.1 2.5 -0.5 1. No. # # # # # # CONC † † † † † † Factor/OD-L -0.5 2.1 2.2 10 11 Logic Check-2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: 11 14 18 0.1 -0.5 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 None ∇ ο with Conc-0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters CRP ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 11 14 18 0.1 2.5 -0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm FIXED ∇ + ∇ 11 340 FIXED + First 11 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L ∇ Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Calibration Specific General ISE Type: Serum ∇ Test Name: ∇ < CRP > POLYGONAL ISE Type Parameters Calibrators General Calibration Specific Calibration Parameters STAT Table Calibration Serum ∇ ο Use Serum Cal. AU2700/AU5400 Serum/Plasma Reagent ID: 047 Parameters General LIH CRP ∇ Dilution μL -0.5 ο Calibration -0. 800 Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Counts: # ∇ ∇ OD Range Low High Slope Check -0.3000 10 11 Pattern1 # † * ф User defined.5 2.0 0.1 2. AU680/AU480 Serum/Plasma Application System Reagent: OSR6147 Specific Test Parameters General LIH ISE Serum ∇ 1 -0.4000 2.5 1.1 -0. Volume R1(R1-1) μL ∇ μL 18 1 70 Test Name: Max OD H 2.1 -0.1 -0.0000 0.1 2. ∇ ∇ ∇ 5* Sec.5 1. For No.CRP.01 2009-08 .1 High High Max. EN. see setting sheets for specific instrument details. reagents stored on board the instrument are stable for 90 days. To avoid the possible build-up of azide compounds. ODC0026 ODC0027 The calibrator CRP values are traceable to IFCC (International Federation of Clinical Chemistry) standard CRM 470.8°C and 11 days when stored at 15…25°C.5 % w/v < 0. Normal Application (0. trauma. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice.2. The normal application is to be used for the detection and evaluation of infection.2-480 mg/L): inflammation. infection. surgery. 8-48 hours after presentation. EDTA and lithium heparinised plasma: Stable in serum and plasma for 2 months when stored at 2. unopened.4 C-reactive protein levels in serum can rise dramatically after myocardial infarction. Calibration Application Normal Highly sensitive Calibrator CRPLatex Calibrator Normal Set CRP Latex Calibrator Highly Sensitive Set Cat. Test Principle When a sample is mixed with R1 buffer and R2 latex suspension.1 % w/v Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. 5. Contents.10 times before placing on board the instrument and at weekly intervals thereafter. Data check parameters must be applied when using Highly Sensitive application on AU2700/AU5400. flush waste-pipes with water after the disposal of undiluted reagent. indicate that bacterial infection is unlikely. 1. Thus CRP Latex reagent is providing a valuable tool for the early diagnosis of infection in preterm infants and neonates. inflammatory disorders and associated diseases. Safety data sheet available for professional user on request. Antisera was produced in healthy animals in facilities free from rinderpest. No. Storage and Stability The reagents are stable. Recalibrate when the following occur: Change in reagent bottle or significant shift in control values. In the diagnostic evaluation of neonates with suspected infection..6 2. CRP reacts specifically with anti-human CRP antibodies coated on the latex particles to yield insoluble aggregates. CRP concentrations above 3 mg/L at the time of hospital admission can predict subsequent cardiac events. Two low CRP levels obtained 24 hours apart. 4 x 30 mL 4 x 30 mL 4 x 50 mL 4 x 50 mL R1 R2 R1 R2 Summary C-reactive protein (CRP) is one of the most sensitive acute-phase reactants. The Highly Sensitive application is not a general screening test for infection/inflammation. R2 should be mixed by inversion 5 .08 – 80 mg/L): Cord blood normally has very low CRP concentrations (median 0. Calibration Monitor. Highly Sensitive Application (0. It assesses both the need for and the effectiveness of antibiotic treatment however CRP values alone cannot be used as a basis for early discontinuance of antibiotic therapy. Once open. peste des petits ruminants. Dispose of all waste material in accordance with local guidelines. Reagent Preparation R1 is ready for use and can be placed directly on board the instrument. The absorbance of these aggregates is proportional to the CRP concentration in the sample.CRP Latex OSR6199 OSR6299 Intended Use Immuno-turbidimetric test for the quantitative determination of C-reactive protein (CRP) in human serum and plasma on Beckman Coulter analysers. Studies have shown that the detection of much lower CRP levels can indicate an increased risk for coronary heart disease in asymptomatic patients. however due to the non specificity of CRP and the wide inter-individual variation. coated with anti-CRP antibodies Preservative 100 mmol/L < 0. Specimen Test Procedure Serum. 7 Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Following calibration. With the Beckman Coulter System CRP Latex reagent. For in vitro diagnostic use only. CRP can be measured down to very low concentrations.01 2009-08 Specific Protein . interpretation of CRP levels must be undertaken with care. Major preventative maintenance was performed on the analyser or a critical part was replaced. bovine spongiform encephalopathy and blue tongue disease. Reagent Composition in the Test Final concentration of reactive ingredients: Glycine buffer Latex.01 BLOSR6x99. and the level may be 2000 times normal.3. The increase occurs within 24 to 48 hours. up to the stated expiry date when stored at 2…8°C. foot and mouth disease. measurements of serial CRP levels are useful. usually in comparison with previous CRP values or other markers. for acceptability using the software options Routine. Calibration Curve.. Depending on the application used (different instrument settings) two measuring ranges are available: 1. on the Beckman Coulter analyser.12 mg/L). or neoplastic proliferation. Rhift Valley fever. tissue injury. the resulting curve should be visually reviewed. 59 0.16 3. The results obtained by any individual laboratory may vary from the given mean value.73 0. and if necessary determine its own reference interval according to good laboratory practice.95 1.59 AU400: n = 80 Within Run Total Application Mean mg/L SD CV% SD CV% Normal 6.20 – 155.Quality Control ITA Control Sera ODC0014.83 2.76 2.02 0. For diagnostic purposes. clinical examinations and other findings. Each laboratory should verify the transferability of the expected values to its own population.20 – 167. AU600.34 137.73 0. for the Highly Sensitive Application.12 0. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.024 0. Other control materials with values determined by this Beckman Coulter system may also be used.26 1.01 4. Precision The following data was obtained for CRP (Latex) normal and highly sensitive assays on an AU640. review all operating parameters. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed.33 0. AU640: n = 80 Within Run Total Application Mean mg/L SD CV% SD CV% Normal 6.09 0.63 2. due to the use of non-human materials in the controls. Linearity The test is linear within a concentration range of 0.93 AU2700: n = 80 Within Run Total Application Mean mg/L SD CV% SD CV% Normal 6. results should always be assessed in conjunction with the patient's medical history.34 1. 0. Calculation The Beckman Coulter analysers automatically compute the CRP concentration of each sample.56 0.01 .44 0.01 5.01 2009-08 EN.08 .14 Highly Sensitive 0.70 1.25 3.998 0.20 3.480mg/L for the Normal Application (AU400/640.73 1.55 0.70 2. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.86 137.23 0. AU2700/5400).02 0. AU400 and AU2700 using 3 serum pools analysed over 20 days. of samples 119 118 Range (mg/L) 0.2 .80 mg/L (AU400/640.01 5.12 64.12 1. If any trends or sudden shifts in values are detected.76 1.12 0.75 2.02 0. Data obtained in your laboratory may differ from these values. diet and geographical location.76 9.546 .20 2.68 146.18 1.94 48.78 1.08 0.40 60.87 59. AU2700/5400).10 0.84 0.65 Highly Sensitive 0.07 1.96 0.22 0.09 0.28 0.01 4.86 Specific Protein BLOSR6x99.91 1. Results of linear regression analysis were as follows: Normal Highly Sensitive Y Method AU640 AU640 X Method Method 2 Method 2 Slope 1.08 0. and CRP (Latex) Control Sera ODC0013 (two levels) should be used for the Highly Sensitive application only.0.05 0.85 64. AU600.93 2.21 3.70 0.20 0.56 0.52 1.19 1.32 0.54 0. ODC0015 and ODC0016 should be used for the Normal and Highly Sensitive applications.07 The lowest detectable level represents the lowest measurable level of CRP that can be distinguished from zero.79 0.74 3. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Please note that the recovery of non-Beckman Coulter controls may vary with reagent lots of immunoassay products.80 0.87 1.01 4. 8 Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems.92 0.02 1.28 0.71 0.21 0.92 137.01 6.35 0.21 1.64 1.825 Correlation Coeff (r) 0. Method Comparison Patient serum samples were used to compare the normal and highly sensitive CRP Latex OSR6199 assays on the AU640 against another commercially available CRP assay (Method 2).38 0. sample type.02 0.27 144.50 Sensitivity The lowest detectable level was estimated as follows: Application Lowest Detectable Level (mg/L) AU640 AU400 AU2700 Normal 0.78 1.00 1.63 Highly Sensitive 0.993 Intercept 0.79 62. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.27 1.09 0. Reference Intervals Normal application < 5 mg/L 9 < 1 mg/L Highly sensitive application Expected values may vary with age.997 No.64 Highly Sensitive 0. sex.38 0. Gallimore R. Ridker PM. Madan A. 5th ed. 2000. Effects of drugs on clinical laboratory tests.20:145-152. Morrow DA. Cannon RO. Young DS. 1987:334pp. Heil W. Markers of inflammation and cardiovascular disease. Gallimore JR. EurJ Pediatr 1990. Hawkins PN. J Lab Med 1996. In: Tietz NW. Dati F. 9. Pepys MB. 10 Limitations Samples containing heterophilic antibodies can cause falsely elevated results. especially turbidity. Ehret W. Philadelphia:WB Saunders Company. 3. Samples with very high CRP concentrations (> 750 mgmL) can generate false low results without appropriate "Z" flags due to excess antigen in the sample. and coronary risk. AACC Press. User defined ¤ Analyser default value CRP Latex Calibrator Normal Set ODC0026 CRP Latex Calibrator Highly Sensitive Set ODC0027 Values set for working in mg/L.84:149-161. Liuzzo G. Criqui M et al.and highly sensitive assays to interference were as follows: Normal Application Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 1000 mg/dL Intralipid Highly Sensitive Application Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances. 7. 4. Amino acids and proteins. 2. Rebuzzi AG. Serial serum C-reactive protein levels in the diagnosis of neonatal infection. 8.331:417-424. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP international reference material CRM 470. Pepys MB. Wasunna A. 2003. Adv Intern Med 2000. Application to clinical and public health practice. Pearson TA. ed.45:391-419. Circulation. Grillo RL. N Engl J Med 1994. Han MY. Töpfer G. Anderson JL.107:499-511.1 Rev. may cause unreliable results. Baudner S. plasma and serum samples.Interfering Substances Results of studies conducted to evaluate the susceptibility of CRP Latex normal. inflammation.01 2009-08 Specific Protein . Setting Sheet Footnotes # † † * 1. Christenson RH. 10. Pediatrics 1998. Whitelaw A. Novel risk factors and markers for coronary disease. C-reactive protein and bacterial infection in preterm infants. WHO/DIL/LAB/99. Alexander RW. Maseri A. Samples with extremely abnormal optical characteristics. Med Clin North Am 2000. may produce atypical results. Schmitt Y.01 BLOSR6x99. Ridker PM.102: 4:E41. EN. Benitz WE. The prognostic value of C-reactive protein and serum amyloid A protein in severe unstable angina. Fundamentals of clinical chemistry. et al. Ramachandra P. especially monoclonal IgM (Waldenström’s macroglobinemia).2:28pp. Silverman LM. Wisser H. 6. C-reactive protein. 5.149:424-427. A statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Biasucci LM. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. Zawta B. Mensah GA. BIBLIOGRAPHY Grant GH. In very rare cases Gammopathy. . 5 2. None ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.5 Advanced Calibration Operation Interval (RB/ACAL) # ∇ # ∇ Calibration Type: 6AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # 0§ ∇ Point 2: # 10† ∇ Point 3: # 40† ∇ Point 4: # 160† ∇ Point 5: # 320† ∇ Point 6: # 480† ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ SERUM/PLASMA APPLICATION Data Check Parameters Serum ∇ Test Name: CRPN ∇ < > Type: <Point Cal.1 R2(R2-1) μL Name Sec.1 Factor/OD-H 2.1 -0.5 2.5 ο Calibration -0. No.5 -0.5 -0.1 2.OD High High μL Min. Volume R1(R1-1) μL ∇ μL 1.5 2. No. For No. OSR6299 Reagent ID: 099 Application Operation Yes ∇ CRP Latex.5 < > ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6199. AU680/AU480 Normal Serum/Plasma Application System Reagent: OSR6199. OSR6299 Specific Test Parameters General LIH ISE Serum ∇ 1 0.1 2.5 2.5 Allowance Range Check -0.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.5 ο Reagent Blank -0.5 2.1 2. ∇ ∇ ∇ 0. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Counts: # ∇ ∇ Factor Range Low High Slope Check -0.1 -0.6 1 120 Test Name: Max OD H 2.6 -0.2* 1 1 High B B 0 480* 0 0 Hour 120 Dilution 10 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.1 -0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 None ∇ ο with Conc-0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters CRPN ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ BSOSR6x99. AU400/AU640 Normal Serum/Plasma Reagent ID: 099 Parameters General LIH CRPN ∇ Dilution μL 0.5 2.5 + ∇ 1-Point Cal.5 480* B 90 Last Last 22 % ∇ CRPN ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 2 150 150 μL μL μL Dilution Dilution Dilution 0 0 10 μL μL μL Pri.: ODC0026 * Values set for working in mg/L ф AU680 Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: Specific Protein .5 2. Test Name: Counts: # CRPN ∇ < > Type Calibration Type: 6AB ∇ Formula: SPLINE ∇ OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal.1 -0.1 2.6 -0.1 -0. # # # # # # CONC 0§ 10† 40† 160† 320† 480† Factor/OD-L -0.01 2009-08 Misc Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Logic Check –2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Logic Check -3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: # User defined § For the zero calibrator saline should be used † CRP Latex calibrator Normal Set Cat. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm FIXED ∇ + ∇ 12 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 570 FIXED + First 12 First Last Last 22 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Test Name: ∇ < CRPN ISE > SPLINE Parameters Calibrators General Calibration Specific Calibration Parameters STAT Table Calibration Type Serum ∇ ο Use Serum Cal.CRP Latex.1 2.1 -0.1 2.5 2. Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A μL 0.1 Max.2* Sec.1 -0.5 2. 5 2.1 Factor/OD-H 2.1 -0.OD μL Min.1 -0.5 2.5 -0.1 -0.5 ο Calibration -0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 None ∇ ο with Conc-0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters CRPHS ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Logic Check –2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Logic Check -3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: # User defined § For the zero calibrator saline should be used † CRP Latex calibrator Highly Sensitive Set Cat. No.5 Advanced Calibration Operation Interval (RB/ACAL) # ∇ # ∇ Calibration Type: 6AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # 0§ ∇ Point 2: # 2.5 2. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Counts: # ∇ ∇ OD Range Low High Slope Check -0.5 2.1 2.5 2.5† ∇ Point 3: # 10† ∇ Point 4: # 20† ∇ Point 5: # 80† ∇ Point 6: # 160† ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Data Check Parameters Serum ∇ Test Name: CRPHS ∇ < > Type: <Point Cal. No.1 Reagent OD limit: First L -0.5 2.01 2009-08 .5 2.1 2.1 2.1 -0. OSR6299 Reagent ID: 099 Application Operation Yes CRP Latex.5 2.1 2.1 Last L -0.1 -0.1 -0.08* Correlation Factor: A 1 On-board stability period: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Test Name: ∇ < CRPHS > SPLINE ISE Type Parameters Calibrators General Calibration Specific Calibration Parameters STAT Table Calibration Serum ∇ ο Use Serum Cal. OSR6299 Specific Test Parameters General LIH ISE Serum ∇ Max OD H 2.08* 1 1 μL High B B 0 80* 0 0 Hour 75 Dilution 10 Sample Volume Pre-Dilution Rate Rgt. ∇ ∇ ∇ 80* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Sec. AU400/AU640 Highly Sensitive Serum/Plasma Reagent ID: 099 Parameters General LIH CRPHS ∇ Dilution μL -0. Test Name: Counts: # CRPHS ∇ < > Type Calibration Type: 6AB ∇ Formula: SPLINE ∇ OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal.1 -0.5 + ∇ 1-Point Cal.5 2.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.: ODC0027 * Values set for working in mg/L ф AU680 Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: Specific Protein BSOSR6x99.1 Dynamic Range: L 0. AU680/AU480 Highly Sensitive Serum/Plasma Application System Reagent: OSR6199.5 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6199. For No.5 -0. None ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.1 2.5† 10† 20† 80† 160† Factor/OD-L -0. Volume R1(R1-1) μL ∇ μL 3 1 75 Range Operation: ∇ Yes Test Name: CRPHS ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 Last Last 22 % ∇ 3 75 75 μL μL μL Dilution Dilution Dilution 0 0 10 μL μL μL Pri.1 High High Max. Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A 0.5 R2(R2-1) μL Name Sec. # # # # # # CONC 0§ 2.1 2.5 Allowance Range Check -0.CRP Latex. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm FIXED ∇ + ∇ 12 570 FIXED + First 12 First Last Last 22 % ∇ Pre-Dilution Rate: 1 Min OD L -0.5 ο Reagent Blank -0. Point MB type factor Calibrator stability period Select the function using the Function key or the Mouse Data Check Parameters Ser ∇ NO 0 0. L -0.0000 0 0 Test No # Name CRPN ∇ Type SERUM/PLASMA APPLICATION Logic check-1 NO Logic Check-2 Logic check-1 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 0 0 0 0.5 2. % On-board stability period Sec Linearity Fst No lag time Select using Space key. L -0.0000 0. AU600 Normal Serum/Plasma Reagent ID: 099 Specific Test Parameters Ser ∇ Max.1 Lst. Vol Dil. OD L -0. Vol 0 0 10 μL μL μL Main 570 Sub Wave Method Reaction Point 1 Point 2 H A B Rate 90 480* 1 0 ¤ Fst Fst 12 Lst Lst NONE FIXED + 22 ∇ ∇ ∇ Min. or select from list displayed by Guide key Calibration Specific Test No # Conc ∇ Factor/OD-H 2.0000 0 0 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 # § † * User defined ¤ Analyser default value For the zero calibrator saline should be used CRP Latex calibrator Normal Set Cat.0000 0 0 NO 0 0.1 # Conc Factor/OD-H 2. Reagent 1 vol Reagent 2 vol 2 150 150 Dil.5 Main Fst Fst Sample Pre-dil. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse OD Conc 0§ 10† 40† 160† 320† 480† Factor/OD-L -0.5 2.1 -0.0000 0.CRP Latex. Vol 0 0 10 μL μL μL Max.5 2.1 -0.1 Lst.5 2. OSR6299 Reagent ID: 099 Application CRP Latex.1 999 Cal type 14 Formula 10 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 # ∇ Point 7 ∇ 1-point cal.5 ∇ 6AB ∇ SPLINE OD # Test name CRPHS % ∇ 12 Lst Lst 570 Sub Wave Method Reaction Point 1 Point 2 H A B Rate 80* 1 0 ¤ 90 NONE FIXED + 22 ∇ ∇ ∇ Fst. H Sample vol.5† 10† 20† 80† 160† Count Process Factor/OD-L -0.5 2. OD L 0. Vol Dil.0000 0 0 NO 0 0. H 2.6 Reagent OD limit Fst.1 -0.2* Correlation factor Min.1 -0. No.0000 0.: ODC0026 Values set for working in mg/L # § † * User defined ¤ Analyser default value For the zero calibrator saline should be used CRP Latex calibrator Highly Sensitive Set Cat.5 2.1 -0. Linearity Fst No lag time % Sec % ∇ On-board stability period Select using Space key. AU600 Highly Sensitive Serum/Plasma Application System Reagent: OSR6199.5 Fst. OD H ∇ ∇ Page ½ Test No # Test name CRPHS Sample type Ser Page ½ System Reagent: OSR6199.1 -0.5 2.1 -0. Reagent 1 vol Reagent 2 vol 3 75 75 Dil.0000 0.0000 0.: ODC0027 Values set for working in mg/L Specific Protein BSOSR6x99.0000 0.0000 0. OD H 2.5 2.1 -0.01 2009-08 . OSR6299 Specific Test Parameters Test No # Test name CRPN ∇ Sample type Sample vol. Vol Dil.5 2. L -0.1 -0.5 2.0000 0 0 0 0 0 0. No.1 -0.0000 0 0 Test No # Data Check Parameters Name NO CRPHS ∇ Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0.08* Correlation factor Sample Pre-dil.1 Dynamic range L 0.1 Dynamic range L 0.5 # Test name CRPN ∇ 6AB ∇ SPLINE ∇ Count Process Cal type 14 Formula 10 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 # ∇ Point 7 ∇ 1-point cal.1 Reagent OD limit Fst.0000 0. or select from list displayed by Guide key Calibration Specific Test No ∇ ∇ Conc 0§ 2. H Lst.5 2. H Lst.5 2.5 2.5 2. Vol Dil. L -0. 5 Advanced Calibration: Calibration Stability Period: 999 # ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + Cal.5 ∇ 999 Advanced Calibration: ∇ MB Type Factor: # Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: 1-Point Cal.5 2.5 2. For the zero calibrator saline should be used CRP Latex calibrator Normal Set Cat. For the zero calibrator saline should be used CRP Latex calibrator Highly Sensitive Set Cat. OSR6299 Specific Test Parameters General LIH ISE Range CRP Latex.0 0.1 -0.1 -0.5 2.: ODC0026 Values set for working in mg/L User defined.5† 10† 20† 80† 160† ο with CONC-0 < > ∇ Calibration Type: Cal.5 2.6 120 120 μL μL μL Dilution Dilution Dilution 0 0 10 μL μL μL 2. None μL μL μL CRPHS Type: Serum Operation: Yes 1 0.5 2.CRP Latex. # # # # # # 6AB CRPHS Type: Serum ∇ Counts: # Factor/OD-H 2. No.1 -0.1 ∇ Last L -0. No.5 2.5 Volume R1 Volume R2 Volume 3.5 2.6 -0. OSR6299 Specific Test Parameters General LIH ISE Serum ∇ Test Name: ∇ < > ∇ Sample: Reagents: μL μL μL Max OD H First H Last H H B 90 ∇ ∇ ∇ Last Last % ∇ 22 Sec.5 2. No.5 2. AU2700/AU5400 Normal Serum/Plasma Reagent ID: 099 Application Application Reagent ID: 099 System Reagent: OSR6199.1 -0. Point: Process: CONC ∇ Test Name: CRPN ∇ < > Type: Serum Counts: # Factor/OD-L -0.0 2.2* B 90 0 H 480* First H Last H 2.1 -0.1 Pri.35 17 25 Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Test Name: CRPN ∇ < > Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Logic Check-2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # § † * User defined.1 -0.: ODC0027 Values set for working in mg/L Specific Protein BSOSR6x99.1 -0.5 80* 0 Pri.5 2.5 2.1 -0.08* Correlation Factor: A 1 On-board stability period: % ∇ Calibration Specific General ISE Calibration Specific General ISE Test Name: ∇ ∇ Formula: SPLINE OD CONC 0§ 2. ∇ ∇ ∇ 570 FIXED + First 12 First Sec.1 -0.1 Reagent OD limit: First L -0.1 -0. 0. No.5 Max OD H 2. # # # # # # OD CONC 0§ 10† 40† 160† 320† 480† Factor/OD-L -0.1 Dynamic Range: L 0. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: SERUM/PLASMA APPLICATION Data Check Parameters Type: ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Serum Data Check Parameters Test Name: CRPHS √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: # § † * ∇ < > Logic Check-2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: 11 15 27 0.1 Slope Check: + ∇ Calibration Type: 6AB ∇ Formula: SPLINE ∇ ∇ Process: CONC ∇ Factor/OD-H 2. None Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 570 FIXED + First 12 First Last Last 22 Pre-Dilution Rate: Min OD L Reagent OD limit: First L ∇ Last L Dynamic Range: L Correlation Factor: Pre-Dilution Rate: 1 Min OD L -0. AU2700/AU5400 Highly Sensitive Serum/Plasma System Reagent: OSR6199.1 1-Point Cal.01 2009-08 .5 2.1 -0.5 70 70 Dilution Dilution Dilution 0 0 10 ∇ ∇ Operation: Yes Range Test Name: CRPN ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 1.5 2. Stable in plasma for 4 days when stored at 2…8°C and 6 months when stored at -20°C. Calibration Monitor.5 mL 2 x 12. D-Dimer is generally used for its negative predictive value. To avoid the possible build-up of azide compounds. Pulmonary Embolism (PE) and Disseminated Intravascular Coagulation (DIC). No. Major preventative maintenance was performed on the analyser or a critical part was replaced.D-DIMER OSR60135 Intended Use Immuno-turbidimetric test for the quantitative determination of D-Dimer in human plasma on Beckman Coulter analysers.2. D-Dimer reacts specifically with anti-human D-Dimer antibodies coated on the latex particles to yield insoluble aggregates. however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. ODR3033 The D-Dimer assay has been calibrated against another commercially available immuno-turbidimetric assay which reports results in µg FEU/mL. Each laboratory should establish its own control frequency. R50/53 Very toxic to aquatic organisms. Mix the R2 gently before use and on a weekly basis thereafter. Contents Tris/HCl NaCl Bovine Serum Albumin Latex coated monoclonal anti human D-Dimer antibodies (mouse) Preservative Precautions and Warnings Hazard Warnings and Risk Phrases: R28 Very toxic if swallowed. No. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. up to the stated expiry date when stored at 2…8°C. EN. Lithium Heparin plasma may also be used. 2 x 12. Unlike when using citrated plasma. respiratory system and skin. Recalibrate the assay every 30 days or when the following occur: Change in reagent lot or significant shift in control values. Quality Control D-Dimer Controls Cat. Calibration D-Dimer Calibrator Cat. R32 Contact with acids liberates very toxic gas. See Setting Sheet for specific instrument details. Exercise the normal precautions required for handling all laboratory reagents. Once open. Storage and Stability The reagents are stable. flush waste-pipes with water after the disposal of material. ODC0029 or other control materials with values determined by this Beckman Coulter system may be used. The absorbance of these aggregates is proportional to the D-Dimer concentration in the sample. Test Principle When a sample is mixed with R1 buffer and R2 latex suspension.01 2009-08 Specific Protein . If any trends or sudden shifts in values are detected. Following calibration. R36/37/38 Irritating to eyes. For in vitro diagnostic use only. Dispose of all waste material in accordance with local guidelines. may cause long-term adverse effects in the aquatic environment. Data check parameters are required. review all operating parameters.01 BLOSR6x135. Use samples undiluted.5 mL R1 R2 Summary1. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. including Deep Vein Thrombosis (DVT). unopened. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. there is no sample dilution with heparin tubes. the resulting curve should be visually reviewed on the Beckman Coulter analyser for acceptability using the software options . The results obtained by any individual laboratory may vary from the given mean value. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Safety data sheet available for professional user on request Biological materials of human origin contained in this product were tested for Anti-HCV. Calibration Curve. Elevated levels of D-Dimer can occur in a variety of clinical conditions associated with fibrin breakdown. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Specimen4 Citrated plasma. As D-Dimer is released into the circulation during the fibrinolytic process. reagents stored on board the instrument are stable for 30 days. the measurement of D-Dimer and higher molecular weight oligomers containing D-Dimer epitopes is considered to reflect the overall activity of clot formation and lysis. Therefore the D-Dimer values in heparin plasma are on average 16% higher over the entire measuring range.Routine. this product should be handled as a potentially infectious material. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument.3 Plasmin degradation of cross-linked fibrin results in the formation of specific degradation products including D-Dimer. 01 2009-08 EN.03 The lowest detectable level represents the lowest measurable level of D-Dimer that can be distinguished from zero.02 0.66 AU400: n = 80 Mean µg FEU/mL 0. CI = Confidence Interval The diagnostic performance of the method was evaluated and compared to the BioMerieux Vidas D-Dimer assay using ROC (Receiver Operating Characteristics) analysis.52 Total CV% 9.15 Total CV% 8.025 Specific Performance Characteristics Data contained within this section are representative of performance on Beckman Coulter systems. Samples exceeding the upper limit of linearity should not be diluted. AU400 and AU2700 using 3 plasma pools analysed over 20 days.025 0. accordingly. Data obtained in your laboratory may differ from these values.01 0.9) 42.7 (35.8 – 49.22 0.01 0. it was remarked that “Predictive values observed in one study do not 7 apply universally”. Clinical Performance in the Evaluation of Venous Thromboembolism using the D-Dimer assay The diagnostic utility of the D-Dimer assay for exclusion of Venous Thromboembolism (VTE) was evaluated in a clinical study conducted on 248 patients.05 AU2700 0.8 – 99. sample type.05 0.9) This data is representative of performance on Beckman Coulter systems. Diagnostic (n) n = 248 Absent 199 / Present 49 Test Vidas µg FEU/mL Beckman Coulter µg FEU/mL SE = Systematic Error In a paper by Altman and Bland in the British Medical Journal in 1994.86 AU2700: n = 80 Mean µg FEU/mL 0.28 0.28 0.55 5. Area 0.9) 98.0 (87.42 SD 0. Note: D-Dimer analysis is system specific and values generated from different manufacturers may differ significantly.16 CV% 6. A negative diagnosis was confirmed using established clinical procedures in 85 out of 86 patients with D-Dimer concentration < 0.42 2.8 – 99.82 to 0.25 – 8 µg FEU/mL. Precision The following data were obtained on an AU640. Results were analysed using a clinical cut-off for D-Dimer concentration of 0. Linearity The test is linear within a concentration range of 0.04 0.02 0. Samples with suspected Venous Thromboembolism (VTE) were analysed for D-Dimer using the D-Dimer assay.02 0.82 to 0.5 µg FEU/mL.17 Total CV% 9. For diagnostic purposes. diet and geographical location.01 0.54 6. Expected values may vary with age.02 Sensitivity The lowest detectable level was estimated as follows: Analyser Lowest Detectable Level (µg FEU/mL) AU640 0.5 µg FEU/mL.92 0.92 SE 0. Data obtained in your laboratory may differ from these values. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.18 Within Run SD 0.87 95% CI 0. Results are summarised in the table below: n % Sensitivity (95% CI) % Specificity (95% CI) % Negative Predictive Value (NPV) (95% CI) 248 98.69 SD 0.60 4. Results are summarised in the table below. but instead should be reported as > 8 µg FEU/mL. Prozone settings must be applied when using the D-Dimer OSR60135 assay.28 0.04 CV% 4.03 CV% 4. Specific Protein BLOSR6x135.44 2.06 0.03 0. and samples with D-Dimer concentration > 0. Each laboratory must determine reference intervals for their individual test populations.57 5.5 µg FEU/mL. This make direct comparison of NPV results between studies difficult.02 0. 48 were confirmed as positive for VTE using established clinical procedures.5 µg FEU/mL were considered positive. Of the 162 patients with D-Dimer concentration > 0.95 3. Reference Intervals5 Reference Interval < 0. Each laboratory should verify the transferability of the expected values to its own population.03 Within Run SD 0.01 .02 0.8 (92. whereby samples with D-Dimer concentration < 0. reagents and instruments. results should always be assessed in conjunction with the patient's medical history. and if necessary determine its own reference interval according to good laboratory practice.03 0.21 0.87 0. AU640: n = 80 Mean µg FEU/mL 0.44 7.Calculation The Beckman Coulter analysers automatically compute the D-Dimer concentration of each sample.12 3.99 2.48 Within Run SD 0.08 AU400 0. sex.5 µg FEU/mL were considered negative. clinical examinations and other findings.17 4.5 µg FEU/mL.55 SD 0.14 7. 7. Töpfer G. Schmitt Y. may cause unreliable results. Olexa SA. 2000. Diagnostic tests 2: Predictive values. especially monoclonal IgM (Waldenström’s macroglobulinemia).079 r = 0. Blood 1979:54:794-804.01 . may produce atypical results. Emerg.7. AACC. such as can occur during lysis therapy. Brizuela BS.01 2009-08 EN. Setting Sheet Footnotes # † * 1. Wakai A. Data on file at Beckman Coulter Biomedical Ltd. BMJ. Brasher M.010x + 0. 6.Method Comparison Patient plasma samples were used to compare this D-Dimer (OSR60135) assay on the AU640 against another commercially available D-Dimer assay. Bland JM. Gaffney PJ. 1994.5 IU/mL 6 Refer to Young for further information on interfering substances.28.. 2.1 Rev. 3. Guder. Samples with very elevated D-Dimer concentrations (>200 µg FEU/mL) can generate false low results without appropriate “Z” flags due to excess antigen in the sample. Limitations8 The D-Dimer assay has been optimised to reduce the risk of prozone occurrence in the presence of abnormally high D-Dimer concentrations. plasma and serum samples. User defined D-Dimer calibrator ODR3033 Values set for working in µg FEU/mL ¤ Analyser default value BIBLIOGRAPHY Budzynski AJ.53 µg FEU/mL Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 700 mg/dL Intralipid Rheumatoid Factor: Interference less than 10% up to 100 IU/mL Heparin: Interference less than 10% up to 1. Ehret W. 36:704-721. 5. Ann Clin Biochem 1999. Altman DG. Gleeson A.996 n = 104 Sample range = 0. AACC Press. 4.295:308-313. Role of D-Dimer Testing in Emergency Medicine. Specific Protein BLOSR6x135. Marder VJ. 20:319-325. Heil W. et al. Med J. Interference in Immunoassay. Samples with extremely abnormal optical characteristics. 2003. In very rare cases gammopathy. Zawta B. 5 ed. Subunit structure of the plasmin-induced degradation products of crosslinked fibrin. 8. Wisser H. Antigenic markers of fragment DD. Results of linear regression analysis were as follows: y = 1. WHO/DIL/LAB/99. WG. Biochem Biophys Acta 1973. th Young DS. Shames P. 309: 102. Winter D. Selby C. especially turbidity. 2002. Use of anticoagulants in diagnostic laboratory investigations and stability of blood.2. Parker ME. Samples containing heterophilic antibodies may cause falsely elevated results. a unique plasmic derivative of human crosslinked fibrin. Effects of Drugs on Clinical Laboratory Tests. . 5 2.5 1-Point Cal.5 2. ∇ ∇ ∇ Sec.1 -0.1 -0. or select from list displayed by Guide key Calibration Specific Test No ∇ ∇ Count Process # Conc ∇ 6AB ∇ SPLINE OD # Test name DDIM % Sec % ∇ On-board stability period 13 Lst Lst 800 Sub Fst.5 2. Specific Protein BSOSR6x135.9 0.5 2.1 -0.01 2009-08 . None ∇ Min.1 -0.1 -0.5 2.5 2.5 2.25* H Correlation Factor: A 1 B On-board stability period: 30 Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2. No.5 ∇ Advanced Calibration: ∇ Test No 30 # # Test Name: Counts: D DDIM ∇ < > Type Calibration Type: 6AB ∇ Formula: SPLINE ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + Cal.0000 0. H Lst.0000 0 0 MB Type Factor: Calibration Stability Period: Data Check Parameters Serum ∇ √ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: 16 2 0.1 -0. Point MB type factor Calibrator stability period 30 Conc † † † † † † Factor/OD-L -0.0 H Reagent OD limit: First L -2.: ODR3033 * Values set for working in µg FEU/mL. H H A B Rate 7 125 125 Dil.1 Cal type 14 Formula 10 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 # ∇ Point 7 ∇ 1-point cal.1 -0.0 Reagent OD limit Fst. Vol Dil.5 2.9 0. L -2. Linearity Fst No lag time Select using Space key.2 12 24 CITRATED PLASMA APPLICATION Test Name: DDIM ∇ < > Type: Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # User defined † D-Dimer Calibrator Cat.0 First H Last L -2.0 Last H Dynamic Range: L 0.5 2.0000 0.D-DIMER. # User defined ¤ Analyser default value † D-Dimer Calibrator Cat.2 12 24 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 0 0 0 0.0 Dynamic range L 0.5 2.0000 0 0 YES 16 2 0.5 2. AU400/AU640 Citrated Reagent ID: 135 Specific Test Parameters Serum ∇ Sample vol.1 -0. Reagent 1 vol Reagent 2 vol Main Fst Fst Sample Pre-dil.25* Correlation factor Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 800 FIXED + First 13 First Last Last 27 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L -2. Point: ο with CONC-0 Slope Check: Select the function using the Function key or the Mouse Data Check Parameters # Logic check-1 Name NO DDIM ∇ Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0. # # # # # # OD CONC † † † † † † Factor/OD-L -0.: ODR3033 * Values set for working in µg FEU/mL. OD L -2. Vol 0 0 0 μL μL μL Max.5 2. AU600 Citrated Plasma Application System Reagent: OSR60135 Specific Test Parameters General LIH ISE Range Test Name: DDIM ∇ < > Type: Sample: Reagents: 2.5 8* 0 Wave Method Reaction Point 1 Point 2 NONE FIXED + 27 ∇ ∇ ∇ Volume R1 Volume R2 Volume 7 125 125 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.0000 0.5 2.1 -0. No. No. L -2. Vol Dil. OD H ∇ Operation: Yes Test No ∇ 2.1 Factor/OD-H 2.1 -0.5 8* 1 0 ¤ 30 ∇ # Test name DDIM Sample type Ser Page ½ System Reagent: OSR60135 Reagent ID: 135 Plasma Application D-DIMER.0 Lst.5 2. 1 -0.1 2.5 ο Reagent Blank -0.0 First H ∇ Last L -2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check % ∇ Noneф 800 ∇nm FIXED ∇ + ∇ 13 Last Last 27 8* 0 0 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Pre-Dilution Rate: 1 Min OD Max OD L -2.5 R2(R2-1) μL Name Sec.: ODR3033 Values set for working in µg FEU/mL.5 -0. No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 30 Day 0 Calibration 30 Day 0 None ∇ ο with Conc-0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters DDIM ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 16 2 0.1 2.5 2. # # # # # # CONC † † † † † † Factor/OD-L -0. ∇ ∇ ∇ 8* 0 Last Last 27 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Sec.25* 1 1 μL High B B 0 125 Dilution 0 Volume R1 Volume R2 Volume 7 125 125 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.1 -0.1 2.0 High High Max.01 2009-08 . Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A 0.5 2.1 2.5 2. AU680 Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: Specific Protein BSOSR6x135.0 -2. Volume R1(R1-1) μL ∇ μL 7 1 125 Range Operation: ∇ Yes Test Name: DDIM ∇ < > Type: Sample: Reagents: 2.1 -0. Test Name: Counts: # Process: CONC ∇ DDIM ∇ < > Calibration Type: 6AB ∇ Formula: SPLINE ∇ OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 30 ∇ Advanced Calibration: # Cal.5 Allowance Range Check -0.5 2.1 2.5 2.5 ο Calibration -0.0 Last H Dynamic Range: L 0. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Counts: # ∇ ∇ OD Range Low High Slope Check -0.5 2.1 -0.0 -2.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.2 12 24 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: √ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ √ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: 16 2 0. AU680/AU480 Citrated Plasma Application System Reagent: OSR61135 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt.5 Advanced Calibration Operation Interval (RB/ACAL) # ∇ # ∇ Calibration Type: 6AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: # † ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Data Check Parameters Serum ∇ CITRATED SERUM APPLICATION PLASMA APPLICATION Test Name: DDIM ∇ < > Type: <Point Cal.2 12 24 # † * ф User defined.D-DIMER. No.OD μL Min.1 2.5 2. None 800 FIXED + First 13 First Common Rgt.1 Factor/OD-H 2.5 2.5 + ∇ 1-Point Cal. AU2700/AU5400 Citrated Reagent ID: 135 Parameters General LIH DDIM ∇ Dilution μL -2.5 2.9 0.5 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61135 Reagent ID: 135 Plasma Application Operation Yes D-DIMER. For No.25* H Correlation Factor: A 1 B On-board stability period: 30 Calibration Specific General ISE Type: Serum ∇ Test Name: ∇ < DDIM > SPLINE ISE Type Parameters Calibrators General Calibration Specific Calibration Parameters STAT Table Calibration Serum ∇ ο Use Serum Cal.5 -0. D-Dimer Calibrator Cat.9 0.1 -0.0 H Reagent OD limit: First L -2. it has been shown to correlate with stainable bone-marrow iron. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Once on board the R2 must be mixed at weekly intervals (see Reagent Preparation). an agglutination mixture occurs. 88 mmol/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. The results obtained by any individual laboratory may vary from the given mean value. up to the stated expiry date when stored at 2…8°C. Calibration Monitor. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice.3 Latex agglutination reactions occur as a result of antibody-coated latex beads aggregating if antigen is present in sufficient quantity. Turbidimeters measure the reduction of incident light due to reflection. 1 Test Principle2. containing ferritin. shape and concentration. is mixed with the Ferritin reagent. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. due to the use of non-human materials in the controls. The Ferritin reagent is a suspension of polystyrene latex particles. In the procedure.5 at 2…8°C up to 7 days at . reagents stored on board the instrument are stable for 30 days. in multiple transfused patients. Under conditions of antibody excess. the measurement of the decrease in light intensity transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction. Calibration Curve. Please note that the recovery of non-Beckman Coulter controls may vary with reagent lots of immunoassay products. and chronic haemolytic anemias. ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. The calibrator ferritin values assigned to the calibrators are traceable to the 3rd International Standard for ferritin. Data check parameters are required. Reagent Preparation R1 is ready for use and can be placed directly on board the instrument.01 2009-08 Specific Protein . of uniform size. Specimen Serum samples only are the recommended specimens. R2 should be mixed by inversion 5 – 10 times before placing on board the instrument. flush waste-pipes with water after the disposal of undiluted reagent. Immune complexes formed in solution scatter light in proportion to their size. Serum ferritin is especially useful in distinguishing iron deficiency from the anemia of chronic disorders because in the latter ferritin levels are increased. Stability in serum: 4. Once open. is the basis of this assay. This is measured spectrophotometrically on Beckman Coulter Chemistry Analysers. Calculation The Beckman Coulter analysers automatically compute the ferritin concentration of each sample. for acceptability using the software options Routine.FERRITIN OSR6150 Intended Use Immuno-turbidimetric test for the quantitative determination of ferritin in human serum on Beckman Coulter analysers. A serum ferritin level of less than 10 µg/L almost always indicates iron deficiency. Dispose of all waste material in accordance with local guidelines. EN. Major preventative maintenance was performed on the analyser or a critical part was replaced. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. To avoid the possible build up of azide compounds. absorption. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. see setting sheets for specific instrument details. Serum ferritin is also increased in other anemias including aplastic anemia. increasing amounts of antigen result in higher scatter. 4 x 24 mL 4 x 5 mL R1 R2 Summary1 Serum ferritin is a sensitive indicator of body iron stores. Storage and Stability The reagents are stable unopened. ODC0015. coated with polyclonal rabbit anti-ferritin antibody. ODR3021. Calibration Serum Protein Multi-Calibrator Cat No. on the Beckman Coulter analyser. Recombinant NIBSC code: 94/572.01 BLOSR6x50. the resulting curve should be visually reviewed. Following calibration. When serum. the serum ferritin may be extremely high. In idiopathic hemochromatosis and.20°C up to 6 months Strongly lipemic samples should be avoided. Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer (pH 8. or when the following occur: Change in reagent lot or significant shift in control values. Contents. If any trends or sudden shifts in values are detected. For in vitro diagnostic use only. review all operating parameters.2) Latex particles coated with rabbit anti-human ferritin Preservative. sideroblastic anemia. Quality Control ITA Control Sera ODC0014. Safety data sheet available for professional user on request. Recalibrate the assay every 14 days. or scatter. Young DS. The lowest detectable level represents the lowest measurable level of ferritin that can be distinguished from zero. Turbidimetric latex immunoassay for serum ferritin. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 20 days. For diagnostic purposes the Ferritin results should always be assessed in conjunction with other available information e. Data obtained in your laboratory may differ from these values.43 2. Principles for competitive-binding assays. Selby C. ed. especially turbidity.964x – 2. Such samples must be serially diluted and results compared to ensure that no such interference exists. Journal of Immunological methods 1984. Samples with extremely abnormal optical characteristics. sample type. especially monoclonal IgM (Waldenström’s macroglobulinemia).000 IU/mL) can generate false low results without appropriate "Z" flags due to excess antigen in the sample. analysis and correlation. 3. 6.549 r = 0.eds. 4. Biochemical aspects of hematology. 1995:234pp.Reference Intervals1 Serum New-born Infants: 6 months to 15 years: Adult male: Adult female: 25 – 200 µg/L 7 – 142 µg/L 20 – 300 µg/L 10 – 120 µg/L Expected values may vary with age. 2. Washington : AACC Press.36:704-721.12 Sensitivity The lowest detectable level in serum on an AU2700 was estimated at 6.81 2. 5th ed. 3rd ed. Ann Clin Biochem 1999.25 SD 1. 7 Setting Sheet Footnotes # † * 1. and if necessary determine its own reference interval according to good laboratory practice. diet and geographical location.4 µg/L. may cause unreliable results.In: Tietz NW. 1996:265pp. 1987:823pp.01 2009-08 EN.0 – 450 µg/L. Young DS. For diagnostic purposes.40 2.71:141 147. In: Kaplan LA. User defined ¤ Analyser default value Serum Protein Multi-Calibrator Cat No. Thompson SG. Tietz NW. ed. Philadelphia: WB Saunders Company.g.. Each laboratory should verify the transferability of the expected values to its own population.995 n = 100 Sample Range = 20 – 408 µg/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Lipemic: Interference less than 20% up to 400 mg/dL Intralipid® Triglyceride: Interference less than 10% up to 1500 mg/dL triglyceride Haemolysis: Interference less than 10% up to 5 g/L haemoglobin Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Rheumatoid Factor: Interference less than 5% up to 500 IU/mL RF Refer to Young for further information on interfering substances. clinical examinations and other findings. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. AACC. 7. clinical impressions and results of other tests. y = 0.03 4. results should always be assessed in conjunction with the patient's medical history. Clinical guide to laboratory tests.01 . Pesce AJ . Clinical Chemistry theory. Effects of preanalytical variables on clinical laboratory tests. 2nd ed.25 2.91 2. Bibliography Specific Protein BLOSR6x50. Values set for working in SI units µg/L equivalent to ng/mL. ed. Effects of Drugs on Clinical Laboratory Tests. Bernard A. sex. Results of linear regression analysis were as follows. Such specimens may result in falsely elevated values when tested with the Ferritin assay.: ODR3021. n = 80 Mean μg/L 40 101 383 Within run SD 0. Klee GG.79 CV% 2.86 8. Lauwerys R. Interference in Immunoassay. 2000. may produce atypical results. AACC Press. Fundamentals of clinical chemistry. Samples with very high Ferritin concentrations (> 20. patients medical history. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. In very rare cases gammopathy. 6 Limitations Certain specimens may contain heterophilic antibodies. St Louis: Mosby. 5. Method Comparison Patient samples were used to compare this Ferritin OSR6150 assay on an AU640 against another commercially available ferritin assay.14 Total CV% 3. Linearity The test is linear within a concentration range of 8. 1997:3-220pp. Fairbanks VF.00 1. Philadelphia: WB Saunders Company. 0000 0 0 SERUM APPLICATION MB Type Factor: Calibration Stability Period: Data Check Parameters Serum ∇ Test Name: FERR ∇ √ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: 11 2 1.2000 0.01 2009-08 .1 -0.0400 11 15 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 0 0 0 0.2000 0.5 2. ∇ ∇ ∇ Sec.5 2. No.8 Wave Method Reaction Point 1 Point 2 NONE FIXED + 18 ∇ ∇ ∇ Max OD H 2. AU400/AU640 Serum Reagent ID: 050 Specific Test Parameters Test No Serum 1 0. None ∇ Min.5 2.0000 0 0 YES 11 2 1.0000 0.5 Process: CONC ∇ ∇ 5AB ∇ POLYGONAL Test Name: Counts: FERR ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 14 Test No ∇ Advanced Calibration: # ∇ Cal.0000 0.1 -0.8 Reagent OD limit Fst.0400 11 15 < > Type: Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # User defined † Serum Protein Multi-Calibrator ODR3021 * Values set for working in SI units μg/L equivalent to ng/mL # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator ODR3021 * Values set for working in SI units μg/L equivalent to ng/mL Specific Protein BSOSR6x50.5 2.1 Factor/OD-H 2.5 Fst. Point MB type factor Calibrator stability period 14 Conc † † † † † Factor/OD-L -0. L 0.5 1-Point Cal. AU600 Serum Application System Reagent: OSR6150 Specific Test Parameters General LIH ISE Range Test Name: FERR ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 18 120 25 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.8 Main Fst Fst Sample Pre-dil.8 0.5 2.0000 0.8 1.1 -0.8 Dynamic range L 8* Correlation factor Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 600 FIXED + First 12 First Last Last 18 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Calibration Specific General ISE Serum # OD Factor/OD-H 2. H H A B Rate Sample vol.8 450* 1 0 ¤ 30 # Test name FERR ∇ Sample type Ser ∇ Page ½ System Reagent: OSR6150 Reagent ID: 050 Application FERRITIN.5 2. Vol Dil.1 -0.8 Lst. OD H ∇ Operation: Yes ∇ 2.1 Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. or select from list displayed by Guide key Calibration Specific Test No # Test name FERR ∇ ∇ Count Process # Conc ∇ % Sec % ∇ On-board stability period 12 Lst Lst 600 Sub 0.1 -0.1 -0. Linearity Fst No lag time Select using Space key.1 -0. Reagent 1 vol Reagent 2 vol 18 120 25 Dil.5 2. Vol 0 0 0 μL μL μL Max. # # # # # OD CONC † † † † † Factor/OD-L -0.8 1.5 2. Point: ο With CONC-0 Slope Check: Select the function using the Function key or the Mouse Data Check Parameters # Logic check-1 Name NO FERR ∇ Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0. Vol Dil.1 -0.5 1. OD L 0. H Lst.8 8* B 30 0 H 450* First H Last H 1. L 0.FERRITIN. 1 2.8 1.8 0.8 0.5 ο Calibration Advanced Calibration Operation Interval (RB/ACAL) + ∇ 1-Point Cal. No.1 2.5 1.5 -0.5 ο Reagent Blank -0.8 450* B 30 Last Last 18 % ∇ 18 120 25 First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.5 2.1 2. ∇ ∇ ∇ 8* Sec. None Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 8* 1 1 μL High B B 0 Volume R1 Volume R2 Volume Max OD H 2.70 0. Volume R1(R1-1) 18 1 120 μL ∇ μL Test Name: FERR ∇ Operation: Yes < > Type: ∇ ∇ Sample: Reagents: 0.5 -0. † Serum Protein Multi-Calibrator ODR3021 * Values set for working in SI units μg/L equivalent to ng/mL Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: Specific Protein BSOSR6x50.8 0.04 11 15 # User defined. For No.8 0. OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 14 ∇ Advanced Calibration # ∇ Cal.1 2. Point: ο with CONC-0 Slope Check: SERUM APPLICATION MB Type Factor: Calibration Stability Period: # ∇ # ∇ Data Check Parameters Serum ∇ Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Test Name: FERR ∇ < > Type: <Point Cal.1 -0. # # # # # CONC † † † † † Factor/OD-L -0.5 2.1 -0.1 -0. AU2700/AU5400 Serum Reagent ID: 050 Parameters General LIH FERR ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6150 Reagent ID: 050 Application FERRITIN.OD Dilution Dilution 0 μL Min.1 2.5 2.01 2009-08 . Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check None 600 ∇nm FIXED ∇ + ∇ 12 Last Last 18 Pre-Dilution Rate: Min OD L Reagent OD limit: First L ∇ Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ ++++ ∇ +++++ ∇ +++++ ∇ 450* 0 0 Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Calibration Specific General ISE Type: Serum ISE FERR ∇ < > POLYGONAL Type Test Name: Counts: # Test Name: FERR Process: CONC ∇ ∇ Calibration Specific < > ∇ Parameters Calibrators General Calibration Parameters STAT Table Calibration Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Serum ∇ ο Use Serum Cal.5 1.8 1. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 14 Day 0 Calibration 14 Day 0 None ∇ ο with Conc-0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters FERR ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: 12 2 0.70 0.04 11 15 √ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Misc Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Type: Serum ∇ √ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: 12 2 0.5 2.5 Counts: # ∇ ∇ OD Range Low High Slope Check -0.OD Reagent OD Limit First Low Last Low 0 μL OD Limit 2.1 Factor/OD-H 2.8 R2(R2-1) 25 μL Dilution 0 Name Sec.1 -0. AU680 Serum Application System Reagent: OSR6150 Specific Test Parameters General LIH ISE Operation Yes ∇ Range Serum 1 0.5 Allowance Range Check -0.8 Sample Volume Pre-Dilution Rate Rgt. None 600 FIXED + First 12 First A 1 On-board stability period: Common Rgt.8 High High Max.FERRITIN. ο Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: FERR ∇ < > Type Serum POLYGONAL + ∇ Counts: # ∇ ∇ OD Range Low High Slope Check -0.5 ο Reagent Blank -0.01 2009-08 Specific Protein . of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 14 Day 0 Calibration 14 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 Parameters Misc CheckedTests Type: √ Logic Check-3 Check Point-1: Check Point Interval: 11 2 1. † Serum Protein Multi-Calibrator ODR3021 * Values set for working in SI units μg/L equivalent to ng/mL BSOSR6x50.1 2.8 High High 1.FERRITIN. 0 Hour Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 30 Day # ∇ ++++ ∇ +++++ ∇ +++++ ∇ 600 ∇nm FIXED ∇ + ∇ 12 None Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 8* 1 1 High B B 450* 0 0 Last Last 18 % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters Calibrators General ∇ Use Serum Cal.8 Max.1 2.2000 0.5 -0.OD 2.5 Sample Volume Pre-Dilution Rate Rgt.5 -0. Volume R1(R1-1) 18 1 120 0 μL OD Limit μL ∇ μL Dilution 0 μL Min.8 0.1 2.8 0. AU480 Serum Reagent ID: 050 Application Range System Reagent: OSR6150 Parameters General Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: FERR ∇ < > Type: Operation Yes ∇ Dilution 0.1 2.8 1.0400 11 15 Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: Serum ∇ Contamination Parameters Data Check Parameters Test Name: FERR ∇ < > Logic Check -2 Check Point-1: Check Point Interval: Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ # User defined.1 2.5 ο Calibration Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal.OD Reagent OD Limit First Low Last Low R2(R2-1) 25 μL Dilution 0 μL Sec.5 Allowance Range Check -0. For No. . 6 Stable in serum and plasma for 7 days when stored at 2…8°C and for 12 months when stored at -20°C. Immune complexes formed in solution scatter light in proportion to their size. 4 x 24 mL 4 x 5 mL R1 R2 Summary1.FERRITIN OSR61138 Intended Use Immuno-turbidimetric test for the quantitative determination of ferritin in human serum and plasma on Beckman Coulter analysers. or when the following occur: Change in reagent lot or significant shift in control values. contains a mixture of 5-chloro-2-methyl-2H-isothiazol-3-one [EC No 247-500-7] and 2-methyl-2H-isothiazol-3-one [EC No 220-239-6] (3:1).4 Latex agglutination reactions occur as a result of antibody-coated latex beads aggregating if antigen is present in sufficient quantity. Calibration Monitor. flush waste-pipes with water after the disposal of undiluted reagent. 78 mmol/L Precautions and Warnings R1 reagent: Irritant. These include chronic infections. Test Principle3. for acceptability using the software options Routine. R1 and R2 reagents: Exercise the normal precautions required for handling all laboratory reagents. is the basis of this assay. If any trends or sudden shifts in values are detected. absorption. up to the stated expiry date when stored at 2…8°C. see setting sheets for specific instrument details. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer (pH 8. Strongly lipemic samples should be avoided. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. chronic inflammatory disorders. leukemias.2) Latex particles coated with rabbit anti-human ferritin Preservative. S37. Storage and Stability The reagents are stable unopened. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. In the Beckman Coulter procedure. ODR3021. For in vitro diagnostic use only. The Ferritin reagent is a suspension of polystyrene latex particles. R43: may cause sensitization by skin contact. Major preventative maintenance was performed on the analyser or a critical part was replaced. review all operating parameters.01 2009-08 Specific Protein . ferritin concentration is often normal. This is measured spectrophotometrically on Beckman Coulter Chemistry Analysers. breast cancer and neuroblastoma. reagents stored on board the instrument are stable for 30 days. Calibration Curve. EN. S60. Refer to Safety Data Sheets for further information. To avoid the possible build up of azide compounds. Data check parameters are required. In patients who have any of these disorders together with iron deficiency. Under conditions of antibody excess. Reagent Preparation R1 is ready for use and can be placed directly on board the instrument.01 BLOSR6x138. Wear suitable gloves. Following calibration. or scatter. Li-heparin plasma and EDTA plasma samples are the recommended specimens. shape and concentration. and malignancies. Avoid contact with skin. An increased ferritin concentration is observed in a large number of chronic diseases. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Contents. Turbidimeters measure the reduction of incident light due to reflection. When a sample containing ferritin is mixed with the Ferritin reagent. ODC0015. especially lymphomas.2 Measurement of ferritin in serum or plasma is a useful indicator of body iron stores in normal persons. ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. Calibration Serum Protein Multi-Calibrator Cat No. the resulting curve should be visually reviewed. rd The calibrator ferritin values assigned to the calibrators are traceable to the 3 International Standard for ferritin. the measurement of the decrease in light intensity transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction. This material and its container must be disposed of as hazardous waste. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Safety Phrases: S24. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Once on board the R2 must be mixed at weekly intervals (see Reagent Preparation). A ferritin level of less than 10 µg/L usually indicates iron deficiency anemia. of uniform size. Dispose of all waste material in accordance with local guidelines. Ferritin concentrations may be extremely high in patients suffering from hemochromatosis and certain liver diseases. Once open. Recalibrate the assay every 14 days. Recombinant NIBSC code: 94/572. increasing amounts of antigen result in higher scatter. Specimen Serum. R2 should be mixed by inversion 5-10 times before placing on board the instrument. heart disease. The results obtained by any individual laboratory may vary from the given mean value. 5. and in individuals with iron deficiency. on the Beckman Coulter analyser. an agglutination mixture occurs. Quality Control ITA Control Sera ODC0014. coated with polyclonal rabbit anti-ferritin antibody. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. 4th ed.01 . 9 Setting Sheet Footnotes # † * 1. Turbidimetric latex immunoassay for serum ferritin. 1997:3 -220pp.2. 9. Philadelphia: WB Saunders Company. Calculation The Beckman Coulter analysers automatically compute the ferritin concentration of each sample. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Each laboratory should verify the transferability of the expected values to its own population.000 IU/mL) can generate false low results without appropriate "Z" flags due to excess antigen in the sample. Such samples must be serially diluted and results compared to ensure that no such interference exists.998 n = 109 Sample Range = 11 – 407 µg/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Lipemic: Interference less than 10% up to 300 mg/dL Intralipid® Triglyceride: Interference less than 10% up to 1500 mg/dL triglyceride Haemolysis: Interference less than 6% up to 5 g/L haemoglobin Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Rheumatoid Factor: Interference less than 10% up to 500 IU/mL RF Refer to Young for further information on interfering substances. eds. In: Kaplan LA. patients medical history. AACC Press. Philadelphia: WB Saunders Company. Klee GG. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 20 days. eds. ed. St Louis: Mosby.17 424 3. Bibliography Specific Protein BLOSR6x138. clinical examinations and other findings.1 1.94 0. Brugnara C. Clinical Chemistry theory.: ODR3021. especially monoclonal IgM (Waldenström’s macroglobulinemia). 2nd ed. Journal of Immunological methods 1984. For diagnostic purposes the Ferritin results should always be assessed in conjunction with other available information e. Soldin SJ. may produce atypical results.98x + 2 r = 0. Biochemical aspects of hematology. 3. AACC Press. 5. Reference Intervals Serum Adults Adult male: Adult female: 7 Serum/Plasma Children Up to 1 month: 1 to 6 months: 6 to 12 months: 1 to 5 years: 6 to 19 years: 1 20 – 250 µg/L 10 – 120 µg/L 6 – 400 µg/L 6 – 410 µg/L 6 – 80 µg/L 6 – 60 µg/L 6 – 320 µg/L Expected values may vary with age.9 7. ed.49 CV% 3. WHO/DIL/LAB/99. diet and geographical location. 2002:31. Clinical guide to laboratory tests.8 Sensitivity The lowest detectable level in serum on an AU2700 was estimated at 6.31 144 2. WHO. plasma and serum samples.Please note that the recovery of non-Beckman Coulter controls may vary with reagent lots of immunoassay products. 1995:234-5. 3rd ed. Young DS. 8. results should always be assessed in conjunction with the patient's medical history. Thompson SG.eds. Selby C. Linearity The test is linear within a concentration range of 8. Data obtained in your laboratory may differ from these values. sample type. Effects of Drugs on Clinical Laboratory Tests. Washington : AACC Press.2 1. Fairbanks VF. Principles for competitive-binding assays.0 – 450 µg/L..36:704-721. 6. Pediatric Reference Ranges. Ashwood ER. especially turbidity.8 µg/L. due to the use of non-human materials in the controls. For diagnostic purposes. Method Comparison Patient samples were used to compare this Ferritin OSR61138 assay on an AU640 against another commercially available ferritin assay. Ann Clin Biochem 1999. analysis and correlation. clinical impressions and results of other tests. Bernard A.1 rev.73 1. 1996:265pp. 2. Tietz NW. Such specimens may result in falsely elevated values when tested with the Ferritin assay. Young DS. In: Burtis CA. may cause unreliable results. and if necessary determine its own reference interval according to good laboratory practice. 5th ed. 2000.84 2. 1987:823pp.71:141-147. User defined ¤ Analyser default value Serum Protein Multi-Calibrator Cat No. Lauwerys R. In very rare cases gammopathy. 2003:89-90.g. Samples with very high Ferritin concentrations (> 20. 4. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. y = 0.01 2009-08 EN. Samples with extremely abnormal optical characteristics. 7. Tietz textbook of clinical chemistry. Wong EC. sex.3 2. Results of linear regression analysis were as follows. Interference in Immunoassay. Values set for working in SI units µg/L equivalent to ng/mL. n = 80 Within run Total Mean µg/L SD CV% SD 40 0. Effects of preanalytical variables on clinical laboratory tests. Pesce AJ .9 3. The lowest detectable level represents the lowest measurable level of ferritin that can be distinguished from zero. 8 Limitations Certain specimens may contain heterophilic antibodies. 8 Dynamic range L 8* Correlation factor Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 600 FIXED + First 12 First Last Last 18 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Calibration Specific General ISE Serum # Factor/OD-H 2.1 -0.1 Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 14 ∇ Advanced Calibration: # ∇ Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal.2000 0. No. Linearity Fst No lag time Select using Space key.2000 0. # # # # # OD CONC † † † † † Factor/OD-L -0. AU600 Serum/Plasma Application System Reagent: OSR61138 Specific Test Parameters General LIH ISE Range Test Name: FERR ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 18 120 25 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.01 2009-08 .5 2.1 -0. AU400/AU640 Serum/Plasma Reagent ID: 138 Specific Test Parameters Test No Serum 1 0. L 0.0000 0.0000 0 0 YES 11 2 1.8 Wave Method Reaction Point 1 Point 2 ∇ ∇ ∇ Max OD H 2.8 1. # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator Cat.8 Main Fst Fst Sample Pre-dil.5 2.: ODR3021 * Values set for working in SI units µg/L.5 2. L 0.5 2.1 Factor/OD-H 2.8 Lst.5 1.0000 0 0 MB Type Factor: Calibration Stability Period: SERUM/PLASMA APPLICATION Data Check Parameters Serum ∇ Test Name: FERR ∇ √ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: 11 2 1.8 450* 1 0 ¤ 30 # Test name FERR ∇ Sample type Ser ∇ Page ½ System Reagent: OSR61138 Reagent ID: 138 Application FERRITIN. Vol Dil. No. equivalent to ng/mL. ∇ ∇ ∇ Sec. Point MB type factor Calibrator stability period 14 Conc † † † † † Factor/OD-L -0. None ∇ Min.1 -0.1 -0. Reagent 1 vol Reagent 2 vol 18 120 25 Dil.8 Reagent OD limit Fst. Vol Dil. OD H ∇ Operation: Yes ∇ 2.8 8* B 30 0 H 450* First H Last H 1.0400 11 15 < > Type: Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # User defined † Serum Protein Multi-Calibrator Cat.5 Fst. equivalent to ng/mL Specific Protein BSOSR6x138. Vol 0 0 0 μL μL μL Max. Point: ο with CONC-0 Slope Check: Select the function using the Function key or the Mouse Data Check Parameters Test No # Logic check-1 Name NO FERR ∇ Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0.1 -0.0000 0.1 -0. or select from list displayed by Guide key Calibration Specific Test No 5AB ∇ POLYGONAL OD # Test name FERR ∇ ∇ Count Process # Conc ∇ % Sec % ∇ On-board stability period 12 Lst Lst FIXED + 18 600 Sub 0.FERRITIN. H Lst.5 2.5 1-Point Cal.1 -0.: ODR3021 * Values set for working in SI units µg/L.8 0.5 Process: CONC ∇ ∇ Test Name: Counts: FERR ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Cal.5 2.5 2.1 -0.0400 11 15 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 0 0 0 0. H H A B Rate Sample vol.8 1.5 2. No.0000 0. OD L 0. 1 2.04 11 15 # User defined.8 0.1 2.1 2. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # ∇ Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ SERUM APPLICATION SERUM/PLASMA APPLICATION Data Check Parameters Serum ∇ Test Name: FERR ∇ < > Type: <Point Cal. Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: Specific Protein BSOSR6x138. OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 14 ∇ Advanced Calibration: # ∇ Cal.1 -0.8 0. AU2700/AU5400 Serum/Plasma Reagent ID: 138 Parameters General LIH FERR ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61138 Reagent ID: 138 Application FERRITIN. # # # # # CONC † † † † † Factor/OD-L -0.8 High High Max.8 0. ∇ ∇ ∇ 8* Sec.5 2. None Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 8* 1 1 μL High B B Volume R1 Volume R2 Volume Max OD H 2. † Serum Protein Multi-Calibrator Cat. AU680 Serum/Plasma Application System Reagent: OSR61138 Specific Test Parameters General LIH ISE Operation Yes ∇ Range Serum 1 0.8 450* B 30 Last Last 18 % ∇ 18 120 25 First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.8 Sample Volume Pre-Dilution Rate Rgt.5 1.1 2.70 0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 14 Day 0 Calibration 14 Day 0 None ∇ ο with Conc-0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters FERR ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 12 2 0.70 0.1 2. None 600 FIXED + First 12 First A 1 On-board stability period: Common Rgt.1 -0.5 1.FERRITIN.5 2.1 -0.04 11 15 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: √ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ √ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: 12 2 0.5 ο Calibration Advanced Calibration Operation Interval (RB/ACAL) + ∇ 1-Point Cal.OD Reagent OD Limit First Low Last Low 0 μL OD Limit 2.5 2. equivalent to ng/mL.01 2009-08 . No. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check None 600 ∇nm FIXED ∇ + ∇ 12 Last Last 18 Pre-Dilution Rate: Min OD L Reagent OD limit: First L ∇ Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ ++++ ∇ +++++ ∇ +++++ ∇ 450* 0 0 Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Calibration Specific General ISE Type: Serum ISE FERR ∇ < > POLYGONAL Type Test Name: Counts: # Process: CONC ∇ Test Name: FERR ∇ < > ∇ Parameters Calibrators General Calibration Specific Calibration Parameters STAT Table Calibration Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Serum ∇ ο Use Serum Cal.5 -0.8 1.8 0. Volume R1(R1-1) 18 1 120 μL ∇ μL Test Name: FERR ∇ Operation: Yes < > Type: ∇ ∇ Sample: Reagents: 0.5 2.5 -0. No.OD Dilution Dilution 0 μL Min.1 -0.8 R2(R2-1) 25 μL Dilution 0 Name Sec.: ODR3021 * Values set for working in SI units µg/L. For No.8 1.1 Factor/OD-H 2.5 Allowance Range Check -0.5 ο Reagent Blank -0.5 Counts: # ∇ ∇ OD Range Low High Slope Check -0. Refer to Safety Data Sheets for further information. absorption. For in vitro diagnostic use only. review all operating parameters. ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. the resulting curve should be visually reviewed. or scatter. Following calibration. An increased ferritin concentration is observed in a large number of chronic diseases. rd The calibrator ferritin values assigned to the calibrators are traceable to the 3 International Standard for ferritin. Ferritin concentrations may be extremely high in patients suffering from hemochromatosis and certain liver diseases. chronic inflammatory disorders. Storage and Stability The reagents are stable unopened. flush waste-pipes with water after the disposal of undiluted reagent. Calibration Curve. Turbidimeters measure the reduction of incident light due to reflection.4 Latex agglutination reactions occur as a result of antibody-coated latex beads aggregating if antigen is present in sufficient quantity. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Dispose of all waste material in accordance with local guidelines. Once open. the measurement of the decrease in light intensity transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction. EN. especially lymphomas.3. an agglutination mixture occurs. Once on board the R2 must be mixed at weekly intervals (see Reagent Preparation). The Ferritin reagent is a suspension of polystyrene latex particles.FERRITIN OSR61203 Intended Use Immuno-turbidimetric test for the quantitative determination of ferritin in human serum and plasma on Beckman Coulter AU analysers. If any trends or sudden shifts in values are detected. A ferritin level of less than 10 µg/L usually indicates iron deficiency anemia. Quality Control ITA Control Sera ODC0014. Strongly lipemic samples should be avoided.2 Measurement of ferritin in serum or plasma is a useful indicator of body iron stores in normal persons. Major preventative maintenance was performed on the analyser or a critical part was replaced. Test Principle3. Immune complexes formed in solution scatter light in proportion to their size. ferritin concentration is often normal. for acceptability using the software options Routine. reagents stored on board the instrument are stable for 60 days. of uniform size. Calibration Monitor. The results obtained by any individual laboratory may vary from the given mean value. These include chronic infections. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Under conditions of antibody excess. To avoid the possible build up of azide compounds. Recombinant NIBSC code: 94/572. R2 should be mixed by inversion 5 – 10 times before placing on board the instrument. shape and concentration. increasing amounts of antigen result in higher scatter. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Data check parameters are required. This is measured spectrophotometrically on Beckman Coulter Chemistry Analysers. or when the following occur: Change in reagent lot or significant shift in control values. Specimen Serum. due to the use of non-human materials in the controls. coated with polyclonal rabbit anti-ferritin antibody. ODC0015. Contents. When a sample containing ferritin is mixed with the Ferritin reagent.3 ) Latex particles coated with rabbit anti-human ferritin Preservative. see setting sheets for specific instrument details.6 Stable in serum and plasma for 7 days when stored at 2…8°C and for 12 months when stored at -20°C. 4 x 24 mL 4 x 12 mL R1 R2 Summary1. In patients who have any of these disorders together with iron deficiency. leukemias. 170 mmol/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Reagent Preparation R1 is ready for use and can be placed directly on board the instrument. up to the stated expiry date when stored at 2…8°C. breast cancer and neuroblastoma. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Li-heparin plasma and EDTA plasma samples are the recommended specimens. Calibration Serum Protein Multi-Calibrator Cat No. is the basis of this assay. heart disease. 5. Recalibrate the assay every 30 days. and in individuals with iron deficiency.02 2009-11 Specific Protein . In the Beckman Coulter procedure. Reagent Composition in the Test Final concentration of reactive ingredients: Glycine buffer (R1: pH 8. on the Beckman Coulter analyser. Please note that the recovery of non-Beckman Coulter controls may vary with reagent lots of immunoassay products. ODR3021. and malignancies.01 BLOSR6x203. R2: pH 7. Tietz textbook of clinical chemistry.eds. 1995:234-5. 4th ed. To investigate samples which are believed to contain interference. Selby C. Data obtained in your laboratory may differ from these values. Method Comparison Patient samples were used to compare this Ferritin OSR61203 assay on an AU400 against another commercially available ferritin assay.Calculation The Beckman Coulter analysers automatically compute the ferritin concentration of each sample. Values set for working in SI units µg/L equivalent to ng/mL. 2nd ed. Effects of Drugs on Clinical Laboratory Tests. 5th ed. and if necessary determine its own reference interval according to good laboratory practice.49 1. 4.000 µg/L) can generate false low results without appropriate "Z" flags due to excess antigen in the sample. Brugnara C.. 8.55 0. Pediatric Reference Ranges. 9. WHO. The results of such samples should be interpreted with extreme care. Bernard A. however as with all immuno-assays there is always a small risk from such interferences and therefore for diagnostic purposes the Ferritin results should always be assessed in 9. may produce atypical results. Setting Sheet Footnotes # † * 1. Wong EC. The lowest detectable level represents the lowest measurable level of ferritin that can be distinguished from zero. Specific Protein BLOSR6x203. Linearity The test is linear within a concentration range of 8.09x + 0. Samples with extremely abnormal optical characteristics.95 SD 0. 8 Limitations This assay has been specifically designed to substantially reduce the risk of interference from HAMA or Heterophilic antibodies.994 n = 462 Sample Range = 14 – 434 µg/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Lipemic: Interference less than 10% up to 1000 mg/dL Intralipid® Haemolysis: Interference less than 10% up to 5 g/L haemoglobin Bilirubin: Interference less than 5% up to 40 mg/dL Rheumatoid Factor: Interference less than 3% up to 500 IU/mL RF Refer to Young for further information on interfering substances. Biochemical aspects of hematology. Lauwerys R. Young DS.24 0. AACC Press. 5. especially turbidity. Soldin SJ. ed. especially monoclonal IgM (Waldenström’s macroglobulinemia). Ashwood ER. Philadelphia: WB Saunders Company.18 CV% 2. 1997:3 -220pp. 2002:31. AACC Press. Reference Intervals Serum Adults Adult male: Adult female: 1 20 – 250 µg/L 10 – 120 µg/L 7 Serum/Plasma Children Up to 1 month: 1 to 6 months: 6 to 12 months: 1 to 5 years: 6 to 19 years: 6 – 400 µg/L 6 – 410 µg/L 6 – 80 µg/L 6 – 60 µg/L 6 – 320 µg/L Expected values may vary with age.71:141-147. Young DS. 6. 10. ed.0 – 450 µg/L. Such samples must be serially diluted and results compared to ensure that no such interference exists. Thompson SG. St Louis: Mosby. analysis and correlation. Effects of preanalytical variables on clinical laboratory tests. Bibliography Fairbanks VF. 3.61 0.13 Sensitivity The lowest detectable level in serum on an AU680 was estimated at 5.02 2009-11 EN. Interference in Immunoassay. Serial dilution may reveal incorrect recovery. results should always be assessed in conjunction with the patient's medical history.36:704-721. patients medical history. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. eds. Philadelphia: WB Saunders Company. may cause unreliable results. User defined ¤ Analyser default value Serum Protein Multi-Calibrator Cat No. clinical impressions and results of other tests.1 rev. diet and geographical location. n = 80 Mean µg/L 25 148 438 Within run SD 0. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 20 days.: ODR3021.01 .92 2.47 µg/L. 7. Clinical guide to laboratory tests.g. Washington : AACC Press.10 conjunction with other available information e. 2003:89-90.95 Total CV% 3. sex. Ismail AA. Each laboratory should verify the transferability of the expected values to its own population. In very rare cases gammopathy. Tietz NW. pre-treatment with non immune serum or assay of the sample in an alternate assay system are all useful in identifying whether the 10 sample contains an interferent. In: Kaplan LA. 3rd ed. eds. Results of linear regression analysis were as follows. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. y = 1.2.91 4. Klee GG. plasma and serum samples.43(4):249-251. PEG precipitation. Turbidimetric latex immunoassay for serum ferritin. Ann Clin Biochem 1999. clinical examinations and other findings.25 r = 0. 2. a number of approaches can be adopted. 1996:265pp. Clinical Chemistry theory. WHO/DIL/LAB/99. 1999:1703pp.71 1. On the interpretation of affirmative follow-up tests in immunoassays: what must not be done? Ann Clin Biochem 2006. Samples with very high Ferritin concentrations (> 20. sample type. Principles for competitive-binding assays. Pesce AJ . It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.21 4. For diagnostic purposes. Journal of Immunological methods 1984. In: Burtis CA. 2000. H H A B Rate Sample vol. H Lst.0 -2. Linearity Fst No lag time Select using Space key.02 2010-07 .FERRITIN.0 Factor/OD-H 2.5 450* 1 0 ¤ 60 # Test name FERR ∇ Sample type Ser ∇ Page ½ System Reagent: OSR61203 Reagent ID: 203 Application FERRITIN.6000 2.0 -2.0 -2.0 -2.5 0. L 0.0000 0.5 2. # User defined ¤ Analyser default value † System Calibrator Cat.: ODR3021 * Values set for working in SI units µg/L.5 2.5 2. # # # # # OD CONC † † † † † Factor/OD-L -2.0000 0.5 Reagent OD limit Fst. OD H ∇ Operation: Yes ∇ Test No 2. Vol Dil.0500 11 14 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 0.5 Lst.5 Dynamic range L 8* Correlation factor Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 660 FIXED + First 12 First Last Last 22 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Calibration Specific General ISE Serum # Factor/OD-H 2.0500 11 14 0.5 2.5 2.0 -2.5 Main Fst Fst Sample Pre-dil.5 8* B 60 0 H 450* First H Last H 2.0 -2. Reagent 1 vol Reagent 2 vol 6 120 60 Dil. L 0.5 1-Point Cal.0000 0. AU400/AU640 Serum/Plasma Reagent ID: 203 Specific Test Parameters Serum 1 0.: ODR3021 * Values set for working in SI units µg/L.5 Fst. or select from list displayed by Guide key Calibration Specific Test No 5AB ∇ SPLINE OD ∇ # Test name FERR ∇ Count Process # Conc ∇ % Sec % ∇ On-board stability period 12 Lst Lst FIXED + 22 660 Sub 0.5 2.5 2.5 Process: CONC ∇ ∇ Test Name: Counts: FERR ∇ < > Type Calibration Type: 5AB ∇ Formula: SPLINE ∇ Cal.0000 # User defined † System Calibrator Cat. Vol Dil.5 Wave Method Reaction Point 1 Point 2 ∇ ∇ ∇ Max OD H 2.0 -2. equivalent to ng/mL. ∇ ∇ ∇ Sec.5 2.0 -2. equivalent to ng/mL Specific Protein BSOSR6x203. OD L 0.5 2. Vol 0 0 0 µL µL µL Max. Point MB type factor Calibrator stability period 30 Conc † † † † † Factor/OD-L -2.6000 2. No. Point: with CONC-0 Slope Check: Select the function using the Function key or the Mouse Data Check Parameters Test No # Logic check-1 Name YES FERR ∇ Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 ∇ NO MB Type Factor: Calibration Stability Period: SERUM/PLASMA APPLICATION Data Check Parameters Serum Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Test Name: FERR ∇ < > Type: Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 11 16 27 0.0000 0.0000 0 0 NO √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 11 16 27 0. None ∇ Min.5 2.5 2. No.0 Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 30 ∇ Advanced Calibration: # ∇ Cal type 13 Formula 10 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. No. AU600 Serum/Plasma Application System Reagent: OSR61203 Specific Test Parameters General LIH ISE Range Test Name: FERR ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 6 120 60 µL µL µL Dilution Dilution Dilution 0 0 0 µL µL µL Pri. 5 R2(R2-1) 60 µL Dilution 0 Name Sec. No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration None ∇ with Conc-0 30 30 Day Day 0 0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters FERR ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: 11 16 27 0.5 -2.5 0.0 2. System Calibrator Cat. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 660 ∇nm FIXED ∇ + ∇ 12 60 Day # ∇ ++++ ∇ +++++ ∇ +++++ ∇ 660 FIXED + First 12 First Last Last 22 Pre-Dilution Rate: Min OD L Reagent OD limit: First L ∇ Last L Dynamic Range: L Correlation Factor: % ∇ A 1 On-board stability period: Calibration Specific General ISE Type: Serum ISE FERR SPLINE ∇ < > Type Test Name: Process: CONC ∇ Test Name: FERR ∇ < > ∇ Parameters Calibrators General Calibration Specific Calibration Parameters STAT Table Calibration Serum ∇ Use Serum Cal.0 -2. AU2700/AU5400 Serum/Plasma Reagent ID: 203 Parameters General LIH FERR Dilution 0.0 2. No.5 2.5 Allowance Range Check -2.0000 0.5 2.0 -2.FERRITIN.5 0.5 0.0 2.6000 2.5 0.5 -2. Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A 8* 1 1 µL High B B 0 450* 0 0 Hour Range ∇ Operation: Max OD H 2.5 450* B 60 Last Last 22 % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Sample Volume Pre-Dilution Rate Rgt. AU680 √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: Specific Protein BSOSR6x203.0 Factor/OD-H 2.5 2. # # # # # CONC † † † † † Factor/OD-L -2.5 2.6000 2.OD Reagent OD Limit First Low Last Low 0 µL OD Limit ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61203 Reagent ID: 203 Application Operation Yes ∇ FERRITIN. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # Lot Calibration ∇ Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ SERUM APPLICATION SERUM/PLASMA APPLICATION Data Check Parameters Serum ∇ Test Name: FERR ∇ < > Type: <Point Cal.5 Counts: # ∇ ∇ OD Range Low High Slope Check -2.5 Dilution 0 µL Min.OD 2.5 2. Calibration Type: 5AB ∇ Formula: SPLINE ∇ Counts: # OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 30 ∇ Advanced Calibration: # ∇ Cal. None Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.0 2.0 2.5 2.5 Reagent Blank -2. ∇ ∇ ∇ 8* Sec.0500 11 14 Pattern1 # † * ф User defined.0 -2. AU680/AU480 Serum/Plasma Application System Reagent: OSR61203 Specific Test Parameters General LIH ISE Serum 1 0.0000 0.: ODR3021 Values set for working in SI units µg/L.0500 11 14 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: 11 16 27 0.5 2.5 High High Max.02 2010-07 .5 Calibration Advanced Calibration Operation Interval (RB/ACAL) + ∇ 1-Point Cal. For No. equivalent to ng/mL.0 -2. Volume R1(R1-1) 6 1 120 µL ∇ µL Test Name: FERR ∇ Yes < > Type: ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 6 120 60 µL µL µL Dilution Dilution Dilution 0 0 0 µL µL µL Pri.5 2. Calibration Monitor. The absorbance of these aggregates is proportional to the haptoglobin concentration in the sample. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. Following calibration. results should always be assessed in conjunction with the patient's medical history. Plasma levels are increased in the presence of acute inflammatory processes.01 2009-08 Specific Protein . and in hepatocellular diseases. Once open. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. and if necessary determine its own reference interval according to good laboratory practice. flush waste-pipes with water after the disposal of undiluted reagent. This material and its container must be disposed of as hazardous waste. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.5 mL 4 x 4. for acceptability using the software options Routine. Safety Phrases: S36. 2 Stable in serum and plasma for 8 months when stored at 2…8°C and 3 months when stored at 15…25°C. To avoid the possible build-up of azide compounds. Refer to Safety Data Sheets for further information. protein losing syndromes (e. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. S60.3 – 2. The results obtained by any individual laboratory may vary from the given mean value. Haptoglobin assays are used primarily to screen for or to follow the course of haemolytic disorders. review all operating parameters. EN. The complexes are rapidly removed by the hepatic Kupffer cells. the resulting curve should be visually reviewed. the equivalent of one intact haemoglobin molecule. ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. nephrotic syndrome or protein losing enteropathies). Storage and Stability The reagents are stable. If any trends or sudden shifts in values are detected. 4 x 16. unopened. sample type.HAPTOGLOBIN OSR6165 Intended Use Immuno-turbidimetric test for the quantitative determination of haptoglobin in human serum and plasma on Beckman Coulter analysers. Major preventative maintenance was performed on the analyser or a critical part was replaced. human haptoglobin reacts specifically with the anti-human haptoglobin antibodies to yield insoluble aggregates. Calculation The Beckman Coulter analysers automatically compute the haptoglobin concentration of each sample. contains sodium azide. Each laboratory should verify the transferability of the expected values to its own population. on the Beckman Coulter analyser. The calibrator haptoglobin values are traceable to IFCC (International Federation of Clinical Chemistry) standard CRM 470. tissue necrosis or malignancy. Plasma levels are decreased in haemolytic disease and ineffective erythropoiesis.01 BLOSR6x65. and in corticosteroid therapy. R22 Harmful if swallowed. No. Calibration Curve. Specimen Serum and EDTA or heparinised plasma.5 mL R1 R2 Summary1 Haptoglobin is an α2-glycoprotein that binds haemoglobin irreversibly. Contents. where the proteins are degraded and the amino acids and iron reutilised. ODR3023. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Each haptoglobin monomer can bind up to 2 haemoglobin αβ dimers. Haptoglobin is therefore central to the preservation of iron and prevents possible damage to the renal tubules by preventing excretion of haemoglobin. clinical examinations and other findings. Haemolysed samples should be avoided. Reference Intervals3 Adults 0. Dispose of all waste material in accordance with local guidelines. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution. Quality Control ITA Control Sera ODC0014. reagents stored on board the instrument are stable for 90 days. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. with either endogenous or exogenous oestrogens. genetic deficiency. sex. For diagnostic purposes. up to the stated expiry date when stored at 2…8°C. Calibration Serum Protein Multi-Calibrator 2 Cat.0 g/L (30 – 200 mg/dL) Expected values may vary with age.6) Goat anti-human haptoglobin antibodies Preservative 78 mmol/L Variable Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. For in vitro diagnostic use only.g. diet and geographical location. Wear suitable protective clothing. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer (pH 7. 20:145-152.05 3. The lowest detectable level represents the lowest measurable level of haptoglobin that can be distinguished from zero.72 0. Young DS. BIBLIOGRAPHY Johnson AM. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP international reference material CRM 470.01 . Linearity The test is linear within a concentration range of 0.01 2.41 0. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days.10 CV% 2. User defined ¤ Analyser default value Serum Protein Multi-Calibrator 2 Cat. 2000.2:33pp. 4 Limitations Samples with extremely abnormal optical characteristics.61 2. Heil W. eds.: ODR3023 Values set for working in SI units (g/L). Wisser H. Data obtained in your laboratory may differ from these values.57 2. Specific Protein BLOSR6x65. et al. WHO/DIL/LAB/99.20 0.0 g/L (30 – 400 mg/dL).22 0.01 2009-08 EN. Ashwood ER. Dati F. Results of linear regression analysis were as follows: y = 1. Ehret W. 2.05 1. Tietz textbook of clinical chemistry. In: Burtis CA. Philadelphia: WB Saunders Company. Effects of drugs on clinical laboratory tests. Rohlfs EM. especially turbidity.66 – 2.50 g/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 1 g/L haemoglobin ® Lipemia: Interference less than 5% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances. Proteins. n = 60 Within Run Total Mean g/L SD CV% SD 0. To work in mg/dL multiply by 100. Setting Sheet Footnotes # † * 1.05 0. AACC Press. may produce atypical results. Method Comparison Patient serum samples were used to compare this Haptoglobin OSR6165 assay on the AU2700 against another commercially available haptoglobin assay. Use of anticoagulants in diagnostic laboratory investigations and stability of blood.03 1. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.12 0. Töpfer G. 5th ed.64 Sensitivity The lowest detectable level in serum on an AU600 analyser was estimated at 0. No. Zawta B. 1999.494-497. Schmitt Y.3 – 4.135 r = 0. J Lab Med 1996.1 Rev.008x + 0. Baudner S.01 g/L. Silverman LM.01 1.Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. 4. 3. plasma and serum samples.993 n = 18 Sample range = 0. 1 -0. No.5 2. No.5 2. Specific Protein . AU600 Serum/Plasma Application System Reagent: OSR6165 Specific Test Parameters General LIH ISE Range Test Name: HAPT ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 165 45 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. # # ο ∇ 3.1 # Conc Factor/OD-H 2.1 -0. Vol Dil. To work in mg/dL multiply by 100.: ODR3023 * Values set for working in SI units (g/L).5 1.01 2009-08 # User defined † Serum Protein Multi-Calibrator Cat.1 Dynamic range L 0. # # ο ∇ 4.5 2.0* Fst Fst 0 0 Lst Lst First H Last H 1.1 -0.5 2.HAPTOGLOBIN.5 2. H 4.5 2. None ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. # # ο ∇ 6. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name HAPT ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0.1 -0. BSOSR6x65.1 -0.0* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: HAPT ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 # SERUM/PLASMA APPLICATION Test Name: Counts: HAPT ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.3* Correlation factor % ∇ 4. # # ο ∇ 2. OD H 1.: ODR3023 * Values set for working in SI units (g/L).5 2.1 -0. Vol Dil. To work in mg/dL multiply by 100.1 -0.1 -0. AU400/AU640 Serum/Plasma Reagent ID: 065 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 600 Sub Fst.1 -0.1 0.1 1-Point Cal.5 ∇ Operation: Yes Test No ∇ ∇ # Test name HAPT Sample type Ser Page ½ System Reagent: OSR6165 Reagent ID: 065 Application HAPTOGLOBIN. OD L Reagent OD limit Fst. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator Cat.1 Lst. None Selected 8. Reagent 1 vol Reagent 2 vol μL μL μL 2 165 45 Dil. # # ο ∇ 5. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. L -0. H -0.5 1. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name HAPT Sample type Ser ∇ On-board stability period 600 END + First 0 First 0 Pri. No. # # ο ∇ 7. ∇ ∇ ∇ Sec. # # # # # OD CONC † † † † † Factor/OD-L -0.3* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. Vol 0 0 0 Max. H Lst.5 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2.5 2. L -0.5 Wave Method Reaction Point 1 Point 2 NONE END + 27 10 Sample vol. No.1 2.5 -0.1 -0.1 -0.5 + ∇ 1-Point Cal. # # ο ∇ 4.1 2. Serum Protein Multi-Calibrator Cat.1 -0.01 2009-08 .3* 1 1 μL High B B 0 4. None ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH HAPT ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # HAPT ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 2.1 2.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6165 Reagent ID: 065 Application Operation Yes HAPTOGLOBIN.5 2.5 -0.0* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 0 10 μL μL μL Pri. ∇ # # # # ο 6.5 -0. For No. # # ο ∇ 5.1 -0. ∇ 7.1 Factor/OD-H 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 600 ∇nm END ∇ + ∇ 0 0 % ∇ 600 END + First 0 First 0 Sec.5 ∇ OD Range Low High -0.6 1 132 Range Operation: ∇ Yes Test Name: HAPT ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 Last Last 27 10 1.1 -0. # # ο ∇ 7. ∇ # # # # ο 4.1 2.5 2.: ODR3023 Values set for working in SI units (g/L). ∇ # # # # ο 5. ∇ # # # # ο 3. Point: ο With CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined. No.OD -0.1 R2(R2-1) μL Name Sec. None Selected 8. Not within expected values g/L* Decimal Places Calibration Specific ISE HAPT ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum Counts: ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: HAPT ∇ < > Test Name: Use Serum Cal. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x65.3* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. Volume R1(R1-1) μL ∇ μL 1. Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A 0.5 2. # # ο ∇ 6.1 -0.5 4.5 -0. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal. AU2700/AU5400 Serum/Plasma Reagent ID: 065 Parameters General LIH HAPT ∇ Dilution μL Max. To work in mg/dL multiply by 100.0* 0 0 Hour 36 Dilution 10 Sample Volume Pre-Dilution Rate Rgt. ∇ # # # # ο 2.5 1. AU680/AU480 Serum/Plasma Application System Reagent: OSR6165 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L g/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.6 132 36 1.5 μL Min.1 2. # # ο ∇ 2. # # ο ∇ 3.1 High High 1.5 1. ∇ ∇ ∇ 0. AU680 <Point Cal. # # # # # CONC † † † † † Factor/OD-L -0.HAPTOGLOBIN. No demographics 8. In a pre-treatment step the whole blood is mixed with Hemoglobin Denaturant (OSR0004) in a 1 : 41 dilution and incubated for a minimum of five minutes at room temperature. Specimen K2-EDTA or NH4-heparinised whole blood. Wear suitable gloves. measurement of HbA1c provides an indication of the mean daily blood glucose concentration over the preceding two months. the antibody-coated microparticles in the HbA1c R1 and the agglutinator in the HbA1c R2 will agglutinate. consisting of a synthetic polymer containing multiple copies of the immunoreactive portion of HbA1c. S60. The HbA1c/Total Hemoglobin ratio is expressed as percentage HbA1c (%HbA1c). avoid foaming and incubate for 5 minutes at room temperature before use. Reagent Composition HbA1c HbA1c R1 HbA1c Antibody (mouse) coupled particles Bovine Serum Albumin Buffer pH 8. considered to be an important diagnostic tool in the monitoring of dietary control and therapeutic regimes during the treatment of diabetes. Note: All pretreated samples should be mixed thoroughly immediately prior to assay. S24. For in vitro diagnostic use only. up to the stated expiry date when stored at 2…8°C. neuropathy. and may reduce the prevalence and severity of late diabetic complications such as retinopathy.4%. and can be placed directly on board the instrument. Effective control of blood glucose levels is important in the prevention of ketosis and hyperglycaemia. S37. Contents. Hemolysed (pretreated) samples are stable up to 8 hours when stored at room temperature. Please note that only Hemoglobin Denaturant OSR0004 can be used with this method. on Beckman Coulter AU analysers. HbA1c Total Hemoglobin 2 x 19 mL 2 x 19 mL 2 x 37. pH 13 Surfactant: 0.1% Proclin Precautions and Warnings Hazard Warnings and Risk Phrases: HbA1c R1 and R2: R43: May cause sensitisation by skin contact. The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio. Product contains a mixture of 5-chloro-2-methyl-4-isothiazolin -3-one [EC No 247-500-7] and 2-methyl-2 H – isothiazol-3-one [EC No 220-239-6] (3:1). The increase in absorbance due to agglutination is measured at 700nm. Reagent Preparation Total Hemoglobin R1 and HbA1c R2 are ready for use. As the glucose remains bound to the red cell throughout its life cycle. nephropathy and cardiac disease. pretreat samples and controls by dilution of whole blood with Hemoglobin denaturant 1 : 41 (for example 25 µLof sample or control plus 1000 µL of Hemoglobin Denaturant Cat No.1 Surfactant: 0. Refer to Safety Data Sheets for further information. if stored in a sealed container.7% Non-ionic detergent HbA1c R2 HbA1c Hapten Bovine Serum Albumin Buffer pH 2. Dispose of all waste material in accordance with local guidelines. unopened.6% Non-ionic detergent Preservative 0.02 2009-12 Specific Protein . Before use. An agglutinator. therefore. a volume of less than 25 µL is not recommended. Storage and Stability The reagents are stable.0 Surfactant Preservative 0.HbA1c (Hemoglobin A1c) OSR6192 Intended Use Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c). Agglutination leads to an increase in the absorbance of the suspension. Addition of the pre-treated blood sample to the Total Hemoglobin reagent results in a green solution. Test Principle The concentrations of both HbA1c and Total Hemoglobin are determined.5 mL R1 R2 R1 Summary1 HbA1c is formed by the non-enzymatic glycation of free amino groups at the N-terminus of the β-chain of hemoglobin A0.1% Proclin Total Hemoglobin Total Hemoglobin R1 Sodium hydroxide 0. HbA1c R1 should be mixed by inversion 5 – 10 times before placing on board the instrument and at weekly intervals thereafter. Due to the viscosity of whole blood. In the absence of HbA1c in the sample. and Hemoglobin Denaturant (sold separately as Cat No. The red blood cells are lysed and the hemoglobin chain is hydrolysed by the protease present in the reagent. Mix thoroughly. which is measured at 600nm. in human blood. HbA1c R2 agglutinator reagent. Avoid contact with skin. Once open. The presence of HbA1c in the sample results in a decrease in the rate of agglutination of the HbA1c R1 and the agglutinator in the HbA1c reagent R2. up to 48 hours when stored at 2…8°C. 2 weeks when stored at 2…8°C and up to 6 months when frozen at ≤ -70°C. EN. Total Hemoglobin is measured via the conversion of all hemoglobin derivatives into alkaline haematin in the alkaline solution of a non-ionic detergent. The level of HbA1c is proportional to the level of glucose in the blood. Measurement of HbA1c is.OSR0004). reagents stored on board the instrument are stable for 30 days. The assay for percent HbA1c. This material and its container must be disposed of as hazardous waste. involves the use of four reagents: Total Hemoglobin R1. OSR0004). causes agglutination of latex coated with HbA1c specific mouse monoclonal antibodies. Samples (non-pretreated) are stable up to 1 week when stored at 25°C. Exercise the normal precautions required for handling all laboratory reagents. Calibrators do not require pretreatment. HbA1c is measured in a latex agglutination inhibition assay.01 BLOSR6x92. and must not be used individually for diagnostic purposes. The increase in absorbance is therefore inversely proportional to the concentration of HbA1c in the sample. HbA1c R1 antibody reagent. results should always be assessed in conjunction with the patient’s medical history. the resulting curve should be visually reviewed. Calibrator 1 is used for calibration of the Total Hemoglobin assay only. If at any time HbA1c controls are out of range. Samples exceeding the upper limit of Total Hemoglobin may be mixed well and the analyses repeated on a freshly denatured sample.18 EN.4-14.915 x IFCC) + 2. HbA1c The analytical range of this assay extends from the concentration of calibrator 1 to calibrator 6.12 0. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Incubate controls with the denaturant at room temperature for exactly 5 minutes before placing onto the system. clinical examinations and other findings. 3. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. % HbA1c The reportable range for the calculated % HbA1c is approximately 3. Once a control has been assayed – discard it – never rerun pre-treated HbA1c controls: instead repeat the pre-treatment step. on the Beckman Coulter analyser.The relationship between results from the NGSP network (DCCT aligned) and the IFCC network has been evaluated. for acceptability.08 CV% 0. Traceability2. Precision The following data was obtained on an AU640 analyser using 3 whole blood pools analysed over 20 days. The results obtained by any individual laboratory may vary from the given mean value. Data obtained in your laboratory may differ from these values. Analytical Range Total Hemoglobin The analytical range for Total Hemoglobin is 7-23 g/dL (4. Following calibration.915 x IFCC) + 2. recalculated using Master Equation) Expected values may vary with age.15). This will ensure that any issues with the pre-treatment process or denaturant solution are identified and the performance of the HbA1c assay (OSR6192) is effectively monitored. 2. Calibration HbA1c Calibrator (ODR3032). patient samples can be processed with the minimum pre-treatment time of 5 minutes up to the maximum defined stability of the pre-treated sample of 8 hours at room temperature. Samples exceeding the upper limit of the analytical range for HbA1c should not be diluted.12 BLOSR6x92. 2 Quality Control HbA1c Control material ODC0022 or other control materials with values determined by this Beckman Coulter system may be used. Adults: Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems. and a Master Equation has been developed for interconversion of results from IFCC to DCCT/NGSP units.01 Specific Protein Within run SD 0. Settling of the red cells before the aliquot is taken for pre-treatment may cause an elevated Total Hemoglobin result.2% (DCCT) 2. sex.98 6.02 2009-12 Total CV% 1.78 1. For diagnostic purposes. For calibration procedure. discontinue the use of the current open bottle of OSR0004 Hemoglobin Denaturant. Note: a calculated result may be outside the reportable range based on either the Total Hemoglobin or the HbA1c result being outside of their respective analytical ranges. but instead should be reported as “% HbA1c > 14. and if necessary determine its own reference interval according to good laboratory practice. Strictly follow the pre-treatment directions. Recalibrate the assay every 14 days. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice.25 0. % HbA1c results generated during this assay are automatically recalculated to DCCT aligned units by the instrument.2% to 14. If any trends or sudden shifts in values are detected. Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheets for analyser-specific assay instructions. Major preventative maintenance was performed on the analyser or a critical part was replaced. using the IFCC approved Master Equation (NGSP = (0.0 – 4.3 The calibrator HbA1c values are traceable to the IFCC HbA1c reference method via IFCC HbA1c reference material. Calibrators 1 to 6 are used for calibration of the HbA1c assay. AU640: n=80 Mean % 4. When the result for Total Hemoglobin is outside the analytical range the calculated % HbA1c should not be reported. Each laboratory should verify the transferability of the expected values to its own population.32 1. The Master Equation also provides these DCCT results with traceability to a higher order reference method. or when the following occur: Change in reagent lot or significant shift in control values.08 0.5 g/dL (9 mmol/L). It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. It is imperative that this step is controlled as accurately as possible.77 SD 0. review all operating parameters.01 .56 10.0 – 6. sample type.5% for a sample with a total hemoglobin of 14.74 1.15 Definition of the relationship between the two networks links IFCC traceable results to clinically meaningful HbA1c results from the DCCT and the United Kingdom Prospective Diabetes Study (UKPDS).3 mmol/L). Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.07 0. MASTER EQUATION DCCT/NGSP = (0. Reference Interval2 4.04 0. diet and geographical location. Results are therefore expressed in DCCT aligned units as recommended by the IFCC.4% HbA1c (IFCC units. please refer to HbA1c Calibrator ODR3032 Instructions for Use. Additional pre-treatment/QC recommendations for manual method: 1.Test Procedure Total Hemoglobin and HbA1c tests must be performed on each pre-treated sample and control. Note: Calibrators do not require pre-treatment with Hemoglobin Denaturant.5%”. Once the effectiveness of the denaturant has been demonstrated in this manner for the minimum defined pre-treatment time. Total haemoglobin values assigned to the THb calibrator are traceable to the IRMM haemoglobin cyanide standard (BCR-522). IFCC Reference System for Measurement of Hemoglobin A1c in Human Blood and the National Standardization Schemes in the United States.5. To work in g/dL. patient’s medical history. clinical status and results of other tests. The labile fraction of glycated hemoglobin (Schiff base attachment of glucose to HbA or HbA1c) does not affect the assay result due to the specificity of the antibody for the stable ketoamine.5 and b = 2.g. Mauri P. 1998: 142-148 Jeppsson J-O. must also be entered in the general tests and the calculated tests of the test section menu (no settings required).08 g/dL).092x . significant blood loss and pregnancy.1 mmol/L and highest calibrators. B=THb.02 2009-12 Specific Protein . Use and assessment of clinical laboratory results.1 – 11. A sample containing hemoglobin E was shown not to interfere with this test. Clinical Laboratory Diagnostics. a = 91. sodium cyanate (50 mg/dL) and urea (83 mmol/L) do not interfere with this assay. Hoshino T. Little R. users should be aware of the possible effect on results due to unknown interferences from medication or endogenous substances. Values set for working in mmol/L. or other hemolytic diseases. Frankfurt/Main: TH-Books Verlagsgesellschaft mbH. Paroni R. a=91. Weykamp C. A third test. the HbA1c results should always be assessed in conjunction with other available information e. 50(1): 166-174 Young DS. B = THb. Set this test as CALCULATED TEST in the INTER TEST menu. Theinpoint L.02mmol/L (0.5 %HbA1c Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 513µmol/L (30 mg/dL) Bilirubin ® Lipemia: Interference less than 10% up to 500 mg/dL Intralipid Triglyceride: Interference less than 10% up to 18mmol/L (1600 mg/dL) Triglyceride Rheumatoid factor (RF) up to 2000 IU/mL. 3. Hoelzel W. Miedema. Hoezel W. Enter the formula (A/B)*a+b.03g/dL). Thienpont L. EN. Results of linear regression analysis were as follows: y = 1. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. BIBLIOGRAPHY 1. Barr J. John. Clin Chem 2004. Concentration of 0. with a resultant decrease in % HbA1c values. Umemoto M. For determination of %HbA1c the above tests (THb and HbA1c) are used. where A=HbA1c. Mauri P. The lowest detectable level represents the lowest measurable level of HbA1c that can be distinguished from zero.15. WG.Sensitivity The lowest detectable level on an AU640 analyser was calculated as: HbA1c 0. Mosca A. % HbA1c. Causes of reduced red cell survival time include hemolytic anaemia. Effects of drugs on clinical laboratory tests. No. 2. Reinauer H Glycohemoglobins In: Thomas L.0. 4 Limitations5 Shortened red cell survival time will reduce the exposure of red cells to glucose. where A = HbA1c . THb 0.01 BLOSR6x92. Data on file at Beckman Coulter Biomedical Ltd. Barr JR. Samples containing > 10% of haemoglobin F may yield a lower than expected result with this test. b=02. Weykamp C. Goodall I.15 in Parameters Specific Test Parameters CALCULATED TEST Niederau CM. 2000. and Sweden: A Method-Comparison Study. Jeppsson J-O. Refer to Young for further information on interfering substances.147 r = 0. Kobold U. Hoshino T. 40(1): 78-89. Setting Sheet Footnotes # † * ** ¥ ж User defined ¤ Analyser default value HbA1c Calibrator Cat. multiply by 1. ed. Miedema K. Samples containing hemoglobin variants S and C may produce up to a 40% elevation of the expected HbA1c value in this assay. Kobold U. Japan. 4. C and F (>10%) should not be compared to published normal or abnormal values. Percentage HbA1c results are therefore not reliable where red cell survival time is reduced. HbA1c results obtained by this test method for blood samples containing Hb variants S. Enter the formula (A/B)*a + b. acetylsalicylic acid (60 mg/dL). Susanto F. Set this test as COMMON TEST PARAMETER TEST NAME in CALCULATED TEST. As with any chemical reaction.: ODR3032. Takei I. 5. Approved IFCC reference method for the Measurement of HbA1c in Human Blood. Wiedmeyer H-M.05mmol/L (0. Method Comparison Patient samples were used to compare this HbA1c OSR6192 assay on the AU640 against another commercially available immunoturbidimetric HbA1c assay.6125. Clin Chem Lab Med 2002. Umemoto M. AACC Press. 5th ed.995 n = 97 Sample range = 5. For diagnostic purposes. Mosca A. Finke A. Paroni R. . B=THb and a=91. # # ∇ 6. None Selected 8. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 14 ∇ Advanced Calibration: # ∇ Cal. No.5 ∇ Operation: Yes ∇ Range Test Name: THb¥ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 11 150 0 µL µL µL Dilution Dilution Dilution 0 0 0 µL µL µL µL µL µL µL µL µL 2.3* 2. where A=HbA1c . 700 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 600 END + First 0 First Last Last 27 % ∇ Pre-Dilution Rate: 1 Min OD L Reagent OD limit: First L -2.15. None Selected 8. # # ∇ 5.5 2.5 and b=2.0 -2. Set this test as CALCULATED TEST in the INTER TEST menu.6125.0 Reagent OD limit: First L -2.4* Correlation Factor: A 1 On-board stability period: Pre-Dilution Rate: 1 Min OD L -2. Enter the formula (A/B)*a+b.5 ** 0 Pri. For determination of %HbA1c the above tests (THb and HbA1c) are used. To work in g/dL multiply by 1.0 -2. # # # # # # Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: 1-Point Cal.1 mmol/L and highest calibrator. . # # ∇ 4.5 2. No. where A=HbA1c . # # ∇ 5.02 2010-06 . B=THb and a=91.0 Dynamic Range: L ** Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Range ∇ Level L: Month # # # # # # L # # Age H Year # # # # # # H # < > Serum # ∇ Test Name: HbA1c¥ Range Specific Test Parameters General LIH ISE Test Name: THb¥ ∇ < > Type: Type: Level H: Month # # # # # # Serum # ∇ Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. Enter the formula (A/B)*a+b. # # ∇ 2. # OD CONC † Factor/OD-L -999999 1-Point Cal.5 2.0 Dynamic Range: L 4. A third test %HbA1c must also be entered in the general tests and the calculated tests of the test section menu (no settings required). # # ∇ 3. For determination of %HbA1c the above tests (THb and HbA1c) are used. # # ∇ 6. # # ∇ 2.0 Last L -2.5 76 76 ∇ ∇ ∇ Sec. Concentration of 0. HbA1c¥ Blood Application HbA1c. # # ∇ 3.15.0 Last L -2. Last Last % ∇ 22 Dilution Dilution Dilution < > ∇ Yes ∇ Reagent ID : 035 System Reagent : OSR6192 Specific Test Parameters General LIH ISE Test Name: Sample: Reagents: Volume R1 Volume R2 Volume Pri.5 2.5 2. Point: MB Type Factor: # † * ** ¥ WHOLE BLOOD APPLICATION Test Name: Counts: THb¥ ∇ < > Type < > POLYGONAL OD CONC † † † † † † with CONC-0 ∇ Type Serum Counts: Factor/OD-L -2.0 -2.5 2. Set this test as CALCULATED TEST in the INTER TEST menu.0 Slope Check: # ∇ Process: CONC ∇ Factor/OD-H 2.5 2. AU400/AU640 Whole Reagent ID: 092 Range ∇ Type: 0 0 0 None ∇ Max OD H First H Last H H B 30 Serum Operation: 3. A third test %HbA1c must also be entered in the general tests and the calculated tests of the test section menu (no settings required). Out of Range L # # # # # # # # Unit: mmol/L* H # # # # # # # # Decimal places: # Panic Value: # # Calibration Specific General ISE Serum # Factor/OD-H 999999 Process: CONC ∇ ∇ Calibration Specific General ISE Test Name: HbA1c¥ ∇ Calibration Type: 6AB ∇ Formula: Cal.6125.5 ∇ Advanced Calibration: Calibration Stability Period: 14 User defined HbA1c Calibrator ODR3032 Values set for working in mmol/L.0 -2. ∇ ∇ ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 700 FIXED + First 13 First Sec. To work in g/dL multiply by 1.5 and b=2. AU400/AU640 Whole Blood Application System Reagent: OSR6192 Specific Test Parameters General LIH ISE Serum Max OD H First H Last H H B 30 0 14. # # ∇ 7.TOTAL Hb. Out of Range L # # # # # # # # Unit: mmol/L* Decimal places: # Panic Value: H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ∇ 7. Point: with CONC-0 Slope Check: # ∇ MB Type Factor: Calibration Stability Period: # † * ¥ User defined HbA1c Calibrator ODR3032 Values set for working in mmol/L .0 -2.5 2. # # ∇ 4. Specific Protein BSOSR6x92. Reagent 1 vol Reagent 2 vol 2. H Lst.0 -2. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name HbA1c¥ ∇ Sample type Ser % Sec % ∇ On-board stability period Linearity Fst No lag time % ∇ On-board stability period 30 Select using Space key. Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † HbA1c Calibrator ODR3032.0 -2.6125. vol Dil.5 2.5 2.5 Sample vol.0 Lst. Linearity Fst No lag time 30 Select using Space key. H Lst.1 mmol/L and highest calibrator.TOTAL Hb.0 Dynamic range L 4.5 ∇ Calibration specific WHOLE BLOOD APPLICATION Test No Count Process ∇ Factor/OD-L -999999 Factor/OD-H 999999 # Conc # Test name THb¥ ∇ AB ∇ Y=AX+B ∇ Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 Point 3 Point 4 Point 5 Point 6 ∇ Point 7 ∇ 1-point cal. L -2. point MB type factor Calibrator stability period # † * ** ¥ OD Conc † 14 Cal type 14 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 # ∇ Point 7 ∇ 1-point cal.5 and b=2. OD L Reagent OD limit Fst.5 2.0 Dynamic range L ** Correlation factor Sample Pre-dil.5 2. For determination of %HbA1c the above tests (THb and HbA1c) are used. A third test %HbA1c must also be entered in the general tests and the calculated tests of the test section menu (no settings required). To work in g/dL multiply by 1.6125. ¥ For determination of %HbA1c the above tests (THb and HbA1c) are used. vol 0 0 0 µL µL µL Main 600 Sub ∇ ∇ ∇ Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil. Enter the formula (A/B)*a+b. L -2. vol Dil.5 2. L -2. A third test %HbA1c must also be entered in the general tests and the calculated tests of the test section menu (no settings required). B=THb and a=91. H 2. where A=HbA1c .3* 1 0 ¤ Fst Fst 0 Lst Lst 700 END + 27 Min. Concentration of 0. where A=HbA1c . % Sec 13 Lst Lst H A B Rate NONE FIXED + 22 Wave Method Reaction Point 1 Point 2 H A B Rate 14. Enter the formula (A/B)*a+b.0 Reagent OD limit Fst. OD H ∇ Page 1/2 Test No # Test name HbA1c¥ Sample type Ser Page 1/2 ∇ ∇ System Reagent: OSR6192 Reagent ID: 035 Blood Application HbA1c. vol Dil.4* Correlation factor ** 1 0 ¤ Min.5 Main 700 Sub ∇ ∇ ∇ Fst. L -2. Set this test as CALCULATED TEST in the INTER TEST menu.5 2. point MB type factor Calibrator stability period 14 Select the function using the Function key or the Mouse User defined ¤ Analyser default value HbA1c Calibrator ODR3032 Values set for working in mmol/L.15 Specific Protein BSOSR6x92.5 2. or select from list displayed by Guide key Ser Level L # Level H # ∇ Page 2/2 Test No # Test name THb¥ ∇ Sample type ∇ Level L # Page 2/2 Level H # # ∇ L # # # # # # M→ M→ M→ M→ M→ M→ # # # # # # H Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Age Y Y Y Y Y Y Age Y Y Y Y Y Y L # # # # # # # # L # Panic value H # # # # # # # # H # # # # # # # Age Y Y Y Y Y Y # # # # # # M M M M M M # # # # # # Age Y Y Y Y Y Y Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Panic value L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Select the function using the Function key or the Mouse Calibration specific Test No # Test name HbA1c¥ ∇ 6AB ∇ POLYGONAL OD ∇ Conc † † † † † † Count Process Factor/OD-L -2. * Values set for working in mmol/L.0 # Conc Factor/OD-H 2. OD H 2. AU600 Whole Reagent ID: 092 Specific test parameters Ser Max.0 -2. To work in g/dL multiply by 1.0 -2.15. H 11 150 0 Dil. vol Dil. Reagent 1 vol Reagent 2 vol Fst. AU600 Whole Blood Application System Reagent: OSR6192 Specific test parameters Test No # Test name THb¥ ∇ Sample type Sample vol.5 3. Set this test as CALCULATED TEST in the INTER TEST menu.5 and b=2. B=THb and a=91.0 -2. vol 0 0 0 µL µL µL Max.0 Lst.5 76 76 Dil. OD L -2.02 2010-06 . For determination of %HbA1c the above tests (THb and HbA1c) are used. Out of Range L # # # # # # # # Unit: Calibration Specific General ISE Test Name: HbA1c¥ ∇ < > POLYGONAL Cal.1 Reagent OD limit: First L -2. # # ∇ 4. None Selected 8. Specific Protein BSOSR6x92.0 -2. Set this test as CALCULATED TEST in the INTER TEST menu. AU2700/AU5400 Whole Reagent ID: 092 Range ∇ Type: 0 0 0 Max OD H 2. No. Enter the formula (A/B)*a+b. No. # OD CONC † Factor/OD-L -999999 1-Point Cal.02 2010-06 .6125.0 Last L -2. # # ∇ 2. # # ∇ 6.5 and b=2. # # # # # # Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: # ∇ 1-Point Cal.5 2. # # ∇ 5.5 2. where A=HbA1c . # # ∇ 7. B=THb and a=91.4* B 30 0 H 14.5 2.5 and b=2.0 Slope Check: # Process: CONC ∇ Factor/OD-H 2. Concentration of 0.5 130 0 µL µL µL Dilution Dilution Dilution 0 0 0 µL µL µL Pri.0 -2.5 ∇ Operation: Yes ∇ Range Test Name: THb¥ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 9. ∇ ∇ ∇ 700 FIXED + First 13 First Sec. # # ∇ 2. To work in g/dL multiply by 1. A third test %HbA1c must also be entered in the general tests and the calculated tests of the test section menu (no settings required). Point: with CONC-0 Slope Check: None ∇ MB Type Factor: Calibration Stability Period: # † * ¥ User defined HbA1c Calibrator ODR3032. # † * ** ¥ User defined HbA1c Calibrator ODR3032. # # ∇ 7.0 -2. # # ∇ 4.5 ∇ Advanced Calibration: Calibration Stability Period: 14 # ∇ Calibration Type: AB ∇ Formula: Y=AX+B ∇ Counts: Calibration Type: 6AB ∇ Formula: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: 14 Cal.1 mmol/L and highest calibrator. HbA1c¥ Blood Application HbA1C. 700 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 600 END + First 0 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ A 1 On-board stability period: Pre-Dilution Rate: 1 Min OD L -0. Set this test as CALCULATED TEST in the INTER TEST menu. For determination of %HbA1c the above tests (THb and HbA1c) are used. where A=HbA1c .15. Point: MB Type Factor: OD CONC † † † † † † with CONC-0 mmol/L* Decimal places: # Panic Value: H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. B=THb and a=91. To work in g/dL multiply by 1.5 H B 30 ** 0 First H Last H None ∇ µL µL µL Serum Operation: Yes 3 65 65 ∇ ∇ ∇ Sec. Out of Range H # # # # # # # # mmol/L* Decimal places: # Panic Value: # # Calibration Specific General ISE Type Serum # Factor/OD-H 999999 Process: CONC ∇ ∇ WHOLE BLOOD APPLICATION Test Name: THb¥ ∇ < > Type Serum ∇ Counts: Factor/OD-L -2.0 4. # # ∇ 3. Enter the formula (A/B)*a+b. None Selected 8. # # ∇ 6.15.0 -2. Values set for working in mmol/L.5 2.3* First H Last H 2.5 2.5 2.6125. Last Last % ∇ 22 µL µL µL Dilution Dilution Dilution < > ∇ ∇ Reagent ID : 035 System Reagent : OSR6192 Specific Test Parameters General LIH ISE Test Name: Sample: Reagents: Volume R1 Volume R2 Volume Pri. # # ∇ 5.0 -2.0 -2. Values set for working in mmol/L. AU2700/AU5400 Whole Blood Application System Reagent: OSR6192 Specific Test Parameters General LIH ISE Serum 1 Max OD H -2.TOTAL Hb.5 2. # # ∇ 3.0 Dynamic Range: L ** Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Range ∇ Level L: Month # # # # # # L # Age H Year # # # # # # H # # < > Type: Level H: Month # # # # # # Serum # ∇ Test Name: HbA1c¥ Range Specific Test Parameters General LIH ISE Test Name: THb¥ ∇ < > Type: Serum # L # # # # # # # # Unit: ∇ Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 2. A third test %HbA1c must also be entered in the general tests and the calculated tests of the test section menu (no settings required). Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Noneф 600 ∇nm END ∇ + ∇ 0 700 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 4. where A=HbA1c . # # # # ∇ 6. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ 14 14 Day Day with Conc-0 Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration 0 0 Hour Hour # † * ж MB Type Factor: 1-Point Calibration Point ∇ User defined HbA1c Calibrator ODR3032. # # # # ∇ 7. # # # # ∇ 5.5 and b=2.TOTAL Hb. # # # # ∇ 2. # # # # ∇ 4. No demographics 8.5 Min.0 -2.15 in Parameters Specific Test Parameters CALCULATED TEST ф AU680 Specific Protein BSOSR6x92.3* 0 0 Last Last 27 % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General Range Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: THbж Panic Value Low # High # ∇ < > Type: High # High # # # # # # # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1.5 1 130 Dilution 0 µL µL ∇ µL Dilution 0 µL R2(R2-1) 0 µL Dilution 0 µL Name Sec. To work in g/dL multiply by 1.6125.02 2010-06 . Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: THbж ∇ < > Type WHOLE BLOOD APPLICATION WHOLE BLOOD APPLICATION Y=AX+B None ∇ Counts: # ∇ ∇ Factor Range Low High Slope Check -999999 999999 Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Lot Calibration Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal.0 High High 2. Values set for working in mmol/L. # # # # ∇ 3. Enter the formula (A/B)*a+b. Set this test in Common Test Parameter test name as CALCULATED TEST. Not within expected values Month # # # # # # Low # # # # # # # # Unit mmol/L* Decimal Places # Parameters Calibrators General Serum ∇ Use Serum Cal.4* 1 1 High B B 14.OD -2. AU680/AU480 Whole Reagent ID: 092 Range Blood Application System Reagent: OSR6192 Parameters General Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: OD Limit Max. B=THb and a=91.5 2.OD Reagent OD Limit First Low Last Low THbж ∇ < > Type: Operation Yes ∇ Sample Volume Pre-Dilution Rate Rgt. 0 Hour ф Common Rgt. Volume R1(R1-1) 9. 5 Max.0 2.5 -2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Noneф 700 ∇nm FIXED ∇ + ∇ 13 Name Sec. No demographics 8.0 -2.0 2.15 in Parameters Specific Test Parameters CALCULATED TEST ф AU680 # † * ** ж Specific Protein BSOSR6x92.5 Calibration -2. # # # # ∇ 5.6125. Values set for working in mmol/L.5 2. # # # # ∇ 3.1 -2. Enter the formula (A/B)*a+b.0 2. where A=HbA1c .5 Reagent Blank -2.0 2. AU680/AU480 Whole Reagent ID: 035 Range Blood Application System Reagent: OSR6192 Parameters General Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: HbA1cж ∇ Operation Yes < > Type: ∇ Dilution -0. Not within expected values Month # # # # # # Low # # # # # # # # Unit mmol/L* Decimal Places # Parameters Calibrators General ∇ Use Serum Cal.OD Reagent OD Limit First Low Last Low R2(R2-1) ** 1 1 0 Hour High B B ** 0 0 65 µL Dilution 0 µL Common Rgt.5 and b=2. Volume R1(R1-1) 3 1 65 0 µL OD Limit µL ∇ µL Dilution 0 µL Min. For No. # # # # ∇ 2. # # # # ∇ 4.5 Sample Volume Pre-Dilution Rate Rgt.5 Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Lot Calibration Calibration Type: 6AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: # † ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal. Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A Last Last 22 % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General Range Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: HbA1cж ∇ Panic Value Low # High # < > Type: High # High # # # # # # # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1. Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: HbA1cж ∇ < > Type Serum WHOLE BLOOD APPLICATION POLYGONAL ∇ Counts: # ∇ ∇ OD Range Low High Slope Check -2.5 Allowance Range Check -2. B=THb and a=91.0 2. # # # # ∇ 6.1 mmol/L and highest calibrator. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ 14 14 Day Day 0 0 Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration Hour Hour MB Type Factor: 1-Point Calibration Point ∇ with Conc-0 User defined HbA1c Calibrator ODR3032. To work in g/dL multiply by 1.HbA1C. Set this test in Common Test Parameter test name as CALCULATED TEST. Concentration of 0.0 High High 2.5 -2.0 2. # # # # ∇ 7.OD 2.02 2010-06 . . Whole Blood Application) OSR61177 HbA1c APT Total Hemoglobin APT HbA1c APT Denaturant Intended Use Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c) in human whole blood on Beckman Coulter AU680 with whole blood automated pre-treatment (APT) capability only. The HbA1c/Total Hemoglobin ratio is expressed as percentage HbA1c (%HbA1c). the antibody-coated microparticles in the HbA1c APT R1 and the agglutinator in the HbA1c APT R2 will agglutinate. considered to be an important diagnostic tool in the monitoring of dietary control and therapeutic regimes during the treatment of diabetes. unopened. Do not top up reagent vials. In the absence of HbA1c in the sample. Total Hemoglobin is measured via the conversion of all hemoglobin derivatives into alkaline haematin in the alkaline solution of a non-ionic detergent. Storage and Stability The reagents are stable. nephropathy and cardiac disease. Dispose of all waste material in accordance with local guidelines.1% Proclin Precautions and Warnings Hazard Warnings and Risk Phrases HbA1c APT R1 and HbA1c APT R2 R43: May cause sensitisation by skin contact. and must not be used individually for diagnostic purposes. neuropathy. Addition of the pre-treated blood sample to the Total Hemoglobin reagent results in a green solution. The increase in absorbance due to agglutination is measured at 700 nm. This material and its container must be disposed of as hazardous waste. HbA1c is measured in a latex agglutination inhibition assay.HbA1c APT (Hemoglobin A1c. Do not mix reagents between kit lots. which is measured at 600 nm. The increase in absorbance is therefore inversely proportional to the concentration of HbA1c in the sample. Once open. Contents.4 Preservative HbA1c APT R2 HbA1c Hapten Bovine Serum Albumin Buffer pH 2. The level of HbA1c is proportional to the level of glucose in the blood. Measurement of HbA1c is.7% Non-ionic detergent HbA1c APT Denaturant HbA1c APT Denaturant R1 Porcine Pepsin Buffer pH 2. and may reduce the prevalence and severity of late diabetic complications such as retinopathy. Wear suitable gloves. measurement of HbA1c provides an indication of the mean daily blood glucose concentration over the preceding two months. Agglutination leads to an increase in the absorbance of the suspension. An agglutinator. As the glucose remains bound to hemoglobin in the red cell throughout the life cycle of the cell. Avoid contact with skin. 2 x 19 mL 2 x 19 mL 2 x 38 mL 2 x 55 mL R1 R2 R1 R1 Summary1 HbA1c is formed by the non-enzymatic glycation of free amino groups at the N-terminus of the β-chain of hemoglobin A0. Total Hemoglobin APT R1.01 BLOSR6x177. HbA1c APT R1 and HbA1c APT Denaturant R1 should be mixed by inversion 5 – 10 times before placing on board the instrument and at weekly intervals thereafter. Refer to Safety Data Sheets for further information.0 Surfactant Preservative 0. causes agglutination of latex coated with HbA1c specific mouse monoclonal antibodies. S24. and can be placed directly on board the instrument. Reagent Composition HbA1c HbA1c APT R1 HbA1c Antibody (mouse) coupled particles Bovine Serum Albumin Buffer pH 8. S60. The red blood cells are lysed and the hemoglobin chain is hydrolysed by the protease present in the reagent. HbA1c APT R2 agglutinator reagent.4%. and HbA1c APT Denaturant R1. Product contains a mixture of 5-chloro-2-methyl-4-isothiazolin -3-one [EC No 247-500-7] and 2-methyl-2 H –isothiazol-3-one [EC No 220-239-6] (3:1). Reagent Preparation Total Hemoglobin APT R1 and HbA1c APT R2 are ready for use.1 Surfactant 0.6% Non-ionic detergent Preservative 0. HbA1c APT R1. The presence of HbA1c in the sample results in a decrease in the rate of agglutination of the HbA1c APT R1 and the agglutinator in the HbA1c APT R2. HbA1c APT R2 and HbA1c APT Denaturant reagents stored on board the instrument are stable for 30 days. consisting of a synthetic polymer containing multiple copies of the immunoreactive portion of HbA1c. Exercise the normal precautions required for handling all laboratory reagents. The assay for percent HbA1c involves the use of four reagents: Total Hemoglobin APT R1. HbA1c APT R1 antibody reagent. up to the stated expiry date when stored at 2…8°C. EN. For in vitro diagnostic use only. Test Principle The concentrations of both HbA1c and Total Hemoglobin are determined. pH 13 Surfactant 0.01 2009-08 Specific Protein . therefore.1% Proclin Total Hemoglobin Total Hemoglobin APT R1 Sodium hydroxide 0. S37. Whole blood is pretreated automatically on board the AU680. The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio. Effective control of blood glucose levels is important in the prevention of ketosis and hyperglycaemia. 06 CV% 0. Samples with any hematocrit disorders may result in instrument flags.3 mmol/L (7 – 23 g/dL). results should always be assessed in conjunction with the patient’s medical history.10 BLOSR6x177. and if necessary determine its own reference interval according to good laboratory practice. 2 Quality Control HbA1c Control material ODC0022 or other control materials with values determined by this Beckman Coulter system may be used. Do not remove the racks which are about to be transferred onto the conveyor belt for processing at the sampling position. Precision The following data was obtained on an AU680 analyser using 3 whole blood pools analysed over 20 days. Analytical Range Total Hemoglobin The analytical range for Total Hemoglobin is 4. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.15 Definition of the relationship between the two networks links IFCC traceable results to clinically meaningful HbA1c results from the DCCT and the United Kingdom Prospective Diabetes Study (UKPDS). however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed.17 Specific Protein Within run SD 0. The Master Equation also provides these DCCT results with traceability to a higher order reference method. recalculated using Master Equation) Expected values may vary with age. sex. Reference Interval2 4.73 0. Please note that only Beckman Coulter HbA1c APT Denaturant can be used with this method. and a Master Equation has been developed for interconversion of results from IFCC to DCCT/NGSP units.: ODR3032. Test Procedure Total Hemoglobin and HbA1c tests must be performed on each pre-treated sample and control. However. Ensure that controls are run at every calibration event.0 – 4. For diagnostic purposes.88 EN.915 x IFCC) + 2. Note: Calibrators do not require pre-treatment with HbA1c APT Denaturant. Major preventative maintenance was performed on the analyser or a critical part was replaced. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. sample type. clinical examinations and other findings. or when the following occur: Change in reagent bottle or significant shift in control values. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Samples exceeding the upper limit of linearity should not be diluted. please refer to HbA1c Calibrator ODR3032 Instructions for Use.3 The calibrator HbA1c values are traceable to the IFCC HbA1c reference method via IFCC HbA1c reference material.5 g/dL). If any trends or sudden shifts in values are detected. review all operating parameters. using the IFCC approved Master Equation (NGSP = (0. Total hemoglobin values assigned to the THb calibrator are traceable to the IRMM hemoglobin cyanide standard (BCR-522).92 0. Please confirm that the dynamic ranges are set appropriately according to the Setting Sheets to ensure correct flagging. MASTER EQUATION DCCT/NGSP = (0. Traceability2.4 – 14.5 %HbA1c at a total hemoglobin level of 9 mmol/L (14.05 0. Calibrator 1 is used for calibration of the Total Hemoglobin APT assay only. Recalibrate the assay every 14 days. The results obtained by any individual laboratory may vary from the given mean value.2 %HbA1c to the concentration of Calibrator 6 which approximately corresponds to 14.915 x IFCC) + 2. No. The relationship between results from the NGSP network (DCCT aligned) and the IFCC network has been evaluated. Data obtained in your laboratory may differ from these values.4 %HbA1c (IFCC units. Following calibration. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Results are therefore expressed in DCCT aligned units as recommended by the IFCC.01 2009-08 Total CV% 0. They have to be mixed thoroughly by inversion and analyzed subsequently by making the test requisition and placing them in a rack on the rack feeder unit close to the sampling lane. HbA1c DCCT The analytical range of this assay extends from 3.56 SD 0. %HbA1c results generated during this assay are automatically recalculated to DCCT aligned units by the instrument.15). Each laboratory should establish its own control frequency.02 0. For calibration procedure. Sedimentation of erythrocytes can lead to a "Tx" flagged result. Samples (non-pretreated) are stable up to 1 week when stored at 25°C. Whole blood samples should be mixed by inverting 5 – 10 times before placing on board the instrument. the resulting curve should be visually reviewed.43 0. but instead should be reported as >14. Reconstituted control material should not be pre-treated with HbA1c APT Denaturant.5%. diet and geographical location. AU680: n = 80 Mean % 5.34 11.2% (DCCT) 2. Each laboratory should verify the transferability of the expected values to its own population. 2 weeks when stored at 2…8°C and up to 6 months when frozen at ≤ -70°C.07 0. If there are more than 3 racks in the queue on the rack feeder.95 0.01 . then manually move those racks backwards to allow the HbA1c test sample to be placed close to the front for priority sampling. Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheets for analyser-specific assay instructions. Calibrators do not require pre-treatment.0 – 6. but should be placed on-board the instrument for on-board denaturation. Calibration HbA1c Calibrator Cat.20 7.05 0. Adults: Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems. on the Beckman Coulter analyser for acceptability. Calibrators 1 to 6 are used for calibration of the HbA1c APT assay. the rack should not be placed closer than 3 positions from the head of the queue.Specimen K2-EDTA or NH4-heparinised whole blood. A valid final HbA1c value can be obtained by mixing the sample thoroughly and analysing immediately as described above for samples with haematocrit disorders. Samples containing hemoglobin variants S and C may produce up to a 40% elevation of the expected HbA1c value in this assay. Barr J. Frankfurt/Main: TH-Books Verlagsgesellschaft mbH. Paroni R.08 g/dL) The lowest detectable level represents the lowest measurable level of HbA1c that can be distinguished from zero.60 – 12. Finke A.05 mmol/L (0. multiply by 1. Hoelzel W. Jeppsson J-O. B = THb. 5. 4.512 r = 0. 5th ed. 40(1): 78-89. the HbA1c results should always be assessed in conjunction with other available information e. clinical status and results of other tests. significant blood loss and pregnancy. Percentage HbA1c results are therefore not reliable where red cell survival time is reduced. Niederau CM. No. Approved IFCC reference method for the Measurement of HbA1c in Human Blood. Miedema K. Miedema. A sample containing hemoglobin E was shown not to interfere with this test. To work in g/dL. For determination of %HbA1c the above tests (THb and HbA1c) are used. 3.026x + 0. Mosca A. Hoezel W.90 %HbA1c Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 513 µmol/L (30 mg/dL) Bilirubin ® Lipemia: Interference less than 10% up to 500 mg/dL Intralipid Triglyceride: Interference less than 10% up to 18 mmol/L (1600 mg/dL) Triglyceride Rheumatoid factor (RF) up to 2000 IU/mL. Paroni R. where A = HbA1c. %HbA1c is calculated automatically by the analyser using the following formula : (A/B)* a + b.960 n = 127 Sample range = 4.01 mmol/L (0. patient’s medical history. Takei I. C and F (> 10%) should not be compared to published normal or abnormal values.5. Reinauer H Glycohemoglobins In: Thomas L. Mosca A. HbA1c results obtained by this test method for blood samples containing Hb variants S. Method Comparison Patient samples were used to compare this HbA1c APT OSR61177 assay on the AU680 against the HbA1c OSR6192 on the AU640 assay. Mauri P.15.02 g/dL) THb 0. Hoshino T. AACC Press. Results of linear regression analysis were as follows: y = 1. b = 2. Jeppsson J-O.: ODR3032 Values set for working in mmol/L. 50(1): 166-174. ed. acetylsalicylic acid (60 mg/dL). WG. Hoshino T. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Clin Chem 2004. EN. BIBLIOGRAPHY 1. Umemoto M. For diagnostic purposes. Clin Chem Lab Med 2002. users should be aware of the possible effect on results due to unknown interferences from medication or endogenous substances. 1998: 142-148. Barr JR. John. Susanto F. and Sweden: A Method-Comparison Study. The labile fraction of glycated hemoglobin (Schiff base attachment of glucose to HbA or HbA1c) does not affect the assay result due to the specificity of the antibody for the stable ketoamine. IFCC Reference System for Measurement of Hemoglobin A1c in Human Blood and the National Standardization Schemes in the United States.01 2009-08 Specific Protein . Umemoto M. Japan. a = 91. Setting Sheet Footnotes # † * ** § User defined HbA1c Calibrator Cat. with a resultant decrease in %HbA1c values. Weykamp C. Kobold U. Results of linear regression analysis were as follows: y = 1. Concentration of 0. Little R. Clinical Laboratory Diagnostics. Theinpoint L.Sensitivity The lowest detectable level on an AU680 analyser was calculated as: HbA1c 0. As with any chemical reaction.01 BLOSR6x177. sodium cyanate (50 mg/dL) and urea (83 mmol/L) do not interfere with this assay. Kobold U.45 %HbA1c Patient samples were used to compare this HbA1c APT OSR61177 assay on the AU680 against an HPLC method.039x + 0. Weykamp C. Causes of reduced red cell survival time include hemolytic anaemia. Samples containing > 10% of haemoglobin F may yield a lower than expected result with this test. Use and assessment of clinical laboratory results. Young DS. 2. Data on file at Beckman Coulter Biomedical Ltd. Mauri P. 4 Limitations5 Shortened red cell survival time will reduce the exposure of red cells to glucose. Wiedmeyer H-M.6125. Refer to Young for further information on interfering substances.1 mmol/L and highest calibrator. Thienpont L. or other hemolytic diseases.80 – 13.437 r = 0.966 n = 105 Sample range = 4. Goodall I. 2000. Effects of drugs on clinical laboratory tests.g. . 4000* 14.0000 102. From Sex Year Month # # # ∇ # # # ∇ # # # ∇ # # # ∇ # # # ∇ # # # ∇ No demographics Not within expected values Year # # # # # # Month Low # # # # # # # # # # # # # # Unit mmol/L* Decimal Places # Parameters Calibrators General ∇ Use Serum Cal.0000 ** Measuring Point-1 0 27 Measuring Point-2 First Last First Last 4.01 2009-08 . For No.6125.5 µL Max OD 76 µL Reagent OD Limit 76 µL First Low 700 ∇nm High None ∇nm Last Low FIXED ∇ High + ∇ Dynamic Range Low 13 High 22 Correlation Factor A B Factor for Maker A % 0 % B No ∇ ∇ Onboard Stability Period 0 Parameters General Range Whole Blood ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: THb§ ∇ < > Type: Value/Flag: Level Normal Ranges: High # # # # # # # # Panic Value Low High # # # ∇ Low # High # To ο ο ο ο ο ο 1.TOTAL Hb.1 mmol/L and highest calibrator.300* 1 0 1 ** 1 0 1 Linearity Limit: Lag Time Check: 0 No 0 30 Day Hour 102.0000 3.0000 3.5 and b=2.0000 Sample Volume Rgt.0000 3. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 14 Day 0 Calibration 14 Day 0 Hour Hour MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 # User defined † HbA1c Calibrator ODR3032 * Values set for working in mmol/L. ο Calibration Specific Calibration Parameters STAT Table Calibration ISE HbA1c AUTOMATED APT APPLICATION Test Name: THb§ ∇ < > Type Whole Blood Y=AX+B Counts: # ∇ ∇ OD Range Low High Slope Check -999999 999999 Allowance Range Check None ∇ ο Reagent Blank ο Calibration Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal.0000 11. Sec Method: Reaction Slope: -2. 8.HbA1c 100. AU680 HbA1c Reagent ID: 201 Automated APT Application Range System Reagent: OSR61177 Parameters General LIH ISE HbA1c Specific Test Parameters Calculated Test Operation: Yes ∇ 100.0000 3. ** Concentration of 0. Specific Protein BSOSR6x177.0000 -2.HbA1c OD Limit Min OD 3. %HbA1c is calculated automatically by the analyser using the following formula: (A/B)*a+b.HbA1c% 101. B=THb and a=91. where A=HbA1c . Volume: R1(R1-1) R2(R2-1) Wavelength: Pri.0 150 0 600 700 END + ∇ µL µL µL ∇nm ∇nm ∇ -2. multiply by 1. 2.0000 3. § For determination of %HbA1c the above tests (THb and HbA1c) are used.T-Hb -2.0000 3. To work in g/dL.HbA1c 5 200 0 μL µL μL -2.15. 3. 7. 5.0000 -2. 4. 6.T-Hb 101. Sec Method: Reaction Slope: -2. AU680 HbA1c HbA1C Reagent ID: 177 Denaturant Reagent ID: 200 Automated APT Application Range System Reagent: OSR61177 Parameters General LIH ISE HbA1c Specific Test Parameters Calculated Test Operation: Yes ∇ 100.0000 3.5 and b=2. For No.0 3. 3.0000 3.0 ο Calibration -2. multiply by 1. Volume: R1(R1-1) R2(R2-1) Wavelength: Pri.01 2009-08 .T-Hb -2.0000 3. %HbA1c is calculated automatically by the analyser using the following formula: (A/B)*a+b.4000* 14. MB Type Factor: 1-Point Calibration Point None ∇ Specific Protein BSOSR6x177.0000 -2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ ο with Conc-0 Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 14 Day 0 Calibration 14 Day 0 Hour Hour # User defined † HbA1c Calibrator ODR3032 * Values set for working in mmol/L.0 3. ** Concentration of 0. Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: HbA1c§ ∇ < > Type HbA1c AUTOMATED APT APPLICATION POLYGONAL ∇ Counts: # ∇ OD Range Low High Slope Check -2.0000 3.0 3.0 -2.0000 3. To work in g/dL.0000 3.0 150 0 600 700 END + ∇ -2.5 µL Max OD µL 76 µL Reagent OD Limit µL 76 µL First Low 700 ∇nm ∇nm High None ∇nm Last Low ∇nm FIXED ∇ High ∇ + ∇ Dynamic Range Low 13 High 22 Correlation Factor A B Factor for Maker A % 0 % B No ∇ ∇ Onboard Stability Period 0 Parameters General Range Type: High # Low # # # # # # # # High Panic Value Low High # # Whole Blood ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: HbA1c§ ∇ < > Value/Flag: Level Normal Ranges: # ∇ Low # To ο ο ο ο ο ο 1. 6.0 Allowance Range Check -2.0000 102.300* 1 0 1 ** 1 0 1 Linearity Limit: Lag Time Check: 0 No 0 30 Day Hour 102.0000 11.0000 ** Measuring Point-1 0 27 Measuring Point-2 First Last First Last 4. From Sex Year Month # # # ∇ # # # ∇ # # # ∇ # # # ∇ # # # ∇ # # # ∇ No demographics Not within expected values Year # # # # # # Month # # # # # # # # # # # # # # Unit mmol/L* Decimal Places # Parameters Calibrators General Whole Blood ∇ ο Use Serum Cal. 2.0000 Sample Volume Rgt.0 3. B=THb and a=91.0 3.T-Hb 101. and highest calibrator.HbA1c OD Limit Min OD µL 3.HbA1c 5 200 0 μL µL μL -2.0 -2.0 3.0 Advanced Calibration Operation ∇ # # ∇ ∇ Interval (RB/ACAL) Calibration Type: 6AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: # † ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal. 7. 5. § For determination of %HbA1c the above tests (THb and HbA1c) are used.6125.1 mmol/L.15. 4. where A=HbA1c.0000 -2. 8.0 ο Reagent Blank -2.HbA1c.HbA1c% 101.HbA1c 100. especially of the GI and respiratory tracts. individuals with secretory IgA deficiency are found to suffer more commonly from mucosal infections. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. Secretory IgA is the predominant immunoglobulin of body secretions such as saliva. Unlike secretory IgA the specific role of serum IgA is unclear. IgD and IgE are present in descending order of concentration in the serum of healthy people. review all operating parameters. tracheobronchial mucus and gastrointestinal secretions. reagents stored on board the instrument are stable for 90 days. The paediatric application is suitable for use with small volume serum/plasma samples.2) Polyethylene glycol 6000 Goat anti-IgA antibodies Preservative 50 mmol/L 3. genitourinary.01 2009-08 Specific Protein . see setting sheets for specific instrument details. nasal secretions.Hypogammaglobulinemias. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution. and autoimmune diseases. Following calibration. flush waste-pipes with water after the disposal of undiluted reagent. . Storage and Stability The reagents are stable. tears. Specimen Serum and EDTA or heparinised plasma. Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer (pH 7.g.Monoclonal gammopathies. For in vitro diagnostic use only. unopened. IgA antibodies occur as serum IgA and as secretory IgA. Calibration Curve. Dispose of all waste material in accordance with local guidelines. Secretory IgA consists of a dimer connected by a J-chain and has a secretory component that protects the molecule from proteolytic enzymes. The calibrator IgA values are traceable to IFCC (International Federation of Clinical Chemistry) standard CRM 470. therefore it is not present in fetal blood. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. To avoid the possible build-up of azide compounds. e. The results obtained by any individual laboratory may vary from the given mean value. neoplasia of the lower GI tract. IgA. Major preventative maintenance was performed on the analyser or a critical part was replaced. Calibration Serum Protein Multi-Calibrator ODR3021.5 % Dependent on titre Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. for acceptability using the software options Routine. the activation of the alternative complement pathway and activation of inflammatory reactions. . It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. 3 Stable in serum and plasma for 8 months when stored at 2…25 °C. Essential functions of secretory IgA are the binding of microorganisms on mucous membranes.01 BLOSR6x171. human IgA reacts specifically with anti-human IgA antibodies to yield insoluble aggregates. If any trends or sudden shifts in values are detected. Individuals with absent IgA have a higher than expected incidence of rheumatic disorders and lymphoma. ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. Quality Control ITA Control Sera ODC0014. on the Beckman Coulter analyser.IgA OSR61171 Intended Use Immuno-turbidimetric test for the quantitative determination of immunoglobulin A (IgA) in human serum and plasma on Beckman Coulter analysers. inflammatory bowel disease. atopy. Once open. Strongly lipemic samples should be avoided. Safety data sheet available for professional user on request. the resulting curve should be visually reviewed. Data check parameters are required. some immunodeficiency states such as Wiskott-Aldrich syndrome and rheumatoid arthritis. IgM. increased levels occur in chronic liver disease. IgA does not cross the placenta. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.2 Immunoglobulin classes IgG. in IgA type multiple myeloma. Changes in serum immunoglobulin concentrations can be classified as follows: . Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. up to the stated expiry date when stored at 2…8 °C. EN. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. chronic infections.Polyclonal gammopathies. and gastrointestinal tracts against infection. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Contents. The absorbance of these aggregates is proportional to the IgA concentration in the sample. it particularly plays a major role in the protection of the respiratory. 4 x 14 mL 4 x 11 mL R1 R2 Summary1. Calibration Monitor. colostrum. 85 4.: ODR3021 Values set for working in SI units (g/L). For diagnostic purposes.04 1.01 2009-08 EN. Frankfurt/Main: TH-Books Verlagsgesellschaft. as a precaution samples from patients with suspected paraproteinaemia should also be tested by electrophoresis. sex. ed.0 g/L (70 – 400 mg/dL) Expected values may vary with age.01 Sensitivity The lowest detectable level in serum on an AU640 analyser was estimated at 0.18 0. Clinical guide to laboratory tests.01 1.32 – 6. n = 80 Within Run Total Mean g/L SD CV% SD 1.1 – 7. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.41 0. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP international reference material CRM 470.40 0.01 .84 g/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 1000 mg/dL Intralipid RF: Interference less than 10% up to 600 IU/mL Refer to Young for further information on interfering substances.02 0.7 – 4. 1998:667-678. The lowest detectable level represents the lowest measurable level of IgA immunoglobulins that can be distinguished from zero. 3. Thomas L. Töpfer G. Tietz NW. WHO/DIL/LAB/99. 4. diet and geographical location. 3rd ed.39 3. Young DS. Heil W. Wisser H. especially turbidity. User defined ¤ Analyser default value Serum Protein Multicalibrator Cat. sample type.03 2. Precision The following data was obtained on an AU640 analyser using 3 serum pools analysed over 20 days.2:35pp. Clinical laboratory diagnostics.151 r = 0. In: Thomas L. plasma and serum samples. Dati F. Data obtained in your laboratory may differ from these values. 2. J Lab Med 1996. Samples with extremely abnormal optical characteristics. When running elevated samples on any of the AU system analysers. 5 Limitations The IgA assay has been optimised to reduce the risk of prozone occurrence in the presence of abnormally high immunoglobulin concentrations. Setting Sheet Footnotes # † * 1. Ehret W.19 CV% 3. and if necessary determine its own reference interval according to good laboratory practice.Calculation The Beckman Coulter analysers automatically compute the IgA concentration of each sample. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.01 g/L. However. 5th ed. may produce atypical results. Schmitt Y. Each laboratory should verify the transferability of the expected values to its own population.0 g/L (10 – 700 mg/dL). Reference Intervals4 Adults 0.79 0. Linearity The test is linear within a concentration range of 0. Zawta B. No.923x + 0. clinical examinations and other findings. et al. Samples with very high IgA concentrations (> 100 g/L polyclonal) can generate false low results without appropriate "Z" flags due to excess antigen in the sample.52 0. Method Comparison Patient serum samples were used to compare this IgA assay on the AU2700 against another commercially available IgA assay. AACC.20:145-152. AACC Press. 5. Results of linear regression analysis were as follows: y = 0. To work in mg/dL multiply by 100. ed. Use of anticoagulants in diagnostic laboratory investigations and stability of blood.09 4. “F” flags or a combination of “F” and “Z” flags may be obtained. Such samples should be diluted using physiological saline so as to recover close to the middle of the measuring range. Use and assessment of clinical laboratory results. 2000.1 Rev.10 2. Effects of Drugs on Clinical Laboratory Tests. results should always be assessed in conjunction with the patient's medical history. BIBLIOGRAPHY Specific Protein BLOSR6x171. Baudner S. Philadelphia: WB Saunders Company.1995:354-357.999 n = 111 Sample range = 0. Immunoglobulins (Ig). 0000 0. Point: ο with CONC-0 Slope Check: Select the function using the Function key or the Mouse Data Check Parameters # Logic check-1 Name YES IgA ∇ Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0. To work in mg/dL multiply by 100.5 1.0000 0. No.5 2.1 Lst.1* H First H Last H ∇ Operation: Yes ∇ ∇ ∇ Page 1/2 System Reagent: OSR61171 Reagent ID: 171 Application IgA.0000 0 0 NO 0 0.1 Dynamic range L 0.1 -0. AU600 Serum/Plasma Application System Reagent: OSR61171 Specific Test Parameters General LIH ISE Range Test Name: IgA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 70 55 μL μL μL Dilution Dilution Dilution 0 115 10 μL μL μL Pri.1 -0.5 2.0000 0.0150 16 27 MB Type Factor: Calibration Stability Period: Data Check Parameters Serum ∇ SERUM/PLASMA APPLICATION Test Name: IgA ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: < > Type: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 11 17 27 0. H 2 70 55 Dil. To work in mg/dL multiply by 100.1 -0.1* Correlation factor H A B Rate # Test name IgA Sample type Ser 1 Max OD H -0.01 2009-08 . No.5 2. 600 END + First 0 First 0 A 1 On-board stability period: ∇ ∇ ∇ Sec. L -0. No.5 1-Point Cal. Point MB type factor Calibrator stability period 999 Conc † † † † † Factor/OD-L -0.0150 16 27 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # User defined † Serum Protein Multicalibrator Cat. Vol 0 115 10 μL μL μL Max.0000 0 0 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 11 17 27 0.1 -0.1 0.5 1.5 7. Vol Dil. # # # # # OD CONC † † † † † Factor/OD-L -0. H Lst. # User defined ¤ Analyser default value † Serum Protein Multicalibrator Cat.1 -0. L -0.5 2.1 -0. OD H 1. OD L Reagent OD limit Fst.1 Factor/OD-H 2.0* 1 0 ¤ 90 Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Calibration Specific General ISE Serum # OD Factor/OD-H 2.0000 0.1 -0. Specific Protein BSOSR6x171.IgA.5 Min.5 2.: ODR3021 * Values set for working in SI units (g/L). Linearity Fst No lag time Select using Space key.5 2.5 2.0* Sample Pre-dil.7700 0. AU400/AU640 Serum/Plasma Reagent ID: 171 Specific Test Parameters Serum Test No Sample vol.1 -0.7700 0.1 -0. or select from list displayed by Guide key Calibration Specific Test No # Test name IgA ∇ ∇ Count Process # Conc ∇ % Sec % ∇ On-board stability period B 90 0 Fst Fst 0 0 Lst Lst Wave Method Reaction Point 1 Point 2 Main 600 Sub 800 END + 27 10 ∇ ∇ ∇ Fst. 800 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 7.5 Process: CONC ∇ ∇ 5AB ∇ POLYGONAL Test Name: Counts: IgA ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 Test No ∇ Advanced Calibration: # ∇ Cal.5 2.1 Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal.: ODR3021 * Values set for working in SI units (g/L). Reagent 1 vol Reagent 2 vol 1. Vol Dil. IgA, AU2700/AU5400 Serum/Plasma Reagent ID: 171 Parameters General LIH IgA ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61171 Reagent ID: 171 Application IgA, AU680 Serum/Plasma Application System Reagent: OSR61171 Specific Test Parameters General LIH ISE Operation Yes ∇ Range Serum 1 Max.OD -0.1 -0.1 High High 1.5 1.5 Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) Dilution 92 μL Min.OD Reagent OD Limit First Low Last Low 1.6 1 56 μL ∇ μL Dilution 0 OD Limit μL Test Name: IgA ∇ Operation: Yes Max OD H -0.1 -0.1 R2(R2-1) 44 μL Dilution 10 Name Sec. 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.1* 1 1 μL High B B 0 7.0* 0 0 Hour < > Type: ∇ ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 Last Last 27 10 1.6 56 44 1.5 1.5 7.0* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 92 10 μL μL μL Pri. ∇ ∇ ∇ 0.1* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check None 600 ∇nm END ∇ + ∇ 0 0 % ∇ 600 END + First 0 First 0 Sec. 800 Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L ∇ Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Calibration Specific General ISE Type: Serum ISE IgA ∇ < > POLYGONAL Type Test Name: Counts: # Process: CONC ∇ Test Name: IgA ∇ < > ∇ Parameters Calibrators General Calibration Specific Calibration Parameters STAT Table Calibration Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Serum ∇ ο Use Serum Cal. OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. No. # # # # # CONC † † † † † Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 Factor/OD-H 2.5 2.5 2.5 2.5 2.5 Counts: # ∇ ∇ OD Range Low High Slope Check -0.1 2.5 -0.1 2.5 Allowance Range Check -0.1 2.5 -0.1 2.5 ο Reagent Blank -0.1 2.5 ο Calibration Advanced Calibration Operation Interval (RB/ACAL) + ∇ 1-Point Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # ∇ Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ SERUM/PLASMA APPLICATION Data Check Parameters Serum ∇ Test Name: IgA ∇ < > Type: <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 None ∇ ο with Conc-0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters IgA ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: 11 17 27 0.0000 0.8000 0.0230 16 27 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: # User defined † Serum Protein Multicalibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100. √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: 11 17 27 0.0000 0.7700 0.0160 16 27 Pattern1 Specific Protein BSOSR6x171.01 2009-08 IgA, AU480 Serum/Plasma Reagent ID: 171 Application Range System Reagent: OSR61171 Parameters General Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: IgA ∇ < > Type: Operation Yes ∇ Dilution Max.OD -0.1 -0.1 High High 1.5 1.5 Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) 1.6 1 56 0 μL OD Limit μL ∇ μL Dilution 92 μL Min.OD Reagent OD Limit First Low Last Low R2(R2-1) 44 μL Dilution 10 μL Sec. 0 Hour 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.1* 1 1 High B B 7.0* 0 0 Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 600 ∇nm END ∇ + ∇ 0 0 % ∇ Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters Calibrators General ∇ Use Serum Cal. ο Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: IgA ∇ < > Type Serum POLYGONAL + ∇ Counts: # ∇ ∇ OD Range Low High Slope Check -0.1 2.5 -0.1 2.5 Allowance Range Check -0.1 2.5 -0.1 2.5 ο Reagent Blank -0.1 2.5 ο Calibration Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 Parameters Misc CheckedTests Type: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: Serum ∇ Contamination Parameters Data Check Parameters Test Name: IgA ∇ < > Logic Check -2 Check Point-1: Check Point Interval: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: 11 17 27 0.0000 0.7700 0.0150 16 27 Pattern1 Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ # User defined † Serum Protein Multicalibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100. Specific Protein BSOSR6x171.01 2009-08 IgA, AU400/AU640 Paediatric Reagent ID: 171 Specific Test Parameters Test No Serum 1 Max OD H Main Fst Fst Sample Pre-dil. Linearity Fst No lag time Select using Space key, or select from list displayed by Guide key Calibration Specific Test No 5AB ∇ POLYGONAL ∇ OD # Test name IgAP ∇ Count Process # Conc ∇ % Sec % ∇ On-board stability period 0 0 Lst Lst H A B Rate 600 Sub Fst. H Lst. H -0.1 -0.1 0.1* B 90 0 H 7.0* First H Last H 1.5 1.5 Wave Method Reaction Point 1 Point 2 800 END + 27 10 ∇ ∇ ∇ Sample vol. Reagent 1 vol Reagent 2 vol 1.5 1.5 7* 1 0 ¤ 90 2 70 55 Dil. Vol Dil. Vol Dil. Vol 10 105 10 μL μL μL Max. OD H ∇ Operation: Yes ∇ # Test name IgAP ∇ Sample type Ser ∇ Page 1/2 System Reagent: OSR61171 Reagent ID: 171 Application IgA, AU600 Paediatric Application System Reagent: OSR61171 Specific Test Parameters General LIH ISE Range Test Name: IgAP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 70 55 μL μL μL Dilution Dilution Dilution 10 105 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 600 END + First 0 First 0 Pri. ∇ ∇ ∇ Sec. 800 ∇ Min. OD L Reagent OD limit Fst. L -0.1 Lst. L -0.1 Dynamic range L 0.1* Correlation factor Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ A 1 On-board stability period: Calibration Specific General ISE Serum # Factor/OD-H 2.5 2.5 2.5 2.5 2.5 Process: CONC ∇ ∇ Test Name: IgAP ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Counts: Cal. No. # # # # # OD CONC † † † † † Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 Test No ∇ Advanced Calibration: # ∇ Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. Point MB type factor Calibrator stability period 999 Conc † † † † † Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 Factor/OD-H 2.5 2.5 2.5 2.5 2.5 1-Point Cal. Point: ο with CONC-0 Slope Check: Select the function using the Function key or the Mouse Data Check Parameters # Name YES IgAP ∇ Logic check-1 Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0.0000 0.0000 0 0 NO 0 0.0000 0.0000 0 0 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 11 17 27 0.0000 0.7700 0.0150 16 27 MB Type Factor: Calibration Stability Period: PAEDIATRIC APPLICATION Data Check Parameters Serum ∇ Test Name: IgAP ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: < > Type: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 11 17 27 0.0000 0.7700 0.0150 16 27 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # User defined † Serum Protein Multicalibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100. # User defined ¤ Analyser default value † Serum Protein Multicalibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100 Specific Protein BSOSR6x171.01 2009-08 IgA, AU2700/AU5400 Paediatric IgA, AU680 Reagent ID: 171 Parameters General LIH IgAP ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61171 Reagent ID: 171 Application Paediatric Application System Reagent: OSR61171 Specific Test Parameters General LIH ISE Operation Yes ∇ Range Serum 1 Max.OD -0.1 -0.1 High High 1.5 1.5 Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) Dilution 82 μL Min.OD Reagent OD Limit First Low Last Low 1.6 1 56 μL ∇ μL Dilution 10 OD Limit μL Test Name: IgAP ∇ Operation: Yes Max OD H -0.1 -0.1 R2(R2-1) 44 μL Dilution 10 Name Sec. 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.1* 1 1 μL High B B 0 7.0* 0 0 Hour < > Type: ∇ ∇ Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 1.6 56 44 1.5 1.5 7.0* 0 μL μL μL Dilution Dilution Dilution 10 82 10 μL μL μL Pri. ∇ ∇ ∇ 0.1* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check None 600 ∇nm END ∇ + ∇ 0 0 % ∇ 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 600 END + First 0 First 0 Sec. 800 Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L ∇ Last L Dynamic Range: L Correlation Factor: % ∇ A 1 On-board stability period: Calibration Specific General ISE Type: Serum ISE IgAP ∇ < > POLYGONAL Type Test Name: Process: CONC ∇ Test Name: IgAP ∇ < > ∇ Parameters Calibrators General Calibration Specific Calibration Parameters STAT Table Calibration Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Counts: # Serum ∇ ο Use Serum Cal. OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. No. # # # # # CONC † † † † † Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 Factor/OD-H 2.5 2.5 2.5 2.5 2.5 Counts: # ∇ ∇ OD Range Low High Slope Check -0.1 2.5 -0.1 2.5 Allowance Range Check -0.1 2.5 -0.1 2.5 ο Reagent Blank -0.1 2.5 ο Calibration Advanced Calibration Operation Interval (RB/ACAL) + ∇ 1-Point Cal. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # ∇ Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ PAEDIATRIC APPLICATION Data Check Parameters Serum ∇ Test Name: IgAP ∇ < > Type: <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 None ∇ ο with Conc-0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters IgAP ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: 11 17 27 0.0000 0.8000 0.0230 16 27 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: # User defined. † Serum Protein Multicalibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100 √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: 11 17 27 0.0000 0.7700 0.0160 16 27 Pattern1 Specific Protein BSOSR6x171.01 2009-08 IgA, AU480 Reagent ID: 171 Paediatric Application Range System Reagent: OSR61171 Parameters General Serum ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: IgAP ∇ < > Type: Operation Yes ∇ Dilution Max.OD -0.1 -0.1 High High 1.5 1.5 Min.OD Reagent OD Limit First Low Last Low Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) 1.6 1 56 10 μL OD Limit μL ∇ μL Dilution 82 μL R2(R2-1) 44 μL Dilution 10 μL Sec. 0 Hour 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.1* 1 1 High B B 7.0* 0 0 Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 600 ∇nm END ∇ + ∇ 0 0 % ∇ Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters Calibrators General Serum ∇ Use Serum Cal. ο Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: IgAP ∇ < > Type POLYGONAL + ∇ Counts: # ∇ ∇ OD Range Low High Slope Check -0.1 2.5 -0.1 2.5 Allowance Range Check -0.1 2.5 -0.1 2.5 ο Reagent Blank -0.1 2.5 ο Calibration Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour ο with Conc-0 Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ Parameters Misc CheckedTests Type: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: Serum ∇ Contamination Parameters Data Check Parameters Test Name: IgAP ∇ < > Logic Check -2 Check Point-1: Check Point Interval: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: 11 17 27 0.0000 0.7700 0.0150 16 27 Pattern1 Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ # User defined. † Serum Protein Multicalibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100 Specific Protein BSOSR6x171.01 2009-08 IgG OSR61172 Intended Use Immuno-turbidimetric test for the quantitative determination of immunoglobulin G (IgG) in human serum, plasma and cerebrospinal fluid on Beckman Coulter AU analysers. For in vitro diagnostic use only. 4 x 22 mL 4 x 20 mL R1 R2 Summary1,2,3,4 Immunoglobulin classes IgG, IgA, IgM, IgD and IgE are present in descending order of concentration in the serum of healthy people. IgG which consists of four subclasses, comprises approximately 75% of total immunoglobulins and 10 – 20% of total serum protein. Approximately one half of total body IgG is present in plasma while the other half, because of IgG's low molecular weight (150 kDa), is distributed in the interstitial fluid to act against tissue infection. IgG is particularly important in the body's long-term defence against infection as it presents a slower but more sustained response than IgM to primary antigenic stimulus; however, the levels of IgG rise rapidly and early on re-exposure to the same antigenic stimulus. IgG promotes phagocytosis and activates complement. Changes in serum immunoglobulin concentrations can be classified as follows: - Hypogammaglobulinemias, IgG deficiency may be genetic as in severe combined immunodeficiency or acquired as in AIDS. Definitive diagnosis of the clinical syndrome requires extensive evaluation of humoral and cellular functions in the immune response. A decrease in IgG also occurs as a result of thermal burns, nephrotic syndrome, protein losing enteropathies and non-IgG myelomas. - Polyclonal gammopathies, levels of IgG are increased in autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome), sarcoidosis, chronic liver disease, some parasitic diseases and chronic or recurrent infections. - Monoclonal gammopathies, e.g. in IgG type multilple myeloma, lymphomas, leukemia, and other malignancies. IgG is the only immunoglobulin that crosses the placenta and is therefore of special importance in the infant’s defence against infection. IgG determination in cerebrospinal fluid (CSF) is used for evaluation of infections involving the central nervous system, neoplasms or primary neurological diseases. CSF IgG measurements may be used to determine the IgG CSF/albumin CSF ratio which is an important factor in differentiating between intrathecal and localised synthesis of IgG. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution, human IgG reacts specifically with anti-human IgG antibodies to yield insoluble aggregates. The absorbance of these aggregates is proportional to the IgG concentration in the sample. Contents, Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer (pH 7.2) Polyethylene glycol 6000 Goat anti-IgG antibodies Preservative 48 mmol/L 3.1 % Dependent on titre Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. To avoid the possible build-up of azide compounds, flush waste-pipes with water after the disposal of undiluted reagent. Dispose of all waste material in accordance with local guidelines. Safety data sheet available for professional user on request. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. Storage and Stability The reagents are stable, unopened, up to the stated expiry date when stored at 2…8 °C. Once open, reagents stored on board the instrument are stable for 90 days. Specimen Serum and EDTA or heparinised plasma 5 Stable in serum and plasma for 8 months when stored at 2…8°C and 4 months when stored at 15…25 °C. Strongly lipemic samples should be avoided. 6 Cerebrospinal fluid: Stable for 72 hours when stored at 4°C. Stable for 6 months when stored frozen at -20 °C. For CSF determinations, strongly icteric or turbid samples should be avoided. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. The paediatric application is suitable for use with small volume serum/plasma samples. Data check parameters are required, see setting sheets for specific instrument details. Calibration Serum Protein Multi-Calibrator ODR3021 The calibrator IgG values are traceable to IFCC (International Federation of Clinical Chemistry) standard CRM 470. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values; Major preventative maintenance was performed on the analyser or a critical part was replaced. Following calibration, the resulting curve should be visually reviewed, on the Beckman Coulter analyser, for acceptability using the software options Routine, Calibration Monitor, Calibration Curve. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. For CSF application, recalibrate every 2 days. EN.01 BLOSR6x172.02 2010-04 Specific Protein Quality Control ITA Control Sera ODC0014, ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. CSF: Control materials with values determined by this Beckman Coulter method may be used. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. The results obtained by any individual laboratory may vary from the given mean value. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. If any trends or sudden shifts in values are detected, review all operating parameters. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Calculation The Beckman Coulter analysers automatically compute the IgG concentration of each sample. Reference Intervals7 7 – 16 g/L (700 – 1600 mg/dL) 15 – 20 y 35 mg/L ± 20 mg/L 21 – 40 y 42 mg/L ± 14 mg/L 41 – 60 y 47 mg/L ± 10 mg/L 0.3 – 0.6 IgG Index Expected values may vary with age, sex, sample type, diet and geographical location. Each laboratory should verify the transferability of the expected values to its own population, and if necessary determine its own reference interval according to good laboratory practice. For diagnostic purposes, results should always be assessed in conjunction with the patient's medical history, clinical examinations and other findings. Adults (Serum) 8 CSF Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Data obtained in your laboratory may differ from these values. Linearity Serum: the test is linear within a concentration range of 0.75 – 30.0 g/L (75 – 3000 mg/dL). CSF: the test is linear within a concentration range of 20 – 500 mg/L (2.0 – 50 mg/dL) Precision The following data was obtained on an AU640 analyser using 3 serum pools analysed over 20 days: n = 80 Within Run Total Mean g/L SD CV% SD CV% 4.31 0.05 1.14 0.14 3.29 10.88 0.16 1.45 0.38 3.49 21.73 0.49 2.24 1.01 4.66 The following data was obtained on an AU640 analyser using 3 CSF pools analysed over 20 days: n = 80 Within Run Total Mean mg/L SD CV% SD CV% 34.86 0.93 2.68 3.32 9.53 101.34 0.90 0.89 3.72 3.67 355.74 3.29 0.93 10.01 2.81 Sensitivity The lowest detectable level in serum on an AU640 analyser was estimated at 0.004 g/L. The lowest detectable level in CSF on an AU640 analyser was estimated at 4.20 mg/L. The lowest detectable level represents the lowest measurable level of IgG immunoglobulins that can be distinguished from zero. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Method Comparison Patient serum samples were used to compare this IgG assay on the AU2700 against another commercially available IgG assay. Results of linear regression analysis were as follows: y = 0.945x + 0.372 r = 0.998 n = 120 Sample range = 1.18 – 29.73 g/L Patient CSF samples were used to compare this IgG assay on the AU2700 against another commercially available IgG assay. Results of linear regression were as follows. y = 0.962x - 3.451 r = 0.997 n = 86 Sample range = 20.59 – 441.85 mg/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Serum Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 1000 mg/dL Intralipid RF: Interference less than 10% up to 1200 IU/mL CSF Icterus: Haemolysis: 9 Interference less than 10% up to 36 mg/dL or 205 µmol/L bilirubin Interference less than 10% up to 5 g/L haemoglobin Refer to Young for further information on interfering substances. Limitations The IgG assay has been optimised to reduce the risk of prozone occurrence in the presence of abnormally high immunoglobulin concentrations. However, as a precaution samples from patients with suspected paraproteinaemia should also be tested by electrophoresis. Samples with very high IgG concentrations (> 300 g/L polyclonal) can generate false low results without appropriate "Z" flags due to excess antigen in the sample. When running elevated samples on any of the AU system analysers, “F” flags or a combination of “F” and “Z” flags may be obtained. Such samples should be diluted using physiological saline so as to recover close to the middle of the measuring range. Samples with extremely abnormal optical characteristics, especially turbidity, may produce atypical results. Please note that there is a requirement to dedicate a separate test channel specifically for CSF sample settings when assigning this IgG application on Beckman Coulter AU analysers. The result of IgG CSF samples may be elevated when immediately following a serum sample. In order to eliminate this effect, it is recommended to: (a) Calibrate CSF IgG separately to other calibrators (b) Avoid freely alternating serum and CSF samples Specific Protein BLOSR6x172.02 2010-04 EN.01 (c) When changing from serum to CSF samples, place a sample cup containing 2% Wash Solution Cat. No.: OSR0001 in the first position of the rack and requisition a test for this sample. Setting Sheet Footnotes # † ∂ * User defined ¤ Analyser default value Serum Protein Multicalibrator Cat. No.: ODR3021. CSF: Prepare a 1 + 44 dilution of calibrator No. 4 in 0.9% saline. Then make four subsequent 1 + 1 dilutions of this to prepare a 5 point calibration curve. Insert the adjusted values in the calibration curve. Separate CSF channel from other types (see IFU for further instruction). Values set for working in SI units (g/L). To work in mg/dL multiply by 100. CSF: Values set for working in SI units (mg/L). To work in mg/dL divide by 10. CSF: note: Refer to IFU for limitations Thomas L. Immunoglobulins (Ig). In: Thomas L, ed. Clinical laboratory diagnostics. Use and assessment of clinical laboratory results. Frankfurt/Main: TH-Books Verlagsgesellschaft, 1998:667-678. Tietz NW, ed. Clinical guide to laboratory tests, 3rd ed. Philadelphia: WB Saunders Company,1995:358-361. Colbert D, ed. Fundamentals of clinical physiology, 1st ed. Hertfordshire; Prentice Hall, 1993:296pp. Mayne PD, ed. Clinical chemistry in diagnosis and treatment, 6th ed. Glasgow:Arnold, 1994:322-326, 323pp. Ehret W, Heil W, Schmitt Y, Töpfer G, Wisser H, Zawta B, et al. Use of anticoagulants in diagnostic laboratory investigations and stability of blood, plasma and serum samples. WHO/DIL/LAB/99.1 Rev.2:35pp. Tietz NW, ed Clinical guide to laboratory tests, 3rd ed. Philadelphia WB Saunders Company, 1995: 360pp Baudner S, Dati F. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP international reference material CRM 470. J Lab Med 1996;20:145-152. Painter PC, Cope JY, Smith JL Reference information for the clinical laboratory. In: Burtis CA, Ashwood ER, eds. Tietz textbook of clinical chemistry,Philadelphia: WB Saunders Company,1999; 1820pp. Young DS. Effects of Drugs on Clinical Laboratory Tests, AACC, 5th ed. AACC Press, 2000. BIBLIOGRAPHY 1. 2. 3. 4. 5. 6. 7. 8. 9. EN.01 BLOSR6x172.02 2010-04 Specific Protein IgG, AU400/AU640 Serum/Plasma Reagent ID: 172 Specific Test Parameters Serum Sample vol. Reagent 1 vol Reagent 2 vol Main Fst Fst Sample Pre-dil. Linearity Fst No lag time Select using Space key, or select from list displayed by Guide key Calibration Specific Test No 5AB ∇ EIA Type 1 OD ∇ # Test name IgG ∇ Count Process # Conc ∇ % Sec % ∇ On-board stability period 0 0 Lst Lst END + 23 10 600 Sub Fst. H Lst. H H A B Rate 2 110 100 Dil. Vol Dil. Vol Dil. Vol 0 190 40 µL µL µL Max. OD H 1.5 1.5 30* 1 0 ¤ 90 ∇ Operation: Yes ∇ Test No # Test name IgG ∇ Sample type Ser ∇ Page 1/2 System Reagent: OSR61172 Reagent ID: 172 Application IgG, AU600 Serum/Plasma Application System Reagent: OSR61172 Specific Test Parameters General LIH ISE Range Test Name: IgG ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 ∇ ∇ ∇ 2 110 100 µL µL µL Dilution Dilution Dilution 0 190 40 µL µL µL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 600 END + First 0 First 0 Pri. ∇ ∇ ∇ Sec. None ∇ Min. OD L Reagent OD limit Fst. L -0.1 Lst. L -0.1 Dynamic range L 0.75* Correlation factor Last Last 23 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.1 First H 1.5 Last L -0.1 Last H 1.5 Dynamic Range: L 0.75* H 30.0* Correlation Factor: A 1 B 0 On-board stability period: 90 Calibration Specific General ISE Serum # Factor/OD-H 2.5 2.5 2.5 2.5 2.5 Process: CONC ∇ ∇ Test Name: Counts: IgG ∇ < > Type Calibration Type: 5AB ∇ Formula: EIA Type 1 ∇ Cal. No. # # # # # OD CONC † † † † † Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal type 13 Formula 6 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. Point MB type factor Calibrator stability period 999 Conc † † † † † Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 Factor/OD-H 2.5 2.5 2.5 2.5 2.5 1-Point Cal. Point: with CONC-0 Slope Check: Select the function using the Function key or the Mouse Data Check Parameters Test No # Logic check-1 Name YES IgG ∇ Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0.0000 0.0000 0 0 NO 0 0.0000 0.0000 0 0 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 11 15 20 0.0000 0.7000 0.1500 11 27 MB Type Factor: Calibration Stability Period: SERUM/PLASMA APPLICATION Data Check Parameters Serum Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Test Name: IgG ∇ < > Type: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 11 15 20 0.0000 0.7000 0.1500 11 27 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # User defined † Serum Protein Multicalibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100. # User defined ¤ Analyser default value † Serum Protein Multicalibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100. Specific Protein BSOSR6x172.02 2010-06 IgG, AU2700/AU5400 Serum/Plasma Reagent ID: 172 Parameters General LIH IgG Dilution Max.OD -0.1 -0.1 High High 1.5 1.5 Dilution 152 µL Min.OD Reagent OD Limit First Low Last Low 0 µL OD Limit ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61172 Reagent ID: 172 Application Operation Yes ∇ IgG, AU680 Serum/Plasma Application System Reagent: OSR61172 Specific Test Parameters General LIH ISE Serum Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) 1.6 1 88 µL ∇ µL Range ∇ Operation: Yes ∇ Test Name: IgG ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) Name Sec. None Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.75* 1 1 80 µL Dilution 32 µL High B B 0 1.6 88 80 µL µL µL Dilution Dilution Dilution 0 152 32 µL µL µL Pri. 600 END + First 0 First 0 Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 23 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis None 600 ∇nm END ∇ + ∇ 0 0 % ∇ ∇ ∇ ∇ Sec. None Last Last 23 10 30.0* 0 0 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.1 First H 1.5 ∇ Last L -0.1 Last H 1.5 Dynamic Range: L 0.75* H 30.0* Correlation Factor: A 1 B 0 On-board stability period: 90 Calibration Specific General ISE Type: Serum ISE IgG ∇ < > EIA Type 1 Type Test Name: Counts: # Process: CONC ∇ Test Name: IgG ∇ < > ∇ Parameters Calibrators General Calibration Specific Calibration Parameters STAT Table Calibration Serum ∇ Use Serum Cal. Calibration Type: 5AB ∇ Formula: EIA Type 1 ∇ OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. No. # # # # # CONC † † † † † Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 Factor/OD-H 2.5 2.5 2.5 2.5 2.5 Counts: # ∇ ∇ OD Range Low High Slope Check -0.1 2.5 -0.1 2.5 Allowance Range Check -0.1 2.5 -0.1 2.5 Reagent Blank -0.1 2.5 Calibration Advanced Calibration Operation Interval (RB/ACAL) + ∇ 1-Point Cal. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # Lot Calibration ∇ Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ SERUM/PLASMA APPLICATION Data Check Parameters Serum ∇ Test Name: IgG ∇ < > Type: <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration None ∇ with Conc-0 999 999 Day Day 0 0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters IgG ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: 11 15 20 0.0000 0.7500 0.3000 11 27 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: 11 15 20 0.0000 0.7500 0.3000 11 27 Pattern1 # User defined. † Serum Protein Multicalibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100. √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: Specific Protein BSOSR6x172.02 2010-06 IgG, AU480 Serum/Plasma Reagent ID: 172 Application Range Serum ∇ System Reagent: OSR61172 Parameters General LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: IgG ∇ < > Type: Operation Yes ∇ Dilution Max.OD -0.1 -0.1 High High 1.5 1.5 Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) 1.6 1 87 0 µL OD Limit µL ∇ µL Dilution 150 µL Min.OD Reagent OD Limit First Low Last Low R2(R2-1) 80 µL Dilution 30 µL Sec. 0 Hour None Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.75* 1 1 High B B 30.0* 0 0 Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 600 ∇nm END ∇ + ∇ 0 0 % ∇ Last Last 23 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters Calibrators General ∇ Use Serum Cal. Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: IgG ∇ < > Type Serum EIA Type 1 + ∇ Counts: # ∇ ∇ OD Range Low High Slope Check -0.1 2.5 -0.1 2.5 Allowance Range Check -0.1 2.5 -0.1 2.5 Reagent Blank -0.1 2.5 Calibration Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Lot Calibration Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ 999 999 Day Day 0 0 Hour Hour Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration MB Type Factor: 1-Point Calibration Point None ∇ with Conc-0 Parameters Misc CheckedTests Type: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: Serum ∇ Contamination Parameters Data Check Parameters Test Name: IgG ∇ < > Logic Check -2 Check Point-1: Check Point Interval: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: 11 15 20 0.0000 0.7000 0.1500 11 27 Pattern1 Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ # User defined. † Serum Protein Multicalibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100. BSOSR6x172.02 2010-06 Specific Protein IgG, AU400/AU640 CSF Reagent ID: 172 Specific test parameters Others 1 Max OD H -0.1 -0.1 20* B 90 Linearity Fst No lag time Select using Space key, or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name IgG ∇ Sample type Others ∇ Level L # Page 2/2 Level H # % Sec % ∇ 0 Sample Pre-dil. H 500* Fst Fst 0 0 Lst Lst END + 23 10 H A B Rate First H Last H 2.5 2.5 Wave Method Reaction Point 1 Point 2 Main 340 Sub ∇ ∇ ∇ Fst. H Lst. H 2.5 2.5 Sample vol. Reagent 1 vol Reagent 2 vol 10 110 68 Dil. vol Dil. vol Dil. vol 0 83 10 µL µL µL Max. OD H ∇ Operation: Yes ∇ Test No # Test name IgG ∇ Sample type Others Page 1/2 ∇ System Reagent: OSR61172 Reagent ID: 172 Application∂ IgG, AU600 CSF Application∂ System Reagent: OSR61172 Specific Test Parameters General LIH ISE Range Test Name: IgG ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 10 110 68 µL µL µL Dilution Dilution Dilution 0 83 10 µL µL µL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period 340 END + First 0 First 0 Pri. ∇ ∇ ∇ Sec. None ∇ Last Last 23 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 500* 1 0 ¤ Min. OD L Reagent OD limit Fst. L -0.1 Lst. L -0.1 Dynamic range L 20* Correlation factor % ∇ A 1 On-board stability period: 90 Specific Test Parameters General LIH ISE Others # # # # # # # Age Y Y Y Y Y Y ∇ Age Y Y Y Y Y Y Range Test Name: IgG ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ∇ 2. # # ∇ 3. # # ∇ 4. # # ∇ 5. # # ∇ 6. # # ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: mg/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H CSF APPLICATION Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name IgG ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 # Conc Factor/OD-H 2.5 2.5 2.5 2.5 2.5 ∇ Calibration Specific General ISE Others # Factor/OD-H 2.5 2.5 2.5 2.5 2.5 Process: CONC ∇ ∇ Test Name: IgG ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 2 ∇ Advanced Calibration: # ∇ Cal. No. # # # # # OD CONC † † † † † Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 1-Point Cal. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. point MB type factor Calibrator stability period 2 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Serum Protein Multicalibrator Cat. No.: ODR3021. Prepare a 1+44 dilution of calibrator No. 4 in 0.9% saline. Then make four subsequent 1+1 dilutions of this to prepare a 5 point calibration curve. Insert the adjusted values in the calibration curve. ∂ Separate CSF channel from other types (see IFU for further instruction) * Values set for working in SI Units (mg/L). To work in mg/dL divide by 10. Note: Refer to IFU for limitations. BSOSR6x172.02 2010-06 # User defined † Serum Protein Multicalibrator Cat. No.: ODR3021. Prepare a 1+44 dilution of calibrator No. 4 in 0.9% saline. Then make four subsequent 1+1 dilutions of this to prepare a 5 point calibration curve. Insert the adjusted values in the calibration curve. ∂ Separate CSF channel from other types (see IFU for further instruction) * Values set for working in SI Units (mg/L). To work in mg/dL divide by 10. Note: Refer to IFU for limitations. Specific Protein Not within expected values Decimal Places Calibration Specific Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration Type Others Counts: ∇ # ∇ Calibration Specific General ISE Type Others # Process: CONC ∇ ∇ Test Name: Test Name: IgG ∇ < > Use Serum Cal. None Selected 8.5 2. # # ∇ 5. # # ∇ 3. No demographics 8. # # ∇ 6.5 Dilution 83 µL Min.5 ∇ OD Range Low High -0. Onboard Stability Period Last Last 23 10 90 Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A 20* 1 1 Day µL High B B 0 500* 0 0 Hour Sample Volume Pre-Dilution Rate Rgt. # # # # ∇ 2. Insert the adjusted values in the calibration curve.9% saline.: ODR3021. # # # # ∇ 3.5 2.5 -0.1 -0.1 -0. AU2700/AU5400 CSF Reagent ID: 172 Parameters General LIH IgG Dilution Max.5 2. ∂ Separate CSF channel from other types (see IFU for further instruction) * Values set for working in SI Units (mg/L). Point: with CONC-0 Slope Check: # ∇ # Lot Calibration ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. None ∇ Last Last 23 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ A 1 On-board stability period: Specific Test Parameters General LIH ISE Others LIH IgG ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # IgG ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Others ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 2.5 + ∇ 1-Point Cal. # # # # ∇ 5.1 R2(R2-1) 68 µL Dilution 10 Name Sec.5 -0.5 -0. Then make four subsequent 1+1 dilutions of this to prepare a 5 point calibration curve. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ 340 END + First 0 First 0 Sec.OD Reagent OD Limit First Low Last Low 0 µL OD Limit ∇ Type: Others < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6172 Reagent ID: 172 Application∂ IgG. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point None ∇ with Conc-0 Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 2 ∇ Advanced Calibration: # ∇ Cal.1 High High 2. # # # # ∇ 4. AU680/AU480 CSF Operation Yes ∇ Application∂ System Reagent: OSR61172 Specific Test Parameters General LIH ISE Others 1 Max OD H -0. # # ∇ 7.1 2.5 2. Prepare a 1+44 dilution of calibrator No. Volume R1(R1-1) 10 1 110 µL ∇ µL Range ∇ Operation: Yes ∇ Test Name: IgG ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 0 500* 2.IgG. 4 in 0.1 2.OD -0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General ISE IgG ∇ < > POLYGONAL mg/L* Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mg/L* H Month # # # # # # CSF APPLICATION Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year 1.5 -0.02 2010-06 2 2 Day Day 0 0 Hour Hour Specific Protein .1 -0. Note: Refer to IFU for limitations.1 Factor/OD-H 2. # # # # # CONC † † † † † Factor/OD-L -0. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Counts: OD Slope Check Allowance Range Check Reagent Blank Calibration Advanced Calibration Operation Interval (RB/ACAL) Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration <Point Cal. No. # # ∇ 4. ∇ ∇ ∇ 20* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.1 2. For No. # # # # ∇ 6. # # # # ∇ 7.1 -0.5 2.5 2.1 2. # # ∇ 2. ф U680 BSOSR6x172. † Serum Protein Multicalibrator Cat. To work in mg/dL divide by 10. No.1 -0.5 10 110 68 µL µL µL Dilution Dilution Dilution 0 83 10 µL µL µL Pri.1 -0. L -0. No.75* Correlation factor Last Last 23 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. Vol 10 180 40 µL µL µL Max. None ∇ Min. ∇ ∇ ∇ Sec. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse Conc † † † † † Factor/OD-L -0.02 2010-06 .5 2. AU600 Paediatric Application System Reagent: OSR61172 Specific Test Parameters General LIH ISE Range Test Name: IgGP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 ∇ ∇ ∇ 2 110 100 µL µL µL Dilution Dilution Dilution 10 180 40 µL µL µL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 600 END + First 0 First 0 Pri.5 1-Point Cal.1 Last H 1.0000 0 0 NO 0 0.1 -0.5 Process: CONC ∇ ∇ Test Name: IgGP ∇ < > Type Calibration Type: 5AB ∇ Formula: EIA Type 1 ∇ Counts: Cal.75* H 30.1 Dynamic range L 0.0000 0. Vol Dil.1 -0.0* Correlation Factor: A 1 B 0 On-board stability period: 90 Calibration Specific General ISE Serum # Factor/OD-H 2.5 1.7000 0.0000 0. H Lst.5 2. OD L Reagent OD limit Fst.1 First H 1. or select from list displayed by Guide key Calibration Specific Test No 5AB ∇ EIA Type 1 ∇ OD # Test name IgGP ∇ Count Process # Conc ∇ % Sec % ∇ On-board stability period 0 0 Lst Lst END + 23 10 H A B Rate 600 Sub Fst. To work in mg/dL multiply by 100.1 -0. L -0. Reagent 1 vol Reagent 2 vol Main Fst Fst Sample Pre-dil.0000 0.1500 11 27 PAEDIATRIC APPLICATION Data Check Parameters Serum Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Logic check-1 Test Name: IgGP ∇ < > Type: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 11 15 20 0.5 2.: ODR3021 * Values set for working in SI units (g/L).0000 0. AU400/AU640 Paediatric Reagent ID: 172 Specific Test Parameters Serum Sample vol. No.5 2.1 -0.5 30* 1 0 ¤ 90 2 110 100 Dil.1 Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 Test No ∇ Advanced Calibration: # ∇ Cal type 13 Formula 6 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 Dynamic Range: L 0. OD H ∇ Operation: Yes ∇ Test No # Test name IgGP ∇ Sample type Ser ∇ Page 1/2 System Reagent: OSR61172 Reagent ID: 172 Application IgG.5 2. Vol Dil.1 -0. # User defined ¤ Analyser default value † Serum Protein Multicalibrator Cat.0000 0 0 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 11 15 20 0.5 2.1 -0. # # # # # OD CONC † † † † † Factor/OD-L -0. H 1.5 2.1500 11 27 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # User defined † Serum Protein Multicalibrator Cat.1 Factor/OD-H 2. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Data Check Parameters # Name YES IgGP ∇ Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0.1 -0.IgG. Linearity Fst No lag time Select using Space key.5 Last L -0.: ODR3021 * Values set for working in SI units (g/L). No.1 Lst.7000 0.1 -0.5 2. To work in mg/dL multiply by 100 Specific Protein BSOSR6x172. 75* H 30.5 -0. Point: With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # Lot Calibration ∇ Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ PAEDIATRIC APPLICATION Data Check Parameters Serum ∇ Test Name: IgGP ∇ < > Type: <Point Cal.5 Reagent Blank -0.IgG. None Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.5 2. ∇ ∇ ∇ Sec.1 2.5 Calibration Advanced Calibration Operation Interval (RB/ACAL) + ∇ 1-Point Cal.75* 1 1 80 µL Dilution 32 µL High B B 0 30.5 2. None Last Last 23 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0. To work in mg/dL multiply by 100 √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: Specific Protein BSOSR6x172.0* 0 0 Hour 1. † Serum Protein Multicalibrator Cat.1 -0.0* Correlation Factor: A 1 B 0 On-board stability period: 90 Calibration Specific General ISE Type: Serum ISE IgGP EIA Type 1 ∇ < > Type Test Name: Process: CONC ∇ Test Name: IgGP ∇ < > ∇ Parameters Calibrators General Calibration Specific Calibration Parameters STAT Table Calibration Serum ∇ Use Serum Cal.7500 0.3000 11 27 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: 11 15 20 0.5 -0.1 2.5 Dilution 142 µL Min.: ODR3021 * Values set for working in SI units (g/L). No.1 2.5 Counts: # ∇ ∇ OD Range Low High Slope Check -0.6 88 80 µL µL µL Dilution Dilution Dilution 10 142 32 µL µL µL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.5 Dynamic Range: L 0.1 First H 1.1 -0.3000 11 27 Pattern1 # User defined.1 Last H 1.0000 0.OD Reagent OD Limit First Low Last Low 10 µL OD Limit ∇ Type: Serum < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61172 Reagent ID: 172 Application Operation Yes ∇ IgG. Calibration Type: 5AB ∇ Formula: EIA Type 1 ∇ Counts: # OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.5 Allowance Range Check -0.1 High High 1.7500 0.5 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration None ∇ with Conc-0 999 999 Day Day 0 0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters IgGP ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: 11 15 20 0.1 2. AU2700/AU5400 Paediatric Reagent ID: 172 Parameters General LIH IgGP Dilution Max.6 1 88 µL ∇ µL Range ∇ Operation: Yes ∇ Test Name: IgGP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) Name Sec.OD -0.02 2010-06 .5 ∇ Last L -0.1 -0.1 -0. AU680 Paediatric Application System Reagent: OSR61172 Specific Test Parameters General LIH ISE Serum Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) 1. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 23 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis None 600 ∇nm END ∇ + ∇ 0 0 % ∇ 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 600 END + First 0 First 0 Pri. For No.1 2.0000 0.5 1.5 2. # # # # # CONC † † † † † Factor/OD-L -0.1 Factor/OD-H 2. No.1 -0. 75* 1 1 High B B 30.1 2. No.: ODR3021 * Values set for working in SI units (g/L).1 2.OD -0.1 -0.0000 0.OD Reagent OD Limit First Low Last Low IgGP ∇ < > Type: Operation Yes ∇ Sample Volume Pre-Dilution Rate Rgt.1500 11 27 Pattern1 Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ # User defined.1 2.5 -0. AU480 Paediatric Reagent ID: 172 Application Range Serum ∇ System Reagent: OSR61172 Parameters General LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: OD Limit Max. 0 Hour None Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. For No.5 Allowance Range Check -0.5 Calibration Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Lot Calibration Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal.5 1.1 High High 1. Volume R1(R1-1) 1. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ 999 999 Day Day 0 0 Hour Hour with Conc-0 Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration MB Type Factor: 1-Point Calibration Point None ∇ Parameters Misc CheckedTests Type: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: Serum ∇ Contamination Parameters Data Check Parameters Test Name: IgGP ∇ < > Logic Check -2 Check Point-1: Check Point Interval: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: 11 15 20 0.6 1 87 Dilution 10 µL µL ∇ µL Dilution 140 µL R2(R2-1) 80 µL Dilution 30 µL Sec.5 -0. † Serum Protein Multicalibrator Cat.1 2. To work in mg/dL multiply by 100 Specific Protein BSOSR6x172.5 Min.IgG.1 2.02 2010-06 . Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: IgGP ∇ < > Type EIA Type 1 + ∇ Counts: # ∇ ∇ OD Range Low High Slope Check -0.7000 0.0* 0 0 Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 600 ∇nm END ∇ + ∇ 0 0 % ∇ Last Last 23 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters Calibrators General Serum ∇ Use Serum Cal.5 Reagent Blank -0. The calibrator IgM values are traceable to IFCC (International Federation of Clinical Chemistry) standard CRM 470. flush waste-pipes with water after the disposal of undiluted reagent.3 Immunoglobulin classes IgG.01 BLOSR6x173. IgM composes approximately 7% of the total plasma immunoglobulins and is the first immunoglobulin to respond to an antigenic stimulus. e. reagents stored on board the instrument are stable for 90 days.Hypogammaglobulinemias. IgM. Elevated levels of IgM in cord serum or during the first four weeks of life may indicate intrauterine or neonatal infections such as rubella. unopened. review all operating parameters. haemoprotozoan infections such as malaria. in Waldenström’s macroglobulinemia and malignant lymphoma. human IgM reacts specifically with anti-human IgM antibodies to yield insoluble aggregates. saline Rh and antibodies to IgG e. . The paediatric application is suitable for use with small volume serum/plasma samples. The essential functions of IgM in the immune response are the agglutination of pathogens and the activation of the classical complement pathway. toxoplasmosis or syphilis. levels of IgM are increased in primary biliary cirrhosis. ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used.01 2009-08 Specific Protein . Once open. Contents. Calibration Curve.g. Major preventative maintenance was performed on the analyser or a critical part was replaced. IgM normally circulates in plasma in a pentameric form and because of its relatively large molecular mass (971 kDa). 75-80% of IgM is located intravascularly. e.IgM OSR61173 Intended Use Immuno-turbidimetric test for the quantitative determination of immunoglobulin M (IgM) in human serum and plasma on Beckman Coulter analysers. To avoid the possible build-up of azide compounds. Quality Control ITA Control Sera ODC0014. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. on the Beckman Coulter analyser. . Lipemic samples should be avoided.2. Calibration Serum Protein Multi-Calibrator ODR3021. viral or bacterial infections and rheumatoid arthritis. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values.5 % Dependent on titre Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. 4 Stable in serum and plasma for 4 months when stored at 2…8 °C and 2 months when stored at 15…25 °C. for acceptability using the software options Routine. Following calibration. Calibration Monitor. Specimen Serum and EDTA or heparinised plasma. rheumatoid factors. Calculation The Beckman Coulter analysers automatically compute the IgM concentration of each sample. see setting sheets for specific instrument details. the resulting curve should be visually reviewed. Storage and Stability The reagents are stable. Data check parameters are required.Polyclonal gammopathies. Safety data sheet available for professional user on request.g. 4 x 14 mL 4 x 11 mL R1 R2 Summary1. Changes in serum immunoglobulin concentrations can be classified as follows: . The absorbance of these aggregates is proportional to the IgM concentration in the sample. Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer (pH 7.g. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. up to the stated expiry date when stored at 2…8 °C. EN. Dispose of all waste material in accordance with local guidelines. The IgM class includes the natural antibodies. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. the ABO blood group isohaemagglutinins. IgA. IgM deficiency is rare and is associated with recurrent pyrogenic infections. cytomegalovirus. IgD and IgE are present in descending order of concentration in the serum of healthy people. If any trends or sudden shifts in values are detected.Monoclonal gammopathies.2) Polyethylene glycol 6000 Goat anti-IgM antibodies Preservative 50 mmol/L 3. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. The results obtained by any individual laboratory may vary from the given mean value. For in vitro diagnostic use only. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution. sample type. 6th ed. Tietz textbook of clinical chemistry. BIBLIOGRAPHY Specific Protein BLOSR6x173. clinical examinations and other findings. eds. To work in mg/dL multiply by 100. Such samples should be diluted using physiological saline so as to recover close to the middle of the measuring range.4 – 2. Cope JY. For diagnostic purposes. 7 Limitations The IgM assay has been optimised to reduce the risk of prozone occurrence in the presence of abnormally high immunoglobulin concentrations.02 1. When running elevated samples on any of the AU system analysers. 2000.44 3.14 0. Setting Sheet Footnotes # † * 1. Zawta B. diet and geographical location. Clinical guide to laboratory tests. especially turbidity.Reference Intervals5.006x + 0. Immunoglobulins (Ig).69 0.01 . 1999. plasma and serum samples. Glasgow: Arnold.19 0.01 2009-08 EN. In: Burtis CA. Effects of Drugs on Clinical Laboratory Tests.1820pp. 5. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. Mayne PD.36 0.346-347.17 0.22 – 4.6 Adults 0. Smith JL. may produce atypical results. as a precaution samples from patients with suspected paraproteinaemia should also be tested by electrophoresis. 2.09 CV% 3. Thomas L.67 g/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 200 mg/dL Intralipid Refer to Young for further information on interfering substances. 3. Painter PC. Heil W. ed. 4. Dati F. WHO/DIL/LAB/99. 7.04 2. Precision The following data was obtained on an AU640 analyser using 3 serum pools analysed over 10 days.000 n = 107 Sample range = 0. Lab Med 1996. Each laboratory should verify the transferability of the expected values to its own population. Data obtained in your laboratory may differ from these values.2 – 2. Töpfer G. Ashwood ER.028 r = 1. sex. and if necessary determine its own reference interval according to good laboratory practice. AACC Press. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP international reference material CRM 470.3 g/L (40 – 230 mg/dL) Children 0. Clinical laboratory diagnostics. Schmitt Y. User defined ¤ Analyser default value Serum Protein Multicalibrator Cat. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Philadelphia:WB Saunders Company. Method Comparison Patient serum samples were used to compare this IgM assay on the AU2700 against another commercially available IgM assay.02 1.01 1. No. Frankfurt/Main: TH-Books Verlagsgesellschaft.2 – 5. Linearity The test is linear within a concentration range of 0.01 g/L.05 2. 1998:667-678.29 4. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Baudner S. AACC. However. 5th ed. Tietz NW. The lowest detectable level represents the lowest measurable level of IgM immunoglobulins that can be distinguished from zero.0 g/L (20 – 200 mg/dL) Expected values may vary with age.48 0. Samples with extremely abnormal optical characteristics. “F” flags or a combination of “F” and “Z” flags may be obtained. Clinical chemistry in diagnosis and treatment. 6. results should always be assessed in conjunction with the patient's medical history.1 Rev. n = 80 Within Run Total Mean g/L SD CV% SD 0. 1994:322-326. Reference information for the clinical laboratory. Samples with very high IgM concentrations (> 100 g/L polyclonal) can generate false low results without appropriate "Z" flags due to excess antigen in the sample. In: Thomas L.1995:360-363. ed.0 g/L (20 – 500 mg/dL).08 Sensitivity The lowest detectable level in serum on an AU640 analyser was estimated at 0. 3rd ed.20:145-152. ed. Philadelphia: WB Saunders Company. Use and assessment of clinical laboratory results.: ODR3021 Values set for working in SI units (g/L). Wisser H. et al.2:35pp. Young DS. Ehret W. Results of linear regression analysis were as follows: y = 1. 0000 0 0 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 11 17 23 0. No.1 -0.1 Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ Test No 999 ∇ Advanced Calibration: # Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 2. OD L Reagent OD limit Fst.1 -0. To work in mg/dL multiply by 100 Specific Protein BSOSR6x173. No.5 2.5 2.1 -0. L -0.5 2.5 2. point MB type factor Calibrator stability period 999 Conc † † † † † Factor/OD-L -0.5 2.1500 11 27 MB Type Factor: Calibration Stability Period: SERUM/PLASMA APPLICATION Data Check Parameters Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Test Name: IgM ∇ < > Type: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 11 17 23 0.0000 0.5 5.1 -0. Linearity Fst No lag time Select using Space key. vol 0 115 10 μL μL μL Max. vol Dil.1 -0.1 -0.5 2.5 Wave Method Reaction Point 1 Point 2 800 END + 27 10 ∇ ∇ ∇ Sample vol. To work in mg/dL multiply by 100.8000 0.1 Lst.8000 0. AU400/AU640 Serum/Plasma Reagent ID: 173 Specific Test Parameters Serum ∇ 1 Max OD H Main Fst Fst Sample Pre-dil.1 0.1 Dynamic range L 0.5 2. # # # # # OD CONC † † † † † Factor/OD-L -0.0000 0 0 NO 0 0. ∇ ∇ ∇ Sec. Point: ο with CONC-0 Slope Check: Select the function using the Function key or the Mouse Data Check Parameters # Logic check-1 Name YES IgM ∇ Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0.: ODR3021 * Values set for working in SI units (g/L).0000 0. vol Dil.0* 1 0 ¤ 90 ∇ Operation: Yes Test No ∇ ∇ # Test name IgM Sample type Ser Page 1/2 System Reagent: OSR61173 Reagent ID: 173 Application IgM.1500 11 27 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # User defined † Serum Protein Multicalibrator Cat. OD H 1.IgM. # User defined ¤ Analyser default value † Serum Protein Multicalibrator Cat.01 2009-08 .0* First H Last H 1.0000 0.5 1. 800 ∇ Min. L -0.5 1-Point Cal.5 # Test Name: Counts: IgM ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Cal.1 -0.1 Factor/OD-H 2.2* Correlation factor Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2. No. H H A B Rate -0. H Lst.1 -0. or select from list displayed by Guide key Calibration Specific Test No ∇ ∇ Count Process # Conc ∇ 5AB ∇ POLYGONAL OD # Test name IgM % Sec % ∇ On-board stability period 0 0 Lst Lst 340 Sub Fst.5 1.2* B 90 0 H 5.: ODR3021 * Values set for working in SI units (g/L). AU600 Serum/Plasma Application System Reagent: OSR61173 Specific Test Parameters General LIH ISE Range Test Name: IgM ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 70 55 μL μL μL Dilution Dilution Dilution 0 115 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 340 END + First 0 First 0 Pri.1 -0.0000 0. Reagent 1 vol Reagent 2 vol 2 70 55 Dil. 2* 1 1 μL High B B 0 5.IgM.5 2. 800 Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L ∇ Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Calibration Specific General ISE Type: Serum ∇ Test Name: ∇ IgM ISE Parameters Calibrators General Calibration Specific Test Name: Counts: # Process: CONC ∇ IgM ∇ < > Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Use Serum Cal. To work in mg/dL multiply by 100 ф AU680 √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: Specific Protein BSOSR6x173.OD Reagent OD Limit First Low Last Low Dilution 92 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61173 Reagent ID: 173 Application Operation Yes IgM.5 -0. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # ∇ Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Data Check Parameters Serum ∇ SERUM/PLASMA APPLICATION Test Name: IgM ∇ < > Type: <Point Cal. No.3000 11 27 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: 11 17 23 0.OD -0.1500 11 27 Pattern1 # User defined.6 56 44 1.1 -0.0000 0.8500 0.01 2009-08 . AU2700/AU5400 Serum/Plasma Reagent ID: 173 Parameters General LIH IgM ∇ Dilution μL Max.1 High High 1.5 2.5 μL Min.5 2.1 -0. No.8000 0.2* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.1 -0.: ODR3021 * Values set for working in SI units (g/L).5 1.5 -0.1 2.1 2. Volume R1(R1-1) μL ∇ μL 1. OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal.1 2. ∇ ∇ ∇ 0. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.1 -0.1 2.0000 0.5 2.5 1.1 Factor/OD-H 2.5 ο Calibration Advanced Calibration Operation Interval (RB/ACAL) + ∇ 1-Point Cal. # # # # # CONC † † † † † Factor/OD-L -0.6 1 56 Range Operation: ∇ Yes Test Name: IgM ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 Last Last 27 10 1.5 ο Reagent Blank -0. † Serum Protein Multicalibrator Cat. For No.1 -0.5 Allowance Range Check -0. AU680/AU480 Serum/Plasma Application System Reagent: OSR61173 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0.0* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 0 92 10 μL μL μL Pri.1 R2(R2-1) μL Name Sec. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ Calibration Parameters STAT Table Calibration < > POLYGONAL Type Serum ∇ ο 340 END + First 0 First 0 Sec.5 Counts: # ∇ ∇ OD Range Low High Slope Check -0.0* 0 0 Hour 44 Dilution 10 Sample Volume Pre-Dilution Rate Rgt.5 5. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 None ∇ ο with Conc-0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters IgM ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 11 17 23 0.1 -0.1 2. 0000 0. ∇ ∇ ∇ Sec.0000 0 0 NO 0 0.0* 1 0 ¤ 90 ∇ Operation: Yes Test No ∇ ∇ # Test name IgMP Sample type Ser Page 1/2 System Reagent: OSR61173 Reagent ID: 1736 Application IgM.5 2.2* Correlation factor Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2. To work in mg/dL multiply by 100.1 -0.1 Lst.5 2.8000 0.5 1-Point Cal.: ODR3021 * Values set for working in SI units (g/L). # User defined ¤ Analyser default value † Serum Protein Multicalibrator Cat.1 -0.0000 0. No.0000 0 0 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 11 17 23 0. AU600 Paediatric Application System Reagent: OSR61173 Specific Test Parameters General LIH ISE Range Test Name: IgMP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 70 55 μL μL μL Dilution Dilution Dilution 10 105 10 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 340 END + First 0 First 0 Pri.0000 0.5 2. Vol 10 105 10 μL μL μL Max.IgM.1500 11 27 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # User defined † Serum Protein Multicalibrator Cat. Vol Dil.8000 0. Point MB type factor Calibrator stability period 999 Conc † † † † † Factor/OD-L -0.1 -0.: ODR3021 * Values set for working in SI units (g/L). H Lst. or select from list displayed by Guide key Calibration Specific Test No ∇ ∇ Count Process # Conc ∇ 5AB ∇ POLYGONAL OD # Test name IgMP % Sec % ∇ On-board stability period 0 0 Lst Lst 340 Sub Fst.1 Factor/OD-H 2.1500 11 27 MB Type Factor: Calibration Stability Period: PAEDIATRIC APPLICATION Data Check Parameters Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Test Name: IgMP ∇ < > Type: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 11 17 23 0.5 2.5 2.5 2.5 2.1 -0.1 -0. Reagent 1 vol Reagent 2 vol 2 70 55 Dil.5 2.0* First H Last H 1.1 -0.5 Wave Method Reaction Point 1 Point 2 800 END + 27 10 ∇ ∇ ∇ Sample vol. 800 ∇ Min.01 2009-08 . Linearity Fst No lag time Select using Space key.1 -0.1 Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ Test No 999 ∇ Advanced Calibration: # Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 # Test Name: Counts: IgMP ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Cal.0000 0. L -0. # # # # # OD CONC † † † † † Factor/OD-L -0.5 1. OD L Reagent OD limit Fst. No. Point: ο with CONC-0 Slope Check: Select the function using the Function key or the Mouse Data Check Parameters # Logic check-1 Name YES IgMP ∇ Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0. Vol Dil.2* B 90 0 H 5.1 -0. No.5 5.1 -0. AU400/AU640 Paediatric Reagent ID: 173 Specific Test Parameters Serum ∇ 1 Max OD H Main Fst Fst Sample Pre-dil.1 0. L -0.1 Dynamic range L 0. H H A B Rate -0.5 1. OD H 1. To work in mg/dL multiply by 100 Specific Protein BSOSR6x173. 1 2.1 Factor/OD-H 2.5 ο Calibration Advanced Calibration Operation Interval (RB/ACAL) + ∇ 1-Point Cal.2* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ Calibration Parameters STAT Table Calibration < > POLYGONAL Type Serum ∇ ο 340 END + First 0 First 0 Sec.5 -0.5 Allowance Range Check -0. AU2700/AU5400 Paediatric Reagent ID: 173 Parameters General LIH IgMP ∇ Dilution μL Max.0000 0.OD -0.8000 0. No. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: # ∇ # ∇ Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ PAEDIATRIC APPLICATION Data Check Parameters Serum ∇ Test Name: IgMP ∇ < > Type: <Point Cal.5 ο Reagent Blank -0.1 -0.1500 11 27 Pattern1 # † * ф User defined.5 Counts: # ∇ ∇ OD Range Low High Slope Check -0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 None ∇ ο with Conc-0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters IgMP ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 11 17 23 0.1 2.01 2009-08 .1 2.1 2.1 -0.5 2.1 High High 1.3000 11 27 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: 11 17 23 0.5 -0.6 1 56 Range Operation: ∇ Yes Test Name: IgMP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 Last Last 27 10 1.5 1.1 R2(R2-1) μL Name Sec. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. # # # # # CONC † † † † † Factor/OD-L -0. OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal.1 -0. To work in mg/dL multiply by 100 AU680 √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: Specific Protein BSOSR6x173. For No. ∇ ∇ ∇ 0.6 56 44 1.8500 0.IgM. 800 Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L ∇ Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Calibration Specific General ISE Type: Serum ∇ Test Name: ∇ IgMP ISE Parameters Calibrators General Calibration Specific Test Name: Counts: # Process: CONC ∇ IgMP ∇ < > Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Use Serum Cal.5 1.0* 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis μL μL μL Dilution Dilution Dilution 10 82 10 μL μL μL Pri.5 2.0* 0 0 Hour 44 Dilution 10 Sample Volume Pre-Dilution Rate Rgt. AU680/AU480 Paediatric Application System Reagent: OSR61173 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0.2* 1 1 μL High B B 0 5.0000 0.5 5.5 2.1 2.: ODR3021 Values set for working in SI units (g/L).1 -0. Volume R1(R1-1) μL ∇ μL 1. Serum Protein Multicalibrator Cat.5 2. No.1 -0.OD Reagent OD Limit First Low Last Low Dilution 82 10 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61173 Reagent ID: 173 Application Operation Yes IgM.5 μL Min.1 -0. Quality Control Control materials.4 The earliest clinical evidence of nephropathy is the appearance of low but abnormal levels (> 30 mg/day or 20 µg/min) of albumin in the urine. reagents stored on board the instrument are stable for 90 days. Stable for 72 hours when stored at 4°C. foot and mouth disease. and proliferative retinopathy in type I diabetes. for acceptability using the software options Routine. The results obtained by any individual laboratory may vary from the given mean value. The absorbance of these aggregates is proportional to the albumin concentration in the sample. Antisera was produced in healthy animals in facilities free from rinderpest. Prospective studies have demonstrated that increased urinary albumin excretion precedes and is highly predictive of diabetic nephropathy. Storage and Stability The reagents are stable. Stable for 6 months when stored frozen at -20°C. Calibration Curve. for 1 month when stored at 2…8°C and 7 days when stored at 15…25°C. without preservative.01 2009-08 Specific Protein . To avoid the possible build-up of azide compounds. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. This material and its container must be disposed of as hazardous waste. Calibration Microalbumin Calibrator Cat. of human origin. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution. bovine spongiform encephalopathy and blue tongue disease. S60: Wear suitable protective clothing. Reagent Composition in the Test Final concentration of reactive ingredients: Tris Buffer (pH 7. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Increased urinary albumin excretion. up to the stated expiry date when stored at 2…8°C. both independently and in conjunction with hyperinsulinemia. human albumin reacts specifically with anti-human albumin antibodies. R22 Harmful if swallowed. For in vitro diagnostic use only. For this purpose.6) Goat anti-human albumin antibodies Preservative 71 mmol/L Variable Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. Once open. Specimen5 Urine: Stable in urine. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. peste des petits ruminants. Following calibration. Contents. atherosclerotic disease and cardiovascular mortality. on the Beckman Coulter analyser. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. Rhift Valley fever.MICROALBUMIN OSR6167 Intended Use Immuno-turbidimetric test for the quantitative determination of albumin in human urine and cerebrospinal fluid on Beckman Coulter analysers. referred to as microalbuminuria. Microalbuminuria is considered a clinically important indicator of deteriorating renal function in diabetic subjects and regular screening is valuable in monitoring both type I and type II diabetes. and patients with microalbuminuria are referred to as having incipient nephropathy. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. with values determined by this Beckman Coulter system may be used. 6 Cerebrospinal fluid. end stage renal disease. 4 x 15 mL 4 x 5 mL R1 R2 Summary1. review all operating parameters.3. the resulting curve should be visually reviewed. Microalbuminuria is defined as an albumin excretion rate between 30-300 mg/24h on 2 of 3 urine collections. Safety Phrases: S36. Calibration Monitor. unopened. If any trends or sudden shifts in values are detected. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. EN. Conventional qualitative tests (chemical strips or dipsticks) for albuminuria do not detect the small increases in urinary albumin excretion seen in early stages of nephropathy. identifies a group of nondiabetic subjects at increased risk of coronary artery disease. The degree of permeability of the blood-CSF barrier may be evaluated by the simultaneous measurement of serum and CSF albumin. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Dispose of all waste material in accordance with local guidelines. Refer to Safety Data Sheets for further information.2.01 BLOSR6x67. In patients with type II diabetes increased urinary albumin excretion is an independent predictor of progressive renal disease. tests for microalbuminuria are used. CSF albumin measurements may also be used to determine the IgG CSF/albumin CSF ratio which is an important factor in differentiating between intrathecal and localised synthesis of IgG. to yield insoluble aggregates. The calibrator Microalbumin values are traceable to a primary albumin standard. ODR3024. contains sodium azide. No. flush waste-pipes with water after the disposal of undiluted reagent. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Major preventative maintenance was performed on the analyser or a critical part was replaced. it is recommended to: a) Process microalbumin calibrators separately to other serum calibrators. Tietz textbook of clinical chemistry.Please note that the recovery of non-Beckman Coulter controls may vary with reagent lots of immunoassay products. For diagnostic purposes.93 1.43 0. c) When changing from serum to urine or CSF samples. n = 60 Within Run Total Mean mg/L SD CV% SD 5. Method Comparison Patient urine samples were used to compare this Albumin OSR6167 assay on the AU400 against another commercially available albumin assay. Data obtained in your laboratory may differ from these values. Philadelphia: WB Saunders Company.2:46pp. 3rd ed.52 mmol/L creatinine 8 Refer to Young for further information on interfering substances. Cope JY. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Schmitt Y.798pp. Reference Intervals1 Urine: Normal Microalbuminuria Clinical albuminuria CSF 7 24-h collection (mg/24h) < 30 30 – 299 ≥ 300 3 mo – 4y >4y 0 – 450mg/L 100 – 300mg/L Timed collection (µg /min) < 20 20 – 199 ≥ 200 Spot collection (µg /mg creatinine) < 30 30 – 299 ≥ 300 Expected values may vary with age. Philadelphia: WB Saunders Company.01 . Setting Sheet Footnotes # † * User defined ¤ Analyser default value System Calibrator Cat. Goldstein DE. The test has a prozone tolerance of 6000 mg/L (600 mg/dL).1 Rev.0 mg/dL r = 0.06 0. Tietz NW. Diabetic Nephropathy. Töpfer G. place a sample cup containing 2% AU detergent in the first position of the urine rack and requisition a test for this sample. Microalbumin OSR6167 can exhibit depressed recovery of analyte when urine and CSF proteins are at a level exceeding 6000 mg/L due to antigen excess effect.43 1.994 n = 100 Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Glucose: Interference less than 5% up to 3000 mg/dL or 166. 8. Specific Protein BLOSR6x67. Samples with extremely abnormal optical characteristics.109x – 1. Clin Chem 2002.07x – 1. Diabetes Care 25:(Suppl.5 – 30 mg/dL).24 Sample range = 9. In: Burtis CA.1999. may produce atypical results. Newman DJ. 7. eds. Parrot M. WHO/DIL/LAB/99.7 – 91. Urine and CSF samples with total protein levels greater than 300 mg/L (the upper limit of the OSR6167 linearity range) should be diluted to allow measurement within the range of the assay. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. Smith JL Reference information for the clinical laboratory. CSF only Note: Refer to leaflet for limitations American Diabetes Association. Ashwood ER. Carbohydrates. Philadelphia: WB Saunders Company. 2. Prozone or hook effect may occur with very elevated microalbumin samples (>6000 mg/L).98 1. Tietz textbook of clinical chemistry.90 1. diet and geographical location. 1):S85-S89. b) Avoid freely alternating serum and urine racks. sample type. McDonald JM. divide by 10.99 r = 993 n = 58 Sample range = 2. In order to eliminate this effect. Urine and CSF samples should be initially screened by an alternative method for grossly abnormal total protein. Ashwood ER. plasma and serum samples. The lowest detectable level represents the lowest measurable level of albumin that can be distinguished from zero. Ashwood ER. 5th ed. 6. Each laboratory should verify the transferability of the expected values to its own population. Limitations The Microalbumin result of a urine or CSF sample may be elevated when it immediately follows a serum sample.: ODR3024 Values set for working in mg/L. MacLaren NK. No. Samples with extremely high levels of protein should not be assayed for Microalbumin. and if necessary determine its own reference interval according to good laboratory practice. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. 1995:24pp Painter PC. eds. et al. due to the use of non-human materials in the controls. Sacks DB. Linearity The test is linear within a concentration range of 5 – 300 mg/L (0.01 2009-08 EN.27 107. Philadelphia WB Saunders Company. In: Burtis CA. Calculation The Beckman Coulter analysers automatically compute the albumin concentration of each sample. 1999. In: Burtis CA.28 2.33 2. sex.48:436-472.46 mg/L. y = 1. Bruns DE. 2000. BIBLIOGRAPHY 1. Effects of drugs on clinical laboratory tests. eds. Wisser H. Sacks DB. Price CP. results should always be assessed in conjunction with the patient's medical history. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Precision The following data was obtained on an AU600 using 3 urine pools analysed over 10 days.1800pp. especially turbidity. 1999.82 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 0. Renal function and nitrogen metabolites.3 – 304 mg/L Patient CSF samples were used to compare this Albumin OSR6167 assay on the AU640 against another commercially available albumin assay. Heil W. 4. Tietz textbook of clinical chemistry. Ehret W. Results of linear regression analysis were as follows. ed Clinical guide to laboratory tests.89 CV% 4. Results of linear regression analysis were as follows: y = 1. 3.1228pp.10 0. AACC Press. 5.17 3. Young DS. Zawta B.14 269. clinical examinations and other findings.78 4.7 mmol/L glucose Creatinine: Interference less than 5% up to 300 mg/dL or 26. To work in (mg/dL). or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name MALB Sample type Uri ∇ On-board stability period 340 END + First 0 First 0 Pri.5 2.1 -0.5 2.5 2.1 -0. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal.MICROALBUMIN.1 Lst.5 ∇ Operation: Yes Test No ∇ ∇ # Test name MALB Sample type Uri Page ½ System Reagent: OSR6167 Reagent ID: 067 Application MICROALBUMIN.5 2. # # ο ∇ 6. Vol 0 0 0 Max. Specific Protein . H 300* Fst Fst 0 0 Lst Lst First H Last H 1.5 2.5 ∇ Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 2. 800 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. None Selected 8. # # ο ∇ 7.1 -0.1 5* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. BSOSR6x67.01 2009-08 # User defined † Microalbumin Calibrator Cat.: ODR3024 * Values set for working in mg/L. Reagent 1 vol Reagent 2 vol μL μL μL 10 150 50 Dil.1 # Conc Factor/OD-H 2. Vol Dil. AU400/AU640 Urine Reagent ID: 067 Specific test parameters Urine ∇ 1 Max OD H Main ∇ ∇ ∇ 340 Sub Fst.5 2.1 -0. ∇ ∇ ∇ Sec. No. To work in mg/dL divide by 10. H -0.5 1.1 -0.1 -0.5 2.5 # Test Name: Counts: MALB ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. H Lst.1 -0. L -0.1 -0.: ODR3024 * Values set for working in mg/L. No. # # # # # OD CONC † † † † † Factor/OD-L -0.5 1.1 -0.1 1-Point Cal. Vol Dil. # # ο ∇ 5.5 Wave Method Reaction Point 1 Point 2 800 END + 27 10 Sample vol. AU600 Urine Application System Reagent: OSR6167 Specific Test Parameters General LIH ISE Range Test Name: MALB ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 10 150 50 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. L -0.1 Dynamic range L 5* Correlation factor % ∇ 300* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Urine ∇ # Range Page 2/2 Level L # Level H # Test Name: MALB ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. OD L Reagent OD limit Fst. OD H 1. # # ο ∇ 4. No.5 2. Out of Range L # # # # # # # # Unit: mg/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # URINE APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name MALB ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0. # # ο ∇ 2. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Microalbumin Calibrator Cat. To work in mg/dL divide by 10. # # ο ∇ 3. ∇ # # # # ο 2. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal. # # ο ∇ 2. # # ο ∇ 4.MICROALBUMIN.5 1. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mg/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.: ODR3024 Values set for working in mg/L. ∇ # # # # ο 6. AU680/AU480 Urine Application System Reagent: OSR6167 Specific Test Parameters General LIH ISE Urine ∇ 1 Max OD H -0. # # ο ∇ 7.5 -0. 800 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Urine ∇ LIH MALB ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # MALB ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 -0. Not within expected values mg/L* Decimal Places Calibration Specific ISE MALB ∇ < Low # # # # # # # # # URINE APPLICATION High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Urine Counts: ∇ # ο ∇ Calibration Specific General ISE Type Urine ∇ Counts: # Process: CONC ∇ Test Name: MALB ∇ < > Test Name: Use Serum Cal. # # ο ∇ 6.5 -0.5 2.5 ∇ OD Range Low High -0. ∇ # # # # ο 4.1 2.1 -0.5 μL Min. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ 340 END + First 0 First 0 Sec. Volume R1(R1-1) μL ∇ μL 8 1 120 Range Operation: ∇ Yes Test Name: MALB ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 0 300* 1. Microalbumin Calibrator Cat. No. # # # # # CONC † † † † † Factor/OD-L -0. 800 Onboard Stability Period Last Last 27 10 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 5* 1 1 90 Day μL High B B 0 300* 0 0 Hour 40 Dilution 10 Sample Volume Pre-Dilution Rate Rgt.OD -0.5 -0. For No. ∇ # # # # ο 5.1 2. ∇ 7.5 + ∇ 1-Point Cal.5 1.5 -0.1 Factor/OD-H 2. No. AU2700 / AU5400 Urine Reagent ID: 067 Parameters General LIH MALB ∇ Dilution μL Max. ∇ # # # # ο 3. No demographics 8.5 8 120 40 μL μL μL Dilution Dilution Dilution 0 0 10 μL μL μL Pri. # # ο ∇ 5.5 2.1 R2(R2-1) μL Name Sec. # # ο ∇ 3. To work in mg/dL divide by 10.1 2.5 2.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6167 Reagent ID: 067 Application Operation Yes MICROALBUMIN. Point: ο With CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined.1 High High 1.1 -0.1 -0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x67.01 2009-08 .1 2. ∇ ∇ ∇ 5* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.1 2.5 2. AU680 <Point Cal. None Selected 8.1 -0.1 -0. Specific Protein .5 2. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name MALB Sample type Others ∇ On-board stability period 340 END + First 0 First 0 Pri.01 2009-08 # User defined † Microalbumin Calibrator Cat. H 300* Fst Fst 0 0 Lst Lst First H Last H 1.5 Wave Method Reaction Point 1 Point 2 800 END + 27 10 Sample vol. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. Note: Refer to leaflet for limitations. None Selected 8.1 -0.5 2. # # ο ∇ 3. AU600 CSF Application System Reagent: OSR6167 Specific Test Parameters General LIH ISE Range Test Name: MALB ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 10 150 50 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. No.1 -0.5 2. # # ο ∇ 7.1 -0.1 Dynamic range L 5* Correlation factor % ∇ 300* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Others ∇ # Range Page 2/2 Level L # Level H # Test Name: MALB ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 2. BSOSR6x67. Reagent 1 vol Reagent 2 vol μL μL μL 10 150 50 Dil.1 -0. vol Dil. L -0. # # ο ∇ 5. To work in mg/dL divide by 10.5 2.1 -0.1 -0. vol Dil.5 2. # # ο ∇ 2. Out of Range L # # # # # # # # Unit: mg/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H CSF APPLICATION Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name MALB ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0.5 2.5 ∇ Calibration Specific General ISE Others ∇ Process: CONC ∇ Factor/OD-H 2. AU400/AU640 CSF Reagent ID: 067 Specific test parameters Others ∇ 1 Max OD H Main ∇ ∇ ∇ 340 Sub Fst.5 1. H Lst.: ODR3024 * Values set for working in mg/L.5 # Test Name: Counts: MALB ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. To work in mg/dL divide by 10. H -0.1 Lst.1 # Conc Factor/OD-H 2. OD L Reagent OD limit Fst. No.5 ∇ Operation: Yes Test No ∇ ∇ # Test name MALB Sample type Others Page 1/2 System Reagent: OSR6167 Reagent ID: 067 Application MICROALBUMIN.1 5* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. vol 0 0 0 Max. L -0. # # ο ∇ 6. No.1 -0. ∇ ∇ ∇ Sec.1 -0. # # ο ∇ 4.1 -0. Note: Refer to leaflet for limitations.MICROALBUMIN.5 1. 800 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: H A B Rate Min. # # # # # OD CONC † † † † † Factor/OD-L -0.1 1-Point Cal. OD H 1.: ODR3024 * Values set for working in mg/L.5 2. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Microalbumin Calibrator Cat. 5 ∇ OD Range Low High -0.5 + ∇ 1-Point Cal. # # # # # CONC † † † † † Factor/OD-L -0.MICROALBUMIN. AU2700/AU5400 CSF Reagent ID: 067 Parameters General LIH MALB ∇ Dilution μL Max. ∇ 7.1 -0.5 2.1 -0.5 1. For No. 800 Onboard Stability Period Last Last 27 10 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 5* 1 1 90 Day μL High B B 0 300* 0 0 Hour 40 Dilution 10 Sample Volume Pre-Dilution Rate Rgt. No demographics 8. Note: Refer to leaflet for limitations. ∇ # # # # ο 6. # # ο ∇ 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x67.5 -0. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. Not within expected values mg/L* Decimal Places Calibration Specific ISE MALB ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Others Counts: ∇ # ο ∇ Calibration Specific General ISE Type Others ∇ Counts: # Process: CONC ∇ Test Name: MALB ∇ < > Test Name: Use Serum Cal. # # ο ∇ 5. † Microalbumin Calibrator Cat. # # ο ∇ 3.1 -0. No. To work in mg/dL divide by 10. 800 ∇ Last Last 27 10 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Specific Test Parameters General LIH ISE Others ∇ LIH MALB ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # MALB ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Others ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 2.: ODR3024 * Values set for working in mg/L. # # ο ∇ 4.01 2009-08 . Ф AU680 <Point Cal.1 -0.1 R2(R2-1) μL Name Sec. # # ο ∇ 6.1 2.5 -0.1 Factor/OD-H 2.1 High High 1. No. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L mg/L* H Month # # # # # # CSF APPLICATION Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.1 2. # # ο ∇ 7.5 -0.1 2. AU680/AU480 CSF Application System Reagent: OSR6167 Specific Test Parameters General LIH ISE Others ∇ 1 Max OD H -0.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit < > ∇ ∇ Type: Others ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6167 Reagent ID: 067 Application Operation Yes MICROALBUMIN. ∇ # # # # ο 2. Volume R1(R1-1) μL ∇ μL 8 1 120 Range Operation: ∇ Yes Test Name: MALB ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 90 0 300* 1.5 -0. ∇ ∇ ∇ 5* Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. None Selected 8.5 1. ∇ # # # # ο 3.5 2.5 2. ∇ # # # # ο 5.1 2.5 8 120 40 μL μL μL Dilution Dilution Dilution 0 0 10 μL μL μL Pri.1 -0. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal.OD -0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ 340 END + First 0 First 0 Sec.5 μL Min.1 2. ∇ # # # # ο 4.1 -0. sex. for acceptability using the software options Routine. Reagent Preparation R1 is ready for use and can be placed directly on board the instrument. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. A decrease in myoglobin may be observed in the presence of circulating antibodies to myoglobin. Calibration Curve. Test Principle When a sample is mixed with R1 buffer and R2 latex solution. EN. Laboratories should establish their own mean and ranges for any QC prior to routine use.MYOGLOBIN OSR6168 Intended Use Immuno-turbidimetric test for the quantitative determination of myoglobin in human serum on Beckman Coulter analysers. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. The absorbance of these aggregates is proportional to the myoglobin concentration in the sample. uremia.10 times before placing on board the instrument and at weekly intervals thereafter. exercise. and CK-MB after a myocardial infarction.g. Myoglobin is very useful for the exclusion of an acute myocardial infarction and for monitoring thrombolytic therapy however it is a non-specific marker for myocardial infarction and must be corroborated by other cardiac-specific markers. therefore may serve as an oxygen reservoir. Each laboratory should verify the transferability of the expected values to its own population. Dispose of all waste material in accordance with local guidelines. cardiac and skeletal muscle. Due to the lack of international standardisation for myoglobin. clinical examinations and other findings. burns and myocardial infarction. flush waste-pipes with water after the disposal of undiluted reagent. to yield insoluble aggregates. Strongly lipemic samples should be avoided. such as troponin I or T. The serum myoglobin concentration increases before a rise in other biochemical cardiac markers. intramuscular injections. Calibrators are traceable to highly purified human cardiac myoglobin and values assigned using a commercially available RIA method. Calibration Myoglobin Calibrator Cat. 4 x 12 mL 4 x 9 mL R1 R2 Summary1. the resulting curve should be visually reviewed. reagents stored on board the instrument are stable for 90 days.3) Preservative 92 mmol/L Variable Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents.4 Myoglobin is the O2-binding protein of striated i. unopened.01 BLOSR6x68. ODR3025. on the Beckman Coulter analyser. human myoglobin reacts specifically with anti-human myoglobin antibodies coated on the latex particles. For in vitro diagnostic use only. Major preventative maintenance was performed on the analyser or a critical part was replaced. A clinical history is required to establish if an increase in serum myoglobin is due to a myocardial infarction or to a release of myoglobin from skeletal muscle. values obtained may differ significantly from other assays. To avoid the possible build-up of azide compounds. up to the stated expiry date when stored at 2…8°C. due to the use of non-human materials in the controls. Myoglobinemia occurs after trauma to either skeletal or cardiac muscle. 5 Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Reagent Composition in the Test Final concentration of reactive ingredients: Glycine Buffer (pH 9. diet and geographical location. Unlike haemoglobin. and if necessary determine its own reference interval according to good laboratory practice. Calculation The Beckman Coulter analysers automatically compute the myoglobin concentration of each sample. Calibration Monitor. For diagnostic purposes. Storage and Stability The reagents are stable. Myoglobin elevation due to skeletal muscle damage shows a pattern essentially identical to that of total CK.e. sample type. seizures. myoglobin is unable to release O2 except at an extremely low pO2. Please note that the recovery of non-Beckman Coulter controls may vary with reagent lots of immunoassay products.0) Latex particles coated with anti-human myoglobin (pH 7. and rheumatoid arthritis. Specimen Test Procedure Serum: Stable in serum for 1 week when stored at 2…8°C and 2 days when stored at 15…25°C. Reference Intervals6 Male 19 – 92 µg/L Female 12 – 76 µg/L Expected values may vary with age. e. Contents. as in many patients with polymyositis. Quality Control Control materials of human origin with values determined by this Beckman Coulter system may be used.01 2009-08 Specific Protien Serum . Once open. in crush injury. inflammatory myopathies. results should always be assessed in conjunction with the patient's medical history. No. The increase in myoglobin occurs 2-4 hours after the onset of symptoms and returns to reference range within 24 hours of onset. Following calibration.2.3. accessible only under conditions of extreme hypoxia. R2 should be mixed by inversion 5 . plasma and serum samples.Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Tietz textbook of clinical chemistry. Alpert JS et al. Effects of drugs on clinical laboratory tests. This assay has a prozone tolerance of 20.01 . ed.000 µg/L. 1998:106-108. Ashwood ER.2:38pp. Clinical laboratory diagnostics. Frankfurt/Main: TH-Books Verlagsgesellschaft.1826pp.1 Rev. Use and assessment of clinical laboratory results. Heil W.36:959-969. Cardiac diseases.88 377. AACC Press. Philadelphia:WB Saunders Company.96 µg/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 10% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 500 mg/dL Intralipid Refer to Young for further information on interfering substances.16 CV% 4. Tietz textbook of clinical chemistry. 5th ed.2. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. Zawta B. 2000. Samples suspected of myoglobin concentrations greater than 20. Schmitt Y. Tietz NW. Philadelphia:WB Saunders Company. Thygesen K. 3rd ed. Reference information for the clinical laboratory. Data obtained in your laboratory may differ from these values. Setting Sheet Footnotes # † * 1. Mair J. Method Comparison Patient serum samples were used to compare this Myoglobin OSR6168 assay on the AU600 against another commercially available myoglobin assay. Use of anticoagulants in diagnostic laboratory investigations and stability of blood.70 0. et al.62 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 3.76 5. 1999. n = 60 Within Run Total Mean µg/L SD CV% SD 45.01 2009-08 EN. 5. Myocardial infarction redefined-A consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction.17 2. Linearity The test is linear within a concentration range of 30 – 800 µg/L. Clinical guide to laboratory tests. especially turbidity. Ehret W. eds. Biochemical aspects of hematology. ed. In: Burtis CA. 7 Limitations Samples containing heterophilic antibodies can cause falsely elevated results.51 2. 7.15 1.15 2. 6. 4. Cope JY. Painter PC. may produce atypical results. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. In: Burtis CA. eds. 1999. WHO/DIL/LAB/99. Samples with extremely abnormal optical characteristics.46 693.1689pp.89 1. The lowest detectable level represents the lowest measurable level of myoglobin that can be distinguished from zero. Results of linear regression analysis were as follows: y = 1. Klee GG. 2.1995:442-443. Ashwood ER. Young DS.114 r = 0.82 18. Töpfer G.30 2. JACC 2000.000 µg/L should be diluted prior to analysis.: ODR3025 Values set for working in µg/L Fairbanks VF.68 9.997 n = 37 Sample range = 3. BIBLIOGRAPHY Specific Protein BLOSR6x68.57 0. Wisser H.388x . Puschendorf B. 3.31 – 300. Smith JL. Philadelphia: WB Saunders Company.14 µg/L. No. In:Thomas L. User defined ¤ Analyser default value Myoglobin Calibrator Cat. MYOGLOBIN.1 -0. Out of Range L # # # # # # # # Unit: µg/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # SERUM APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name MYO ∇ 4AB ∇ POLYGONAL OD ∇ Conc † † † † Count Process Factor/OD-L -0. ∇ ∇ ∇ Sec. OD L -0. Specific Protein .: ODR3025 * Values set for working in µg/L. Vol Dil.5 1.01 2009-08 # User defined † Myoglobin Calibrator Cat.5 2. None Selected 8. Vol Dil. # # ο ∇ 6. # # ο ∇ 7.5 # Test Name: Counts: MYO ∇ < > Type Calibration Type: 4AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. L -0.5 Last H 1.1 # Conc Factor/OD-H 2.1 Dynamic range L 30* Correlation factor % ∇ 800* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: MYO ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. AU600 Serum Application System Reagent: OSR6168 Specific Test Parameters General LIH ISE Range Test Name: MYO ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Max OD H 2. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 12 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # # # OD CONC † † † † Factor/OD-L -0. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name MYO Sample type Ser ∇ On-board stability period 570 FIXED + First 12 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Min. # # ο ∇ 3. AU400/AU640 Serum Reagent ID: 068 Specific test parameters Serum ∇ 1 -0.: ODR3025 * Values set for working in µg/L. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Myoglobin Calibrator Cat.5 1. OD H ∇ Operation: Yes Test No ∇ 2.1 Main ∇ ∇ ∇ 570 Sub -0. None ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.5 1. No. No. # # ο ∇ 2.1 -0. # # ο ∇ 4.5 Wave Method Reaction Point 1 Point 2 H A B Rate 11 120 90 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.1 -0. # # ο ∇ 5.1 Lst. H Sample vol.5 2.1 Reagent OD limit Fst.5 2.5 First H 1. No. Reagent 1 vol Reagent 2 vol μL μL μL 11 120 90 Dil.5 2.5 2. H 800* Fst Fst 12 Lst Lst FIXED + 27 Fst.1 -0.5 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2.5 2.1 -0.1 -0. L -0. H Lst.1 30* B 90 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil.1 -0. BSOSR6x68. Vol 0 0 0 Max.5 ∇ # Test name MYO Sample type Ser Page ½ System Reagent: OSR6168 Reagent ID: 068 Application MYOGLOBIN.1 1-Point Cal. 1 -0. # # # # CONC † † † † Factor/OD-L -0. # # ο ∇ 6. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x68. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 4AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined.: ODR3025 Values set for working in µg/L AU680 <Point Cal.1 2. ∇ 7. ∇ # # # # ο 3. Myoglobin Calibrator Cat.5 ∇ OD Range Low High -0.MYOGLOBIN.1 -0. Volume R1(R1-1) μL ∇ μL 7 1 76 Test Name: Max OD H 2.5 800* B 90 Last Last 27 % ∇ MYO ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 7 76 57 μL μL μL Dilution Dilution Dilution 0 0 10 μL μL μL Pri.5 2.1 2. None ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. ∇ # # # # ο 6. # # ο ∇ 4.1 -0.5 2.5 1.5 -0. Not within expected values µg/L* Decimal Places Calibration Specific ISE MYO ∇ < Low # # # # # # # # # SERUM APPLICATION High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum Counts: ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: # Process: CONC ∇ Test Name: MYO ∇ < > Test Name: Use Serum Cal.1 -0. # # ο ∇ 7.1 -0.1 R2(R2-1) μL Name Sec.5 -0.5 1.1 High High Max. ∇ # # # # ο 2. # # ο ∇ 2.1 -0. For No. ∇ # # # # ο 4. AU680/AU480 Serum Application System Reagent: OSR6168 Specific Test Parameters General LIH ISE Serum ∇ 1 -0.01 2009-08 .1 2.5 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6168 Reagent ID: 068 Application Operation Yes MYOGLOBIN.1 -0.5 -0. None Selected 8. AU2700/AU5400 Serum Reagent ID: 068 Parameters General LIH MYO ∇ Dilution μL -0.OD μL Min. Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A 30* 1 1 μL High B B 0 800* 0 0 Hour 57 Dilution 10 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.5 + ∇ 1-Point Cal. No. Calibration Type: 4AB ∇ Formula: POLYGONAL ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal.5 1. ∇ ∇ ∇ 30* Sec. No.5 1.5 2. ∇ # # # # ο 5. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.1 2. No demographics 8. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm FIXED ∇ + ∇ 12 570 FIXED + First 12 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH MYO ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # MYO ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 5. # # ο ∇ 3.1 Factor/OD-H 2. prealbumin is an excellent indicator of protein status (levels fall during periods of protein malnutrition). EN.5 mL R1 R2 Summary1.PREALBUMIN OSR6175 Intended Use Immuno-turbidimetric test for the quantitative determination of prealbumin in human serum on Beckman Coulter analysers. Quality Control ITA Control Sera ODC0014.It is a negative acute phase reactant whose levels also fall in inflammation and malignancy as well as in cirrhosis of the liver and protein wasting diseases of the gut or kidneys. Storage and Stability The reagents are stable. unopened. It binds and transports approximately 10% of both serum thyroxine and triiodothyronine and also plays a significant role in the metabolism of vitamin A by complexing with retinol-binding protein. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.2 Prealbumin (transthyretin). ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. Calculation The Beckman Coulter analysers automatically compute the prealbumin concentration of each sample. and if necessary determine its own reference interval according to good laboratory practice. Calibration Monitor. sex. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Each laboratory should verify the transferability of the expected values to its own population. flush waste-pipes with water after the disposal of undiluted reagent.01 2009-08 Specific Protein . The absorbance of these aggregates is proportional to the prealbumin concentration in the sample. Levels of prealbumin increase in Hodgkin's disease. clinical examinations and other findings. reagents stored on board the instrument are stable for 90 days. for acceptability using the software options Routine. The calibrator prealbumin values are traceable to IFCC (International Federation of Clinical Chemistry) standard CRM 470. on the Beckman Coulter analyser. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. ODR3029.2 – 0. Following calibration. and small pool size. due to the use of non-human materials in the controls. a high proportion of essential to non essential amino acids. human prealbumin reacts specifically with the anti-human prealbumin antibodies to yield insoluble aggregates. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. 3 Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. Specimen Test Procedure Serum: Stable for 6 months when stored at 2…8°C and 3 days when stored at 15…25°C. diet and geographical location.4 g/L (20 – 40 mg/dL) Expected values may vary with age. 4 x 15 mL 4 x 6. Dispose of all waste material in accordance with local guidelines. results should always be assessed in conjunction with the patient's medical history.01 BLOSR6x75. Please note that the recovery of non-Beckman Coulter controls may vary with reagent lots of immunoassay products. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. If any trends or sudden shifts in values are detected. For in vitro diagnostic use only. sample type. Calibration Curve. Other acute phase proteins may be assayed to differentiate whether a decrease in prealbumin is due to malnutrition or inflammation. review all operating parameters. Once open. Reagent Composition in the Test Final concentration of reactive ingredients: Solution of polymers in phosphate buffered saline Rabbit anti-human prealbumin antibodies Preservative (pH 7. A number of genetic variants have been described of which most are associated with extracelluar deposition of amyloid fibrils in various tissues. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Calibration Prealbumin Calibrator Cat. Major preventative maintenance was performed on the analyser or a critical part was replaced. The results obtained by any individual laboratory may vary from the given mean value. up to the stated expiry date when stored at 2…8°C.1 – 7. Reference Intervals4 Serum (Adults) 0. the resulting curve should be visually reviewed. a nonglycosylated tetrameric protein composed of four identical subunits is primarily synthesised in the liver. Because of its relatively short half life. Strongly lipemic samples should be avoided. Contents. To avoid the possible build-up of azide compounds.3) Variable Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. For diagnostic purposes. because of decreased synthesis and to a lesser extent increased degradation. No. a high tryptophan content. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. Effects of drugs on clinical laboratory tests.20:145-152. Schmitt Y. No. Rohlfs EM. 3.2:39pp.01 2009-08 EN. plasma and serum samples.: ODR3029 Values set for working in SI units (g/L).02 CV% 3.974 n = 70 Sample range = 0. Linearity The test is linear within a concentration range of 0.70 0. 1999. WHO/DIL/LAB/99. Data obtained in your laboratory may differ from these values.963x . 5 ed.45 0.06 0. To work in mg/dL multiply by 100.001 2. Ehret W. th 5. Heil W. Tietz textbook of clinical chemistry.12 0.90 0.10 1. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.1 Rev. rd 2. Clinical guide to laboratory tests. Baudner S.05 – 0. Method Comparison Patient serum samples were used to compare this Prealbumin OSR6175 assay on the AU600 against another commercially available prealbumin assay. 2000. Johnson AM. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP international reference material CRM 470. Tietz NW. In: Burtis CA.76 Sensitivity The lowest detectable level on an AU600 analyser was estimated at 0. Use of anticoagulants in diagnostic laboratory investigations and stability of blood.8 g/L (3 – 80 mg/dL). Zawta B. Philadelphia:WB Saunders Company. Setting Sheet Footnotes # † * User defined ¤ Analyser default value Prealbumin Calibrator Cat. The lowest detectable level represents the lowest measurable level of prealbumin that can be distinguished from zero. Silverman LM. AACC Press.1995:608-609. especially turbidity.0. 5 Limitations Samples with extremely abnormal optical characteristics.06 0.86 2. et al.500-501. Proteins. Töpfer G. may produce atypical results. Wisser H. eds. ed.01 0.01 1. Young DS.018 r = 0. Results of linear regression analysis were as follows: y = 0.01 1.004 g/L. Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. BIBLIOGRAPHY 1.Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.001 0.01 . Philadelphia: WB Saunders Company. 4. Ashwood ER.40 g/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 500 mg/dL Intralipid Refer to Young for further information on interfering substances.03 – 0. Specific Protein BLOSR6x75. 3 ed. n = 60 Within Run Total Mean g/L SD CV% SD 0. J Lab Med 1996. Dati F. 1 # Conc Factor/OD-H 2. # # ο ∇ 2. # # # # # OD CONC † † † † † Factor/OD-L -0.: ODR3029 * Values set for working in SI units (g/L) .8* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: PALB ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 First H 1.PREALBUMIN. To work in mg/dL multiply by 100 Specific Protein . AU400/AU640 Serum Reagent ID: 075 Specific test parameters Serum ∇ Sample vol. AU600 Serum Application System Reagent: OSR6175 Specific Test Parameters General LIH ISE Range Test Name: PALB ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil.5 2.5 2.01 2009-08 # User defined † Prealbumin Calibrator Cat. # # ο ∇ 4.1 -0. No.5 # Test Name: Counts: PALB ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.1 Last H 1. OD H 1. # # ο ∇ 5. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name PALB Sample type Ser ∇ 340 END + First 0 First 0 Pri. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Prealbumin Calibrator Cat. No. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # SERUM APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name PALB ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0. Reagent 1 vol Reagent 2 vol μL μL μL Fst.03* Correlation factor 0. Vol 0 0 0 Max.5 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2.5 Last L -0. Linearity Fst No lag time % Sec 0 0 Lst Lst 800 END + 27 10 3 150 65 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key. Vol Dil.03* H 0.: ODR3029 * Values set for working in SI units (g/L) . # # ο ∇ 6. L -0. 800 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.1 -0.5 2. # # ο ∇ 7.5 Dynamic Range: L 0.5 2.5 2. None Selected 8. Vol Dil. H ∇ ∇ ∇ Main 340 Sub 3 150 65 Dil.1 Lst. ∇ ∇ ∇ Sec. H Lst. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal.1 1-Point Cal.1 -0.5 2. L -0.1 -0.5 ∇ Operation: Yes Test No ∇ ∇ # Test name PALB Sample type Ser Page ½ System Reagent: OSR6175 Reagent ID: 075 Application PREALBUMIN. To work in mg/dL multiply by 100 BSOSR6x75. OD L Reagent OD limit Fst.1 -0.1 Dynamic range L 0. No.5 1.5 2.1 -0.1 -0. # # ο ∇ 3.8* Correlation Factor: A 1 B 0 On-board stability period: 90 H A B Rate Min.1 -0.5 2. 5 2. AU680/AU480 Serum Application System Reagent: OSR6175 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt. Point: ο With CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined.1 2. # # ο ∇ 6. None Selected 8.5 1.8* 0 0 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.4 120 52 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.5 ο Calibration Advanced Calibration Operation Interval (RB/ACAL) + ∇ 1-Point Cal.OD -0. Not within expected values g/L* Decimal Places Calibration Specific ISE PALB ∇ < Low # # # # # # # # # SERUM APPLICATION High # # # # # # # # Calibration Parameters STAT Table Calibration > Type Serum ∇ ο Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 2. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.03* 1 1 μL High B B 0 52 Dilution 0 2.5 2. Volume R1(R1-1) μL ∇ μL 2. 800 ∇ Last Last 27 10 0. 340 END + First 0 First 0 Common Rgt.1 2.1 2.5 ο Reagent Blank -0. AU2700/AU5400 Serum Reagent ID: 075 Parameters General LIH PALB ∇ Dilution μL Max. # # ο ∇ 5.PREALBUMIN. # # ο ∇ 7. # # # # # OD CONC † † † † † Factor/OD-L -0.5 μL Min.5 # Process: CONC ∇ Test Name: PALB ∇ < > Test Name: Use Serum Cal. # # ο ∇ 3. # # ο ∇ 2.1 -0. No.1 High High 1. ∇ # # # # ο 3. † Prealbumin Calibrator Cat.03* H 0. ∇ # # # # ο 4. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x75.8* Correlation Factor: A 1 B 0 On-board stability period: 90 Specific Test Parameters General LIH ISE Serum ∇ LIH PALB ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # PALB ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. ∇ # # # # ο 5.1 2.5 -0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L g/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.5 2. For No. No.5 Allowance Range Check -0.5 Dynamic Range: L 0.1 -0.4 1 120 Range Operation: ∇ Yes Test Name: PALB ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec. No demographics 8. ∇ # # # # ο 6. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 340 ∇nm END ∇ + ∇ 0 0 % ∇ ∇ ∇ ∇ Sec. ∇ 7.1 -0.1 Last H 1.01 2009-08 .1 -0.5 2.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6175 Reagent ID: 075 Application Operation Yes PREALBUMIN.1 2.5 Last L -0. ∇ # # # # ο 2.: ODR3029 * Values set for working in SI units (g/L) .1 First H 1. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal.5 -0. To work in mg/dL multiply by 100 ф AU680 <Point Cal.1 POLYGONAL ∇ Counts: # ∇ Factor Range Low High Slope Check -0.1 -0. # # ο ∇ 4. Reagent Composition in the Test Final concentration of reactive ingredients: Glycine buffer (pH 8.0) Latex coated with human IgG Preservative 170 mmol/L < 0. unopened. see setting sheets for specific instrument details. Dispose of all waste material in accordance with local guidelines. The absorbance of these aggregates is proportional to the RF concentration in the sample. for acceptability using the software options .01 2009-08 Specific Protein . No. Following calibration. For in vitro diagnostic use only. Calibration Monitor. IgA or IgE.5% 0. where the disease tends to be more severe. reagents stored on board the instrument are stable for 90 days. flush waste-pipes with water after the disposal of undiluted reagent. up to the stated expiry date when stored at 2…8°C. If any trends or sudden shifts in values are detected. However. Calibration RF Latex Calibrator Cat. These are usually IgM antibodies. Major preventative maintenance was performed on the analyser or a critical part was replaced. Higher titres of RF are more specific for the diagnosis of RA and are more common in patients with rapidly progressive joint destruction and in those with extraarticular manifestations such as subcutaneous rheumatic nodules. 4 x 24 mL 4 x 8 mL R1 R2 Summary1. infectious hepatitis. Safety data sheet available for professional user on request. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. A positive RF is also seen in autoimmune rheumatic diseases and in non-rheumatic conditions with variable frequency e. SLE. 3 Stable in serum and plasma for: 1 day at 20…25°C 8 days at 2…8°C 3 months at -20°C (avoid repeated freezing and thawing) Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.09% Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. subacute bacterial endocarditis and other bacterial infections. NIBSC 64/2. ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. Rheumatoid factor sensitivity in rheumatoid arthritis varies from 30% in population-based studies to 70 – 80% in hospital-based studies. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values. review all operating parameters.g.2 Rheumatoid factors (RF) are antibodies directed against antigenic determinants on the Fc fragment of IgG. Data check parameters are required. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. RF is a non-specific test and a positive RF is observed in 1 – 5% of the healthy population at low titres and in 15 – 20% of elderly subjects with other chronic disease states. To avoid the possible build-up of azide compounds. R2 should be mixed by inversion 5 – 10 times before placing on board the instrument and at weekly intervals thereafter. on the Beckman Coulter analyser. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. The results obtained by any individual laboratory may vary from the given mean value. RF reacts specifically with IgG coated on the latex particles to yield insoluble aggregates.: ODC0028.RF Latex OSR61105 Intended Use Immuno-turbidimetric test for the quantitative determination of RF (rheumatoid factor) antibodies in human serum and plasma on Beckman Coulter analysers. chronic liver diseases. Calibration Curve. Biological materials of human origin contained in R2 were tested for Anti-HCV. Once open. EN. Contents. 4 The calibrator RF value is traceable to WHO International reference material. chronic active pulmonary diseases. Sjögren’s syndrome. parasitic infections and viral infections. Na-/K-EDTA & citric acid plasma.Routine. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Specimen Serum and Li-/Na-heparin. Reagent Preparation R1 is ready for use and can be placed directly on board the instrument. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.01 BLOSR6x105. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. the resulting curve should be visually reviewed. this product should be handled as a potentially infectious material. Quality Control ITA Control Sera ODC0014. Storage and Stability The reagents are stable. but may be IgG. Test Principle When a sample is mixed with R1 buffer and R2 IgG latex suspension. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. sex.996x . AU640: n = 80 Mean IU/mL 10.38 0.79 0.47 0.26 20. Frankfurt/Main: TH-Books Verlagsgesellschaft.79 2. sample type. Genth E. Zawta B.69 0.37 112. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.81 AU400: n = 80 Mean IU/mL 9. WHO/DIL/LAB/99.90 20. 5.01 2009-08 EN. 1998:810-813.88 1.30 Total CV% 7. User defined ¤ Analyser default value RF Latex Calibrator Cat. Setting Sheet Footnotes # † § * 1. Clinical laboratory diagnostics.10 CV% 3.98 CV% 4. Clinical guide to laboratory tests.63 2.64 0. ed.71 117.1990. Effects of Drugs on Clinical Laboratory Tests. 2000. Each laboratory should verify the transferability of the expected values to its own population.1 Rev. Linearity The test is linear within a concentration range of 10 – 120 lU/mL.42 AU400 2. Heil W. Expected values may vary with age.217 r = 0. Young DS.996 n = 55 Sample range = 6.01 BIBLIOGRAPHY Specific Protein . Autoantibodies in rheumatoid arthritis.04 2. 2nd ed. Anderson SG. In: Thomas L. and if necessary determine its own reference interval according to good laboratory practice.07 1. 5th ed. No.96 2.62 0. 7. Mierau R.51 3. AACC.22 The lowest detectable level represents the lowest measurable level of RF that can be distinguished from zero. Bentzon MW. AU400 and AU2700 using 4 serum pools analysed over 20 days.39 0. 6. clinical examinations and other findings.16 1.89 3.11 2.2:41pp.36:565-578. Results of linear regression analysis were as follows: y = 0.81 SD 0.93 Within Run SD 0.5 percentile). Autoantibodies and specific serum proteins in the diagnosis of rheumatological disorders. may produce atypical results. 2.97 0.1.72 2. AACC Press.52 SD 0. Ehret W. Samples with very high RF concentrations (> 1500 IU/mL) can generate false low results without appropriate "Z" flags due to excess antigen in the sample.35 0.96 1.24 CV% 3. Schmitt Y. Bull Wld Hlth Org 1970.30 – 103.51 0. Töpfer G. Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood. 3. in particular type IgM (Waldenstrom’s macroglobulinemia).79 1.06 76.25 1. Use and assessment of clinical laboratory results.20 IU/mL Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin ® Lipemia: Interference less than 5% up to 1000 mg/dL Intralipid In very rare cases gammopathy.77 0. Plasma and Serum Samples. Method Comparison Patient serum samples were used to compare this RF Latex OSR61105 assay on the AU640 against other commercially available RF Latex assay (Method 2).59 Sensitivity The lowest detectable level was estimated as follows: Analyzer Lowest Detectable Level (IU/mL) AU2700 1.41 1. 4. 7 Refer to Young for further information on interfering substances. Limitations Samples with extremely abnormal optical characteristics.11 Total CV% 7. For diagnostic purposes.75 0.60 1.66 2.45 0. Philadelphia: WB Saunders Company.54 0. Wisser H. ed.: ODC0028 For the zero calibrator saline should be used Values set for working in IU/mL Ismail AA. Snowden N. Krag P. et al.24 0. Houba V.21 78. may cause unreliable results.87 114.30 0. In-house data on file Tietz NW.61 Within Run SD 0. especially turbidity. Ann Clin Biochem 1999. Precision The following data was obtained for the RF (Latex) assay on an AU640.46 0. International reference preparation of rheumatoid arthritis serum.Calculation The Beckman Coulter analysers automatically compute the RF concentration of each sample. Data obtained in your laboratory may differ from these values.27 0. diet and geographical location.6 Adult ≤ 14 IU/mL th This value is based on serum samples from 144 test subjects (97.47 0.97 Total CV% 5.93 Within Run SD 0. Reference Intervals5.99 19. BLOSR6x105.38 AU640 1.74 75. results should always be assessed in conjunction with the patient's medical history.42: 311-318.87 SD 0.65 AU2700: n = 80 Mean IU/mL 9. L -2.0000 0 0 Check Point-1 Check Point-2 Check Point-3 Decision value-1 Decision value-2 Decision value-3 Limit Point 1 Limit Point 2 12 19 27 0.1500 11 14 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: # † * § User defined Latex Calibrator Cat.0 Reagent OD limit Fst. Reagent 1 vol Reagent 2 vol 3 120 40 Dil. Vol 0 0 0 μL μL μL Max.5 Wave Method Reaction Point 1 Point 2 None FIXED + 19 ∇ ∇ ∇ Max OD H 2.1 Factor/OD-H 2.: ODC0028 Values set for working in IU/mL For the zero calibrator saline should be used Specific Protein .1 -0.5 2.1 -0.5 2.1 -0.1 -0.1 Cal type 14 Formula 10 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 # ∇ Point 7 ∇ 1-point cal.0000 0 0 NO 0 0.0000 0.5 2. Vol Dil.: ODC0028 Values set for working in SI IU/mL For the zero calibrator saline should be used BSOSR6x105. AU400/AU640 Serum/Plasma Reagent ID: 105 Specific Test Parameters Serum ∇ 1 -2. L -2.5 1-Point Cal.0 Lst. No.0000 0.0 Main Fst Fst Sample Pre-dil.5 2.5 2. NONE ∇ Min.5 2.8000 2. # # # # # # OD CONC 0§ † † † † † Factor/OD-L -0. OD L -2. AU600 Serum/Plasma Application System Reagent: OSR61105 Specific Test Parameters General LIH ISE Range Test Name: RF ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 3 120 40 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.0 Dynamic range L 10* Correlation factor Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: 660 FIXED + First 12 First Last Last 19 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: % ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2.1 -0. Vol Dil.1500 11 14 MB Type Factor: Calibration Stability Period: SERUM/PLASMA APPLICATION Data Check Parameters Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Test Name: RF ∇ < > Type: √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 12 19 27 0.5 2.0000 0. H H A B Rate Sample vol.01 2009-08 # † * § User defined ¤ Analyser default value Latex Calibrator Cat.1 -0.1 -0.5 2.0000 0.5 2.1 -0.5 2.8000 2.5 Fst.RF Latex.5 2. Linearity Fst No lag time Select using Space key.5 2.5 2.5 120* 1 0 ¤ 90 ∇ # Test name RF Sample type Ser Page ½ System Reagent: OSR61105 Reagent ID: 105 Application RF Latex. Point MB type factor Calibrator stability period 999 Conc 0§ † † † † † Factor/OD-L -0. OD H ∇ Operation: Yes Test No ∇ 2. ∇ ∇ ∇ Sec.1 -0. No.0 10* B 90 0 H 120* First H Last H 2. No.5 ∇ Advanced Calibration: ∇ Test No 999 # # Test Name: Counts: RF ∇ < > Type Calibration Type: 6AB ∇ Formula: SPLINE ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + Cal.1 -0. or select from list displayed by Guide key Calibration Specific Test No ∇ ∇ Count Process # Conc ∇ 6AB ∇ SPLINE OD # Test name RF % Sec % ∇ On-board stability period 12 Lst Lst 660 Sub -2. Point: ο with CONC-0 Slope Check: Select the function using the Function key or the Mouse Data Check Parameters # Logic check-1 Name YES RF ∇ Type Ser Logic Check-2 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 Logic Check-3 Check Point-1 Check Point Interval Decision value-1 Decision value-2 Limit Point 1 Limit Point 2 ∇ NO 0 0.0 -2. H Lst. 5 2.0 R2(R2-1) μL Name Sec. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 660 ∇nm FIXED ∇ + ∇ 12 660 FIXED + First 12 First Last Last 19 Pre-Dilution Rate: Min OD L Reagent OD limit: First L ∇ Last L Dynamic Range: L Correlation Factor: 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ % ∇ Calibration Specific General ISE Type: Serum ∇ Test Name: ∇ < RF > SPLINE ISE Type Parameters Calibrators General Calibration Specific Calibration Parameters STAT Table Calibration Serum ∇ ο Use Serum Cal.5 2. Volume R1(R1-1) μL ∇ μL 2.5 2.: ODC0028 Values set for working in IU/mL For the zero calibrator saline should be used.5 ο Reagent Blank -0.0 -2.5 2.5 + ∇ 1-Point Cal. For No.0 High High Max.1 2.0000 0.RF Latex.1 -0.0 -2. # # # # # # CONC 0§ † † † † † Factor/OD-L -0.1 2.OD μL Min.1500 11 14 Pattern1 # † * § Ф User defined RF Latex Calibrator Cat.5 2.1500 11 14 Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: Type: Serum ∇ Logic Check-3 Check Point-1: Check Point Interval: Decision Value-1: Decision Value 2: Limit Point 1: Limit Point 2: 12 19 27 0.5 2.5 2.0000 0. AU680 √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: Check Pattern: Specific Protein BSOSR6x105.5 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR61105 Reagent ID: 105 Application Operation Yes RF Latex.1 -0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 None ∇ ο with Conc-0 Hour Hour Parameters CheckedTests Test Name: Contamination Parameters RF ∇ Data Check Parameters < > Logic Check -2 Check Point-1: Check Point Interval: Decision Value-1: Decision Value-2: Limit Point 1: Limit Point 2: ∇ Misc √ Logic Check-1 Check Point-1: Check Point-2: Check Point-3: Decision Value-1: Decision Value-2: Decision Value-3: Limit Point 1: Limit Point 2: 12 19 27 0.1 -0.1 -0. No.5 2. AU2700/AU5400 Serum/Plasma Reagent ID: 105 Parameters General LIH RF ∇ Dilution μL -2. NONE Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.0 -2.1 2. ∇ ∇ ∇ 10* Sec.6 96 32 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.0 -2.1 2.8000 2. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Counts: # ∇ ∇ OD Range Low High Slope Check -0.1 Factor/OD-H 2.1 -0.5 -0.1 2. Test Name: Counts: # Process: CONC ∇ RF ∇ < > Calibration Type: 6AB ∇ Formula: SPLINE ∇ OD Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration # Cal.01 2009-08 .6 1 96 Test Name: Max OD H 2.5 120* B 90 Last Last 19 % ∇ RF ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 2.5 Advanced Calibration Operation Interval (RB/ACAL) # ∇ # ∇ Calibration Type: 6AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # 0§ ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: # † ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ SERUM/PLASMA APPLICATION Data Check Parameters Serum ∇ Test Name: RF ∇ < > Type: <Point Cal.5 -0.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.5 ο Calibration -0. No.8000 2.5 2. AU680/AU480 Serum/Plasma Application System Reagent: OSR61105 Specific Test Parameters General LIH ISE Serum ∇ 1 -2.5 Allowance Range Check -0. Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A 10* 1 1 μL High B B 0 120* 0 0 Hour 32 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.1 2. TRANSFERRIN OSR6152 Intended Use Immuno-turbidimetric test for the quantitative determination of transferrin in human serum and plasma on Beckman Coulter analysers. For in vitro diagnostic use only. 4 x 7 mL 4 x 8 mL R1 R2 Summary1,2 Transferrin is the principle plasma protein for the transport of iron. Transferrin has two binding sites for iron; they are strong at physiological pH but weaken with decreasing pH. Transferrin is largely but not exclusively synthesised by the liver. Measurement of plasma transferrin levels is useful in the differential diagnosis of anemia, and will rise with iron deficiency anemia. In congenital atransferrinemia, a very low level of transferrin is accompanied by iron overload and a severe hypochromic anemia resistant to iron therapy. High levels of transferrin occur in pregnancy and during oestrogen administration. It is decreased in conditions, which are associated with increased protein loss such as nephrotic syndrome, protein-deficiency states, and in chronic liver disease. Transferrin is a negative acute phase reactant and will decrease during any inflammatory state or malignancy. Transferrin is often used in conjunction with iron to calculate transferrin saturation. Test Principle When a sample is mixed with R1 buffer and R2 antiserum solution, human transferrin reacts specifically with anti-human transferrin antibodies to yield insoluble aggregates. The absorbance of these aggregates is proportional to the transferrin concentration in the sample. Contents, Reagent Composition in the Test Final concentration of reactive ingredients: Tris buffer (pH 7.2) Polyethylene glycol 6000 Goat anti-transferrin antibodies Preservative 30 mmol/L 0.8 % w/v Variable Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. To avoid the possible build-up of azide compounds, flush waste-pipes with water after the disposal of undiluted reagent. Dispose of all waste material in accordance with local guidelines. Safety data sheet available for professional user on request. Reagent Preparation The reagents are ready for use and can be placed directly on board the instrument. Storage and Stability The reagents are stable, unopened, up to the stated expiry date when stored at 2…8 °C. Once open, reagents stored on board the instrument are stable for 90 days. Specimen Serum and EDTA or heparinised plasma. 3 Stable in serum and plasma for 8 months when stored at 2…8 °C and 4 months when stored at 15…25 °C. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. The paediatric application is suitable for use with small volume serum/plasma samples. Calibration Serum Protein Multi-Calibrator Cat. No. ODR3021. MC Cal A Cat No. ODR30037 for Mastercurve enabled systems only. Please refer to User Guide for further instructions. ® The calibrator values are traceable to ERM – DA470. Recalibrate the assay when the following occur: Change in reagent lot or significant shift in control values; Major preventative maintenance was performed on the analyser or a critical part was replaced. Following calibration, the resulting curve should be visually reviewed for acceptability, on the Beckman Coulter analyser, using the software options to access the Calibration Monitor. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Quality Control ITA Control Sera ODC0014, ODC0015 and ODC0016 or other control materials with values determined by this Beckman Coulter system may be used. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. The results obtained by any individual laboratory may vary from the given mean value. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. If any trends or sudden shifts in values are detected, review all operating parameters. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Calculation The Beckman Coulter analysers automatically compute the transferrin concentration of each sample. EN.01 BLOSR6x52.01 2009-08 Specific Protein Reference Intervals4,5 Serum (Adults) Serum (Children) 0 − 4 day 3 month – 10 year 2.0 – 3.6 g/L (200 – 360 mg/dL) 1.30 – 2.75 g/L (130 – 275 mg/dL) 2.03 – 3.6 g/L (203 – 360 mg/dL) Expected values may vary with age, sex, sample type, diet and geographical location. Each laboratory should verify the transferability of the expected values to its own population, and if necessary determine its own reference interval according to good laboratory practice. For diagnostic purposes, results should always be assessed in conjunction with the patient's medical history, clinical examinations and other findings. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Data obtained in your laboratory may differ from these values. Linearity The test is linear within a concentration range of 0.75 − 7.50 g/L (75 − 750 mg/dL). Precision The following data was obtained on an AU600 using 3 serum pools analysed over 10 days. n = 60 Within Run Total Mean g/L SD CV% SD 1.47 0.01 0.62 0.01 2.84 0.02 0.64 0.02 6.51 0.06 0.88 0.08 CV% 0.96 0.86 1.28 Sensitivity The lowest detectable level in serum on an AU600 analyser was estimated at 0.01 g/L. The lowest detectable level represents the lowest measurable level of transferrin that can be distinguished from zero. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. Method Comparison Patient serum samples were used to compare this Transferrin OSR6152 assay on the AU400 against another commercially available transferrin assay. Results of linear regression analysis were as follows: y = 0.937x + 0.327 r = 0.995 n = 24 Sample range = 0.49 – 4.95 g/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 3% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 1000 mg/dL Intralipid Refer to Young for further information on interfering substances. 6 Limitations Samples with extremely abnormal optical characteristics, especially turbidity, may produce atypical results. Setting Sheet Footnotes # † ₪ * 1. 2. 3. 4. 5. 6. User defined ¤ Analyser default value Serum Protein Multi-Calibrator Cat. No.: ODR3021 MC Cal A Cat. No. ODR30037 Values set for working in SI units (g/L). To work in mg/dL multiply by 100. Grant GH, Silverman LM, Christenson RH. Amino Acids and proteins. In: Teitz NW, ed. Fundamentals of clinical chemistry. Philadelphia: WB Saunders Company, 1987:333-334pp. Thomas L. Transferrin saturation (TfS). In: Thomas L, ed. Clinical laboratory diagnostics. Use and assessment of clinical laboratory results. Frankfurt/Main: TH-Books Verlagsgesellschaft, 1998:275-277pp. Ehret W, Heil W, Schmitt Y, Töpfer G, Wisser H, Zawta B, et al. Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood, Plasma and Serum Samples. WHO/DIL/LAB/99.1 Rev.2:43pp. Baudner S, Dati F. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP International reference material CRM 470. J Lab Med 1996;20:145-152pp. Painter PC, Cope JY, Smith JL. Reference information for the clinical laboratory. In: Burtis CA, Ashwood ER, eds. Tietz textbook of clinical chemistry. Philadelphia:WB Saunders Company, 1999;1836pp. Young DS. Effects of drugs on clinical laboratory tests, 5th ed. AACC Press, 2000. BIBLIOGRAPHY Specific Protein BLOSR6x52.01 2009-08 EN.01 TRANSFERRIN, AU400/AU640 Serum/Plasma Reagent ID: 052 Specific test parameters Serum ∇ Sample vol. Reagent 1 vol Reagent 2 vol μL μL μL Fst. H Lst. H ∇ ∇ ∇ Main 380 Sub 2 35 40 Dil. Vol Dil. Vol Dil. Vol 0 165 80 Max. OD H 1.5 1.5 ∇ Operation: Yes Test No ∇ ∇ # Test name TRF Sample type Ser Page ½ System Reagent: OSR6152 Reagent ID: 052 Application TRANSFERRIN, AU600 Serum/Plasma Application System Reagent: OSR6152 Specific Test Parameters General LIH ISE Range Test Name: TRF ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil. Linearity Fst No lag time % Sec 0 0 Lst Lst 800 END + 27 10 2 35 40 μL μL μL Dilution Dilution Dilution 0 165 80 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key, or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name TRF Sample type Ser ∇ 380 END + First 0 First 0 Pri. ∇ ∇ ∇ Sec. 800 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.1 First H 1.5 Last L -0.1 Last H 1.5 Dynamic Range: L 0.75* H 7.50* Correlation Factor: A 1 B 0 On-board stability period: 90 H A B Rate Min. OD L Reagent OD limit Fst. L -0.1 Lst. L -0.1 Dynamic range L 0.75* Correlation factor 7.50* 1 0 ¤ 90 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: TRF ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name TRF ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 # Conc Factor/OD-H 2.5 2.5 2.5 2.5 2.5 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2.5 2.5 2.5 2.5 2.5 # SERUM/PLASMA APPLICATION Test Name: Counts: TRF ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 Advanced Calibration: # ∇ Cal. No. # # # # # OD CONC † † † † † Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 1-Point Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100. BSOSR6x52.01 2009-08 # User defined † Serum Protein Multi-Calibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100. Specific Protein TRANSFERRIN, AU2700/AU5400 Serum/Plasma Reagent ID: 052 Parameters General LIH TRF ∇ Dilution μL Max.OD -0.1 -0.1 High High 1.5 1.5 μL Min.OD Reagent OD Limit First Low Last Low Dilution 132 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6152 Reagent ID: 052 Application Operation Yes TRANSFERRIN, AU680/AU480 Serum/Plasma Application System Reagent: OSR6152 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) μL ∇ μL 1.6 1 28 Range Operation: ∇ Yes Test Name: TRF ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.75* 1 1 μL High B B 0 32 Dilution 64 1.6 28 32 μL μL μL Dilution Dilution Dilution 0 132 64 μL μL μL Pri. 380 END + First 0 First 0 Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 380 ∇nm END ∇ + ∇ 0 0 % ∇ ∇ ∇ ∇ Sec. 800 ∇ Last Last 27 10 7.50* 0 0 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.1 First H 1.5 Last L -0.1 Last H 1.5 Dynamic Range: L 0.75* H 7.50* Correlation Factor: A 1 B 0 On-board stability period: 90 Specific Test Parameters General LIH ISE Serum ∇ LIH TRF ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # TRF ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L g/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 2. ∇ # # # # ο 3. ∇ # # # # ο 4. ∇ # # # # ο 5. ∇ # # # # ο 6. ∇ 7. No demographics 8. Not within expected values g/L* Decimal Places Calibration Specific ISE TRF ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Serum Counts: ∇ # ο ∇ SERUM/PLASMA APPLICATION Calibration Specific General ISE Type Serum ∇ Counts: # Process: CONC ∇ Test Name: TRF ∇ < > Test Name: Use Serum Cal. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal. No. # # # # # CONC † † † † † Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 Factor/OD-H 2.5 2.5 2.5 2.5 2.5 ∇ OD Range Low High -0.1 2.5 -0.1 2.5 -0.1 2.5 -0.1 2.5 -0.1 2.5 + ∇ 1-Point Cal. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined Serum Protein Multi-Calibrator Cat. No.: ODR3021 Values set for working in SI units (g/L). To work in mg/dL multiply by 100. AU680 <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x52.01 2009-08 TRANSFERRIN, AU680/AU480 Mastercurve Serum/Plasma Application Reagent ID: 052 System Reagent: OSR6152 Parameters General Range Serum ∇ ∇ LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: TRF ∇ < > Type: Operation Yes Dilution Max.OD -0.1 -0.1 High High 1.5 1.5 Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) 1.6 1 28 0 μL OD Limit μL ∇ μL Dilution 132 μL Min.OD Reagent OD Limit First Low Last Low R2(R2-1) 32 μL Dilution 64 μL Name Sec. 0 Hour ф 800 Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.75* 1 1 High B B 7.50* 0 0 Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Noneф 380 ∇nm END ∇ + ∇ 0 0 % ∇ Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Parameters General Range Serum ∇ Panic Value Low # High # LIH ISE HbA1c Specific Test Parameters Calculated Test Test Name: TRF ∇ < > Type: High # High # # # # # # # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 2. ∇ # # # # ο 3. ∇ # # # # ο 4. ∇ # # # # ο 5. ∇ # # # # ο 6. ∇ 7. No demographics 8. Not within expected values Month # # # # # # Low # # # # # # # # Unit g/L* Decimal Places # Parameters Calibrators General ∇ ο Use Serum Cal. Calibration Specific Calibration Parameters STAT Table Calibration ISE SERUM/PLASMA APPLICATION Test Name: TRF ∇ < > Type Serum ∇ Yes ∇ # ∇ Calibration Type: 5MC ∇ Formula: POLYGONAL ∇ Counts: # ∇ <Calibrator Parameters> OD Range Calibrator OD Conc Low High Slope Check Point 1: 0.95* ∇ Point 2: 2.63* Allowance Range Check ∇ Point 3: 4.13* ∇ Point 4: 5.75* ∇ ο Reagent Blank Point 5: 7.21* ∇ ο Calibration Point 6: ∇ Point 7 Advanced Calibration ∇ Point 8 Operation ∇ Point 9 ∇ Point 10 Interval (RB/ACAL) ∇ 1 <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 # ₪ ∇ Point-2 ∇ Use Master Curve MC1 ∇ ∇ ο Lot Calibration OD Range Low High Stability 0.4013 0.9364 Reagent Blank 999 Day 0 Calibration 999 Day 0 Hour Hour MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 # * ₪ ф BSOSR6x52.01 2009-08 User defined Values set for working in SI units (g/L). To work in mg/dL multiply by 100. MC Cal A ODR30037 AU680 Specific Protein TRANSFERRIN, AU400/AU640 Paediatric Reagent ID: 052 Specific test parameters Serum ∇ Sample vol. Reagent 1 vol Reagent 2 vol μL μL μL Fst. H Lst. H 1.5 1.5 ∇ ∇ ∇ Main 380 Sub 2 35 40 Dil. Vol Dil. Vol Dil. Vol 10 165 70 Max. OD H ∇ Operation: Yes Test No ∇ ∇ # Test name TRFP Sample type Ser Page ½ System Reagent: OSR6152 Reagent ID: 052 Application TRANSFERRIN, AU600 Paediatric Application System Reagent: OSR6152 Specific Test Parameters General LIH ISE Range Test Name: TRFP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume Wave Method Reaction Point 1 Point 2 Fst Fst Sample Pre-dil. Linearity Fst No lag time Select using Space key, or select from list displayed by Guide key Test No ∇ # ∇ H # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ M M M M M M Age Y Y Y Y Y Y # # # # # # L # Test name TRFP Sample type Ser ∇ Level L # % Sec 0 0 Lst Lst H A B Rate 800 END + 27 10 2 35 40 μL μL μL Dilution Dilution Dilution 10 165 70 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period 380 END + First 0 First 0 Pri. ∇ ∇ ∇ Sec. 800 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.1 First H 1.5 Last L -0.1 Last H 1.5 Dynamic Range: L 0.75* H 7.50* Correlation Factor: A 1 B 0 On-board stability period: 90 90 Min. OD L Reagent OD limit Fst. L -0.1 Lst. L -0.1 Dynamic range L 0.75* Correlation factor 7.50* 1 0 ¤ Specific Test Parameters General LIH ISE Serum ∇ # # # # # # # Age Y Y Y Y Y Y Range Page 2/2 Level H # Test Name: TRFP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: g/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name TRFP ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 # Conc Factor/OD-H 2.5 2.5 2.5 2.5 2.5 ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2.5 2.5 2.5 2.5 2.5 # Test Name: TRFP ∇ < > Type Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. No. # # # # # OD CONC † † † † † Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 1-Point Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Serum Protein Multi-Calibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100. BSOSR6x52.01 2009-08 # User defined † Serum Protein Multi-Calibrator Cat. No.: ODR3021 * Values set for working in SI units (g/L). To work in mg/dL multiply by 100. Specific Protein TRANSFERRIN, AU2700/AU5400 Paediatric Reagent ID: 052 Parameters General LIH TRFP ∇ Dilution μL Max.OD -0.1 -0.1 High High 1.5 1.5 μL Min.OD Reagent OD Limit First Low Last Low Dilution 132 10 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6152 Reagent ID: 052 Application Operation Yes TRANSFERRIN, AU680/AU480 Paediatric Application System Reagent: OSR6152 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) μL ∇ μL 1.6 1 28 Range Operation: ∇ Yes Test Name: TRFP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec. 800 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.75* 1 1 μL High B B 0 7.50* 0 0 Hour 32 Dilution 54 1.6 28 32 μL μL μL Dilution Dilution Dilution 10 132 54 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 10 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 380 ∇nm END ∇ + ∇ 0 0 % ∇ 90 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ 380 END + First 0 First 0 Pri. ∇ ∇ ∇ Sec. 800 ∇ Last Last 27 10 % ∇ Pre-Dilution Rate: 1 Min OD Max OD L H Reagent OD limit: First L -0.1 First H 1.5 Last L -0.1 Last H 1.5 Dynamic Range: L 0.75* H 7.50* Correlation Factor: A 1 B 0 On-board stability period: 90 Specific Test Parameters General LIH ISE Serum ∇ LIH TRFP ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # TRFP ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General ISE TRFP ∇ < > POLYGONAL Test Name: g/L* Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L g/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 2. ∇ # # # # ο 3. ∇ # # # # ο 4. ∇ # # # # ο 5. ∇ # # # # ο 6. ∇ 7. No demographics 8. Not within expected values Decimal Places Calibration Specific Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration Type Serum Counts: ∇ # ο ∇ PAEDIATRIC APPLICATION Calibration Specific General ISE Type Serum ∇ # Process: CONC ∇ Test Name: TRFP ∇ < > Use Serum Cal. Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Counts: OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal. No. # # # # # CONC † † † † † Factor/OD-L -0.1 -0.1 -0.1 -0.1 -0.1 Factor/OD-H 2.5 2.5 2.5 2.5 2.5 ∇ OD Range Low High -0.1 2.5 -0.1 2.5 -0.1 2.5 -0.1 2.5 -0.1 2.5 + ∇ 1-Point Cal. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * Ф User defined Serum Protein Multi-Calibrator Cat. No.: ODR3021 Values set for working in SI units (g/L). To work in mg/dL multiply by 100. AU680 <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour Specific Protein BSOSR6x52.01 2009-08 Carbamazepine OSR6414 2 x 16 mL 2x 2 x 16 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the quantitative determination of carbamazepine in human serum and plasma on Beckman Coulter analysers. For in vitro diagnostic use only. Summary Carbamazepine is an anticonvulsant drug, used in particular for the treatment of trigeminal neuralgia , all forms of partial epilepsy, generalised tonic-clonic 2-4 seizures, and simple and complex partial seizures. Effective serum concentration of carbamazepine is essential for seizure control. However, serum 5,6 carbamazepine concentrations show only a moderate correlation to dose, due to individual differences in absorption, metabolism and clearance. 6 Moreover, co-administration of other antiepileptic agents can significantly increase serum carbamazepine levels. Toxicity of carbamazepine associated with therapy may or may not be dose related. However, the central nervous system symptoms of vertigo, dizziness, and diplopia are dose-related with chronic therapy. In conjunction with other clinical information, monitoring carbamazepine levels will provide physicians with an effective tool to aid in adjusting dosage and achieving optimal therapeutic effect while avoiding both subtherapeutic and toxic drug levels. 2-4 1 Test Principle7 This assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a colour change that can be measured spectrophotometrically. In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment of β-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive β-galactosidase fragments, and no active enzyme will be formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample. Reagent Composition R1 Buffer R1 Lyo R2 Buffer R2 Lyo MOPS (3-(N-morpholino)propanesulfonic acid buffer), mouse monoclonal anti-carbamazepine antibodies, stabiliser and preservative. Enzyme acceptor, stabiliser, buffer salts and preservative. MES (2-(N-morpholino)ethanesulfonic acid buffer) and preservative. Enzyme donor conjugated to carbamazepine, chlorophenol red-β-D-galactopyranoside, buffer salts, stabiliser and preservative. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. Contains sodium azide. R22; Harmful if swallowed. Safety Phrases: S36, S60. Wear suitable protective clothing. This material and its container must be disposed of as hazardous waste. Dispose of all waste material in accordance with local guidelines. To avoid the possible build-up of azide compounds, flush waste-pipes with water after the disposal of undiluted reagent. Refer to Safety Data Sheets for further information. Reagent Preparation Remove the kit from refrigerated storage (2…8°C) immediately prior to preparation of the solutions. Prepare the R2 solution before the R1 solution to minimise possible contamination. R2 (Enzyme donor solution): Connect the R2 lyo bottle to the R2 buffer bottle using one of the enclosed adapters. Mix by gentle inversion, ensuring that all the lyophilised material from the R2 lyo bottle is transferred into the R2 buffer bottle. Avoid the formation of foam. Detach the R2 lyo bottle and adapter from the R2 buffer bottle and discard. Cap the R2 buffer bottle and let stand for approximately 5 minutes at 15…25°C. Mix again. Record the reconstitution date on the bottle label. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. Ensure the reagent is homogeneous before use. R1 (Enzyme acceptor solution): Connect the R1 lyo bottle to the R1 buffer bottle using one of the enclosed adapters. Mix by gentle inversion, ensuring that all the lyophilised material from the R1 lyo bottle is transferred into the R1 buffer bottle. Avoid the formation of foam. Detach the R1 lyo bottle and adapter from the R1 buffer bottle and discard. Cap the R1 buffer bottle and let stand for approximately 5 minutes at 15…25°C. Mix again. Record the reconstitution date on the bottle label. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. Ensure the reagent is homogeneous before use. NOTE 1: The components supplied in this kit are intended for use as an integral unit. Do not mix components from different lots. NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the appropriate reagent bottle. The R2 working solution (enzyme donor) should be yellow-orange in colour. A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded. NOTE 3: The R1 and R2 solutions must be at the reagent compartment temperature of the analyser before performing the assay. NOTE 4: To ensure reconstituted R1 stability, protect from prolonged, continuous exposure to bright light. NOTE 5: Do not freeze reconstituted reagents. EN.01 BLOSR6414.01 2009-08 TDM Storage and Stability The reagents are stable, unopened, up to the stated expiry date when stored at 2...8°C. Once reconstituted, reagents stored on board the instrument are stable for 60 days. Specimen Serum or plasma (Na or Li heparin; Na EDTA) may be used. Stable in serum and plasma for 7 days when stored at 2…8°C and 4 weeks when stored at -20˚C. Avoid repeated freezing and thawing. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. Calibration Core TDM Multi-calibrator, Cat. No. ODC6411. The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values; Major preventative maintenance was performed on the analyser or a critical part was replaced. Following calibration, the resulting curve should be visually reviewed, on the Beckman Coulter analyser, for acceptability using the software options Routine, Calibration Monitor, Calibration Curve. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Quality Control Control materials with values determined by this Beckman Coulter system may be used. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. The results obtained by any individual laboratory may vary from the given mean value. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. If any trends or sudden shifts in values are detected, review all operating parameters. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Calculation The Beckman Coulter analysers automatically compute the carbamazepine concentration of each sample. Expected Values The effective serum/plasma carbamazepine concentrations for seizure control have been reported as 8 – 12 µg/mL for adults receiving carbamazepine 5,9-12 as the sole antiepileptic agent. Other therapeutic ranges for carbamazepine have also been suggested The expected range provided is only a guide for drug dosage. Prior to the adjustment of dose, results should always be assessed in conjunction with other available information such as patients medical history, mode of drug administration, timing of sample collection, other drug treatments and clinical 13 symptoms. 4,8 Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Data obtained in your laboratory may differ from these values. Linearity The test is linear within a concentration range of 0.5 µg/mL and the value of the highest calibrator (approximately 20 µg/mL or 84.6 µmol/L). Specimen results greater than the highest calibrator can be reported as greater than the value of the highest calibrator or diluted one part sample with one part Core TDM Multi-Calibrator 1 and reassayed. The value obtained on reassay should be derived as follows: Actual Value = (2 x diluted value) – Concentration of Core TDM Multi-Calibrator 1. Samples reported as less than the analytical range can be confirmed by diluting one part sample of known value with one part of the original patient sample. The assayed result of this dilution, when multiplied by 2, should approximate the original value of the known sample to confirm the low patient result. The confirmed result should be reported as < 0.28 µg/mL. If the assayed result of the first dilution, when multiplied by 2, does not approximate the original result of the known sample, further dilutions utilising saline are needed. Precision The following data was obtained on an AU2700 using serum pools and control sera. Two replicates of each sample were analysed twice daily over 20 days. n = 80 Mean µg/mL 4.2 7.1 12.1 Within Run SD 0.14 0.14 0.22 CV% 3.3 2.0 1.8 SD 0.28 0.34 0.50 Total CV% 6.7 4.8 4.1 Method Comparison Patient serum samples were used to compare this Carbamazepine OSR6414 assay on the AU640 against another commercially available carbamazepine assay. Results of linear regression analysis were as follows: y = 0.942x – 0.07 r = 0.997 n = 135 Sample range = 0.5 – 26.4 µg/mL Sensitivity The lowest detectable level on an AU2700 analyser was estimated at 0.28 µg/mL. The lowest detectable level (LDL) represents the lowest measurable level of carbamazepine that can be distinguished from zero. It is calculated as the absolute mean plus three standard deviations of 25 replicates of an analyte free sample. Interference No significant interference (<10%) was observed with the following substances: Substance Concentration Substance Bilirubin ≤ 1026 µmol/L Total Protein Haemoglobin ≤ 10 g/L Triglyceride Rheumatoid Factor ≤ 180 IU/mL TDM BLOSR6414.01 2009-08 Concentration ≤ 120 g/L ≤ 11.3 mmol/L EN.01 Specificity The following compounds when tested with the Carbamazepine assay, yielded the following percent cross-reactivity results: Compound Concentration Tested (µg/mL) % Cross reactivity Amitriptyline 100 18.6 Carbamazepine-10,11-epoxide 250 7.4 Diazepam 250 4.8 Imipramine 200 5.6 Methsuximide 1000 1.0 Nortriptyline 50 17.2 Phenothiazine 200 8.6 Probenecid 500 2.0 Limitations • • Samples containing antibodies to E. coli β-galactosidase may result in artificially high results which will not fit the clinical profile. The incidence of patients having such antibodies is extremely low. As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the sample, which could cause falsely elevated results. User defined ¤ Analyser default value Core TDM Multi-calibrator Cat. No.: ODC6411 Values set for working in µg/mL. To work in SI units (µmol/L) multiply by 4.23 Setting Sheet Footnotes # † * BIBLIOGRAPHY 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Blom S.: Trigeminal neuralgia: its treatment with a new anticonvulsant drug (G-32883) Lancet, Is. 1962; 839-840. Eadie MJ, Tyler JH Anticonvulsant Therapy: Pharmacological Basis and Practice. In: Churchhill Livingstone, Edinburgh. Great Britain, 1974: Chapter 7. Penry JK, Newmark ME. The use of antiepileptic drugs. Annals of Internal Medicine, 1979; 90: 207-218. Scheuer ML, Pedley TA. The evaluation and treatment of seizures. N. Engl. J. Med., 1990; 322 (21):1468-1474. Larkin JG, Herrick AL, McGuire GM, Percy-Robb IW, Brodie MJ. Antiepileptic Drug Monitoring at the Epilepsy Clinic: A Prospective Evaluation. Epilepsia, 1991; 32: 89-95. Altafullah I, Talwar D, Loewenson R, Olson K, Lockman LA. Factors Influencing Serum Levels of Carbamazepine and Carbamazepine-10, 11-epoxide in children. Epilepsy 1989; Res. 4: 72-80. Henderson DR, Friedman SB, Harris JD, et al. CEDIA™, a new homogeneous immunoassay system. Clin Chem. 1986; 32:1637-1641. Troupin A, Ojemann LM, Halpern L, Dodrill C, Wikus R, Friel P. Carbamazepine - a double blind comparison with phenytoin. Neurology 1977; 27: 511-519. Strandjord RE, Johannessen SI. Single-drug therapy with carbamazepine in patients with epilepsy: serum levels and clinical effects. Epilepsia 1980; 21: 655662. Simonsen H, Olsen PZ, Khul V, Lund M, Wendelboe J. A comparative controlled study between carbamazepine and diphenylhydantoin in psychomotor epilepsy. Epilepsia 1976; 17: 169-176. Shorvon SD, Chadwick D, Galbraith AW, Reynolds EH. One drug for epilepsy. Br. Med. J. 1978;1:474-476. MacKichan JJ, Kutt H. Carbamazepine: Therapeutic use and serum concentration monitoring. In: Taylor WJ, Finn AL eds. Individualizing Drug Therapy: Practical Applications of Drug Monitoring. New York: Gross, Townsend, Frank, Inc., 1981:1-25. Hallworth M, Capps N, eds. Therapeutic drug monitoring and clinical biochemistry, London:ACB Venture Publications, 1993. EN.01 BLOSR6414.01 2009-08 TDM CARBAMAZEPINE, AU400/AU640 Serum/Plasma Reagent ID: 414 Specific test parameters Serum ∇ Sample vol. Reagent 1 vol Reagent 2 vol μL μL μL Fst. H Lst. H ∇ ∇ ∇ Main 570 Sub 2 87 87 Dil. vol Dil. vol Dil. vol 0 0 0 Max. OD H ∇ Operation: Yes Test No ∇ 2.50 2.50 2.50 ∇ # Test name CBZ Sample type Ser Page 1/2 System Reagent: OSR6414 Reagent ID: 414 Application CARBAMAZEPINE, AU600 Serum/Plasma Application System Reagent: OSR6414 Specific Test Parameters General LIH ISE Range Test Name: CBZ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. 24 Sample Pre-dil. Linearity Fst No lag time NO % Sec ∇ ∇ ∇ Fst Fst Lst Lst Sec. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key, or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name CBZ Sample type Ser ∇ 570 RATE1 + First 24 First Last Last 27 Wave Method Reaction Point 1 Point 2 660 RATE1 + 27 Min. OD L -2.00 Reagent OD limit Fst. L -2.00 Lst. L -2.00 Dynamic range L 0.5* Correlation factor H A B Rate 20* 1.04 0 ¤ NO % ∇ Pre-Dilution Rate: 1 Min OD Max OD L -2.00 H 2.50 Reagent OD limit: First L -2.00 First H 2.50 Last L -2.00 Last H 2.50 Dynamic Range: L 0.5* H 20* Correlation Factor: A 1.04 B 0 On-board stability period: 60 60 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: CBZ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: µg/mL* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name CBZ ∇ AA ∇ Y=AX+B OD ∇ Conc † † Count Process Factor/OD-L -999999 -999999 # Conc Factor/OD-H 9999999 9999999 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 9999999 9999999 # SERUM/PLASMA APPLICATION Test Name: Counts: CBZ ∇ < > Type Calibration Type: AA ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. No. # # OD CONC † † Factor/OD-L -999999 -999999 1-Point Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 9 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Core TDM Multi-Calibrator Cat. No.: ODC6411 * Values set for working in µg/mL. To work in SI units (µmol/L) multiply by 4.23 BSOSR6414.01 2009-08 # User defined † Core TDM Multi-Calibrator Cat. No.: ODC6411 * Values set for working in µg/mL. To work in SI units (µmol/L) multiply by 4.23 TDM ∇ # # # # ο 2. AU2700/AU5400 Serum/Plasma Reagent ID: 414 Parameters General LIH CBZ ∇ Dilution μL -2. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AA ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined. Not within expected values µg/mL* Decimal Places Calibration Specific ISE CBZ ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High -999999 999999 ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 9999999 9999999 # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: CBZ ∇ < > Test Name: Use Serum Cal.00 Last H 2. # # OD CONC † † Factor/OD-L -999999 -999999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal.6 70 70 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. ∇ # # # # ο 5. # # ο ∇ 2.50 Dynamic Range: L 0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour TDM BSOSR6414.OD μL Min. ∇ ∇ ∇ Sec. # # ο ∇ 7.00 -2.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.: ODC6411 Values set for working in µg/mL. For No. # # ο ∇ 4.00 High High Max.5* H 20* Correlation Factor: A 1.50 Reagent OD limit: First L -2.50 Last L -2. None Selected 8. 660 ∇ 570 RATE1 + First 24 First Common Rgt. Volume R1(R1-1) μL ∇ μL 1.50 2. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. # # ο ∇ 6. To work in SI units (µmol/L) multiply by 4. # # ο ∇ 5.50 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6414 Reagent ID: 414 Application Operation Yes CARBAMAZEPINE.6 1 70 Range Operation: ∇ Yes Test Name: CBZ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec. Core TDM Multi-Calibrator Cat.23 AU680 <Point Cal.00 -2.04 μL High B B 0 70 Dilution 0 1. No. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 NO % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 570 ∇nm RATE1 ∇ + ∇ 24 Last Last 27 20* 0 0 Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: NO % ∇ Pre-Dilution Rate: 1 Min OD Max OD L -2.50 2.04 B 0 On-board stability period: 60 60 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH CBZ ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # CBZ ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5* 1 1. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/mL* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. No demographics 8. ∇ # # # # ο 6. No.00 H 2. ∇ # # # # ο 3. # # ο ∇ 3. Calibration Type: AA ∇ Formula: Y=AX+B ∇ Cal.CARBAMAZEPINE. ∇ # # # # ο 4. ∇ 7. AU680/AU480 Serum/Plasma Application System Reagent: OSR6414 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt.01 2009-08 .00 First H 2. It may not be immediately apparent whether the patient has been under or overdosed. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. flush waste-pipes with water after the disposal of undiluted reagent. EN. Calibration Digitoxin Calibrator Cat. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. up to the stated expiry date when stored at 2…8°C. Cardiac 1 glycosides have a low therapeutic ratio (a very small difference between therapeutic and tissue toxic levels). Following calibration.01 2009-08 TDM .Routine. Test Principle R1 contains a monoclonal antibody specific for digitoxin that binds to microparticles covalently coated with a digitoxin derivative in R2. This difference results in digitoxin being more lipid soluble and highly bound to protein with the effect that it has a relatively long half life of 5-7 days and requires higher concentrations to achieve therapeutic effectiveness. Intoxication symptoms are often indistinguishable from the original condition for which the drug was prescribed. Data obtained in your laboratory may differ from these values. the resulting curve should be visually reviewed.01 BLOSR6403. There is a marked patient 2 variability in response to the same dose of drug. Storage and Stability The reagents are stable. unopened. ODC6403. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. The results obtained by any individual laboratory may vary from the given mean value. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.4 in adjusting patient dosage to achieve optimal therapeutic effect while avoiding useless subtherapeutic or harmful toxic dosage levels. Its structure is the same as digoxin except for the loss of the C-12 hydroxyl group.8 mL R1 R2 Summary Digitoxin is a naturally occurring cardiac glycoside that is used to treat congestive heart failure and atrial fibrillation. Monitoring serum digitoxin levels combined with other clinical data can provide the physician with useful information to aid 3. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. R2 should be mixed by inversion 5 – 10 times before placing on board the instrument and at fortnightly intervals thereafter. To avoid the possible build-up of azide compounds. thus inhibiting the agglutination reaction. Specimen5 Serum: Stable in serum for 3 months when stored at 2…8°C and 2 weeks when stored at 15…25°C. Digitoxin from the sample competes with the microparticle-bound digitoxin for the antibody. Therapeutic Range6 Effective levels 13 – 39 nmol/L (10 – 30 ng/mL) Toxic Levels >39 nmol/L (30 ng/mL) Consider these ranges as guidelines only. Calibration Monitor. Once open. Calculation The Beckman Coulter analysers automatically compute the digitoxin concentration of each sample. Major preventative maintenance was performed on the analyser or a critical part was replaced. Dispose of all waste material in accordance with local guidelines. on the Beckman Coulter analyser. 2 x 21 mL 2 x 12. Reagent Preparation R1 is ready for use and can be placed directly on board the instrument. If any trends or sudden shifts in values are detected. For in vitro diagnostic use only. Calibration Curve.DIGITOXIN OSR6403 Intended Use Immuno-inhibition test for the quantitative determination of digitoxin in human serum on Beckman Coulter analysers. which can be measured spectrophotometrically at 700 nm. The resulting agglutination reaction causes an increase in turbidity. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. No. Quality Control Control materials with values determined by this Beckman Coulter system may be used. These calibrators are gravimetrically prepared then verified by a commercially available process. Reagent Composition in the Test Final concentration of reactive ingredients: Monoclonal anti-digitoxin antibody Digitoxin – derivative coated microspheres Variable Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. for acceptability using the software options . review all operating parameters. Contents. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. reagents stored on board the instrument are stable for 30 days. often resulting in unpredictable serum drug levels. 2nd Ed.5:222-4. In such cases the analysis must be repeated following ultrafiltration of the samples (exclusion threshold: MW 100. does not approximate the original result of the known sample. the standard serum digitoxin concentration measurement can be clinically misleading until the Fab fragment is eliminated from the body.63 Sensitivity The lowest detectable level on an AU640 analyser was estimated at 1.50 0. et al.90 ng/mL).8 Digoxigenin-mono-digitoxide 25 18. No.055x – 1. Setting Sheet Footnotes # † * 1.66 1. 7 Specificity The following compounds have been tested for cross reactivity in the assay. the possibility exists for interference by human anti-mouse antibodies (HAMA) in the sample. The confirmed result should be reported as < 1. Surawicz B. GlaxoSmithKline Product Information. Töpfer G. should approximate the original value of the known sample to confirm the low patient result.. McDevitt DG. Effects of drugs on clinical laboratory tests.22 2. further dilutions utilising saline are needed.20:389-404.23 CV% 3. Series on pharmacology in practice 3. Young DS. Making digitalis safer.Linearity The test is linear within a concentration range of 0 – 118 nmol/L (0 .36 1. eds. which could cause falsely elevated results. 20. Prednisone.5 Dihydrodigitoxigenin 25 19.2:29pp. Drugs 1980. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 10 days. Digitalis.62 63. Substance Conc. If the assayed result of the first dilution. To work in ng/mL divide by 1.470 r = 0.01 2009-08 EN. Vliesta RE. Drug Ther 1975.1 Rev.127-47.: ODC6403 Values set for working in SI units (nmol/L). Ehret W. Tested ng/mL Cross-reaction (%) Digitoxigenin 12. Inc. 2000.01 . will interfere with digitalis immunoassay measurements.5 332.61 1. Thus.0 ng/mL digitoxin. New York: Grune and Stratton.96 1. The lowest detectable level represents the lowest measurable level of digitoxin that can be distinguished from zero. AACC Press.5 Digoxin 25 17. In rare cases. ® Digoxin Immune Fab. 6. samples from digitalised patients may yield clinically implausible values of 0. Digitalis glycosides. 7.5 A cross-reaction of less than 10% was found for the following: Dihydrodigoxin. WHO/DIL/LAB/99. User defined ¤ Analyser default value System Calibrator Cat. August 2001. Heil W. Results of linear regression analysis were as follows: y = 1.4 Digoxigenin 25 17. Schmitt Y. Surawiicz B. 2. 5th ed. Method Comparison Patient serum samples were used to compare this Digitoxin OSR6403 assay on the AU640 against another commercially available digitoxin assay. Samples reported as less than the analytical range can be confirmed by diluting one part sample of known value with one part of the original patient sample. The assayed result of this dilution. American Association for Clinical Chemistry.14 1.000). Testosterone.2 nmol/L. Factors affecting individual tolerance to digitalis. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. when multiplied by 2. Therapeutic Drug Monitoring and Toxicology Laboratory Improvement Program. Serum digitoxin concentration ® 8 should be obtained before administration of Digibind if at all possible.4 Digitoxigenin-mono-digitoxide 25 168.54:675-84. Bresnahan JF. Taggart AJ.09 SD 0. Limitations As with any assay employing mouse antibodies. Wisser H.22-Dihydrodigoxigenin. Digitalis: Its place in modern therapy. 1994 pp. In: Fisch C.82 Total CV% 4. 3. Mayo Clin Proc 1979. Zawta B. n = 60 Mean nmol/L 15.94 Within Run SD 0.59 – 62.179 nmol/L. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. 1969. plasma and serum samples.36 nmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin ® Lipemia: Interference less than 5% up to 1000 mg/dL Intralipid RF: Interference less than 10% up to 505 IU/mL RF Refer to Young for further information on interfering substances.61. 4.4 Digoxigenin-bis-digitoxide 25 11. McNeely MDD. Drug Monitoring Data (Pocket Guide II).31. BIBLIOGRAPHY TDM BLOSR6403. and Oubain.71 111. such as Digibind.0 Digitoxigenin-bis-digitoxide 25 144. when multiplied by 2. 8.961 n = 108 Sample range = 4. 5. Mortelmans S.21 0. H 118* Fst Fst 12 Lst Lst First H Last H 2.1 Main ∇ ∇ ∇ 700 Sub -0.1 -0. No.5 2.5 NONE FIXED1 + 27 Max OD H 2.5 2. Point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Digitoxin Calibrator Cat.5 2. No. # # ο ∇ 5. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name DGT Sample type Ser ∇ On-board stability period Pri.5 2. No.31 TDM . Vol Dil.1 -0. AU400/AU640 Serum Reagent ID: 403 Specific test parameters Serum ∇ 1 -0.1 -0.5 2. None Selected 8.1 1-Point Cal. # # ο ∇ 2. Vol 0 0 0 Max.1 -0. Vol Dil. To work in ng/mL divide by 1.1 -0.1 -0.1 -0.31 BSOSR6403. 700 ∇ FIXED1 ∇ + ∇ First 12 First % ∇ Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. # # ο ∇ 4. To work in ng/mL divide by 1.5 Fst.01 2009-08 # User defined † Digitoxin Calibrator Cat.DIGITOXIN.5 2.1 -0.5 ∇ Test Name: Counts: DGT ∇ < > Type Calibration Type: 6AB ∇ Formula: EIA TYPE 1 ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: - Cal. H Lst. H Sample vol.1 -0.5 2.5 2.5 2.1 -0.5 2. None ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.5 ∇ Advanced Calibration: 999 # ∇ # Calibration specific Test No # Test name DGT ∇ 6AB ∇ EIA TYPE 1 OD ∇ Conc † † † † † † Count Process Factor/OD-L -0. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 14 Formula 6 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 # ∇ Point 7 ∇ 1-point cal.5 2. OD H ∇ Operation: Yes Test No ∇ 2. OD L -0. L -0. Out of Range L # # # # # # # # Unit: nmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # SERUM APPLICATION Select the function using the Function key or the Mouse Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2.1 -0. Reagent 1 vol Reagent 2 vol μL μL μL 6 210 128 Dil.1 Reagent OD limit Fst.5 ∇ # Test name DGT Sample type Ser Page ½ System Reagent: OSR6403 Reagent ID: 403 Application DIGITOXIN. # # ο ∇ 6. # # ο ∇ 7.1 Dynamic range L 0* Correlation factor 118* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: DGT ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.: ODC6403 * Values set for working in SI units (nmol/L). # # # # # # OD CONC † † † † † † Factor/OD-L -0.5 2. # # ο ∇ 3.1 # Conc Factor/OD-H 2.5 2.1 Lst. AU600 Serum Application System Reagent: OSR6403 Specific Test Parameters General LIH ISE Range Test Name: DGT ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 6 210 128 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Sec. L -0.1 0* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil.: ODC6403 * Values set for working in SI units (nmol/L). # # ο ∇ 5.31 AU680 <Point Cal.1 -0.5 -0.1 -0.1 -0. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour TDM BSOSR6403.5 ∇ OD Range Low High -0. ∇ # # # # ο 5. ∇ # # # # ο 4.5 2.1 Factor/OD-H 2. # # ο ∇ 4.1 2. For No.1 2.5 2.5 -0.1 2.: ODC6403 Values set for working in SI units (nmol/L).1 -0.5 2.5 2. ∇ # # # # ο 6. Not within expected values nmol/L* Decimal Places Calibration Specific ISE DGT ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > EIA TYPE 1 Type Serum Counts: ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: # Process: CONC ∇ Test Name: DGT ∇ < > Test Name: Use Serum Cal. Calibration Type: 6AB ∇ Formula: EIA TYPE 1 ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ 999 ∇ Advanced Calibration: # Cal. ∇ # # # # ο 2. # # # # # # CONC † † † † † † Factor/OD-L -0.1 -0. Volume R1(R1-1) μL ∇ μL 3 1 105 Test Name: Max OD H 2.5 2. None ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 0* A 1 On-board stability period: Common Rgt.01 2009-08 . # # ο ∇ 7.1 -0.5 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6403 Reagent ID: 403 Application Operation Yes DIGITOXIN. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 700 ∇nm FIXED1 ∇ + ∇ 12 Pri. ∇ 7. None Selected 8.1 2.5 -0. No demographics 8. No. To work in ng/mL divide by 1.1 R2(R2-1) μL Name Sec.5 -0.1 High High Max. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 6AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: # † ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined.5 -0.1 -0.5 2.5 2. ∇ # # # # ο 3.5 2. Digitoxin Calibrator Cat. # # ο ∇ 2.1 -0. No. Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A 0* 1 1 μL High B B 0 118* 0 0 Hour 64 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. 700 ∇ FIXED1 ∇ + ∇ First 12 First % ∇ Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH DGT ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # DGT ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.DIGITOXIN.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.5 2. # # ο ∇ 3.1 2.5 118* B 30 Last Last 27 % ∇ DGT ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 3 105 64 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Sec.1 -0. AU680/AU480 Serum Application System Reagent: OSR6403 Specific Test Parameters General LIH ISE Serum ∇ 1 -0.OD μL Min.5 - ∇ 1-Point Cal. # # ο ∇ 6.1 2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L nmol/L* H Month # # # # # # SERUM APPLICATION Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. AU2700/AU5400 Serum Reagent ID: 403 Parameters General LIH DGT ∇ Dilution μL -0. often resulting in unpredictable serum drug levels.derivative coated microspheres ≤ 1.0 mg/L 0. Following calibration.6 mL 2 x 12. For in vitro diagnostic use only. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. flush waste-pipes with water after the disposal of undiluted reagent. No.8 – 2.4 Digoxin . Digoxin from the sample competes with the microparticle-bound digoxin for the antibody. as well as some types of cardiac arrhythmias. Reagent Preparation R1 is ready for use and can be placed directly on board the instrument. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. ODC6404. It may not be immediately apparent whether the patient has been under or overdosed.4 nmol/L (0 . Calculation The Beckman Coulter analysers automatically compute the digoxin concentration of each sample.4 therapeutic effect while avoiding useless subtherapeutic or harmful toxic dosage levels. reagents stored on board the instrument are stable for 30 days. Contents. for acceptability using the software options Routine. the resulting curve should be visually reviewed. Linearity The test is linear within a concentration range of 0 – 6.6 nmol/L (0. These calibrators are gravimetrically prepared then verified by a commercially available process.8 mL R1 R2 Summary Digoxin is a potent cardiac glycoside widely prescribed for the treatment of patients suffering from congestive heart failure. pH 6. Dispose of all waste material in accordance with local guidelines. Calibration Monitor. up to the stated expiry date when stored at 2…8°C. The resulting agglutination reaction causes an increase in turbidity.01 2009-08 TDM . Intoxication symptoms are often indistinguishable from the original condition for which the drug was prescribed. 2 x 17. which can result from a combination of factors. Strongly lipemic samples should be avoided.25 mol/L Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. thus inhibiting the agglutination reaction.01 BLOSR6404. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Test Principle R1 contains a monoclonal antibody specific for digoxin that binds to microparticles covalently coated with a digoxin derivative in R2. Reagent Composition in the Test Final concentration of reactive ingredients: Monoclonal anti-digoxin antibody BIS-TRIS buffer. Specimen5 Serum: Stable in serum for 3 months when stored at 2…8°C and 2 weeks when stored at 15…25°C. which can be measured spectrophotometrically at 700 nm.1 nmol/L (2. Major preventative maintenance was performed on the analyser or a critical part was replaced. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Cardiac 1 glycosides have a low therapeutic ratio (a very small difference between therapeutic and tissue toxic levels). review all operating parameters.0 ng/mL) Toxic levels > 3.DIGOXIN OSR6404 Intended Use Immuno-inhibition test for the quantitative determination of digoxin in human serum on Beckman Coulter analysers. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. There is a marked patient variability in 2 response to the same dose of drug.5 ng/mL). To avoid the possible build-up of azide compounds. Quality Control Control materials with values determined by this Beckman Coulter system may be used.0 – 2. Calibration Curve. If any trends or sudden shifts in values are detected. when multiplied by 2. Storage and Stability The reagents are stable. Digoxin intoxication is a common and serious problem in the clinical setting. Therapeutic Range6 Effective levels 1. The assayed result of this dilution. Monitoring serum digoxin levels combined with other clinical data can provide the physician with useful information to aid in adjusting patient dosage to achieve optimal 3. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. Samples reported as less than the analytical range can be confirmed by diluting one part sample of known value with one part of the original patient sample. should approximate the original value of the known sample to confirm the low patient EN. Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems.4 ng/mL) Consider these ranges as guidelines only. R2 should be mixed by inversion 5 – 10 times before placing on board the instrument and at fortnightly intervals thereafter. unopened. The results obtained by any individual laboratory may vary from the given mean value. on the Beckman Coulter analyser. Data obtained in your laboratory may differ from these values. Calibration Digoxin Calibrator Cat. Once open. Whitfield MF. 11. Olley P. American Association for Clinical Chemistry. Clin Chem 1983. samples from digitalised patients may yield clinically implausible values of 0.98 0. the possibility exists for interference by human anti-mouse antibodies (HAMA) in the sample. Clin Chem 1985. Are immunoassays for digoxin reliable? Clin Biochem 1984.008x + 0.01 . Greenway DC. Digoxin-like immunoreactivity in the serum of neonates and uremic patients.90 Sensitivity The lowest detectable level on an AU400 analyser was estimated at 0.2 nmol/L.. Nanjii AA. Setting Sheet Footnotes # † * 1. the standard serum digoxin concentration measurement can be clinically misleading until the Fab fragment is eliminated from the body.31:1078-9. The Drug Monit 1985.0 ng/mL digoxin. User defined ¤ Analyser default value Calibrator Cat. AACC Press. BIBLIOGRAPHY TDM BLOSR6404. Endogenous digoxin-like immunoreactive factors: Impact on digoxin measurements and potential physiological implications. Digitonin. The confirmed result should be reported as < 0. If the assayed result of the first dilution. 3. Estriol. 10. as measured in the Abbott TDx. 2nd ed. The presence of DLIF in a sample can result in falsely elevated digoxin assay results. newborn infants and pregnant women) have been 8-14 reported to contain an unidentified component that gives positive results with a number of immunoassays. GlaxoSmithKline Product Information. Rosenkranz B. 13.29:1972-4. The lowest detectable level represents the lowest measurable level of digoxin that can be distinguished from zero. McDevitt DG. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample. ® Digoxin Immune Fab. 9. Mayo Clin Proc 1979. Surawiicz B.42 0. Töpfer G. Digitalis. 17α-Hydroxyprogesterone. New York: Grune and Stratton. Series on pharmacology in practice 3. Jacobsen BE. The amount of DLIF in these patient 9-12 samples is extremely variable. Drug Monitoring Data (Pocket Guide II). Hick JM.87 0. which could cause falsely elevated results. Bresnahan JF. 5. 1994:65pp. No.35 – 3. Dalton JG.48 0. Pudek MR. will interfere with digitalis immunoassay measurements. This component has been termed digoxin-like immunoreactive factor (DLIF). 12. McNeely MDD. Valdes.e.000). Vliesta RE. In: Fisch C. Method Comparison Patient serum samples were used to compare this Digoxin OSR6404 assay on the AU400 against another commercially available digoxin assay. Yatscoff RW. Falsely increased results for digoxin in sera from patients with liver disease: Ten immunoassay kits compared. Serum digoxin concentration should be obtained before ® 15 administration of Digibind if at all possible. Oubain. Drug Ther 1975. Digitoxigenin. Plasma and Serum Samples.17:317-20. Clin Chem 1985. To work in ng/mL divide by 1. such as Digibind . In rare cases. Precision The following data was obtained on an AU2700 using 3 control sera analysed over 20 days.2:29pp.06 2. Thus. Limitations As with any assay employing mouse antibodies.1 Rev. In such cases the analysis must be repeated following ultrafiltration of the samples (exclusion threshold: MW 100.5 Dihydrodigoxin 2. 20:389-404. 8. Digitalis: Its place in modern therapy.95 2. 2000. Prednisone.19 nmol/L. Results of linear regression analysis were as follows: y = 1. Young DS.77 0.127-47.46 4.05 4. Ehret W. 4. 1969. Digitalis glycosides. Seven different digoxin immunoassay kits compared with respect to interference by a digoxin-like immunoreactive substance in serum from premature and full-term infants. 5th ed. Clin Chem 1984.30:588.6:461-4. does not approximate the original result of the known sample. Soldin SJ.35 nmol/L Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Icterus: Interference less than 5% up to 40 mg/dL or 684 µmol/L bilirubin Haemolysis: Interference less than 5% up to 5 g/L haemoglobin ® Lipemia: Interference less than 10% up to 700 mg/dL Intralipid RF: Interference less than 5% up to 490 IU/mL RF 7 Refer to Young for further information on interfering substances. WHO/DIL/LAB/99.10 0. β-Estradiol.28. 11α-Hydroxyprogesterone. n = 80 Within Run Total Mean nmol/L SD CV% SD CV% 0. further dilutions utilising saline are needed. Effects of drugs on clinical laboratory tests. but in some cases these levels have been shown to approach concentrations that are in the therapeutic range of digoxin. Mortelmans S. 2. Heil W. Specificity Cross reactivity for the following substances was determined in accordance with the equation: Cross-reactivity (%) = Conc of analyte at 50% signal strength x 100 Conc of cross reactant at same signal level Substance Cross-reaction (%) Lanocide C 54 Digoxigenin Bisdigitoxoside 100 Digoxigenin Monodigitoxoside 38 Digoxigenin 13 Digitoxin 11. August 2001. Making digitalis safer. eds. Brett EM. Falsely elevated digoxin concentrations in patients with liver disease.05 1. Falsely increased digoxin concentrations in samples from neonates and infants. 6. Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood. Frolich JC. D-Digitoxose.5:222-4.31:1525-32. Wisser H. Spironolacetone. Inc. when multiplied by 2. Surawicz B. Papanastasiou-Diamandi A.03 3. Taggart AJ. 14. 7. R. 15.09 1. et al. Progesterone.01 2009-08 EN. Therapeutic drug monitoring and toxicology laboratory improvement program. Heyes J. patients with renal and/or hepatic failure. Lindwood C.5 Gitoxin 2 A cross-reaction of less than 1% was found for the following: Dehydroisoandrosterone.54: 675-84.023 r = 0.7:202-6.05 1. The sera from patients in specific patient populations (i. Seccombe DW. Factors affecting individual tolerance to digitalis.: ODC6404 Values set for working in SI units (nmol/L). Prednisolone. Zawta B. Desjardins PRE.976 n = 100 Sample range = 0. Drugs 1980. Jr. Schmitt Y.result. The Drug Monit 1984. Out of Range L # # # # # # # # Unit: nmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # SERUM APPLICATION Select the function using the Function key or the Mouse Calibration specific Test No # Test name DIG ∇ 6AB ∇ EIA TYPE 1 OD ∇ Conc † † † † † † Count Process Factor/OD-L -0. None Selected 8. # # ο ∇ 5. OD L -0.5 2. # # ο ∇ 7.5 ∇ Advanced Calibration: 999 # ∇ # Test Name: Counts: DIG ∇ < > Type Calibration Type: 6AB ∇ Formula: EIA TYPE 1 ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: - Cal.5 2.5 2.1 1-Point Cal. No. # # ο ∇ 2. vol 0 0 0 Max. 700 ∇ FIXED1 ∇ + ∇ First 12 First % ∇ Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Digoxin Calibrator Cat.5 Fst. # # ο ∇ 3. Reagent 1 vol Reagent 2 vol μL μL μL 12 176 128 Dil.5 2.5 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 2.5 ∇ # Test name DIG Sample type Ser Page 1/2 System Reagent: OSR6404 Reagent ID: 404 Application DIGOXIN. L -0.1 Reagent OD limit Fst. AU600 Serum Application System Reagent: OSR6404 Specific Test Parameters General LIH ISE Range Test Name: DIG ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 12 176 128 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Sec. No. H Sample vol.5 2. # # ο ∇ 6. # # # # # # OD CONC † † † † † † Factor/OD-L -0. None ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.1 -0.1 -0.4* 1 0 ¤ 30 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: DIG ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 2. OD H ∇ Operation: Yes Test No ∇ 2.5 NONE FIXED1 + 27 Max OD H 2. vol Dil.5 2.5 2. # # ο ∇ 4.1 -0.5 2. H Lst. vol Dil.: ODC6404 * Values set for working in SI units (nmol/L).: ODC6404 * Values set for working in SI units (nmol/L) . L -0.1 -0.01 2009-08 # User defined † Digoxin Calibrator Cat.1 -0.5 2.1 -0.1 Lst.1 0* B 30 Linearity Fst No lag time % Sec % ∇ 0 Sample Pre-dil. H 6.5 2. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 14 Formula 6 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 # ∇ Point 7 ∇ 1-point cal.1 -0.1 -0.28 TDM .DIGOXIN.5 2. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name DIG Sample type Ser ∇ On-board stability period Pri.1 -0.4* Fst Fst 12 Lst Lst First H Last H 2.28 BSOSR6404.5 2.1 # Conc Factor/OD-H 2. To work in ng/mL divide by 1. AU400/AU640 Serum Reagent ID: 404 Specific test parameters Serum ∇ 1 -0.1 -0.1 Dynamic range L 0* Correlation factor 6. To work in ng/mL divide by 1.1 Main ∇ ∇ ∇ 700 Sub -0.1 -0. No. 5 -0.5 - ∇ 1-Point Cal.5 2.5 -0. Not within expected values nmol/L* Decimal Places Calibration Specific ISE DIG ∇ < Low # # # # # # # # # SERUM APPLICATION High # # # # # # # # Calibration Parameters STAT Table Calibration > EIA TYPE 1 Type Serum Counts: ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: # Process: CONC ∇ Test Name: DIG ∇ < > Test Name: Use Serum Cal.28 AU680 <Point Cal.5 2. Dynamic Range Low ф Correlation Factor A None ∇nm Factor for Maker A 0* 1 1 μL High B B 0 6.1 2.1 -0. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L nmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.4* 0 0 Hour 64 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt. # # ο ∇ 4.1 -0.1 2.5 2.5 2. None Selected 8.5 -0.1 R2(R2-1) μL Name Sec. None ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: 0* A 1 On-board stability period: Common Rgt.1 -0.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2. # # ο ∇ 5.01 2009-08 . AU680/AU480 Serum Application System Reagent: OSR6404 Specific Test Parameters General LIH ISE Serum ∇ 1 -0. ∇ # # # # ο 5. # # ο ∇ 6. # # ο ∇ 7. ∇ # # # # ο 3. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour TDM BSOSR6404.5 6. ∇ # # # # ο 6. # # ο ∇ 2.1 -0.5 -0. Calibration Type: 6AB ∇ Formula: EIA TYPE 1 ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ 999 ∇ Advanced Calibration: # Cal. Volume R1(R1-1) μL ∇ μL 6 1 88 Test Name: Max OD H 2. # # # # # # CONC † † † † † † Factor/OD-L -0.1 2.DIGOXIN.1 2. ∇ # # # # ο 2.: ODC6404 Values set for working in SI units (nmol/L) .5 2. For No. ∇ 7. ∇ # # # # ο 4.1 Factor/OD-H 2.5 2.5 ∇ OD Range Low High -0. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 6AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: # † ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined.5 -0.1 High High Max.1 -0.5 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 700 ∇nm FIXED1 ∇ + ∇ 15 Pri.1 -0.5 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6404 Reagent ID: 404 Application Operation Yes DIGOXIN.4* B 30 Last Last 27 % ∇ DIG ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis 6 88 64 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Sec.5 2. To work in ng/mL divide by 1.5 2. No demographics 8. AU2700/AU5400 Serum Reagent ID: 404 Parameters General LIH DIG ∇ Dilution μL -0.1 -0. No.1 -0.1 2. Digoxin Calibrator Cat.OD μL Min. # # ο ∇ 3.1 -0. No. 700 ∇ FIXED1 ∇ + ∇ First 15 First % ∇ Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH DIG ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # DIG ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.1 2. Cap the R2 buffer bottle and let stand for approximately 5 minutes at 15…25°C. Mix again. Prepare the R2 solution before the R1 solution to minimise possible contamination. In the assay. EN. Therefore.01 2009-08 TDM . The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample. inhibiting the reassociation of inactive β-galactosidase fragments.2 with ribosomal protein synthesis. metabolisation and is. The R2 working solution (enzyme donor) should be yellow-orange in colour. To avoid the possible build-up of azide compounds. Mix by gentle inversion. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. These fragments spontaneously reassociate to form fully active enzyme that. Gentamycin undergoes very little. Serum or plasma gentamycin concentration is impacted by the mode of administration.01 BLOSR6420. buffer salts. Ensure the reagent is homogeneous before use. Record the reconstitution date on the bottle label. R22. Klebsiella. surfactant and preservative. which has been genetically engineered into two inactive fragments. and no active enzyme will be formed. ensuring that all the lyophilised material from the R1 lyo bottle is transferred into the R1 buffer bottle. NOTE 4: To ensure reconstituted R1 stability. therefore. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. NOTE 1: The components supplied in this kit are intended for use as an integral unit. stabiliser and preservative. buffer salts. R1 (Enzyme acceptor solution): Connect the R1 lyo bottle to the R1 buffer bottle using one of the enclosed adapters. Avoid the formation of foam. if any. Dispose of all waste material in accordance with local guidelines. Pseudomonas aeruginosa. coli. eliminated as the parent drug by glomerular filtration. continuous exposure to bright light. protect from prolonged. For in vitro diagnostic use only. Do not mix components from different lots. S60. If analyte is not present in the sample. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. Serratia. cleaves a substrate. buffer salts. analyte in the sample competes with analyte conjugated to one inactive fragment of β-galactosidase for antibody binding site. the duration of the treatment and physiological changes during the illness and therapy. Enzyme acceptor. If analyte is present in the sample. ensuring that all the lyophilised material from the R2 lyo bottle is transferred into the R2 buffer bottle. NOTE 5: Do not freeze reconstituted reagents. flush waste-pipes with water after the disposal of undiluted reagent. it binds to antibody. Refer to Safety Data Sheets for further information. Trough gentamycin concentrations usually ensure that drug elimination is adequate and the drug concentration is above minimum inhibitory concentration. Cap the R1 buffer bottle and let stand for approximately 5 minutes at 15…25°C. The therapeutic range should be measured at peak as well as trough concentrations. goat anti-mouse antibodies. Proteus mirabilis. Avoid the formation of foam. A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded. This material and its container must be disposed of as hazardous waste. NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the appropriate reagent bottle. Detach the R2 lyo bottle and adapter from the R2 buffer bottle and discard. Gentamycin’s toxic effect is produced by interfering 1.Gentamycin OSR6420 2 x 12 mL 2x 2 x 9 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the quantitative determination of gentamycin in human serum and plasma on Beckman Coulter analysers. Peak serum or plasma concentrations of gentamycin are suggested to ensure that adequate antimicrobial activity is obtained. NOTE 3: The R1 and R2 solutions must be at the reagent compartment temperature of the analyser before performing the assay. chlorophenol red-β-D-galactopyranoside. generating a colour change that can be measured spectrophotometrically. Staphylococcus epidermidis and other microorganisms. Reagent Composition R1 Buffer R1 Lyo R2 Buffer R2 Lyo MOPS (3-(N-morpholino)propanesulfonic acid buffer). the volume of extracellular fluid. Staphylococcus aureus. Contains sodium azide. Test Principle5 This assay is based on the bacterial enzyme β-galactosidase. Record the reconstitution date on the bottle label. Ensure the reagent is homogeneous before use. buffer salts. Reagent Preparation Remove the kit from refrigerated storage (2…8°C) immediately prior to preparation of the solutions. Harmful if swallowed. Mix by gentle inversion. Wear suitable protective clothing. R2 (Enzyme donor solution): Connect the R2 lyo bottle to the R2 buffer bottle using one of the enclosed adapters. Summary Gentamycin is an aminoglycoside antibiotic used in the treatment of infections caused by E. mouse monoclonal anti-gentamycin antibody. antibody binds to analyte conjugated on the inactive fragment. Detach the R1 lyo bottle and adapter from the R1 buffer bottle and discard. leaving the inactive enzyme fragments free to form active enzyme. in the assay format. Safety Phrases: S36. Enterobacter.4 trough gentamycin serum or plasma levels is critical in the prevention of serious complications with the adjustment of dosage administration as indicated. Mix again. stabiliser and preservative MOPS (3-(N-morpholino)propanesulfonic acid buffer). monitoring of peak and 3. surfactant and preservative Enzyme donor conjugated to gentamycin. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed.2– 17.Storage and Stability The reagents are stable. No.13 µg/mL. Samples reported as less than the analytical range can be confirmed by diluting one part sample of known value with one part of the original patient sample.999 n = 135 Sample range = 0. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems. when multiplied by 2.09 0. The value obtained on reassay should be derived as follows: Actual Value = (2 x diluted value) – Concentration of Antibiotic TDM Multi-Calibrator 1. the resulting curve should be visually reviewed.3 3.11 0.3 mmol/L IgG ≤ 51 g/L Rheumatoid Factor ≤ 1270 IU/mL TDM BLOSR6420.4 6. Linearity The test is linear within a concentration range of 0. Data obtained in your laboratory may differ from these values. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.15 0. Different gentamycin therapeutic ranges have also ben reported by other investigators. Specimen results greater than the highest calibrator can be reported as greater than the value of the highest calibrator or diluted one part sample with one part Antibiotic TDM Multi-Calibrator 1 and reassayed. If any trends or sudden shifts in values are detected. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. up to the stated expiry date when stored at 2.13 r= 0.01 . Na EDTA) may be used.. Calibration Antibiotic TDM Multi-Calibrator.. Calculation The Beckman Coulter analysers automatically compute the gentamycin concentration of each sample.5 3.6 SD 0.984x + 0.08 0. unopened. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Avoid repeated freezing and thawing. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. n = 80 Mean µg/mL 2.6-8 usually ensure that drug elimination is adequate. Two replicates of each sample were analysed twice daily over 20 days. Calibration Monitor. ODC6413. Specimen Serum or plasma (Na or Li heparin.17 CV% 3. Once reconstituted. review all operating parameters. Precision The following data was obtained on an AU2700 using serum pools and control sera. for acceptability using the software options Routine. The assayed result of this dilution. should approximate the original value of the known sample to confirm the low patient result.5 Within Run SD 0. Results of linear regression analysis were as follows: y = 0. It is calculated as the absolute mean plus three standard deviations of 25 replicates of an analyte free sample. Trough concentrations between 1-2 µg/mL 1. further dilutions utilising saline are needed.8 Method Comparison Patient serum samples were used to compare this Gentamycin OSR6420 assay on the AU640 against another commercially available gentamycin assay.24 µg/mL and the value of the highest calibrator (approximately 12 µg/mL or 25. The lowest detectable level (LDL) represents the lowest measurable level of gentamycin that can be distinguished from zero. Major preventative maintenance was performed on the analyser or a critical part was replaced. on the Beckman Coulter analyser.8 1. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. The results obtained by any individual laboratory may vary from the given mean value.8°C.4 2-3.13 µg/mL. reagents stored on board the instrument are stable for 30 days. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. timing of sample collection. Cat. Prior to the adjustment of dose. when multiplied by 2. mode of drug administration. The confirmed result should be reported as < 0. If the assayed result of the first dilution.25 Total CV% 5.1 4. Stable in serum and plasma for 7 days when stored at 2…8°C and 4 weeks when stored at -20°C.1 µmol/L).3 µg/mL Sensitivity The lowest detectable level on an AU640 analyser was estimated at 0. The expected range provided is only a guide for drug dosage. other drug treatments and clinical 9 symptoms. Expected Values In most adults a peak therapeutic response is achieved with gentamycin concentrations between 5-8 µg/mL. does not approximate the original result of the known sample.01 2009-08 EN. Following calibration. Quality Control Control materials with values determined by this Beckman Coulter system may be used. Calibration Curve. results should always be assessed in conjunction with other available information such as patients medical history.9 2. The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard. Interference No significant interference (<10%) was observed with the following substances: Substance Concentration Substance Concentration Bilirubin ≤ 1026 µmol/L IgM ≤ 26 g/L Haemoglobin ≤ 10 g/L Total Protein ≤ 120 g/L IgA ≤ 27 g/L Triglyceride ≤ 11. Zoccoli MA. New York: MacMillan Publishing Company.1 Streptomycin 6. Gilman A.32(9): 16371641.00 < 0.1 Ethacrynic Acid 0. Please pay specific attention to the contamination parameters provided in the setting sheet. the possibility exists for interference by human anti-mouse antibodies (HAMA) in the sample.Specificity The following compounds when tested with the Gentamycin OSR6420 assay. No.1 Trimethoprim 0. 6.09 To prevent contamination by gentamycin containing reagents instigate the following corrective procedure.60 < 1.00 < 0.1 Cephaloridine 6. 1987. in Pesce.00 < 0. A New Homogeneous Immunoassay System. 1977:34: 723-737. London:ACB Venture Publications. Scandinavian Journal of Infectious Disease 1979:132 (suppl. The Aminoglycosides.1 Sulfadiazine 0. In: Gilman AG.60 < 1. eds.00 < 0.1 Cephaloglycin 6.6 Penicillin G 6.00 < 0.60 < 1. Therapeutic drug monitoring and clinical biochemistry.1 Kanamycin B 6. 8.00 < 1. Harris JD.01 2009-08 TDM . Gentamycin results from patients receiving this drug should be interpreted with care. OSR0001 and enter the following settings in Parameter – Special . Barza M.V.1 Carbenicillin 6. 1978. Antimicrobial Agents. J.A.00 < 0. Lauermann M.1 Ticarcillin 6.24 < 0. and Kaplan.R. Chem. Kahlmeter G.00 < 0. In order to optimise workflow it is recommended to assay specimens for gentamycin in batches.1 Cefamandole Nafate 6. 1986. User defined ¤ Analyser default value Antibiotic TDM Multi-Calibrator Cat.0 Neomycin 6.Contamination Parameters.0 Amphotericin 0. The Clinical Importance of Determination of Aminoglycodise Concentrations.00 < 0. 1990. Carryover from reagents containing gentamycin may cause spuriously high results. Mosby Co. 7. Goodman LS. As with any assay employing mouse antibodies. Setting Sheet Footnotes # † ∝ ‡ Bibliography 1.72 < 1. Dipersio. Disposition of Toxic Drugs and Chemicals in Man. C.52 1.36 < 0. Mandell GL.0 Sulfamethoxazole 0.72 < 1.1 Cephalosporin C 6.1 Lincomycin 6.60 < 1.00 < 0. 5. Aminoglycoside Assay Methods and Clinical Relevence.J. pp. The Pharmacological Basis of Therapeutics.00 < 0. coli β-galactosidase may result in artificially high results which will not fit the clinical profile. 3rd edition.01 62. 3.0 Limitations • • • • Samples containing antibodies to E. Prepare a 20% aqueous solution of Wash Solution Cat No.3:202-215.1 Chloramphenicol 6. Clinical Pharmacokinetics and Nephrotoxicity Aspects on Assay Techniques.00 < 0.60 < 1. Proceedings of Amsterdam Symposium. yielded the following percent cross-reactivity results: Compound Concentration Tested (µg/mL) % Cross reactivity 5-Fluorocytosine 0.1 Spectinomycin 6.15 Oxytetracycline 1.1 Methicillin 6.01 BLOSR6420.00 < 0.72 < 1.60 < 1. Barza M.0 Sisomicin 0.00 < 0.6 Amikacin 6. Clin. Why Monitor Serum Levels of Gentamicin? Clinical Pharmacokinetics 1978. Sisomicin shows significant cross reaction (>50%) with the Gentamycin assay. Sande MA.1 Ampicillin 6. Manning WB. which could cause falsely elevated results.1 Cephalexin 6. Mattie H.06 < 0.: ODC6413 Values set for working in µg/mL. Cravey RH.00 < 0.00 < 0.0 Sulfanilamide 6. Drug therapy reviews: Antimicrobial spectrum.1 Dideoxykanamycin 6.6 Vancomycin 0. 18). 4.1 Clindamycin 6.00 < 0. Capps N.1 Cephalothin 6.00 < 0. pharmacology and therapeutic use of antibiotics-part 4: amimoglycosides. (eds) Methods in Clinical Chemistry.18 < 0. Friedman SF.1 Tobramycin 6. Baselt RC. L.1 Sulthiame 6.0 Kanamycin A 6.1 Methotrexate 0. A. To work in SI units (µmol/L) multiply by 2.72 < 1.00 < 0.00 < 0.0 Rifampicin 0. Gentamicin and Tobramycin. 805-807.00 < 0.1 Erythromycin 0.0 Methylprednisolone 0.00 < 0.0 Prednisolone 0.: Gentamicin and Other Aminoglycosides.1 Tetracycline 6. American Journal of Hospital Pharmacy..0 Furosemide 0. Henderson DR. eds.00 < 0. The incidence of patients having such antibodies is extremely low.1 Penicillin V 0. EN. 9. 2.0 Fusidic Acid 0.00 < 0. Hallworth M. Scheife T. CEDIA™.1 Netilmicin 0. 1980:1162-1180.00 < 0.00 < 0.60 < 1. 1993. . OD L -2. No. # # ο ∇ 4. AU600 Serum/Plasma Application System Reagent: OSR6420 Specific Test Parameters General LIH ISE Range Test Name: GENT‡ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 100 75 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.00 -2. # # ο ∇ 3. H Lst. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse ‡ To prevent contamination by Gentamycin containing reagents instigate the following corrective procedure Prepare a 20% aqueous solution of wash Solution Cat No OSR0001 and enter the following settings in Parameter –Special – Contamination Parameters AU640 Preceding Following RGT. H -2.50 2.00 Dynamic range L 0. OD H 2.00 Main ∇ ∇ ∇ 570 Sub Fst.00 0. Reagent 1 vol Reagent 2 vol μL μL μL 2 100 75 Dil. probe Clean cnt ALL GENT CLN 5 CUV Y Mixer Y # User defined † ∝ Preceding (ALL) (ALL) (ALL) (ALL) Reag Type R1 R1 R2 R2 Following GENT GENT GENT GENT Reag Type R1 R2 R1 R2 Reag Probe CLN-1/CLN-2 CLN-1/CLN-2 CLN-1/CLN-2 CLN-1/CLN-2 Wash Cnt 5 5 5 5 Cancel No No No No Mixer Yes Yes Yes Yes Cuvette Yes Yes Yes Yes ¤ Analyser default value System Antibiotic TDM Multi-Calibrator Cat.: ODC6413 Values set for working in µg/mL. # # ο ∇ 7. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # L # Test name GENT Sample type Ser ∇ Level L # Page 2/2 Level H # % Sec B 30 % ∇ 0 12∝ Fst Fst 24 Lst Lst First H Last H 2. L -2.50 2. # # ο ∇ 5.24∝ Correlation factor 12∝ 1 0 ¤ NO % ∇ 30 Specific Test Parameters General LIH ISE Serum ∇ # # # # # # # Age Y Y Y Y Y Y Range Test Name: GENT ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. To work in SI units (µmol/L) multiply by 2.50 2.50 Sample vol.00 Lst.GENTAMYCIN.50 660 RATE1 + 27 Max OD H 2.50 ∇ Operation: Yes Test No ∇ ∇ # Test name GENT‡ Sample type Ser Page 1/2 System Reagent: OSR6420 Reagent ID: 420 Application GENTAMYCIN. ∇ ∇ ∇ Sec. L -2. vol Dil. None Selected 8.09 TDM BSOSR6420.probe Wash cnt Cancel Mixer CUV (ALL) GENT CLN 5 No Yes Yes AU400 ‡ To prevent contamination by Gentamycin containing reagents instigate the following corrective procedure Prepare a 20% aqueous solution of Wash Solution Cat No OSR0001 and enter the following settings in Parameter – Special – Contamination Parameters AU600 Preceding Following RGT . # # ο ∇ 2. AU400/AU640 Serum/Plasma Reagent ID: 420 Specific test parameters Serum ∇ 1 -2. No. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 9 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.01 2009-08 . # # ο ∇ 6.24∝ H Sample Pre-dil. # # OD CONC † † Factor/OD-L -999999 -999999 1-Point Cal. Linearity Fst No lag time NO Select using Space key.00 Reagent OD limit Fst. Out of Range L # # # # # # # # Unit: Panic value µg/mL∝ Decimal places: # H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name GENT ∇ AA ∇ Y=AX+B OD ∇ Conc † † Count Process Factor/OD-L -999999 -999999 # Conc Factor/OD-H 9999999 9999999 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 9999999 9999999 # SERUM/PLASMA APPLICATION Test Name: Counts: GENT ∇ < > Type Calibration Type: AA ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. vol Dil. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: On-board stability period 570 RATE1 + First 24 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. vol 0 0 0 Max. # # OD CONC † † Factor/OD-L -999999 -999999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 Advanced Calibration: # None ∇ 1-Point Cal.6 80 60 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.00 -2. Volume R1(R1-1) μL ∇ μL 1. # # ο ∇ 6.6 1 80 Test Name: Max OD H 2. ∇ # # # # ο 2.50 2.00 -2.50 2.00 High High Max. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.50 12* B 30 Last Last 27 GENT‡ ∇ < > Type: Yes Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H 0 1. # # ο ∇ 4.00 R2(R2-1) μL Name Sec.00 -2.24* 1 1 μL High B B 0 12* 0 0 Hour 60 Dilution 0 Range Operation: ∇ Sample Volume Pre-Dilution Rate Rgt.50 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6420 Reagent ID: 420 Application Operation Yes GENTAMYCIN.probe Wash Cleaning Mixer AU2700/ AU680 cnt (ALL) GENT CLN 5 No Yes Wash Cnt 5 5 5 Cleaning No No No Mixer Yes Yes Yes CUV Yes Cuvette Yes Yes Yes <Point Cal.50 2. # # ο ∇ 3. # # ο ∇ 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 ∇ ο with Conc-0 Hour Hour AU480 Preceding (ALL) (ALL) (ALL) Reag Type R1 R1 R2 Following GENT GENT GENT Reag Type R1 R2 R1 Reag Probe CLN-1/CLN-2 CLN-1/CLN-2 CLN-1/CLN-2 TDM BSOSR6420.50 2.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2. ∇ # # # # ο 6. None Selected 8. No. No demographics 8. Not within expected values µg/mL* Decimal Places Calibration Specific ISE GENT‡ ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High -999999 999999 ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 9999999 9999999 # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: GENT‡ ∇ < > Test Name: Use Serum Cal. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/mL* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt. ∇ # # # # ο 5. Calibration Type: AA ∇ Formula: Y=AX+B ∇ Cal.01 2009-08 .OD μL Min. For No. Point: ο with CONC-0 Slope Check: # ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AA ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ ‡ To prevent contamination by Gentamycin containing reagents instigate the following corrective procedure Prepare a 20% aqueous solution of wash Solution Cat No OSR0001 and enter the following settings in Parameter – Special – Contamination Parameters Ф AU680 Preceding Following RGT.00 -2. AU680/AU480 Serum/Plasma Application System Reagent: OSR6420 Specific Test Parameters General LIH ISE Serum ∇ 1 -2. ∇ ∇ ∇ 0. # # ο ∇ 5.24* Sec.GENTAMYCIN. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check NO % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 570 ∇nm RATE1 ∇ + ∇ 24 570 RATE1 + First 24 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: 30 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ NO % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH GENT‡ ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # GENT‡ ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. AU2700/AU5400 Serum/Plasma Reagent ID: 420 Parameters General LIH GENT‡ ∇ Dilution μL -2. ∇ 7. # # ο ∇ 7. ∇ # # # # ο 4. ∇ # # # # ο 3. 302 mg/L) is included in the kit. When the R1 Lyo has completely dissolved.01 BLOSR6x202. up to the stated expiry date when stored at 2…8°C. The calibrator paracetamol value is traceable to a gravimetrically prepared paracetamol standard. lipemic and icteric samples should be avoided.3. The change in absorbance is directly proportional to the concentration of paracetamol present in the sample.48 U/mL pH 8. Specimen7 Serum and heparinised plasma. Test Principle6 Paracetamol in the sample is hydrolysed by aryl acylamidase to yield p-aminophenol and acetic acid. The p-aminophenol formed reacts specifically with o-cresol and ammoniacal copper sulphate. Reaction Principle Aryl Acylamidase Paracetamol p-Aminophenol + Acetic Acid Indophenol (blue) p-Aminophenol + o-Cresol + Ammoniacal Copper Sulphate Contents. To avoid the possible build-up of azide compounds.6 Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. Dispose of all waste material in accordance with local guidelines. Stable in serum and plasma for 14 days when stored at 2. Once open. EN. tightly capped immediately after each use.0 mmol/L pH 10. For in vitro diagnostic use only. Mix gently by inversion and place on board the instrument. Summary1.. Reagent Preparation R1: Dissolve the contents of one vial of R1 Lyo (white cap) completely by adding approximately 10 mL of R1 buffer. flush waste-pipes with water after the disposal of calibrator material. or when the following occur: Change in reagent lot or significant shift in control values. Test Procedure Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.01 2009-08 TDM . unopened. to form indophenol.8°C and 45 days when stored at -20°C.6 < 4. Reagent Composition in the Test Final concentration of reactive ingredients: o-Cresol Aryl Acylamidase Buffer Sodium carbonate Ammonium chloride Copper Sulphate Paracetamol Calibrator Paracetamol (4-acetamidophenol) Buffer Preservative 0. provided it is free from contamination. and is measured at 600nm.4.48% ≥ 0. R2: The reagent is ready for use and can be placed directly on board the instrument. unopened. Paracetamol overdose can lead to severe hepatic damage and can result in hepatic failure and death if left untreated. Calibration Paracetamol Calibrator (2000 µmol/L.8% < 0.PARACETAMOL OSR61202 3 x 20 mL 3x 3 x 20 mL 3 x 3 mL R1 Buffer R1 Lyo R2 Calibrator Intended Use Enzymatic test for the quantitative determination of Paracetamol (Acetaminophen) in human serum and plasma on Beckman Coulter analysers. Storage and Stability The reagents are stable. Haemolysed. reagents stored on board the instrument are stable for 14 days. up to the stated expiry date when stored at 2…8°C. Major preventative maintenance has been performed on the analyser or a critical part has been replaced. Early diagnosis of paracetamol overdose is important.2.48% < 0. the calibrator is stable for 30 days. Safety data sheet available for professional user on request.5 Paracetamol is a drug commonly used for its analgesic and antipyretic properties. Once prepared. The assay is specific for the parent compound and does not detect paracetamol metabolites. However. and stored at 2…8°C. excessive long term use has been reported to lead to hepatotoxicity and nephrotoxicity. pour the contents of the reconstituted enzyme vial back into the same R1 buffer bottle containing the remaining 10 mL of reagent.048% 2. Recalibrate the assay every 7 days.. The calibrator is stable. as initiation of therapy within 16 hours of ingestion reduces the potential for hepatic injury and decreases the rate of mortality. Quality Control BioRad Lyphochek Immunoassay Plus Controls or other control materials with values determined by this Beckman Coulter system can be used. 1 Rev. Liver toxicity after acetaminophen ingestion. Ehret W.AMA 1977: 238.57 µmol/L (0. Method Comparison Patient serum samples were used to compare this Paracetamol OSR61202 assay on the AU640 against another commercially available paracetamol assay. Price CP. Schmitt Y. Guder WG. 1999: 788pp. An IgM Paraprotein causing a falsely low result in an enzymatic assay for acetaminophen. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.5 1. Barker JD.5 0. >497 µmol/L (>75 mg/L) and >265 µmol/L (>40 mg/L) at 4 hours. have been reported as 9 toxic. 2000.4 220 1.1 0.Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. clinical examinations and other findings. results should always be assessed in conjunction with the patient's medical history. Tietz Textbook of Clinical Chemistry Philadelphia: WB Saunders Company. may cause unreliable results.01 2009-08 EN. Tietz NW In:Clinical Guide to Laboratory Tests 3rd. 5. Evaluation of an enzymatic procedure for the measurement of acetaminophen. Hammond PM. 8 Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems.6 0. . Br J Clin Pharmacol 1979: 7. icteric and lipemic samples should be avoided. plasma and serum samples. 1980: 78. 382-392. especially IgM (Waldenström’s macroglobulinemia). To work in mg/L. 1999: 927-929.6 0. If any trends or sudden shifts in values are detected. TDM BLOSR6x202. CV% 3.016x + 29. 500-501. 2002. Calculation The Beckman Coulter analysers automatically compute the paracetamol concentration of each sample. Zawta B. The results obtained by any individual laboratory can vary from the given mean value. Precision The following data was obtained on an AU640 using 3 serum pools analysed over 20 days. Icteric and lipemic samples may cause false depression of results. AACC. review all operating parameters. 9. results from any samples exhibiting these characteristics should be interpreted with care. ed. 8 hours and 12 hours post ingestion respectively.2 Sensitivity The lowest detectable level on an AU2700 analyser was estimated as 2. Anuras S. 2. Young DS. The nephrotoxicity and hepatotoxicity of antipyretic analgesics. Data obtained in your laboratory can differ from these values. 299-301. 358-361. Wisser H. Chronic excessive acetaminophen use and liver damage. 4. Results of linear regression analysis were as follows: y = 1. Consequently. divide by 6.5 3.182 r = 1. 155-157 11.01 . Ann Intern Med 1997: 87. Poulocek FP. Lewis RK. 7. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. AACC Press. Hullin DA. Assessment and treatment of acetaminophen overdose. Effects of Drugs on Clinical Laboratory Tests. Prescott LF. In: Burtis CA. Scawen MD. Concentrations in serum of >993 µmol/L (>150 mg/L). Heil W. 10. et al.7 2. 1999 : 45.4 6. 8.5 676 2.5 g/L N-Acetyl Cysteine Salicylic acid: Interference less than 3% up to 5 mmol/L Salicylic Acid Acetylsalicylic acid: Interference less than 3% up to 1 g/L Acetylsalicylic Acid In very rare cases gammopathy. BIBLIOGRAPHY Porter WH. 11 Setting Sheet Footnotes # ¤ † * 1. Limitations Haemolysed. The concentration of paracetamol in serum or plasma is dependent on the time interval post ingestion. 765-774. Ashwood ER eds. Clin Chem. Töpfer G. Alexander M. Haemolytic samples may cause false elevation of results. Clinical Toxicology.000 n = 106 Sample range = 0 – 1943 µmol/L Interfering Substances Icterus: Interference less than 10% up to 8 mg/dL (137 µmol/L) bilirubin Haemolysis: Interference less than 10% up to 4 g/L haemoglobin ® Lipemia: Interference less than 10% up to 700 mg/dL Intralipid N-Acetyl Cysteine: Interference less than 10% up to 0. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Therapeutic Range The therapeutic range for paracetamol varies and is reported as 66 – 199 µmol/L (10 – 30 mg/L). It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. User defined Analyser default value Paracetamol Calibrator included in the kit Values set for working in SI units (µmol/L). Clin Chem 1983: 29. Clin Pharm 1991: 10. 5th ed. 3.2.39 mg/L) The lowest detectable level represents the lowest measurable level of paracetamol that can be distinguished from zero. J. Linearity The test is linear within a concentration range of 99 – 2500 µmol/L (15 – 378 mg/L) for serum and plasma.9 10 Refer to Young for further information on interfering substances. Acetaminophen hepatotoxicity. Gastroenterol. Ambre J. Philadelphia: WB Saunders Company. n = 80 Within Run Total Mean µmol/L SD CV% SD 68 0. 443-452. de Carle DJ. For diagnostic purposes. WHO/DIL/LAB/99.62. Black M. 6. To work in mg/L divide by 6. To work in mg/L divide by 6.1 -0. # # ο ∇ 5. vol Dil.5 1. ∇ ∇ ∇ Sec. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. OD H 1. L -0.1 Lst. # # ο ∇ 7. No. AU400/AU640 Serum/Plasma Reagent ID: 202 Specific test parameters Serum ∇ 1 Max OD H Main ∇ ∇ ∇ 600 Sub Fst.1 99* Sample Pre-dil. # OD CONC † Factor/OD-L 1815* 1-Point Cal.5 1. H Lst.PARACETAMOL. # # ο ∇ 2. None Selected 8. OD L Reagent OD limit Fst.5 150 150 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Wavelength: Method: Reaction slope: Measuring Point 1: Correlation Factor: A 1 On-board stability period: Select using Space key. vol Dil. point MB type factor Calibrator stability period 7 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Paracetamol Calibrator included in the kit * Values set for working in SI Units (µmol/L). # # ο ∇ 6. H -0.62 TDM BSOSR6x202. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name PARA Sample type Ser ∇ 600 END + First 10 Pri.62 # User defined † Paracetamol Calibrator included in the kit * Values set for working in SI Units (µmol/L). vol 0 0 0 Max. # # ο ∇ 3. L -0.01 2009-08 .5 150 150 Dil. Reagent 1 vol Reagent 2 vol μL μL μL 7. AU600 Serum/Plasma Application System Reagent: OSR6x202 Specific Test Parameters General LIH ISE Range Test Name: PARA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 7.1 Dynamic range L 99* Correlation factor Measuring Point 2: Linearity : No Lag Time: First Last 2500* 1 0 ¤ % ∇ On-board stability period 14 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: PARA ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 4.5 700 END + 27 Sample vol. Linearity Fst No lag time % Sec B 14 % ∇ 0 H 2500* Fst Fst 10 Lst Lst First H Last H 1.5 ∇ Operation: Yes Test No ∇ ∇ # Test name PARA Sample type Ser Page 1/2 System Reagent: OSR6x202 Reagent ID: 202 Application PARACETAMOL. Out of Range L # # # # # # # # Unit: µmol/L* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name PARA ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L 1815* # Conc Factor/OD-H 3025* ∇ SERUM/PLASMA APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 3025* # Test Name: Counts: PARA ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: 7 # ∇ Cal. 700 ∇ Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Wave Method Reaction Point 1 Point 2 H A B Rate Min. For No. No. None Selected 8. To work in mg/L divide by 6. ∇ # # # # ο 3.5 1. ∇ # # # # ο 2.1 -0. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 600 ∇nm END ∇ + ∇ 10 600 END + First 10 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Onboard Stability Period 14 Day LIH Influence Check YES ∇ Lipemia +++++ ∇ Icterus ++ ∇ Hemolysis ++++ ∇ % ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH PARA ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # PARA ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. ∇ ∇ ∇ 99* Sec. # # ο ∇ 2. ∇ # # # # ο 4. No demographics 8. Point: ο with CONC-0 Slope Check: # Interval (RB/ACAL) Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 7 Day 0 Calibration 7 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined Paracetamol Calibrator included in the kit Values set for working in SI Units (µmol/L).PARACETAMOL. # # ο ∇ 4. # # ο ∇ 6. # OD CONC † Factor/OD-L 1815* Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: 7 # ∇ None ∇ 1-Point Cal. ∇ # # # # ο 5. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour TDM BSOSR6x202.62 AU680 <Point Cal.OD -0. ∇ # # # # ο 6.1 -0. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. AU2700/AU5400 Serum/Plasma Reagent ID: 202 Parameters General LIH PARA ∇ Dilution μL Max. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µmol/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.1 R2(R2-1) μL Name Sec. # # ο ∇ 5. # # ο ∇ 7. # # ο ∇ 3.5 1. 700 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 99* 1 1 μL High B B 0 2500* 0 0 Hour 120 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. 700 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Common Rgt.5 μL Min.01 2009-08 .5 2500* 0 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. Volume R1(R1-1) μL ∇ μL 6 1 120 Range Operation: ∇ Yes Test Name: PARA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 14 Last Last 27 % ∇ 6 120 120 1. Not within expected values µmol/L* Decimal Places Calibration Specific ISE PARA ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High 1815* 3025* ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 3025* # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: PARA ∇ < > Test Name: Use Serum Cal. ∇ 7.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6x202 Reagent ID: 202 Application Operation Yes PARACETAMOL.1 High High 1. AU680/AU480 Serum/Plasma Application System Reagent: OSR6x202 Specific Test Parameters General LIH ISE Serum ∇ 1 Max OD H -0. Reagent Composition R1 Buffer R1 Lyo R2 Buffer R2 Lyo MOPS (3-[N-morpholino]propanesulfonic acid buffer). NOTE 5: Do not freeze reconstituted reagents. chlorophenol red-β-D-galactopyranoside. stabilisers and preservative. After 3 oral doses of 2 to 3 mg/kg. which is then excreted in the urine in equal amounts of the 4 free form and the form conjugated with glucuronic acid. Wear suitable protective clothing.8-10 In combination with other clinical information. continuous exposure to bright light. and clearance. cleaves a substrate. inhibiting the reassociation of inactive β-galactosidase fragments. S60. buffer salts. and no active enzyme will be formed. ensuring that all the lyophilised material from the R2 lyo bottle is transferred into the R2 buffer bottle. an agent devoid of hypnotic activity. goat anti-mouse antibodies. In the assay. MOPS (3-[N-morpholino]propanesulfonic acid buffer). Detach the R1 lyo bottle and adapter from the R1 buffer bottle and discard. 7 metabolism. Summary Phenobarbital has been widely prescribed for the treatment of epilepsy. analyte in the sample competes with analyte conjugated to one inactive fragment of β-galactosidase for antibody binding site. antibody binds to analyte conjugated on the inactive fragment. If analyte is present in the sample. buffer salts and preservative. will provide physicians with an essential tool to aid in adjusting dosage and achieving optimal therapeutic effect. Mix again.01 2009-08 TDM . ensuring that all the lyophilised material from the R1 lyo bottle is transferred into the R1 buffer bottle. ataxia. while avoiding both sub-therapeutic and harmful toxic drug levels. NOTE 1: The components supplied in this kit are intended for use as an integral unit. Avoid the formation of foam.2 Test Principle11 This assay is based on the bacterial enzyme β-galactosidase. Contains sodium azide. particularly for controlling focal motor or sensory and grand mal seizures. paradoxical excitement. buffer salts and preservative. This material and its container must be disposed of as hazardous waste.6 therapeutic range for maximum seizure control. Ensure the reagent is homogeneous before use. it binds to antibody. Detach the R2 lyo bottle and adapter from the R2 buffer bottle and discard. releasing agent. Phenobarbital in circulation is 4 approximately 40% to 50% bound to plasma proteins with relatively low association constants. which has been genetically engineered into two inactive fragments. Mix by gentle inversion. non-specific hepatic changes. flush waste-pipes with water after the disposal of undiluted reagent. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample. The major metabolic pathway of phenobarbital is hydroxylation of the phenyl ring to p-hydroxyphenobarbital. the shoulder-hand syndrome and coma. For in vitro diagnostic use only.Phenobarbital OSR6413 2 x 16 mL 2x 2 x 16 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the quantitative determination of phenobarbital in human serum and plasma on Beckman Coulter analysers. Dispose of all waste material in accordance with local guidelines. R2 (Enzyme acceptor solution): Connect the R2 lyo bottle to the R2 buffer bottle using one of the enclosed adapters. Refer to Safety Data Sheets for further information. Record the reconstitution date on the bottle label. Toxicity of phenobarbital therapy includes sedation. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. NOTE 3: The R1 and R2 solutions must be at the reagent compartment temperature of the analyser before performing the assay. nystagmus. buffer salts and preservative. phenobarbital is almost completely absorbed with peak levels achieved by 12 to 18 hours. Safety Phrases: S36. generating a colour change that can be measured spectrophotometrically. in the assay format. Enzyme donor conjugated to phenobarbital. These fragments spontaneously reassociate to form fully active enzyme that. Mix by gentle inversion. NOTE 4: To ensure reconstituted R2 stability. 3. Enzyme acceptor. R22. Harmful if swallowed. Avoid the formation of foam. blood dyscrasia (including coagulation defects in neonates of mothers given the drug during pregnancy). Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. To avoid the possible build-up of azide compounds. Cap the R2 buffer bottle and let stand for approximately 5 minutes at 15…25°C. The need for monitoring phenobarbital concentrations is due to the narrow therapeutic index and the wide variability in individual rates of drug absorption. Phenobarbital concentrations of 15-40 µg/mL in serum are normally considered to be within the 5. R1 (Enzyme donor solution): Connect the R1 lyo bottle to the R1 buffer bottle using one of the enclosed adapters. 1. Ensure the reagent is homogeneous before use. The R1 working solution (enzyme donor) should be yellow-orange in colour. Cap the R1 buffer bottle and let stand for approximately 5 minutes at 15…25°C. Mix again. Reagent Preparation Remove the kit from refrigerated storage (2…8°C) immediately prior to preparation of the solutions. If analyte is not present in the sample. protect from prolonged.01 BLOSR6413. EN. Prepare the R1 solution before the R2 solution to minimise possible contamination. rash (including severe exfoliative forms). A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded. monitoring serum or plasma phenobarbital levels osteomalacia. Do not mix components from different lots. NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the appropriate reagent bottle. leaving the inactive enzyme fragments free to form active enzyme. mouse monoclonal anti-phenobarbital antibody. Record the reconstitution date on the bottle label. 2 – 71. Prior to the adjustment of dose. The assayed result of this dilution.01 . reagents stored on board the instrument are stable for 60 days. timing of sample collection. Precision The following data was obtained on an AU2700 using serum pools and control sera. up to the stated expiry date when stored at 2. n = 80 Within Run Total Mean µg/mL SD CV% SD CV% 7. The results obtained by any individual laboratory may vary from the given mean value. should approximate the original value of the known sample to confirm the low patient result. The confirmed result should be reported as < 0.73 r = 0.2 1. Na EDTA) may be used. the resulting curve should be visually reviewed.. Specimen Serum or plasma (Na or Li heparin.32 2. further dilutions utilising saline are needed. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. Major preventative maintenance was performed on the analyser or a critical part was replaced. Calculation The Beckman Coulter analysers automatically compute the phenobarbital concentration of each sample. Linearity The test is linear within a concentration range of 1. Once reconstituted.8 µmol/L).1 0. Avoid repeated freezing and thawing. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. does not approximate the original result of the known sample. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements.56 1.8 0.Storage and Stability The reagents are stable. results should always be assessed in conjunction with other available information such as patient’s medical history. Results of linear regression analysis were as follows: y = 0.. Specimen results greater than the highest calibrator can be reported as greater than the value of the highest calibrator or diluted one part sample with one part Core TDM Multi-Calibrator 1 and reassayed. Samples reported as less than the analytical range can be confirmed by diluting one part sample of known value with one part of the original patient sample.6 µg/mL. Calibration Core TDM Multi-calibrator. If the assayed result of the first dilution. It is calculated as the absolute mean plus three standard deviations of 25 replicates of an analyte free sample. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems. The lowest detectable level (LDL) represents the lowest measurable level of phenobarbital that can be distinguished from zero. Following calibration. on the Beckman Coulter analyser. other drug treatments and clinical symptoms. Cat. The value obtained on reassay should be derived as follows: Actual Value = (2 x diluted value) – Concentration of Core TDM Multi-Calibrator 1.6 µg/mL. mode of drug administration.5 45. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. 5 The expected range provided is only a guide for drug dosage.01 2009-08 EN. Two replicates of each sample were analysed twice daily over 20 days.2 µg/mL and the value of the highest calibrator (approximately 80 µg/mL or 344.8°C. If any trends or sudden shifts in values are detected. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Stable in serum and plasma for 24 hours when stored at 2…8°C and 2 weeks when stored at -20°C. No. when multiplied by 2. Some therapeutic drug concentrations are reduced when a sample is stored in a separator tube for a prolonged period of time (>2 hrs).999 n = 139 Sample range = 1.5 0. interference No significant interference (<10%) was observed with the following substances: Substance Concentration Substance Bilirubin ≤ 1129 µmol/L Total Protein Haemoglobin ≤ 10 g/L Triglyceride Rheumatoid Factor ≤ 180 IU/mL Concentration ≤ 130 g/L ≤ 11. a therapeutic response is achieved with phenobarbital concentrations in the 15-40 µg/mL range (65-172 µmol/L). Expected Values In most patients. 12 Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. ODC6411 The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard. Quality Control Control materials with values determined by this Beckman Coulter system may be used.5 14.8 0. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice.50 3. Data obtained in your laboratory may differ from these values.2 0. unopened. Calibration Monitor.3 mmol/L Specificity The following compounds when tested with the Phenobarbital assay yielded the following percent cross-reactivity results: TDM BLOSR6413. Calibration Curve. when multiplied by 2.25 1.964x + 0.4 µg/mL Sensitivity The lowest detectable level on an AU640 analyser was calculated as 0.9 Method Comparison Patient serum samples were used to compare this Phenobarbital OSR6413 assay on the AU640 against another commercially available phenobarbital assay.39 5.20 2. review all operating parameters. for acceptability using the software options Routine. . and Serum Half life. Neurol.P. J. Med.M.3-dimethylbarbituric acid 2-Phenyl-2-ethylmalonamide 5-(ρ-Hydroxyphenyl)-5-phenylhydantoin Amitriptyline Aprobarbital Barbital Butabarbital Carbamazepine-10.90:207-218.Compound 1. 1986. R.: Usefulness of Blood Levels of Anti-Epileptic Drugs. 1972.: Antiepileptic Drugs: Biotransformation.12 ≤ 0. Manning. Saldand. T. N. O.6 ≤ 2. M.: Osteomalacia with long-term anticonvulsant therapy in epilepsy.74:117-135. Eadie. EN. a New Homogeneous Immunoassay System. Lennox-Buchthal.. M. Henderson.16:367-391. 1990. 6. Buchthal.1:373-384. Nelson. 2. London: Churchill Livingstone. S.. Penry.A.. 4. Brit.12 < 0.12 < 0.9 < 0. K...O. C.1960.. Hauptmann. Farwell... D. Glazko. Stamp. Ellenberg.. W.J. User defined ¤ Analyser default value Core TDM Multi-calibrator Cat.J. Limitations • • Samples containing antibodies to E.C.12 2.J.11-epoxide Carbamazepine Chlorazepate Chlorpromazine Diazepam Ethotoin Ethosuximide Glutethimide Imipramine Mephenytoin Methsuximide Pentobarbital Phenytoin ρ-Hydroxyphenobarbital Primidone Promethazine Secobarbital Sulthiame Valproic acid Concentration Tested (µg/mL) 1000 1000 1000 1000 1000 2000 1000 1000 1000 2000 1000 1000 1000 1000 1000 2000 1000 1000 1000 400 2000 1000 1000 2000 1000 2000 % Cross reactivity < 0. J. Deut. K. 7. 1979.12 < 0. Arch. the possibility exists for interference by human anti-mouse antibodies (HAMA) in the sample.3:283-288.: Aspects of the Pharmacology of Phenytoin (Dilantin) and Phenobarbital Relevent to Their Dosage in theTreatment of Epilepsy. Sulzbacher. F.32(9):1637-1641..: Luminal bei Epilepsy. Y. Hewmark.31.J.E. F. which could cause falsely elevated results.: Absorption of Therapeutic Drugs by Barrier Gels in Serum Separator Blood Collection Tubes. in Woodbury.: Serum Concentrations of Diphenylhydantion (Phenytoin) and Phenobarbital and Their Relation to Therapeutic and Toxic Effects.7 Amobarbital (>20%) and Mephobarbital (>100%) show significant interference with the Phenobarbital assay. Richens. Pentry. Dasgupta. Buchthal. and Schmidt. Med. 1970. Penry.H.D.12 < 0. He. Engl. A. 9.E.01 2009-08 TDM .2 < 0.12 ≤ 0. No. Tyrer.. The incident of patients having such antibodies is extremely low... Svensmark.K. J.: The use of anti-epileptic drugs. Clin. Wschr. 11.59:1907-1909 3.12 ≤ 5. To work in SI units (µmol/L) multiply by 4..R. Rowe.12 < 0. Annals of Internal Medicine. R.01 BLOSR6413.12 < 0.: CEDIA. Epilepsia. D.. NY: Raven Press.335-343.. Med.12 < 0. Neurol.F.: Anticonvulsant Therapy: Pharmacological Basis and Practice.R. Dean. coli β-galactosidase may result in artificially high results which will not fit the clinical profile. Metabolism.E.12 < 0.1974. F.A.3 < 0.G.. 1974. Harris.I. J.. Lee. (eds):Antiepileptic Drugs. J. 1993:456-461. Friedman. McLawhon.K.. 1971. A. American Journal of Clinical Pathology. Epilepsia.12 < 0.12 < 0. Munch. Neurochir. Setting Sheet Footnotes # † * Bibliography 1.. and Zoccoli. A.H.. Svensmark. J.12 < 0. Hirtz.12 < 0.: Phenobarbital for febril seizures -effects on intelligence and on seizure recurrence.3 ≤ 1. M. 1975. Kutt. Chem. A. 1912. 10. 5. 8. Psychiat..4:69-72. S. D. Kinnaman G. D.12 ≤ 0.: Relation of Serum Concentration to Control Seizures. S.B.322:363-369... J. K. 12. J. M.B..5 < 0.B. As with any assay employing mouse antibodies.12 < 0..: ODC6411 Values set for working in µg/mL. Buchthal.12 < 0. . To work in SI units (µmol/L) multiply by 4. H Lst. None Selected 8.05 0 ¤ NO % ∇ Pre-Dilution Rate: 1 Min OD Max OD L -2.00 H 2. OD L -2. # # ο ∇ 2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Core TDM Multicalibrator Cat. # # OD CONC † † Factor/OD-L -999999 -999999 1-Point Cal. # # ο ∇ 4. Out of Range L # # # # # # # # Unit: µg/mL* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name PHB ∇ AA ∇ Y=AX+B OD ∇ Conc † † Count Process Factor/OD-L -999999 -999999 # Conc Factor/OD-H 9999999 9999999 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 9999999 9999999 # SERUM/PLASMA APPLICATION Test Name: Counts: PHB ∇ < > Type Calibration Type: AA ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. # # ο ∇ 6.31 TDM . AU400/AU640 Serum/Plasma Reagent ID: 413 Specific test parameters Serum ∇ Sample vol.05 B 0 On-board stability period: 60 60 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: PHB ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 3. Linearity Fst No lag time NO % Sec ∇ ∇ ∇ Fst Fst Lst Lst Sec.50 Last L -2.00 Dynamic range L 1. L -2.00 Reagent OD limit Fst.00 First H 2.2* H 80* Correlation Factor: A 1.50 2. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 9 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.: ODC6411 * Values set for working in µg/mL.: ODC6411 * Values set for working in µg/mL.2* Correlation factor H A B Rate 80* 1. Reagent 1 vol Reagent 2 vol μL μL μL Fst. # # ο ∇ 5. No. # # ο ∇ 7. 24 Sample Pre-dil. vol Dil. OD H ∇ Operation: Yes Test No ∇ 2.50 2. To work in SI units (µmol/L) multiply by 4.50 ∇ # Test name PHB Sample type Ser Page 1/2 System Reagent: OSR6413 Reagent ID: 413 Application PHENOBARBITAL. vol 0 0 0 Max. L -2. H ∇ ∇ ∇ Main 570 Sub 2 120 120 Dil.00 Last H 2.31 BSOSR6413. No. AU600 Serum/Plasma Application System Reagent: OSR6413 Specific Test Parameters General LIH ISE Range Test Name: PHB ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 120 120 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.PHENOBARBITAL.50 Reagent OD limit: First L -2. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name PHB Sample type Ser ∇ 570 RATE1 + First 24 First Last Last 27 Wave Method Reaction Point 1 Point 2 660 RATE1 + 27 Min. No.00 Lst.50 Dynamic Range: L 1. vol Dil.01 2009-08 # User defined † Core TDM Multicalibrator Cat. Volume R1(R1-1) μL ∇ μL 1. # # ο ∇ 7. ∇ # # # # ο 4. ∇ # # # # ο 2.00 First H 2.05 B 0 On-board stability period: 60 60 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH PHB ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # PHB ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.00 -2. # # ο ∇ 2.05 μL High B B 0 96 Dilution 0 1. Calibration Type: AA ∇ Formula: Y=AX+B ∇ Cal.31 AU680 <Point Cal.2* H 80* Correlation Factor: A 1.50 2.OD μL Min. ∇ ∇ ∇ Sec. Core TDM Multicalibrator Cat.50 Dynamic Range: L 1.50 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6413 Reagent ID: 413 Application Operation Yes PHENOBARBITAL.2* 1 1. ∇ 7. Not within expected values µg/mL* Decimal Places Calibration Specific ISE PHB ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High -999999 999999 ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 9999999 9999999 # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: PHB ∇ < > Test Name: Use Serum Cal. # # ο ∇ 6. 660 ∇ 570 RATE1 + First 24 First Common Rgt. For No. No demographics 8. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour TDM BSOSR6413. None Selected 8. No. ∇ # # # # ο 3.00 H 2.00 High High Max. ∇ # # # # ο 6.50 2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/mL* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AA ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 NO % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 570 ∇nm RATE1 ∇ + ∇ 24 Last Last 27 80* 0 0 Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: NO % ∇ Pre-Dilution Rate: 1 Min OD Max OD L -2. # # ο ∇ 3. No. To work in SI units (µmol/L) multiply by 4. AU2700/AU5400 Serum/Plasma Reagent ID: 413 Parameters General LIH PHB ∇ Dilution μL -2. AU680/AU480 Serum/Plasma Application System Reagent: OSR6413 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt.PHENOBARBITAL.01 2009-08 . # # ο ∇ 4. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 1.6 1 96 Range Operation: ∇ Yes Test Name: PHB ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec. ∇ # # # # ο 5.50 Last L -2. # # ο ∇ 5.: ODC6411 Values set for working in µg/mL.50 Reagent OD limit: First L -2.00 -2.6 96 96 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. # # OD CONC † † Factor/OD-L -999999 -999999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal.00 Last H 2. If analyte is not present in the sample. buffer salts and preservative. For in vitro diagnostic use only. and no active enzyme will be formed. Record the reconstitution date on the bottle label. Stable in serum and plasma for 7 days when stored at 2…8°C and 4 weeks when stored at -20°C. MOPS (3-(N-morpholino)propanesulfonic acid buffer).. R22. detergent. in the assay format. Mix again. The R2 working solution (enzyme donor) should be yellow-orange in colour. Detach the R2 lyo bottle and adapter from the R2 buffer bottle and discard. Mix by gentle inversion. Summary Phenytoin (diphenylhydantoin) is one of the most widely prescribed anti-convulsant drugs for the treatment of epilepsy. Dispose of all waste material in accordance with local guidelines. to achieve optimal therapeutic effect and avoid both 1. A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded. Harmful if swallowed. ensuring that all the lyophilised material from the R1 lyo bottle is transferred into the R1 buffer bottle. cortical focal seizures and temporal lobe epilepsy. up to the stated expiry date when stored at 2. unopened. leaving the inactive enzyme fragments free to form active enzyme. Mix by gentle inversion. Ensure the reagent is homogeneous before use. S60.6 seizure control. R1 (Enzyme acceptor solution): Connect the R1 lyo bottle to the R1 buffer bottle using one of the enclosed adapters.. Safety Phrases: S36. which has been genetically engineered into two inactive fragments. Reagent Preparation Remove the kit from refrigerated storage (2…8°C) immediately prior to preparation of the solutions. Refer to Safety Data Sheets for further information. Wear suitable protective clothing. 2-7 2 Phenytoin concentrations of 10 to 20 µg/mL for adults and 6 to 14 µg/mL for children in serum are considered to be the therapeutic range for maximum 5. EN. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. mouse monoclonal anti-phenytoin antibody. If analyte is present in the sample. Avoid the formation of foam. releasing agent. Record the reconstitution date on the bottle label. This material and its container must be disposed of as hazardous waste. Avoid the formation of foam.01 2009-08 TDM . Cap the R2 buffer bottle and let stand for approximately 5 minutes at 15…25°C. Monitoring phenytoin concentrations in serum is essential during therapy by providing physicians with an index for adjusting dosage. buffer salts. ensuring that all the lyophilised material from the R2 lyo bottle is transferred into the R2 buffer bottle. NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the appropriate reagent bottle. Storage and Stability The reagents are stable.Phenytoin OSR6411 2 x 16 mL 2x 2 x 16 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the quantitative determination of phenytoin in human serum and plasma on Beckman Coulter analysers. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. NOTE 1: The components supplied in this kit are intended for use as an integral unit. Mix again. R2 (Enzyme donor solution): Connect the R2 lyo bottle to the R2 buffer bottle using one of the enclosed adapters. In the assay. NOTE 5: Do not freeze reconstituted reagents. Reagent Composition R1 Buffer R1 Lyo R2 Buffer R2 Lyo MOPS (3-(N-morpholino)propanesulfonic acid buffer). it binds to antibody. NOTE 4: To ensure reconstituted R1 stability. flush waste-pipes with water after the disposal of undiluted reagent. Specimen Serum or plasma (Na or Li heparin. buffer salts. particularly grand mal epilepsy 1 (major motor). The toxicity of phenytoin is often dose-related and affects mainly the central nervous system. antibody binds to analyte conjugated on the inactive fragment. inhibiting the reassociation of inactive β-galactosidase fragments. NOTE 3: The R1 and R2 solutions must be at the reagent compartment temperature of the analyser before performing the assay. Prepare the R2 solution before the R1 solution to minimise possible contamination.01 BLOSR6411. Ensure the reagent is homogeneous before use. Cap the R1 buffer bottle and let stand for approximately 5 minutes at 15…25°C. continuous exposure to bright light. Na EDTA) may be used. analyte in the sample competes with analyte conjugated to one inactive fragment of β-galactosidase for antibody binding site. reagents stored on board the instrument are stable for 60 days. Once reconstituted. Contains sodium azide. stabiliser and preservative. To avoid the possible build-up of azide compounds. Avoid repeated freezing and thawing. cleaves a substrate. generating a colour change that can be measured spectrophotometrically. Enzyme acceptor.8°C. buffer salts and preservative. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample. Enzyme donor conjugated to phenytoin.7 subtherapeutic and harmful toxic drug levels. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. Detach the R1 lyo bottle and adapter from the R1 buffer bottle and discard. Do not mix components from different lots. Test Principle8 This assay is based on the bacterial enzyme β-galactosidase. These fragments spontaneously reassociate to form fully active enzyme that. protect from prolonged. stabiliser and preservative. chlorophenol red-β-D-galactopyranoside. The lowest detectable level (LDL) represents the lowest measurable level of phenytoin that can be distinguished from zero. for acceptability using the software options Routine. the resulting curve should be visually reviewed. Quality Control Control materials with values determined by this Beckman Coulter system may be used. Expected Values Investigator 1 Buchthal and Lennox-Buchthal 2 Finn and Olanow 3 Jusko 6 Buchthal and Svensmark 4 Sohn and Ferrendelli 7 Penry and Newmark Therapeutic Range (µg/mL) Adult Children 15 – 25 10 – 20 6 – 14 10 – 20 10 – 20 10 – 25 10 – 20 The expected range provided is only a guide for drug dosage.57 2. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Calibration Core TDM Multi-calibrator. Calibration Curve.01 . Two replicates of each sample were analysed twice daily over 20 days. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed.3 14. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems.31 0. Results of linear regression analysis were as follows: y = 0.3 4. No. results should always be assessed in conjunction with other available information such as patients medical history.2 Method Comparison Patient serum samples were used to compare this Phenytoin OSR6411 assay on the AU640 against another commercially available phenytoin assay. Calibration Monitor. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. The value obtained on reassay should be derived as follows: Actual Value = (2 x diluted value) – Concentration of Core TDM Multi-Calibrator 1.63 1.01 r = 0. Major preventative maintenance was performed on the analyser or a critical part was replaced.7 µg/mL.5 µg/mL Sensitivity The lowest detectable level on an AU640 analyser was estimated at 0.969x – 0.3 Total SD 0.0 Within Run SD CV% 0. should approximate the original value of the known sample to confirm the low patient result. If the assayed result of the first dilution.6 25.3 4. Cat.01 2009-08 EN. The results obtained by any individual laboratory may vary from the given mean value.4 µmol/L). Interference No significant interference (<10%) was observed in this Phenytoin assay from the following substances: Substance Bilirubin Haemoglobin Triglycerides Concentration ≤ 1026 µmol/L or 60 mg/dL ≤ 10 g/L or 1000 mg/dL 22. Samples reported as less than the analytical range can be confirmed by diluting one part sample of known value with one part of the original patient sample. Following calibration. ODC6411 The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard. on the Beckman Coulter analyser. It is calculated as the absolute mean plus three standard deviations of 25 replicates of an analyte free sample.998 n = 135 Sample range = 0. does not approximate the original result of the known sample. Linearity The test is linear within a concentration range of 0. Specimen results greater than the highest calibrator can be reported as greater than the value of the highest calibrator or diluted one part sample with one part Core TDM Multi-Calibrator 1 and reassayed. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. If any trends or sudden shifts in values are detected. The confirmed result should be reported as < 0. n = 80 Mean µg/mL 4. when multiplied by 2.9 0.6 mmol/L or 2000 mg/dL Other substances and/or factors not listed may interfere with the test and cause false results (e.6 – 54. when multiplied by 2.g. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. The assayed result of this dilution. further dilutions utilising saline are needed. Calculation The Beckman Coulter analysers automatically compute the phenytoin concentration of each sample.Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions.05 CV% 7. Data obtained in your laboratory may differ from these values.24 5.6 µg/mL and the value of the highest calibrator (approximately 40 µg/mL or 158. timing of sample collection. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. other drug treatments and clinical 9 symptoms. mode of drug administration.6 0.6 µg/mL. technical or procedural errors). TDM BLOSR6411. Precision The following data was obtained on an AU2700 using serum pools and control sera. review all operating parameters. Prior to the adjustment of dose.42 2. 1986. 1981. Ferrendelli JA: Inhibition of Ca Transport into Rat Brain Synaptosomes by Diphenylhydantoin (DPH).3 Amobarbital 1000 0.11-epoxide 1000 0.4 Mephenytoin 3000 0.0 Limitations • • Samples containing antibodies to E. 5. Zoccoli MA: CEDIA®. Penry JK.4 Diazepam 2000 1.7 HPPH 500 1. Fin AL (eds): Individualizing Drug Therapy: Practical Application of Drug Monitoring. 4. J. Schmidt KP (eds): Antiepileptic Drugs. coli β-galactosidase may result in artificially high results which will not fit the clinical profile.0 Pentobarbital 1000 0.0 Valproic Acid 7000 0.96. Neurochir. Buchthal F. 1973. 1971. Exp.1 Carbamazepine 500 0. Ann. New York: Raven Press. Schmidt KP (eds): Antiepileptic Drugs. in Woodbury DM..0 Amitriptyline 3000 0. which could cause falsely elevated results.0 Primidone 1000 0.6 Secobarbital 1000 0. 3. in Taylor WJ. in Woodbury DM.74:117-136. Bibliography EN. Henderson DR.: ODC6411 Values set for working in µg/mL. Townsend. 1979. New York: Gross. 1976.0 Glutethimide 500 4. Kutt H: Diphenylhydantoin: Relation of Plasma Levels to Clinical Control.. Petersen I. Pentry JK.1 Chlorpromazine 2500 0.8 HPPH-Glucuronide 1000 0. in Kellaway P.01 2009-08 TDM . Jusko WJ: Bioavailability and Disposition Kinetics of Phenytoin in Man. Manning WB.6 p-Hydroxyphenobarbital 1000 0. 9.01 BLOSR6411.0 Ethotoin 1000 0.2 PEMA 1000 0. Med. Capps N. Finn AL. To work in SI units (µmol/L) multiply by 3. No.90:207-218. Pharmacol.3 Oxaprozin 500 2. 7. Penry JK. Harris JD. London:ACB Venture Publications.115-136. the possibility exists for interference by human anti-mouse antibodies (HAMA) in the sample. A New Homogeneous Immunoassay System.193-209.0 Hydantoin 2000 0. New York: Raven Press.1 Chlorazepate 2000 0. (eds): Quantitative Analytic Studies in Epilepsy. Friedman SB.. Lennox-Buchthal MA: Diphenylhydantoin: Relation of Anticonvulsant Effect to Concentration in Serum. Therapeutic drug monitoring and clinical biochemistry. Ther. Setting Sheet Footnotes # † * 1.0 Imipramine 4000 0. Clin Chem. 6.0 Sulthiame 500 0.3 Promethazine 1500 1. Newmark ME: The Use of Anti-Epileptic Drugs. Vol2. 8.211-218.7 Mephobarbital 1000 1. New York:Raven Press. Buchthal F. Psychiat. 1981. Inc.32(9):1637-1641.185:272-275.Specificity The following compounds when tested with the Phenytoin assay.0 Phenobarbital 2000 0. Sohn RS. 2. of Intern.9 Chlordiazepoxide 2000 0. Hallworth M. User defined ¤ Analyser default value Core TDM Multi-Calibrator Cat.. 1993. As with any assay employing mouse antibodies. Frank. The incidence of patients having such antibodies is extremely low.0 Phensuximide 2000 0. Neurol. eds.63-85.1 Methsuximide 5000 0.5 Ethosuximide 1000 0. Svensmark O: Serum Concentrations of Diphenylhydantoin (Phenytoin) and Phenobarbital and Their Relation to Therapeutic and Toxic Effects.2 Carbamazepine-10. 1972. yielded the following percent cross-reactivity results: Compound Concentration Tested (µg/mL) % Cross reactivity 5-(p-methylphenyl)-5-phenylhydantoin 500 6. Olanow CW: Phenytoin: Therapeutic use and Serum Concentration Monitoring. . # # ο ∇ 6.96 TDM . AU400/AU640 Serum/Plasma Reagent ID: 411 Specific test parameters Serum ∇ Max OD H 2. # # ο ∇ 2.5 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. L -2. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Core TDM Multi-Calibrator Cat. Out of Range L # # # # # # # # Unit: µg/mL* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name PHT ∇ AA ∇ Y=AX+B OD ∇ Conc † † Count Process Factor/OD-L -999999 -999999 # Conc Factor/OD-H 9999999 9999999 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 9999999 9999999 # SERUM/PLASMA APPLICATION Test Name: Counts: PHT ∇ < > Type Calibration Type: AA ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. To work in SI units (µmol/L) multiply by 3.00 Dynamic Range: L 0.6* Correlation factor H A B Rate 40* 1 0 ¤ NO % ∇ Pre-Dilution Rate: 1 Min OD L -2. OD H ∇ Operation: Yes Test No ∇ 2.00 Reagent OD limit Fst.00 Reagent OD limit: First L -2.: ODC6411 * Values set for working in µg/mL.00 Dynamic range L 0.96 BSOSR6411. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name PHT Sample type Ser ∇ 570 RATE1 + First 24 First Last Last 27 Wave Method Reaction Point 1 Point 2 Min. Reagent 1 vol Reagent 2 vol μL μL μL 2. # # ο ∇ 5.50 Main ∇ ∇ ∇ 570 Sub 2. No.00 Last L -2. H First H Last H H Sample vol. No. # # ο ∇ 3.50 2.PHENYTOIN.01 2009-08 # User defined † Core TDM Multi-Calibrator Cat. vol Dil. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 9 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.50 2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period Select using Space key. None Selected 8. AU600 Serum/Plasma Application System Reagent: OSR6411 Specific Test Parameters General LIH ISE Range Test Name: PHT ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2. # # ο ∇ 4. OD L -2. ∇ ∇ ∇ Sec. # # ο ∇ 7.50 2.: ODC6411 * Values set for working in µg/mL.6* Correlation Factor: A 1 On-board stability period: 60 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: PHT ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. To work in SI units (µmol/L) multiply by 3.50 40* B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil. H Lst. L -2. Fst Fst 24 Lst Lst 660 RATE1 + 27 Fst. vol 0 0 0 Max.00 Lst. # # OD CONC † † Factor/OD-L -999999 -999999 1-Point Cal. No.5 87 87 Dil.50 ∇ # Test name PHT Sample type Ser Page 1/2 System Reagent: OSR6411 Reagent ID: 411 Application PHENYTOIN. vol Dil. Volume R1(R1-1) μL ∇ μL 1.96 AU680 <Point Cal.: ODC6411 Values set for working in µg/mL. ∇ ∇ ∇ 40* 0 Sec.00 High High Max.OD μL Min.00 -2. # # ο ∇ 6.00 Reagent OD limit: First L -2. # # ο ∇ 7.6* 1 1 μL High B B 0 40* 0 0 Hour 60 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. # # ο ∇ 4.00 Dynamic Range: L 0.50 2. AU680/AU480 Serum/Plasma Application System Reagent: OSR6411 Specific Test Parameters General LIH ISE Serum ∇ Max OD H 2. # # ο ∇ 5. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0.7 60 60 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. # # ο ∇ 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check NO % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 570 ∇nm RATE1 ∇ + ∇ 24 570 RATE1 + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.00 -2. ∇ # # # # ο 2.00 Last L -2. ∇ # # # # ο 5.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2. ∇ # # # # ο 6. Not within expected values µg/mL* Decimal Places Calibration Specific ISE PHT ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High -999999 999999 ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 9999999 9999999 # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: PHT ∇ < > Test Name: Use Serum Cal. AU2700/AU5400 Serum/Plasma Reagent ID: 411 Parameters General LIH PHT ∇ Dilution μL -2.50 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour TDM BSOSR6411. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. ∇ # # # # ο 4.50 2. Calibration Type: AA ∇ Formula: Y=AX+B ∇ Cal.50 R2(R2-1) μL Name Sec. To work in SI units (µmol/L) multiply by 3. For No. ∇ 7.7 1 60 Range Operation: ∇ Yes Test Name: PHT ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 Last Last 27 1. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/mL* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. # # ο ∇ 3.PHENYTOIN. ∇ # # # # ο 3. No. # # OD CONC † † Factor/OD-L -999999 -999999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal. Core TDM Multi-Calibrator Cat.01 2009-08 .50 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6411 Reagent ID: 411 Application Operation Yes PHENYTOIN. No. None Selected 8.6* Correlation Factor: A 1 On-board stability period: 60 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH PHT ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # PHT ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. No demographics 8. Point: ο With CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AA ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined.50 2. Refer to Safety Data Sheets for further information. These effects include anorexia. Conversely. Cap the R2 buffer bottle and let stand for approximately 5 minutes at 15…25°C. Avoid the formation of foam. In the assay. Detach the R2 lyo bottle and adapter from the R2 buffer bottle and discard. stabilisers and preservative. A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded. If analyte is not present in the sample. Detach the R1 lyo bottle and adapter from the R1 buffer bottle and discard. For in vitro diagnostic use only. buffer salts and preservative. low protein diet. MES (2-(N-morpholino)ethanesulfonic acid buffer). Severe side effects such as increased cardiac rate. cerebral seizures. This material and its container must be disposed of as hazardous waste. vomiting. it binds to antibody. Toxic effects of theophylline usually occur at concentrations above 20 µg/mL in adults . EN. arrhythmia. the therapeutic range for theophylline is 10 to 20 µg/mL in adults 3 4-7 and 5 to 10 µg/mL in newborns for treatment of apnea. Reagent Composition R1 Buffer R1 Lyo R2 Buffer R2 Lyo MOPS (3-(N-morpholino)propanesulfonic acid buffer). Cap the R1 buffer bottle and let stand for approximately 5 minutes at 15…25°C. Storage and Stability The reagents are stable. The R2 working solution (enzyme donor) should be yellow-orange in colour. up to the stated expiry date when stored at 2. analyte in the sample competes with analyte conjugated to one inactive fragment of β-galactosidase for antibody binding site. Mix again. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. S60. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.01 BLOSR6412. NOTE 3: The R1 and R2 solutions must be at the reagent compartment temperature of the analyser before performing the assay. NOTE 5: Do not freeze reconstituted reagents. Mix again.8°C. reagents stored on board the instrument are stable for 60 days. and preservative. and respiratory or cardiac arrest usually occur at concentrations above 40 µg/mL. Safety Phrases: S36. inhibiting the reassociation of inactive β-galactosidase fragments. Test Principle10 This assay is based on the bacterial enzyme β-galactosidase. Ensure the reagent is homogeneous before use. which has been genetically engineered into two inactive fragments. patients with hepatic disease and in those on a high carbohydrate. Summary Theophylline is a methylxanthine derivative which is widely used in the treatment of asthma. Theophylline elimination is slowed in obese patients. although mild symptoms can occur above 15 µg/mL. Contains sodium azide. generating a colour change that can be measured spectrophotometrically. These fragments spontaneously reassociate to form fully active enzyme that. in the assay format. Mix by gentle inversion. Once reconstituted. mouse monoclonal anti-theophylline antibody. 8. and no active enzyme will be formed.9 Monitoring of theophylline concentrations in serum is essential. theophylline elimination is more rapid among cigarette smokers. R1 (Enzyme acceptor solution): Connect the R1 lyo bottle to the R1 buffer bottle using one of the enclosed adapters. obstructive lung disease and neonatal apnea. chlorophenol red-β-D-galactopyranoside and preservative. since individuals can vary in their rates of theophylline clearance. protect from prolonged. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. Harmful if swallowed. In combination with other clinical data. NOTE 4: To ensure reconstituted R1 stability. antibody binds to analyte conjugated on the inactive fragment. 1 2 The effect of theophylline is closely correlated with concentration of the drug in serum. Do not mix components from different lots. headaches and nervousness. Ensure the reagent is homogeneous before use. ensuring that all the lyophilised material from the R2 lyo bottle is transferred into the R2 buffer bottle.. Premature infants have very low rates of 4 2 theophylline elimination. Enzyme donor conjugated to theophylline. To avoid the possible build-up of azide compounds. Mix by gentle inversion. R22. R2 (Enzyme donor solution): Connect the R2 lyo bottle to the R2 buffer bottle using one of the enclosed adapters. monitoring serum theophylline levels may provide the physician with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity. cleaves a substrate. but may also occur at lower concentrations. stabiliser. Wear suitable protective clothing. Record the reconstitution date on the bottle label. unopened. Prepare the R2 solution before the R1 solution to minimise possible contamination. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. Record the reconstitution date on the bottle label. Enzyme acceptor. continuous exposure to bright light. leaving the inactive enzyme fragments free to form active enzyme. If analyte is present in the sample.Theophylline OSR6412 2 x 16 mL 2x 2 x 16 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the quantitative determination of theophylline in human serum and plasma on Beckman Coulter analysers. nausea.. NOTE 1: The components supplied in this kit are intended for use as an integral unit. ensuring that all the lyophilised material from the R1 lyo bottle is transferred into the R1 buffer bottle. Avoid the formation of foam.01 2009-08 TDM . NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the appropriate reagent bottle. Reagent Preparation Remove the kit from refrigerated storage (2…8°C) immediately prior to preparation of the solutions. Dispose of all waste material in accordance with local guidelines. flush waste-pipes with water after the disposal of undiluted reagent. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.Specimen Serum or plasma (Na or Li heparin.98 CV% 8. Two replicates of each sample were analysed twice daily over 20 days. n = 80 Mean µg/mL 4. mode of drug administration. Precision The following data was obtained on an AU2700 using serum pools and control sera. on the Beckman Coulter analyser.8 SD 0.8 22. The confirmed result should be reported as < 0. Data obtained in your laboratory may differ from these values. Quality Control Control materials with values determined by this Beckman Coulter system may be used. Following calibration. >20 >111 The expected range provided is only a guide for drug dosage. should approximate the original value of the known sample to confirm the low patient result.8 µg/mL and the value of the highest calibrator (approximately 40 µg/mL or 222 µmol/L).1 4. when multiplied by 2.48 Within Run CV% 5. Na EDTA) may be used. Stable in serum and plasma for 7 days when stored at 2…8°C and 4 weeks when stored at -20˚C. does not approximate the original result of the known sample. for acceptability using the software options Routine. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. other drug treatments and clinical 14 symptoms. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems.1 Total SD 0. The assayed result of this dilution.01 .8 µg/mL Sensitivity The lowest detectable level on an AU640 analyser was estimated at 0. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions.6 mmol/L Rheumatoid Factor ≤ 180 IU/mL TDM BLOSR6412. It is calculated as the absolute mean plus three standard deviations of 25 replicates of an analyte free sample.12 r = 0.2 2. results should always be assessed in conjunction with other available information such as patients medical history. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. further dilutions utilising saline are needed. 5 – 15 28 – 83 4 Ogilvie >20 >111 5 Jacobs et al. Major preventative maintenance was performed on the analyser or a critical part was replaced.01 2009-08 EN. Prior to the adjustment of dose. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. The value obtained on reassay should be derived as follows: Actual Value = (2 x diluted value) – Concentration of Core TDM Multi-Calibrator 1. Calculation The Beckman Coulter analysers automatically compute the theophylline concentration of each sample.3 Method Comparison Patient serum samples were used to compare this Theophylline assay OSR6412 on the AU640 against another commercially available theophylline assay. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Interference No significant interference (<10%) was observed with the following substances: Substance Concentration Substance Concentration Bilirubin ≤ 1129 µmol/L Total Protein ≤ 120 g/L Haemoglobin ≤ 10 g/L Triglyceride ≤ 22. Samples reported as less than the analytical range can be confirmed by diluting one part sample of known value with one part of the original patient sample.9 2.998 n = 135 Sample range =0. Expected Values Therapeutic Toxic Investigator µg/mL µmol/L µg/mL µmol/L 11 Mitenko and Ogilvie 5 – 20 28 – 111 12 Buelow et al. review all operating parameters. Results of linear regression analysis were as follows: y = 0. 8 – 20 44 – 111 2 Hendeles and Weinberger 10 – 20 55 – 111 13 Weinberger and Bronsky 8 – 20 44 – 111 3 Aranda et al.22 0. If the assayed result of the first dilution. when multiplied by 2. Calibration Monitor.2 11. the resulting curve should be visually reviewed. The lowest detectable level (LDL) represents the lowest measurable level of theophylline that can be distinguished from zero.8 – 37.4 µg/mL. No. The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard. Cat. Avoid repeated freezing and thawing.973x + 0. The results obtained by any individual laboratory may vary from the given mean value. Linearity The test is linear within a concentration range of 0. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Specimen results greater than the highest calibrator can be reported as greater than the value of the highest calibrator or diluted one part sample with one part Core TDM Multi-Calibrator 1 and reassayed.37 0.60 0. timing of sample collection. ODC6411. Calibration Curve. If any trends or sudden shifts in values are detected.4 µg/mL. Calibration Core TDM Multi-Calibrator.34 0.7 5. Kalisker A. Bowers LD: Theophylline concentrations may be falsely high in serum or uremic patients (letter to the editors). Petty TL: Intravenous aminophylline dosage.289:600-603. European Journal of Clinical Pharmacology 1975. Friedman SB. 1993.08 Prednisone 2000 < 0.2 7-Methyluric Acid 1000 < 0.1 3.235:1983-1986. Marzouk N. Journal of the American Medical Association 1976. Raisys VA. Senior RM.8 Diprophylline 2000 ≤ 0. Chem. Weinberger MM: Theophylline therapeutic use and serum concentration monitoring. et al.08 Pseudoehedrine 2000 < 0.1 Hypoxanthine 1000 < 0. Annals of Internal Medicine 1975. and toxicity. Parsons WD. Neims AH: Pharmacokinetic aspects of theophylline in premature newborns. Harris JD.3. 17.7-Dimethylxanthine 1000 ≤ 1. Neff TA.4 7-(β-hydroxypropyl)theophylline 1818 1. Charmes JP.08 Xanthine 1000 < 0. Journal of the American Medical Association 1976. Smith CM. Weinberger MM: Theophylline-induced seizures in adults.32:1637-1641. Piafsky KM.59:440-444. Journal of Pediatrics 1974.295:413-416. 12. CEDIA™. Chidsey CA.: ODC6411 Values set for working in µg/mL.7-Dimethyluric Acid 1000 ≤ 0.31-66. Sitar DS. Therapeutic drug monitoring and clinical biochemistry. the possibility exists for interference by human anti-mouse antibodies (HAMA) in the sample. 1984. Buelow KB. Opein KE. Journal of Allergy and Clinical Immunology 1977.01 2009-08 TDM . Wong SHY. yielded the following percent cross-reactivity results: Compound Concentration Tested (µg/mL) % Cross reactivity Allopurinol 1000 ≤ 0. No. The xanthines. Use of serum theophylline measurement for guidance.5 1. Int J Clin Pharmacol 1989. Bell TD: Variation in theophylline clearance rate with time in chronic childhood asthma.3 3-Methyxanthine 1430 1.82:784-787.29:1698-1699.08 1-Methyluric Acid 1000 ≤ 0.3-Dimethyluric Acid.08 1-Methyxanthine 1000 1. 13. 19. which could cause falsely elevated results. Larsson H. 11. Correlation with serum concentrations. McComb Lewis S.08 Caffeine 645 3. Hendeles L. Kessler G: Clinical experience with theophylline.5 1. Drug Monit.08 1. 15-19 Due to cross-reactivity with 1. Matthay RA. Eichler E. Ogilvie RI: Drug therapy.8 1. Sautereau DS. 1986. 7. Capps N.1 3-Methyluric Acid 1000 ≤ 0. 3. Setting Sheet Footnotes # † * 1.292:1218-1222. eds.3:267-293. Sutton FD. Ther. 8. Breiner R. Messenfer LJ: Increase in apparent theophylline concentration in the serum of two uremic patients as measured by some immunoassay methods (caused by 1. a new homogeneous immunoassay system. Leroux-Robert C: Theophylline toxicity risks and chronic renal failure. 6. Goodman LS and Gilman A eds: The Pharmacological Basis of Therapeutics. Jacobs MH. 16.4 7-Methyxanthine 1000 0. Weinberger MW.1 Ampicillin 2000 < 0. 1981:vol 1. The incidence of patients having such antibodies is extremely low. eds: Individualizing Drug Therapy: Practical Applications of Drug Monitoring. Loughnan PM. the Theophylline assay should not be used to quantitate samples from uremic patients. In: Gilman AG.6 Clindamycin 2000 < 0. Finn AL. Aranda JV. To work in SI units (µmol/L) multiply by 5. Henderson DR.1 8-Chlorotheophylline 360 5. Mitenko PA and Ogilvie RI. Bibliography EN.2 Phenobarbital 2000 < 0. New York: MacMillan Publishing Company. Ginchansky EJ.7-Trimethyluric Acid 1000 ≤ 0. serum concentration. Valette JP. 4. Ainardi V. Kapke GF: Positive interference with immunoassay of theophylline in serum of uremics. Zwillich CW.3-dimethyluric acid?) (letters to the editors).08 Sulthiame 1000 < 0.08 Uric Acid 1000 < 0. 14.Specificity The following parent compounds and metabolites when tested with the theophylline assay. Nelson KM.84:421-427. Dosage of theophylline in bronchial asthma. Inc. Weinberger MM.7 Heparin 2000 < 0.8:119-123.08 Xanthosine 1000 < 0. Clin Chem 1983.27:398-401. 18.235:2110-2113. Cohn WM. McClatchey KD: Abnormal theophylline levels in plasma by fluorescence polarisation immunoassay in patients with renal disease.3-Dimethyluric Acid 200 9. Mathews SE. letters to the editor. Clin. 1980:592-607. coli β-galactosidase may result in artificially high results which will not fit the clinical profile.31:1575-1577. New York: Gross Townsend Frank.29:2125-2126. Lachatre G. User defined ¤ Analyser default value Core TDM Multi-Calibrator Cat. New England Journal of Medicine 1973b. Ogilvie RI: Clinical pharmacokinetics of theophylline. London:ACB Venture Publications. Bronsky EA: Evaluation of oral bronchodilator therapy in asthmatic children. 9. Relationships between dosage. Leideman T: Plasma theophylline level and ventilatory function in chronic obstructive pulmonary disease during prolonged oral treatment with choline theophyllinate. Matthay RA. In: Taylor WJ. Clin Chem 1983. Clayton LT.: Rational intravenous doses of theophylline..55 Rall TW.5 Urea 2000 < 0.08 Limitations • • • Samples containing antibodies to E. LeBel CP. 5.08 Terbutaline 2000 < 0. 1985.08 7-(2-Hydroxyethyl)theophylline 1430 1. New England Journal of Medicine 1975. Clinical Pharmacokinetics 1978.6:458-460. New England Journal of Medicine 1976. 10. Nicot G.08 Theobromine 800 2.7-Dimethyluric Acid 1000 < 0. Hallworth M. 15. As with any assay employing mouse antibodies. Patel JA. 2. Clin Chem. Leung P.01 BLOSR6412. . 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period 570 RATE1 + First 24 First Last Last 27 Min.8* Correlation Factor: A 1 On-board stability period: 60 Specific Test Parameters General LIH ISE Serum ∇ # ∇ L # # # # # # M M M M M M # # # # # # # Test No ∇ # Test name THEO Select using Space key. To work in SI units (µmol/L) multiply by 5. Fst 24 Lst Fst. vol Dil. Out of Range # # # # # # Age Y Y Y Y Y Y L # # # # # # # # Unit: µg/mL* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # L H Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range Age Y Y Y Y Y Y Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name THEO ∇ AA ∇ Y=AX+B OD ∇ Conc † † Count Process Factor/OD-L -999999 -999999 # Conc Factor/OD-H 9999999 9999999 ∇ Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 9999999 9999999 # SERUM/PLASMA APPLICATION Test Name: Counts: THEO ∇ < > Type Calibration Type: AA ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. # # ο ∇ 3. # # ο ∇ 2.00 Reagent OD limit Fst.00 Dynamic range L 0.: ODC6411 * Values set for working in µg/mL. L -2. No.50 40* Point 2 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Fst Lst Sample Pre-dil. # # ο ∇ 7.50 2. # # ο ∇ 5.01 2009-08 # User defined † Core TDM Multi-Calibrator Cat. AU600 Serum/Plasma Application System Reagent: OSR6412 Specific Test Parameters General LIH ISE Range Test Name: THEO ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. No. # # ο ∇ 6.55 TDM .50 2.: ODC6411 * Values set for working in µg/mL.55 BSOSR6412. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 9 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.8* Correlation factor NO % ∇ Pre-Dilution Rate: 1 Min OD L -2. vol Dil. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Core TDM Multi-Calibrator Cat.50 2. # # OD CONC † † Factor/OD-L -999999 -999999 1-Point Cal. To work in SI units (µmol/L) multiply by 5. # # ο ∇ 4. H Lst.00 Dynamic Range: L 0. L -2. OD H ∇ Operation: Yes Test No ∇ 2.00 Last L -2. vol 0 0 0 Max.50 Main ∇ ∇ ∇ 570 Sub 2. AU400/AU640 Serum/Plasma Reagent ID: 412 Specific test parameters Serum ∇ Max OD H 2. OD L -2. or select from list displayed by Guide key Sample type Ser ∇ Level L # H # # # # # # M→ M→ M→ M→ M→ M→ Page 2/2 Level H # Range Test Name: THEO ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. ∇ ∇ ∇ Sec.00 Reagent OD limit: First L -2. Reagent 1 vol Reagent 2 vol μL μL μL 2 87 87 Dil. None Selected 8. H H A B Rate First H Last H H Wave Method Reaction Point 1 660 RATE1 + 27 Sample vol.THEOPHYLLINE. No.00 Lst.50 40* 1 0 ¤ ∇ # Test name THEO Sample type Ser Page 1/2 System Reagent: OSR6412 Reagent ID: 412 Application THEOPHYLLINE. No demographics 8. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check NO % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 570 ∇nm RATE1 ∇ + ∇ 24 570 RATE1 + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.55 AU680 <Point Cal. Calibration Type: AA ∇ Formula: Y=AX+B ∇ Cal. # # ο ∇ 2.8* 1 1 μL High B B 0 40* 0 0 Hour 70 Dilution 0 Sample Volume Pre-Dilution Rate Rgt.8* Correlation Factor: A 1 On-board stability period: 60 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH THEO ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # THEO ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 3. ∇ 7. # # ο ∇ 6.00 Dynamic Range: L 0. ∇ # # # # ο 4.00 Reagent OD limit: First L -2. ∇ # # # # ο 6.THEOPHYLLINE. To work in SI units (µmol/L) multiply by 5.01 2009-08 .6 70 70 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.50 2. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AA ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0. ∇ ∇ ∇ 40* 0 Sec.50 2.50 R2(R2-1) μL Name Sec. AU680/AU480 Serum/Plasma Application System Reagent: OSR6412 Specific Test Parameters General LIH ISE Serum ∇ Max OD H 2. # # ο ∇ 5. Volume R1(R1-1) μL ∇ μL 1.OD μL Min. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. ∇ # # # # ο 3. Not within expected values µg/mL* Decimal Places Calibration Specific ISE THEO ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High -999999 999999 ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 9999999 9999999 # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: THEO ∇ < > Test Name: Use Serum Cal. # # OD CONC † † Factor/OD-L -999999 -999999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal. For No.: ODC6411 Values set for working in µg/mL.50 2. No. No.00 -2.50 2. ∇ # # # # ο 5. None Selected 8.00 Last L -2.00 High High Max.6 1 70 Range Operation: ∇ Yes Test Name: THEO ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 Last Last 27 1. # # ο ∇ 4.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2. ∇ # # # # ο 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour TDM BSOSR6412.00 -2.50 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6412 Reagent ID: 412 Application Operation Yes THEOPHYLLINE. AU2700/AU5400 Serum/Plasma Reagent ID: 412 Parameters General LIH THEO ∇ Dilution μL -2. # # ο ∇ 7. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/mL* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. Core TDM Multi-Calibrator Cat. stabiliser and preservative. unopened. EN. R1 (Enzyme acceptor solution): Connect the R1 lyo bottle to the R1 buffer bottle using one of the enclosed adapters. Storage and Stability The reagents are stable. R2 (Enzyme donor solution): Connect the R2 lyo bottle to the R2 buffer bottle using one of the enclosed adapters. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. NOTE 3: The R1 and R2 solutions must be at the reagent compartment temperature of the analyser before performing the assay. protect from prolonged. NOTE 1: The components supplied in this kit are intended for use as an integral unit. metabolism and clearance. analyte in the sample competes with analyte conjugated to one inactive fragment of β-galactosidase for antibody binding site. If analyte is not present in the sample. Reagent Preparation Remove the kit from refrigerated storage (2…8°C) immediately prior to preparation of the solutions. generating a colour change that can be measured spectrophotometrically.. Test Principle11 This assay is based on the bacterial enzyme β-galactosidase. antibody binds to analyte conjugated on the inactive fragment. Pharmacokinetics of VPA are highly variable. chlorophenol red-β-D-galactopyranoside. Do not mix components from different lots. R22.10 well as individual variations in volume of distribution. Ensure the reagent is homogeneous before use. but is also effective against absence seizures. Contains sodium azide. The most common side effects are gastrointestinal disturbances such as nausea and vomiting.8 primarily albumin. over 90% of VPA in the circulation is bound to plasma proteins. If analyte is present in the sample. S60. Cap the R2 buffer bottle and let stand for approximately 5 minutes at 15…25°C. which has been genetically engineered into two inactive fragments. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. and no active enzyme will be formed. in the assay format. continuous exposure to bright light. Sodium Salicylate. For in vitro diagnostic use only. To avoid the possible build-up of azide compounds. VPA has the fewest adverse effects of all the widely-used anti-epileptic agents. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample. as 9. In the assay. This material and its container must be disposed of as hazardous waste. Monitoring VPA concentrations during therapy is essential in order to provide the physician with an indicator for adjusting dosage. up to the stated expiry date when stored at 2. buffer salts. Enzyme acceptor. Enzyme donor conjugated to valproic acid. Refer to Safety Data Sheets for further information. Dispose of all waste material in accordance with local guidelines. buffer salts and preservative. Reagent Composition R1 Buffer R1 Lyo R2 Buffer R2 Lyo HEPES (N-[2-Hydroxyethyl]piperazine-N’-[2-ethanesulfonic acid]) buffer. inhibiting the reassociation of inactive β-galactosidase fragments.01 BLOSR6415. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. leaving the inactive enzyme fragments free to form active enzyme. A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded. Mix by gentle inversion. goat anti-mouse antibodies. BSA. Avoid the formation of foam. NOTE 4: To ensure reconstituted R1 stability. mouse monoclonal anti-valproic acid antibody. reagents stored on board the instrument are stable for 45 days. it binds to antibody. Detach the R2 lyo bottle and adapter from the R2 buffer bottle and discard.Valproic Acid OSR6415 2 x 12 mL 2x 2 x 9 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the quantitative determination of valproic acid in human serum and plasma on Beckman Coulter analysers.8°C. Mix again. Avoid the formation of foam. ensuring that all the lyophilised material from the R1 lyo bottle is transferred into the R1 buffer bottle. 2-propylpentanoic acid) is an anticonvulsant medication that is primarily used for the treatment of primary and secondary generalised 1-5 seizures. Wear suitable protective clothing. NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the appropriate reagent bottle. These fragments spontaneously reassociate to form fully active enzyme that. HEPES (N-[2-Hydroxyethyl]piperazine-N’-[2-ethanesulfonic acid]) buffer. depending on the form of the drug and route of administration. cleaves a substrate. Harmful if swallowed. Summary Valproic acid (VPA. NOTE 5: Do not freeze reconstituted reagents. Once reconstituted. Prepare the R2 solution before the R1 solution to minimise possible contamination. Mix by gentle inversion. flush waste-pipes with water after the disposal of undiluted reagent. Safety Phrases: S36. Record the reconstitution date on the bottle label. stabiliser and preservative. Cap the R1 buffer bottle and let stand for approximately 5 minutes at 15…25°C.01 2009-08 TDM . Ensure the reagent is homogeneous before use.. ensuring that all the lyophilised material from the R2 lyo bottle is transferred into the R2 buffer bottle. The R2 working solution (enzyme donor) should be yellow-orange in colour. Mix again. Detach the R1 lyo bottle and adapter from the R1 buffer bottle and discard. At therapeutic concentrations. 6 7. stabilisers and preservative. Record the reconstitution date on the bottle label. The value obtained on reassay should be derived as follows: Actual Value = (2 x diluted value) – Concentration of Core TDM Multi-Calibrator 1. n = 80 Mean µg/mL 12.2 – 153.6 Method Comparison Patient serum samples were used to compare this Valproic Acid assay OSR6415 on the AU640 against another commercially available valproic acid assay.0 4. for acceptability using the software options Routine. The lowest detectable level (LDL) represents the lowest measurable level of valproic acid that can be distinguished from zero. Data obtained in your laboratory may differ from these values. Calibration Monitor. Following calibration. Calibration Curve. Results of linear regression analysis were as follows: y = 0. These target values should fall within the corresponding acceptable ranges given in the relevant product literature.3 µg/mL Sensitivity The lowest detectable level on an AU2700 analyser was estimated at 2.49 CV% 4.3 mmol/L TDM BLOSR6415. on the Beckman Coulter analyser. It is calculated as the absolute mean plus three standard deviations of 25 replicates of an analyte free sample. Cat. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. The results obtained by any individual laboratory may vary from the given mean value. when multiplied by 2. Na EDTA) may be used. Linearity The test is linear within a concentration range of 3. the resulting curve should be visually reviewed.952x – 1.2 r = 0. Avoid repeated freezing and thawing. other drug treatments and clinical 15 symptoms. Precision The following data was obtained on an AU2700 using serum pools and control sera.40 3. Calibration Core TDM Multi-Calibrator. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Specimen results greater than the highest calibrator can be reported as greater than the value of the highest calibrator or diluted one part sample with one part Core TDM Multi-Calibrator 1 and reassayed.0 2. timing of sample collection.5 Within Run SD 0. Two replicates of each sample were analysed twice daily over 20 days. results should always be assessed in conjunction with other available information such as patients medical history. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems.0 µg/mL and the value of the highest calibrator (approximately 150 µg/mL or 1039. should approximate the original value of the known sample to confirm the low patient result. No. The assayed result of this dilution.4 g/L ≤ 200 IU/mL ≤ 100 g/L ≤ 11. review all operating parameters.9 g/L Total Protein IgG ≤ 43 g/L Triglyceride Concentration ≤ 8.01 2009-08 EN. does not approximate the original result of the known sample. The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard. mode of drug administration. Quality Control Control materials with values determined by this Beckman Coulter system may be used. Samples reported as less than the analytical range can be confirmed by diluting one part sample of known value with one part of the original patient sample.9 3. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions.53 Total CV% 9. Interference No interference was observed with the following substances: Substance Concentration Substance Bilirubin ≤ 1026 µmol/L IgM Haemoglobin ≤ 10 g/L Rheumatoid Factor IgA ≤ 7. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.4 48.Specimen Serum or plasma (Na or Li heparin. Expected Values The effective serum/plasma VPA concentration for seizure control has been reported as 50-100 µg/mL (347 – 693 µmol/L). ODC6411.01 .2 1. further dilutions utilising saline are needed. Prior to the adjustment of dose.5 µmol/L).06 1.8 97. Stable in serum and plasma for 7 days when stored at 2…8°C and 4 weeks when stored at -20°C. when multiplied by 2. Calculation The Beckman Coulter analysers automatically compute the valproic acid concentration of each sample. The confirmed result should be reported as < 2 µg/mL. 12-14 The expected range provided is only a guide for drug dosage. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Major preventative maintenance was performed on the analyser or a critical part was replaced.0 µg/mL.50 1.998 n = 123 Sample range = 2. If any trends or sudden shifts in values are detected. If the assayed result of the first dilution.5 SD 1.12 2. As with any assay employing mouse antibodies. Clin. Clin. 14. 10.8 3-Oxo-2-propylpentanoic acid 3. Gabreëls FJM. Miners JO. Henderson DR.4:601-616. Chem. Zoccoli MA.: ODC6411 Values set for working in µg/mL. Scand. Valproic acid: therapeutic use and serum concentration monitoring. 1986.15:367-389. User defined ¤ Analyser default value Core TDM Multi-calibrator Cat.2 2-Propyl-2-pentanoic acid 1.9 Carbamazepine < 0. Clin. Am. Clin. 1985. Mueller G.. 4. 1983. Friedman SB. Frank.3'-pentadienoic acid 14. Harris JD.0 Salicylic acid < 0.11-epoxide < 0.25(Suppl.8 2-Phenyl-2-ethylmalonamide (PEMA) < 0.32:1637-1641. 5. 1987. yielded the following percent cross-reactivity results: Compound % Cross reactivity 3-Hydroxy-2-propylpentanoic acid 4. Use of ethosuximide and valproate in the treatment of epilepsy. Cloyd JC. 11. Rawlins MD.J. which could cause falsely elevated results. Capps N. 2. Rimmer EM.84(Suppl 1A):34-41.5:441-446.9 Clonazepam < 0. New anticonvulsants in pediatrics: Carbamazepine and valproate.84 (Suppl 1A): 3-6. Am.04 Primidone <1. Zaccara G. Pharmacotherapy 1985. 1):S44-S49. Weightman E. Finn AL. the possibility exists for interference by human anti-mouse antibodies (HAMA) in the sample. Messori A. Leppik IE. 1981: 87-108.4 4-Hydroxy-2-propylpentanoic acid 4. Manning WB. 8. 1986.CEDIA™. Br.3 Diazepam < 0. Pharmacol.004 Limitations • Samples containing antibodies to E. Neurol. Clancy RR. J. Pharmacokinetics of di-N-propylacetate in epileptic patients.Specificity The following compounds when tested with the Valproic Acid assay.8:97-105. 1988. Langer DH. No. Individualizing Drug Therapy: Practical Applications of Drug Monitoring New York: Gross. Ann. Side effects of valproate. 1988. 3. Probl. 1989. eds. Drug interactions involving aspirin (acetylsalicylic acid) and salicylic acid. Comparison of monotherapy with valproate and other antiepileptic drugs in the treatment of seizure disorders.01 BLOSR6415. Acta.06 Phenytoin < 0. Clin. To work in SI units (µmol/L) multiply by 6. Med. The incidence of patients having such antibodies is extremely low. In: Taylor WJ. Gram L. Valproate: an updated review. 12. • Setting Sheet Footnotes # † * 1. Pharmacokinet. Plasma concentrations of sodium valproate: Their clinical value. (1988) Clinical pharmacokinetics of valproic acid. Chadwick DW.3 Phenobarbital 0. Plasma protein binding of valproic acid in healthy subjects and in patients with renal disease. a New Homogeneous Immunoassay System. Inc. van der Kleijn E.5:171-184.04 Carbamazepine-10. London:ACB Venture Publications. Europ. 15. 1993.3 2-Propylglutaric acid < 0. Hallworth M. Pharmacokinet. 1978. J. 9. Curr. Adverse effects of valproate.17:133-209. Clin.0 2-Propyl-4-pentanoic acid 22. 1988. Dreifuss FE. J. Richens A.4 2-Propylsuccinic acid < 0. Gugler R. Wallace SJ. Townsend. 13.17:327-344. Neurol. 1975. Schmidt D. Bentsen KD.72:129-139. 6. Turnbull DM. Schobben F.01 2009-08 TDM . coli β-galactosidase may result in artificially high results which will not fit the clinical profile. eds. Med. Pharmacol. Neurol. 7. Pediatr.16 2-Propyl-2. Moroni F. An update on sodium valproate.4 5-Hydroxy-2-propylpentanoic acid 5.14:38-42. Epilepsia 1984. BIBLIOGRAPHY EN. Therapeutic drug monitoring and clinical biochemistry.93 Chadwick D. . # # ο ∇ 3. Linearity Fst No lag time NO % Sec ∇ ∇ ∇ Fst Fst Lst Lst Sec. # # ο ∇ 4. H Lst.05 0 ¤ NO % ∇ Pre-Dilution Rate: 1 Min OD Max OD L -2. Out of Range L # # # # # # # # Unit: µg/mL* Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name VPA ∇ AA ∇ Y=AX+B OD ∇ Conc † † Count Process Factor/OD-L -999999 -999999 # Conc Factor/OD-H 9999999 9999999 ∇ SERUM/PLASMA APPLICATION Calibration Specific General ISE Serum ∇ Process: CONC ∇ Factor/OD-H 9999999 9999999 # Test Name: Counts: VPA ∇ < > Type Calibration Type: AA ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. To work in SI units (µmol/L) multiply by 6.50 Reagent OD limit: First L -2. AU400/AU640 Serum/Plasma Reagent ID: 415 Specific test parameters Serum ∇ Sample vol. vol Dil. vol 0 0 0 Max.00 Last H 2. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 9 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.00 Lst. L -2. OD H ∇ Operation: Yes Test No ∇ 2. # # ο ∇ 2.93 TDM . None Selected 8.50 2.00 Dynamic range L 3* Correlation factor H A B Rate 150* 1. No. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: % ∇ On-board stability period Select using Space key.50 Dynamic Range: L 3* H 150* Correlation Factor: A 1.93 BSOSR6415.05 B 0 On-board stability period: 45 45 Specific Test Parameters General LIH ISE Serum ∇ # Range Page 2/2 Level L # Level H # Test Name: VPA ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.: ODC6411 * Values set for working in µg/mL. 24 Sample Pre-dil. OD L -2.50 2. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name VPA Sample type Ser ∇ 570 RATE1 + First 24 First Last Last 27 Wave Method Reaction Point 1 Point 2 660 RATE1 + 27 Min.: ODC6411 * Values set for working in µg/mL. vol Dil.00 Reagent OD limit Fst. H ∇ ∇ ∇ Main 570 Sub 2 85 64 Dil. # # ο ∇ 6.VALPROIC ACID.50 Last L -2. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † Core TDM Multicalibrator Cat. # # ο ∇ 5.00 First H 2. No.01 2009-08 # User defined † Core TDM Multicalibrator Cat. Reagent 1 vol Reagent 2 vol μL μL μL Fst. AU600 Serum/Plasma Application System Reagent: OSR6415 Specific Test Parameters General LIH ISE Range Test Name: VPA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 85 64 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. # # OD CONC † † Factor/OD-L -999999 -999999 1-Point Cal. L -2. # # ο ∇ 7. No.00 H 2. To work in SI units (µmol/L) multiply by 6.50 ∇ # Test name VPA Sample type Ser Page 1/2 System Reagent: OSR6415 Reagent ID: 415 Application VALPROIC ACID. 660 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 3* 1 1.50 Dynamic Range: L 3* H 150* Correlation Factor: A 1.OD μL Min. ∇ # # # # ο 3. # # ο ∇ 7.00 First H 2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/mL* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AA ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined. # # OD CONC † † Factor/OD-L -999999 -999999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal. Volume R1(R1-1) μL ∇ μL 1.50 < > ∇ ∇ Type: Serum ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6415 Reagent ID: 415 Application Operation Yes VALPROIC ACID.00 -2.01 2009-08 . No demographics 8. ∇ # # # # ο 4.00 High High Max. # # ο ∇ 6. # # ο ∇ 2.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2. No.VALPROIC ACID. Not within expected values µg/mL* Decimal Places Calibration Specific ISE VPA ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Serum Counts: ∇ Factor Range Low High -999999 999999 ∇ # ο ∇ Calibration Specific General ISE Type Serum ∇ Counts: Factor/OD-H 9999999 9999999 # Process: CONC ∇ SERUM/PLASMA APPLICATION Test Name: VPA ∇ < > Test Name: Use Serum Cal.05 B 0 On-board stability period: 45 45 Day # ∇ +++++ ∇ +++++ ∇ +++++ ∇ Specific Test Parameters General LIH ISE Serum ∇ LIH VPA ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # VPA ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Serum ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. None Selected 8. ∇ # # # # ο 5. Core TDM Multicalibrator Cat. For No. To work in SI units (µmol/L) multiply by 6.AU680/AU480 Serum/Plasma Application System Reagent: OSR6415 Specific Test Parameters General LIH ISE Serum ∇ Sample Volume Pre-Dilution Rate Rgt.50 2. # # ο ∇ 5. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Last Last 27 NO % ∇ Onboard Stability Period LIH Influence Check Lipemia Icterus Hemolysis Noneф 570 ∇nm RATE1 ∇ + ∇ 24 Last Last 27 150* 0 0 Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: NO % ∇ Pre-Dilution Rate: 1 Min OD Max OD L -2.00 -2.8 77 58 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. AU2700/AU5400 Serum/Plasma Reagent ID: 415 Parameters General LIH VPA ∇ Dilution μL -2.00 Last H 2.50 Reagent OD limit: First L -2.: ODC6411 Values set for working in µg/mL. 660 ∇ 570 RATE1 + First 24 First Common Rgt. Calibration Type: AA ∇ Formula: Y=AX+B ∇ Cal. # # ο ∇ 3.8 1 77 Range Operation: ∇ Yes Test Name: VPA ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume R2(R2-1) μL Name Sec.93 AU680 <Point Cal.00 H 2. ∇ ∇ ∇ Sec.50 Last L -2.50 2.05 μL High B B 0 58 Dilution 0 1. ∇ 7. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour TDM BSOSR6415. ∇ # # # # ο 2. # # ο ∇ 4. No. ∇ # # # # ο 6. and preservative. Avoid the formation of foam. about 30% of the dose is excreted unchanged and the remainder as metabolites. in the assay format. Ecstasy drugs. S60. stabiliser.081 mg/L mouse monoclonal antibodies reactive to d-amphetamine and 7.4 methylenedioxy-methamphetamine (MDMA).67 g/L chlorophenol red-β-D-galactopyranoside. R2 Buffer Piperazine-N. and depending on urinary pH.N-bis [2-ethanesulfonic acid] buffer. Wear suitable protective clothing. The amount of active enzyme formed and resultant absorbance change are proportional to the amount of drug present in the sample. euphoria. Approximately 70% of a dose is eliminated in urine in the first 24 hours after administration. A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. are a group of ring substituted 5 methylenedioxy analogues of amphetamine and are among the most abused illicit drugs used in the dance scene in Europe. cleaves a substrate.6.156 g/L enzyme acceptor. Mix by gentle inversion. Record the reconstitution date on the bottle label. Safety Phrases: S36. 7. 4. inhibiting the reassociation of inactive β-galactosidase fragments.01 2009-08 DAU . Ensure the reagent is homogenous before use.4-methylenedioxyethylamphetamine (MDEA). Dispose of all waste material in accordance with local guidelines. 2. drug in the sample competes with drug conjugated to one inactive fragment of β-galactosidase for antibody binding site. These fragments spontaneously reassociate to form fully active enzyme that. and no active enzyme will be formed. 1. For in vitro diagnostic use only. their effects include excitement. NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the proper reagent bottle. Refer to Safety Data Sheets for further information. 2-4 Test Principle8 This assay is based on the bacterial enzyme β-galactosidase. with about 43% of the dose 2.0 µg/L enzyme donor conjugated to MDMA.N-bis [2-ethanesulfonic acid] buffer.4 methylenedioxy-ethylamphetamine (MDEA).4 psychologically and physiologically addictive. Detach the R1 lyo bottle and adapter from the R1 buffer bottle and discard. Do not mix components from different lots. Approximately 62% of a methamphetamine dose is eliminated in urine in the first 24 hours after administration. The assay provides only a preliminary analytical test result. and reduced sense of fatigue. EN. ensuring that all the lyophilised material from the R1 lyo bottle is transferred into the R1 buffer bottle. R22. including ecstasy. 3. Reagent Composition R1 Buffer Piperazine-N. flush waste-pipes with water after the disposal of undiluted reagent. 3. Mix by gentle inversion. increased blood pressure. Cap the R1 buffer bottle and let stand approximately 5 minutes at 15…25°C.4 may develop a psychosis that can be indistinguishable from acute schizophrenia. high dose users 3. it binds to antibody. generating a colour change that can be measured spectrophotometrically. antibody binds to drug conjugated on the inactive fragment. leaving the inactive enzyme fragments free to form active enzyme. buffer salts. 6 administration. To avoid the possible build-up of azide compounds. Chronic. which has been genetically engineered into two inactive fragments. 6. detergent. buffer salts. anxiety. particularly when using a preliminary positive result. R2 Lyo 7.4 methylenedioxy-amphetamine (MDA). Summary Amphetamines and amphetamine derivatives. Mix again. Detach the R2 lyo bottle and adapter from the R2 buffer bottle and discard. such as 3. Harmful if swallowed. Contains sodium azide. insomnia. buffer salts and preservative. 11. The R2 working solution (Enzyme Donor) should be yellow-orange in colour. A more specific alternative chemical method must be used to obtain a confirmed 1 analytical result. In the assay. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. ensuring that all the lyophilised material from the R2 lyo bottle is transferred into the R2 buffer bottle.01 BLOSR6323. Prepare the R2 solution before the R1 solution to minimise possible contamination. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. decreased appetite. R1 Lyo 0.3 µg/L enzyme donor conjugated to d-methamphetamine. stabiliser and preservative. including amphetamine. Reagent Preparation Prepare the following solutions using cold reagents and buffers. If drug is not present in the sample. Record the reconstitution date on the bottle label. Ensure the reagent is homogenous before use. R1 (Enzyme acceptor solution): Connect the R1 lyo bottle to the R1 buffer bottle using one of the enclosed adapters. Mix again.4 Side effects at low doses include irritability. If drug is present in the sample. Amphetamines are 3. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. NOTE 1: The components supplied in this kit are intended for use as an integral unit. blurred vision. This material and its container must be disposed of as hazardous waste. are classified as sympathomimetic amines with CNS stimulant activity.4.4 Amphetamines are rapidly absorbed from the gastrointestinal tract and widely distributed throughout the body. R2 (Enzyme donor solution): Connect the R2 lyo bottle to the R2 buffer bottle using one of the enclosed adapters. alertness.5 mg/L mouse monoclonal antibody reactive to 3.4-methylenedioxymethamphetamine (MDMA) and 3.7 Amphetamines may remain detectable in urine for 3-4 days after excreted unchanged and the remainder as metabolites. and preservative.12 µg/L enzyme donor conjugated to d-amphetamine. Remove the kit from refrigerated storage (2…8°C) immediately prior to preparation of the solutions. Cap the R2 buffer bottle and let stand approximately 5 minutes at 15…25°C. 3.Amphetamines/Ecstasy OSR6323 2 x 16 mL 2x 2 x 16 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the qualitative and semi-quantitative assay of amphetamines and ecstasy in human urine on Beckman Coulter analysers.081 mg/L mouse monoclonal antibodies reactive to d-methamphetamine. and heart palpitations. Avoid the formation of foam. Clinical consideration and professional judgement should be applied to any drug of abuse test result. Confirm a positive result by a more specific method based on an alternative chemical principle. No. 2 replicates of each sample were analysed twice daily over 20 days. Care should be taken when interpreting concentration results since there are many other factors that may influence a urine test result such as fluid intake and other biological factors.. 1000 µg/L Cut-off DAU Multi-drug Control. use the following calibrators: Calibrator Name DAU Negative Calibrator DAU Secondary Cut-off Multi-drug Calibrator DAU Primary Cut-off Multi-drug Calibrator DAU Intermediate Multi-drug Calibrator DAU High Multi-drug Calibrator Cat. Treat human urine as potentially infectious material. review all operating parameters. DAU BLOSR6323. ODC0006. Quality Control Each laboratory should establish its own control frequency. the other 25% below the cut-off. DAU Intermediate Multi-drug Calibrator. Obtain another sample for testing if adulteration of the sample is suspected. for acceptability using the software options Routine. 500 µg/L or 1000 µg/L. Samples can be stored at 15…25°C for a maximum of 7 days after which storage at 2…8°C is recommended. protect from prolonged. one 25% above the cut-off. Specimen Urine: Collect urine samples in clean glass or plastic containers. Values obtained for the controls should fall within specified limits. DAU Secondary Cut-off Multi-drug Calibrator. The setting sheet contains separate applications for semi-quantitative and qualitative assays. While confirmation techniques other than GC/MS may be adequate for some drugs of abuse. Semi-quantitative results Relative concentrations of amphetamines/ecstasy can be established by calibrating the assay with the DAU Negative Calibrator. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Samples producing a response value less than the response value of the calibrator are considered negative. 500 µg/L Cut-off: DAU Speciality Control. ODC6315 ODC6316 d-Methamphetamine (ng/mL = µg/L) 1000 500 Semi-quantitative evaluation For semi-quantitative analysis of samples.8°C. No.e. reagents stored on board the instrument are stable for 45 days. 9 Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. ODC6314 ODC6316 ODC6315 ODC6317 ODC6318 d-Methamphetamine (ng/mL = µg/L) 0 500 1000 3000 5000 The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard. unopened. on the Beckman Coulter analyser. Once reconstituted. Expected Values Results should always be negative with respect to the chosen cut-off i. Adulteration of urine samples can affect the test results. the resulting curve should be visually reviewed. NOTE 5: Do not freeze reconstituted reagents. Primary or Secondary Cut-off is used as a reference in distinguishing between positive and negative samples.01 .NOTE 3: The R1 and R2 solutions must be at the reagent compartment storage temperature of the analyser before performing the assay. Chain of custody recommendations should 10 be applied if applicable. Storage and Stability The reagents are stable. Following calibration. and the DAU High Multi-drug Calibrator.. Calibration Curve. The Beckman Coulter system automatically flags each positive sample with the letter P and each negative sample with the letter N. Precision The following data was obtained on an AU640 using the DAU Primary and Secondary Multi-drug Cut-off Calibrators and two levels of controls corresponding to ± 25% of each cut-off. Data obtained in your laboratory may differ from these values. If any trends or sudden shifts in values are detected. continuous exposure to bright light. GC/MS is generally accepted as a rigorous confirmation technique for all drugs since it provides the best level of 1 confidence in the result. Calibration Monitor. Quality control material The controls required are dependent on which assay is being performed.01 2009-08 EN. It is recommended that two levels of controls be run.. DAU Primary Cut-off Multi-drug Calibrator. NOTE 4: To ensure reconstituted R1 stability. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Major preventative maintenance was performed on the analyser or a critical part was replaced. Good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Centrifuge specimens with high turbidity before testing. ODC0007. Calculation Qualitative results The DAU Multi-drug Calibrator. Samples producing a response value equal to or greater than the response value of the calibrator are considered positive. Calibration Qualitative evaluation For qualitative analysis of samples use either of the following Cut-off calibrators: Calibrator Name DAU Primary Cut-off Multi-drug Calibrator DAU Secondary Cut-off Multi-drug Calibrator Cat. up to the stated expiry date when stored at 2. 5 3.4 42.3 1. yielded the following percent cross-reactivity results: Compound Concentration Tested (µg/L) d-Amphetamine 1000 l-Amphetamine 40.1 2.3 0. mA/min SD %CV 375 86 1.4 5.7 2.4 7.4-Methylenedioxy-methamphetamine (MDMA) 500 N-Methylbenzodioxazolybutanamine( MBDB) 900 Benzodioxazolybutanamine (BDB) 1000 Phentermine 25.7 Amphetamines/Ecstasy Semi-quantitative Assay n=80 Within run µg/L Mean.1 5.9 3.000 3.2 Total SD 32.0 500 497 23.0 6.000 d.1 750 92 4. 1000 µg/L cut-off protocol. Results were as follows: 500 µg/L cut-off Qualitative Assay + Comparative Screening Method + 105 0 1 30 Comparative Screening Method + 1000 µg/L cut-off Qualitative Assay + 91 0 1 40 500 µg/L cut-off Semi-quantitative Assay + Comparative Screening Method + 105 0 0 32 Comparative Screening Method + - 1000 µg/L cut-off Semi-quantitative Assay + 91 0 1 40 Sensitivity The lowest detectable level (LDL) represents the lowest measurable level of amphetamines that can be distinguished from zero.1 5. µg/L SD %CV 375 345 10.0 7.0 1. Substance Concentration Substance Concentration Acetone ≤ 10 g/L Haemoglobin ≤ 3 g/L Ascorbic acid ≤ 15 g/L Human serum albumin ≤ 5 g/L Creatinine ≤ 5 g/L Oxalic acid ≤ 1 g/L Ethanol ≤ 10 g/L Riboflavin ≤ 75 mg/L Galactose ≤ 100 mg/L Sodium chloride ≤ 60 g/L ≤ 5 g/L Urea ≤ 20 g/L γ-globulin Glucose ≤ 15 g/L Other substances and/or factors not listed may interfere with the test and cause false results (e.000 3.1 %CV 9.4-Methylenedioxyethylamphetamine (MDEA) 300 d-Methamphetamine 1.3 0.5 750 776 12.01 2009-08 %Cross Reactivity 104 1.1 1250 1489 29.8 4.9 Method Comparison Patient urine samples were used to compare this Amphetamines/Ecstasy OSR6323 assay on the AU640 against another commercially available screening assay.g. technical or procedural errors).2 4.l-Methamphetamine 1.0 88 0.3 4.6 1.9 500 108 1.l-Amphetamine 1.250 l-Ephedrine 250.7 2.01 BLOSR6323.000 l-Methamphetamine 8.3 4.000 d.7 625 618 34.4 625 133 2.7 1250 141 2.4 4.8 45.5 172 100 77 18 116 196 121 76 3.1 2.6 34.7 %CV 3.6 1.4-Methylenedioxy-amphetamine (MDA) 1000 3.8 2.3 2.000 d-Pseudoephedrine 160.7 1000 115 2.l-Phenylpropanolamine 500.000 d. It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.5 6.9 24 100 DAU .0 Total SD 3.6 59.6 99.Amphetamines/Ecstasy Qualitative Assay n=80 Within run µg/L Mean.5 1.6 1000 1000 41. Specificity The following parent compounds and metabolites when tested with the DAU Amphetamines/Ecstasy assay.4 6.000 p-Methoxyamphetamine (PMA) 2000 p-Methoxymethamphetmaine (PMMA) 500 EN.8 4. Cut-off 500 µg/L 1000 µg/L LDL µg/L on AU640 26 45 Interference No interference was observed from the following substances added to the normal endogenous concentrations found in urine when tested with the Amphetamines/Ecstasy assay. et al. and gave a negative response when tested at the concentrations listed below. NJ: Medical Economics Books. Oradell.000 50.J.000. Calif. 1989.01 . 6th ed.2 µL Selected cut-off value BIBLIOGRAPHY Hawks RL. NY: WH Freeman & Co.A.Structurally unrelated compounds were tested with the Amphetamines/Ecstasy assay. 1993 Julien RM.. Profiles of Urine Samples Taken from Ecstasy users at Rave Parties: Analysis by Imuunoassays. Ann Clin Biochem 1997.000.16:1-26.000. Seller EM.000 10. 1992.6 µL. Clinical pharmacokinetics of non opiate abused drugs.J. Miller NS.000 1. 5. Foster City. eds. DAU BLOSR6323. 4th ed.000. Analytical methodology.000.000. Compound Acetaminophen** Acetylsalicylic acid Amoxicillin Benzoylecgonine Captopril Chlordiazepoxide Cimetidine Codeine Diazepam Digoxin Enalapril Fluoxetine Ibuprofen Levothyroxine Methadone Morphine Nifedipine Phencyclidine Phenobarbital d-Propoxyphene Ranitidine Salicyluric acid Secobarbital 9 11-nor -∆ -THC-COOH Verapamil Tolmetin ** Paracetamol Concentration (µg/L) 1.000.000. Scholer A. Zeeuw RD.: ODC6314. 2001. HPLC and GC/MS. Clin Pharmacokinetics.000 1. Brenneisen R.000 1. 10. A Primer of Drug Action. 47th ed.: ODC6315 (1000 µg/L cut-off) or ODC6316 (500 µg/L cut-off) System Calibrator Cat. User defined ¤ Analyser default value System Calibrator Cat.000 1. Drugs of Abuse. 1988. Cravey RH. Oradell.000.000 1. New York.000 500.000 100. NIDA Research Monograph.000 100.000 1.000 500. Chiang CN.000. J. Sample volume for 500 µg/L protocol : 4 µL Sample volume for 1000 µg/L cut-off protocol: 1. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 500 µg/L cut-off protocol.000 500. No. 9.000..01 2009-08 EN. ODC6315. Busto U. Recommendations for the reliable detection of illicit drugs in urine in the European Union.000 250.000. Elsohly M. a new homogeneous immunoassay system.000 Setting Sheet Footnotes # † ‡ § * 1. with special attention to the workplace.000 250. 2.000. Bendayan R. 1995.000. 69(Apr 11):11983.. ODC6316. Torre RDL. Friedman SB. ODC6317 and ODC6318 Sample volume for 1000 µg/L cut-off protocol : 2 µL.32:1637-1641. eds. Notice of mandatory guidelines for federal workplace drug testing program: Final guidelines.000 1.000 1. Harris JD. Slaby AE.000 1. Physician’s Desk Reference. 3. Salamone S.000.000 1. Segura J.000 1. 1986. Gold MS. 8. 7.000 1. Toxicol. Henderson DR. 4.: Chemical Toxicology Institute. Sample volume for 500 µg/L protocol : 3.000 1.000. Williams J.000 1. Anal.34:339-344.73:30-41. Federal Register.25:258-269.000 1. Nos. McNally A. In: Giannini AJ.000. In: Hawks RL. 6. Clin Chem.P. Amphetamine and its derivatives. 1986. CEDIA™. NJ: Medical Economics Books.000 1. Murphy T. Urine Testing for Drugs of Abuse. 1989 Zhao H. # # ο ∇ 4. H First H Last H H Sample vol. Sample volume for 1000 µg/L cut-off protocol: 2µL.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: 45 Specific Test Parameters General LIH ISE Urine ∇ * Range Page 2/2 Level L * Level H * Test Name: AMP ∇ < > Type: Level L: * Level H: Value/Flag: Flag ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 6. No.5 2.5 Main ∇ ∇ ∇ 570 Sub 2. None Selected 8. Sample volume for 1000 µg/L cut-off protocol: 2µL. AU600 Qualitative Application System Reagent: OSR6323 Specific Test Parameters General LIH ISE Range Test Name: AMP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume ‡ 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. H Lst. Vol 0 0 0 Max.5 ∇ # Test name AMP Sample type URI Page ½ System Reagent: OSR6323 Reagent ID: 323 Application AMPHETAMINES/ECSTASY. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. OD H ∇ Operation: Yes Test No ∇ 2. Fst Fst 24 Lst Lst 660 RATE + 27 Fst. # # ο ∇ 7. ∇ ∇ ∇ Sec.01 2009-08 999 Select the function using the Function key or the Mouse User defined ¤ Analyser default value DAU Multi-Drug Calibrators Cat.0 Lst. No.: ODC6315 (1000 µg/L cut-off) or ODC6316 (500 µg/L cut-off) Selected cut-off value. Reagent 1 vol Reagent 2 vol μL μL μL ‡ 87 87 Dil. Point MB type factor Calibrator stability period # † * ‡ BSOSR6323.AMPHETAMINES/ECSTASY. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name AMP ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L -99999 # Conc Factor/OD-H 99999 ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 99999 # Test Name: Counts: AMP ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. Sample volume for 500 µg/L protocol : 4µL DAU . AU400/AU640 Qualitative Reagent ID: 323 Specific test parameters Urine ∇ Max OD H 2.0 Last L -2. Vol Dil. # # ο ∇ 5.5 2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period Select using Space key. No. OD L -2.0 Reagent OD limit Fst. # OD CONC † Factor/OD-L -99999 1-Point Cal. Vol Dil. L -2. L -2. or select from list displayed by Guide key Test No ∇ Flag ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name AMP Sample type URI ∇ 570 RATE + First 24 First Last Last 27 Wave Method Reaction Point 1 Point 2 Min.5 2.: ODC6315 (1000 µg/L cut-off ) or ODC6316 (500 µg/L cut-off) Selected cut-off value. # # ο ∇ 2. Sample volume for 500 µg/L protocol : 4µL # † * ‡ User defined DAU Multi-Drug Calibrators Cat.0 Dynamic range L -99999 Correlation factor H A B Rate 99999 1 0 ¤ NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.5 99999 B 45 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil. # # ο ∇ 3.0 Reagent OD limit: First L -2. 660 Onboard Stability Period Last Last 27 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A μL -99999 1 1 45 Day High B B 0 99999 0 0 Hour 70 Dilution 0 Sample Volume Pre-Dilution Rate Rgt.5 2. # # ο ∇ 6.5 2.0 -2. ∇ # # # # ο 5.: ODC6315 (1000 µg/L cut-off) or ODC6316 (500 µg/L cut-off) Selected cut-off value. ∇ # # # # ο 2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. # # ο ∇ 4.0 High High Max. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. DAU Multi-Drug Calibrators Cat. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * § ф User defined. # # ο ∇ 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE ∇ + ∇ 24 570 RATE + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2. ∇ # # # # ο 3. # OD CONC † Factor/OD-L -99999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour DAU BSOSR6323. ∇ # # # # ο 6.2µL AU680 <Point Cal. ∇ # # # # ο 4.AMPHETAMINES/ECSTASY. AU2700/AU5400 Qualitative Reagent ID: 323 Parameters General LIH AMP ∇ Dilution μL -2.5 < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6323 Reagent ID: 323 Application Operation Yes AMPHETAMINES/ECSTASY AU680/AU480 Qualitative Application System Reagent: OSR6323 Specific Test Parameters General LIH ISE Urine ∇ Max OD H 2. None Selected 8. No.5 R2(R2-1) μL Name Sec. Volume R1(R1-1) μL ∇ μL § 1 70 Range Operation: ∇ Yes Test Name: AMP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 45 100 NO % ∇ § 70 70 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. # # ο ∇ 5.0 -2.0 Last L -2. For No.5 2.5 2. Not within expected values µg/L Decimal Places Calibration Specific ISE AMP ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ Factor Range Low High -99999 99999 ∇ # ο ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Type Urine ∇ Counts: Factor/OD-H 99999 # Process: CONC ∇ Test Name: AMP ∇ < > Test Name: Use Serum Cal. Sample volume for 500 µg/L protocol : 3. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L* H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level * Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ ∇ ∇ 99999 0 Sec. ∇ 7.6µL. No. No demographics 8.0 Reagent OD limit: First L -2. # # ο ∇ 3. # # ο ∇ 7.01 2009-08 .OD μL Min. Sample volume for 1000 µg/L cut-off protocol: 1.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine ∇ LIH AMP ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # AMP ∇ < > Type: Specific Test Parameters Calculated Test Type: High * Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. 0 Lst. H Sample vol.AMPHETAMINES/ECSTASY. Nos.0 # Conc Factor/OD-H 2.5 2.5 2. ODC6315. OD L -2. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. or select from list displayed by Guide key Test No ∇ # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # Test name AMP Sample type URI 570 RATE1 + First 24 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. 24 Lst Lst First H Last H 2.0 0 B 45 Linearity Fst No lag time NO % Sec % ∇ 0 H 5000 Fst Fst Sample Pre-dil.0 -2. ODC6316.0 -2. L -2. # # ο ∇ 6.: ODC6314.0 -2. OD H ∇ Operation: Yes Test No ∇ ∇ # Test name AMP Sample type URI Page 1/2 2.5 ∇ Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 2. vol Dil. ODC6316.5 2. vol Dil. # # ο ∇ 5.: ODC6314. # # ο ∇ 4. L -2. ODC6317 and ODC6318 BSOSR6323. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name AMP ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -2.5 2.5 660 RATE1 + 27 Max OD H 2. ∇ ∇ ∇ Sec. # # # # # OD CONC † † † † † Factor/OD-L -2. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † DAU Negative & Multi-Drug Calibrators Cat.5 2.5 2.0 -2.01 2009-08 # User defined † DAU Negative & Multi-Drug Calibrators Cat.0 -2. None Selected 8.0 1-Point Cal.5 # Test Name: Counts: AMP ∇ < > Type SEMI-QUANTITATIVE APPLICATION Calibration Type: 5AB ∇ Formula: EIA TYPE 1 ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.5 2. Nos.5 2. AU600 Semi-quantitative Application Reagent ID: 323 Specific test parameters Urine ∇ 1 -2.0 Reagent OD limit Fst. # # ο ∇ 7.5 2. ODC6315. vol 0 0 0 Max. # # ο ∇ 3. # # ο ∇ 2. AU400/AU640 AMPHETAMINES/ECSTASY.0 Main ∇ ∇ ∇ 570 Sub -2. Reagent 1 vol Reagent 2 vol μL μL μL 2 87 87 Dil.0 Dynamic range L 0 Correlation factor 5000 1 0 ¤ NO % ∇ On-board stability period 45 Specific Test Parameters General LIH ISE Urine ∇ Age Y Y Y Y Y Y # Range ∇ Level L # Page 2/2 Level H # Test Name: AMP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.0 -2.5 System Reagent: OSR6323 Reagent ID: 323 Semi-quantitative Application System Reagent: OSR6323 Specific Test Parameters General LIH ISE Range Test Name: AMP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.0 -2.0 -2.5 2. No.0 -2.5 Fst. ODC6317 and ODC6318 DAU .5 2. H Lst. OD μL -2. ∇ # # # # ο 6.01 2009-08 . ∇ # # # # ο 4. Volume R1(R1-1) Test Name: AMP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 45 100 NO % ∇ 1. For No. ∇ ∇ ∇ Sec.5 2.0 Counts: # ∇ ∇ OD Range Low High Slope Check -2. No demographics 8.5 2.5 R2(R2-1) μL Name Sec.0 Max.0 Reagent OD limit: First L -2. 660 Onboard Stability Period Last Last 27 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0 1 1 45 Day μL High B B 0 5000 0 0 Hour 70 Dilution 0 Range Operation: ∇ Yes Sample Volume Pre-Dilution Rate Rgt. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour DAU BSOSR6323.5 2. ODC6315.0 Dilution High High 0 0 OD Limit 2.AMPHETAMINES/ECSTASY. # # ο ∇ 5.5 2.5 ο Reagent Blank -2. ODC6317 and ODC6318 ф AU680 <Point Cal.0 -2.0 2. None Selected 8. ∇ # # # # ο 5. ∇ # # # # ο 3.6 70 70 2. # # # # # OD CONC † † † † † Factor/OD-L -2.5 2. # # ο ∇ 6.0 Last L -2.0 -2.5 1.OD Reagent OD Limit First Low Last Low < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Parameters General Specific Test Parameters Calculated Test System Reagent: OSR6323 Operation Yes Specific Test Parameters General LIH ISE Urine ∇ Max OD H 2.5 # Process: CONC ∇ Test Name: Use Serum Cal. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # µg/L* Month # # # # # # Month # # # # # # Panic Value Low # High # L µg/L* H Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ 7.0 2. # # ο ∇ 4.0 2.0 2. ∇ # # # # ο 2.5 5000 0 Noneф 570 ∇nm RATE1 ∇ + ∇ 24 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL 2. # # ο ∇ 2.5 Allowance Range Check -2.6 1 70 μL ∇ μL Min.0 -2. Test Name: AMP ∇ < > SEMI-QUANTITATIVE APPLICATION SEMI-QUANTITATIVE APPLICATION Calibration Type: 5AB ∇ Formula: EIA TYPE 1 ∇ + ∇ Cal.5 Pri. # # ο ∇ 3.0 -2. # # ο ∇ 7.5 -2. Nos.0 Dynamic Range: L 0 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine ∇ # Range Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Test Name: AMP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. † DAU Negative & Multi-Drug Calibrators Cat.: ODC6314.5 ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ 1-Point Cal. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Parameters General LIH AMP ∇ < > ISE HbA1c Test Name: 570 RATE1 + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.0 -2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. No. Not within expected values Decimal Places Calibration Specific ISE AMP ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > EIA TYPE 1 Type Urine ∇ ο Calibration Specific General ISE Type Urine ∇ Counts: Factor/OD-H 2.0 2.5 2.5 -2. AU680/AU480 Semi-quantitative Application System Reagent: OSR6323 Reagent ID: 323 Semi-quantitative Application Reagent ID: 323 LIH AMP ∇ Dilution μL -2. Point: ο With CONC-0 Slope Check: MB Type Factor: ICF: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. ODC6316. AU2700/AU5400 AMPHETAMINES/ECSTASY. .. R22 Harmful if swallowed. Half lives range 4. If drug is present in the sample. ensuring that all the lyophilised material from the R2 Lyo bottle is transferred into the R2 Buffer bottle.25°C. Safety Phrases: S36. and no active enzyme will be formed. which has been genetically engineered into two inactive fragments. ensuring that all the lyophilised material from the R1 Lyo bottle is transferred into the R1 Buffer bottle.Barbiturates OSR6315 2 x 16 mL 2x 2 x 16 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the qualitative and semi-quantitative assay of barbiturate in human urine on Beckman Coulter analysers.8°C) and let stand for at least 30 minutes.6 from 20 to 120 hours. buffer salts. stabiliser. 0.6 Depending on the degree of lipid solubility. Avoid the formation of foam. NOTE 1: The components supplied in this kit are intended for use as an integral unit. EN.. R1 (Enzyme acceptor solution): Connect the R1 Lyo bottle to the R1 Buffer bottle using one of the enclosed adapters.67 g/L chlorophenol red-β-D-galactopyranoside. Wear suitable protective clothing. Detach the R2 Lyo bottle and adapter from the R2 Buffer bottle and discard. 17. In the assay.6 metabolites and others mainly as unchanged drug. buffer salts. barbiturates are usually taken orally in pill form. buffer salts. Piperazine-N. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. urine may test positive for approximately 4 30 hours after administration or as long as several weeks. Record the reconstitution date on the bottle label. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2.5 hypodermically. inhibiting the reassociation of inactive β-galactosidase fragments. Mix by gentle inversion.N-bis [2-ethanesulfonic acid] buffer. Dispose of all waste material in accordance with local guidelines. When used as a substance of abuse. cleaves a substrate. and preservative. NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the appropriate reagent bottle. antibody binds to drug conjugated on the inactive fragment. 1. stabiliser and preservative. The assay provides only a preliminary analytical test result. Avoid the formation of foam. barbiturates are commonly characterised as short. Summary Barbiturates belong to a broad class of CNS-depressant drugs known as sedatives/hypnotics. Detach the R1 Lyo bottle and adapter from the R1 Buffer bottle and discard. A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded. Clinical consideration and professional judgement should be applied to any drug of abuse test result. Cap the R1 Buffer bottle and let stand approximately for 5 minutes at 15. Ensure the reagent is homogeneous before use. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. in the assay format.2 mg/L monoclonal antibodies reactive to barbiturates.. Refer to Safety Data Sheets for further information. These fragments spontaneously reassociate to form fully active enzyme that.1 µg/L enzyme donor conjugated to a barbiturate derivative. R2 (Enzyme donor solution): Connect the R2 Lyo bottle to the R2 Buffer bottle using one of the enclosed adapters. it binds to antibody. Contains sodium azide. or long-acting. flush waste-pipes with water after the disposal of undiluted reagent.8°C) and let stand for at least 30 minutes. Prepare the R2 solution before the R1 solution to minimise possible contamination. Remove the kit from refrigerated storage (2…8°C) immediately prior to preparation of the solutions.171 g/L enzyme acceptor. If drug is not present in the sample. A more specific alternative chemical method must be used to obtain a confirmed 1 analytical result.. S60. Reagent Composition R1 Buffer R1 Lyo R2 Buffer R2 Lyo Piperazine-N. Depending on the specific barbiturate taken. but habitual users and addicts have been known to dissolve the compounds and inject them 2. Record the reconstitution date on the bottle label. This material and its container must be disposed of as hazardous waste. Do not mix components from different lots. Mix again. Ensure the reagent is homogeneous before use. and preservative.. Cap the R2 Buffer bottle and let stand approximately for 5 minutes at 15. detergent. 2-4 Test Principle7 This assay is based on the bacterial enzyme β-galactosidase. some being excreted in the urine mainly as active and inactive 4. intermediate. generating a colour change that can be measured spectrophotometrically.01 2009-08 DAU . Mix again. particularly when using a preliminary positive result.25°C. The R2 working solution (enzyme donor) should be yellow-orange in colour. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2.. leaving the inactive enzyme fragments free to form active enzyme. Reagent Preparation Prepare the following solutions using cold reagents and buffers. Mix by gentle inversion. For in vitro diagnostic use only. 2. The amount of active enzyme formed and resultant absorbance change are proportional to the amount of drug present in the sample.01 BLOSR6315.. To avoid the possible build-up of azide compounds. Barbiturates are variously metabolised by the liver.N-bis [2-ethanesulfonic acid] buffer. 2. and preservative.3. drug in the sample competes with drug conjugated to one inactive fragment of β-galactosidase for antibody binding site. Quality Control Each laboratory should establish its own control frequency. Data contained within this section is representative of performance on Beckman Coulter systems. 8 Samples can be stored at 15…25°C for a maximum of 7 days after which storage at 2…8°C is recommended. Semi-quantitative results Relative concentrations of barbiturtes can be established by calibrating the assay with the DAU Negative Calibrator.01 10 . NOTE 4: To ensure reconstituted R1 stability.. protect from prolonged. Major preventative maintenance was performed on the analyser or a critical part was replaced.NOTE 3: The R1 and R2 solutions must be at the reagent compartment temperature of the analyser before performing the assay. Obtain another sample for testing if adulteration of the sample is suspected. on the Beckman Coulter analyser. DAU Secondary Cut-off Multi-drug Calibrator. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions.e.. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Calibration Monitor. use the following calibrators: Calibrator Name Cat. Six replicates of each sample were analysed twice daily over 5 days. ODC0006.01 2009-08 EN. Good laboratory practice suggests that controls be run each day patient samples are measured and each time calibration is performed. one 25% above the cut-off. DAU Primary Cut-off Multi-drug Calibrator. the resulting curve should be visually reviewed. Primary or Secondary Cut-off is used as a reference in distinguishing between positive and negative samples. Specimen Urine: Collect urine samples in clean glass or plastic containers.Routine. Adulteration of urine samples can affect the test results.8°C. unopened. While confirmation techniques other than GC/MS may be adequate for some drugs of abuse. 200 µg/L Cut-off: DAU Speciality Control. Following calibration. up to the stated expiry date when stored at 2. Data obtained in your laboratory may differ from these values. The setting sheet contains separate applications for semi-quantitative and qualitative assays. Calibration Qualitative evaluation For qualitative analysis of samples use either of the following Cut-off calibrators: Calibrator Name Cat. Treat human urine as potentially infectious material. 200 µg/L or 300 µg/L. Calculation Qualitative results The DAU Multi-drug Calibrator. reagents stored on board the instrument are stable for 60 days. Once reconstituted. It is recommended that two levels of controls be run. NOTE 5: Do not freeze reconstituted reagents. ODC0007. review all operating parameters. for acceptability using the software options . DAU Intermediate Multi-drug Calibrator. Centrifuge specimens with high turbidity before testing. No. and the DAU High Multi-drug Calibrator. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. Secobarbital (ng/mL = µg/L) DAU Primary Cut-off Multi-drug Calibrator ODC6315 300 DAU Secondary Cut-off Multi-drug Calibrator ODC6316 200 Semi-quantitative evaluation For semi-quantitative analysis of samples. Samples producing a response value less than the response value of the calibrator are considered negative. If any trends or sudden shifts in values are detected. Secobarbital (ng/mL = µg/L) DAU Negative Calibrator ODC6314 0 DAU Secondary Cut-off Multi-drug Calibrator ODC6316 200 DAU Primary Cut-off Multi-drug Calibrator ODC6315 300 DAU Intermediate Multi-drug Calibrator ODC6317 800 DAU High Multi-drug Calibrator ODC6318 3000 The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. 300 µg/L Cut-off: DAU Multi-drug Control. Quality control material The controls required are dependent on which assay is being performed. Chain of custody 9 recommendations should be applied if applicable. Calibration Curve. Care should be taken when interpreting concentration results since there are many other factors that may influence a urine test result such as fluid intake and other biological factors. Values obtained for the controls should fall within specified limits. Precision The following data was obtained on an AU640 using the DAU Primary and Secondary Multi-drug Calibrators and two levels of controls corresponding to ± 25% of each cut-off. Storage and Stability The reagents are stable. Expected Values Specific Performance Characteristics Results should always be negative with respect to the chosen cut-off i. the other 25% below the cut-off. DAU BLOSR6315. No. continuous exposure to bright light. GC/MS is generally accepted as a rigorous confirmation technique for all drugs since it provides the 1 best level of confidence in the result. The Beckman Coulter system automatically flags each positive sample with the letter P and each negative sample with the letter N. Samples producing a response value equal to or greater than the response value of the calibrator are considered positive. Confirm a positive result by a more specific method based on an alternative chemical principle. 1 375 435 11.8 1.0 0.7 9.1 6.6 1.7 3. mA/min 150 320 200 359 250 393 225 363 300 406 375 446 Within run SD 2.5 Total %CV 1.Barbiturates Qualitative Assay n=60 µg/L Mean.2 7.4 1.6 4.6 Method Comparison Patient urine samples were used to compare this Barbiturates assay on the AU640 against another commercially available screening assay.6 1. 200 µg/L cut-off protocol.0 3.4 1.2 2.0 5.3 1.2 Total SD 6.Reactivity Secobarbital 200 100 Amobarbital 207 109 Aprobarbital 195 80 Barbital 1 000 18 Butabarbital 198 78 Butalbital 213 92 Cyclopentobarbital 190 115 Pentobarbital 270 66 Phenobarbital 195 83 Talbutal 130 160 EN. technical or procedural errors). Specificity The following parent compounds and metabolites when tested with the Barbiturates assay.7 5.01 2009-08 DAU . yielded the following percent cross-reactivity results: Compound Concentration Tested (µg/L) % Cross .2 6.6 12.9 2.3 4. 200 µg/L cut-off Semi-quantitative Assay + Comparative Screening Method + 74 0 Comparative Screening Method + 300 µg/L cut-off Semi-quantitative Assay + 55 0 - 0 68 - 0 81 Sensitivity The lowest detectable level (LDL) represents the lowest measurable level of barbiturate that can be distinguished from zero.2 %CV 0.6 3.4 1.0 3.7 200 195 7.01 BLOSR6315.0 1.0 5. Cut-off 200 µg/L 300 µg/L LDL µg/L on AU640 23 23 Interfering Substances No interference was observed from the following substances added to the normal endogenous concentrations found in urine when tested with the Barbiturates assay (< 10% of baseline): Substance Acetone Ascorbic acid Creatinine Ethanol Galactose γ-globulin Glucose Concentration ≤ 10 g/L ≤ 15 g/L ≤ 5 g/L ≤ 10 g/L ≤ 100 mg/L ≤ 5 g/L ≤ 15 g/L Substance Haemoglobin Human serum albumin Oxalic acid Riboflavin Sodium chloride Urea Concentration ≤ 3 g/L ≤ 5 g/L ≤ 1 g/L ≤ 75 mg/L ≤ 60 g/L ≤ 20 g/L Other substances and/or factors not listed may interfere with the test and cause false results (e. It is calculated as the absolute mean plus three standard deviations of 25 replicates of the Negative Kit Calibrator. µg/L SD %CV 150 135 6.7 17.4 3. Discrepant samples were investigated using a confirmatory GC/MS reference method.3 225 203 6.g.2 %CV 4.3 300 300 18.8 250 269 8.9 3. Results were as follows: 300 µg/L cut-off Qualitative Assay 200 µg/L cut-off Qualitative Assay + + Comparative Screening Method + 75 0 Comparative Screening Method + 57 0 - 1* 68 - 0 81 *This sample was tested by GC/MS and was found to contain 318 µg/L secobarbital.5 5.8 Barbiturates Semi-quantitative Assay n=60 Within run µg/L Mean.7 4.3 5.9 0.5 5..5 3.6 4.8 3.7 SD 5. 38pp. Miller NS. Analytical methodology. NIDA Research Monograph 1986.Structurally unrelated compounds were tested with the Barbiturates assay.: ODC6314. Jones KL. a new homogeneous immunoassay system. 1989. Nos. United Kingdom laboratory guidelines for legally defensible workplace drug testing: Urine Drug Testing. 1995. New York. Byer CO.0. 2001. Chiang CN. Compound Concentration (µg/L) Acetaminophen** 500 000 Acetylsalicylic acid 500 000 Amoxicillin 100 000 Amphetamine 500 000 Benzoylecgonine 500 000 Captopril 500 000 Chlordiazepoxide 100 000 Cimetidine 500 000 Diazepam 500 000 Digoxin 100 000 Enalapril 500 000 Fluoxetine 500 000 Ibuprofen 500 000 Levothyroxine 50 000 Methadone 500 000 Methamphetamine 500 000 Nifedipine 500 000 Phencyclidine 500 000 Propoxyphene 500 000 Ranitidine 500 000 Salicyluric acid 500 000 9 10 000 11-nor -∆ -THC-COOH Verapamil 500 000 ** Paracetamol Limitations In view of the cross-reactivity profile of the Barbiturates assay. Henderson DR. NJ: Medical Economics Books.: Chemical Toxicology Institute. Friedman SB. No. 9. ODC6316. 1992. Gold MS. Harris JD. Williams J. Slaby AE. 3rd ed.01 2009-08 EN. 200 µg/L cut-off protocol. 4.34:339-344. Segura J. Drugs and Alcohol. Recommendations for the reliable detection of illicit drugs in urine in the European Union.29:665-670.32:1637-1641. Calif. Clin Chem 1986. 2. In: Hawks RL. BIBLIOGRAPHY DAU BLOSR6315. eds. New York. Baselt RC. and gave a negative response when tested at the concentrations listed below. 7. Oradell. 8. NY: Harper & Row. CEDIA™. NY: WH Freeman & Co. ODC6317 and ODC6318 Selected cut-off value Hawks RL. 1979. Gold MS. User defined ¤ Analyser default value Calibrator Cat. 3. Ann Clin Biochem 1997. 6.73:30-41. In: Giannini AJ. 10. semi-quantitative results may not correlate with the levels of individual drugs/metabolites in the sample. with special attention to the workplace. Foster City. ODC6315.01 . et al. 4th ed. Cravey RH. Setting Sheet Footnotes # † * 1. Shainberg LW. 6th ed. eds. Urine Testing for Drugs of Abuse.69 (Apr 11):11983. Sedative-hypnotics: Pharmacology and use.: ODC6315 or ODC6316 Calibrator Cat. Ver 1. 1989. Sedative/hypnotics. Torre RDL. Zeeuw RD. Notice of Mandatory Guidelines for Federal Workplace Drug Testing Program: Final guidelines. Miller NS. Julien RM. 1988. Federal Register. 5. Disposition of Toxic Drugs and Chemicals In Man. J Fam Practice. A Primer of Drug Action. Drugs of Abuse. ODC6316 (200 µg/L cut-off) * Selected cut-off value # User defined † DAU Multi-Drug Calibrator Cat. No. None Selected 8. vol Dil. # # ο ∇ 2. Fst Fst 24 Lst Lst Main 570 Sub 660 RATE + 27 ∇ ∇ ∇ First H Last H H Fst. No.5 2.: ODC6315 (300 µg/L cut-off). OD L -2. ∇ ∇ ∇ Sec. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name BAR ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L -99999 # Conc Factor/OD-H 99999 ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Urine # Factor/OD-H 99999 Process: CONC ∇ ∇ Test Name: Counts: BAR ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. Reagent 1 vol Reagent 2 vol 6 87 87 Dil. # # ο ∇ 4. AU400/AU640 Qualitative Reagent ID: 315 Specific test parameters Urine Max OD H 2.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: 60 Specific Test Parameters General LIH ISE Urine * # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L * Age Y Y Y Y Y Y Level H * Test Name: BAR ∇ < > Type: Level L: * Level H: Value/Flag: Flag ∇ Normal Ranges: Age L Sex Year 1. # OD CONC † Factor/OD-L -99999 1-Point Cal. H Sample vol. vol 0 0 0 μL μL μL Max. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † DAU Multi-Drug Calibrator Cat.5 # Test name BAR ∇ Sample type URI ∇ Page 1/2 System Reagent: OSR6315 Reagent ID: 315 Application BARBITURATES. or select from list displayed by Guide key Test No Flag L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name BAR ∇ Sample type URI ∇ 570 RATE + First 24 First Last Last 27 Wave Method Reaction Point 1 Point 2 Min.: ODC6315 (300 µg/L cut-off).0 Reagent OD limit: First L -2.BARBITURATES.0 Reagent OD limit Fst. ODC6316 (200 µg/L cut-off) * Selected cut-off value DAU BSOSR6315. AU600 Qualitative Application System Reagent: OSR6315 Specific Test Parameters General LIH ISE Range Test Name: BAR ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 6 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. # # ο ∇ 5. L -2. vol Dil. # # ο ∇ 3. # # ο ∇ 7. No. L -2. H Lst. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ο ∇ 6.0 Last L -2.01 2009-08 . 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period Select using Space key.5 2.0 Lst.5 2.0 Dynamic range L -99999 Correlation factor H A B Rate 99999 1 0 ¤ NO % ∇ Pre-Dilution Rate: 1 Min OD L -2. OD H ∇ Operation: Yes ∇ Test No 2.5 2.5 99999 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A μL -99999 1 1 60 Day High B B 0 99999 0 0 Hour Sample Volume Pre-Dilution Rate Rgt.01 2009-08 . No.5 2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: Flag Low ∇ Level * Specificl Ranges: From To Sex Year Month Year # # # # ∇ ο 1.5 2. † DAU Multi-Drug Calibrator Cat. No.5 2.0 Last L -2. # # ο ∇ 4. For No. # # ο ∇ 3. Not within expected values µg/L* Decimal Places Calibration Specific ISE BAR ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ # ο ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Type Urine Counts: Factor/OD-H 99999 # Process: CONC ∇ ∇ Test Name: BAR ∇ < > Use Serum Cal.0 -2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.OD Reagent OD Limit First Low Last Low 0 μL OD Limit 2. # # # # ∇ ο 6.BARBITURATES.5 ∇ Type: Urine < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6315 Reagent ID: 315 Application Operation Yes ∇ BARBITURATES. # # # # ∇ ο 5.5 2. None Selected 8. # # ο ∇ 6. 7.: ODC6315 (300 µg/L cut-off) ODC6316 (200 µg/L cut-off) * Selected cut-off value ф AU680 Hour Hour DAU BSOSR6315. # # ο ∇ 2. # # ο ∇ 7.0 High High Max. No demographics 8.5 R2(R2-1) ф 660 Onboard Stability Period Last Last 27 87 μL Dilution 0 Name Sec. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined.2 61 61 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine LIH BAR ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: * BAR ∇ < > Type: Specific Test Parameters Calculated Test Type: High * Urine ∇ Range Level L: * Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # # # ∇ ο 3. Volume R1(R1-1) 6 1 87 μL ∇ μL Range ∇ Operation: Yes ∇ Test Name: BAR ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 100 NO % ∇ 4. # # ο ∇ 5.0 Reagent OD limit: First L -2. AU2700/AU5400 Qualitative Reagent ID: 315 Parameters General LIH BAR Dilution -2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE ∇ + ∇ 24 570 RATE + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.OD Dilution 0 μL Min. ∇ ∇ ∇ 99999 0 Sec. # OD CONC † Factor/OD-L -99999 ∇ Factor Range Low High -99999 99999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 <Point Cal.0 -2. # # # # ∇ ο 4. # # # # ∇ ο 2. AU680/AU480 Qualitative Application System Reagent: OSR6315 Specific Test Parameters General LIH ISE Urine Max OD H 2. # # # # # OD CONC † † † † † Factor/OD-L -2. # # ο ∇ 5. # # ο ∇ 2. Nos. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. H 3000 Fst Fst 24 Lst Lst First H Last H 2.01 2009-08 .0 -2.0 Lst.0 -2. ∇ ∇ ∇ Sec. ODC6317 and ODC6318 DAU BSOSR6315. ODC6316.5 2.5 Main 570 Sub 660 RATE1 + 27 ∇ ∇ ∇ Max OD H 2. ODC6316.0 # Conc Factor/OD-H 2.0 -2. vol Dil.5 ∇ Calibration Specific General ISE Urine # Factor/OD-H 2.5 2. AU600 Semi-quantitative Application System Reagent: OSR6315 Specific Test Parameters General LIH ISE Range Test Name: BAR ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 6 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. vol 0 0 0 μL μL μL Max. # # ο ∇ 7. ODC6315. vol Dil.: ODC6314.0 -2. Nos.0 0 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil. Reagent 1 vol Reagent 2 vol 6 87 87 Dil.0 -2. ODC6317 and ODC6318 # User defined † DAU Negative & Multi-Drug Calibrators Cat. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † DAU Negative & Multi-Drug Calibrators Cat. # # ο ∇ 6.0 Reagent OD limit Fst. No.5 2. or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name BAR ∇ Sample type URI ∇ On-board stability period 570 RATE1 + First 24 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min.0 Dynamic range L 0 Correlation factor 3000 1 0 ¤ NO % ∇ 60 Specific Test Parameters General LIH ISE Urine # # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L # Age Y Y Y Y Y Y Level H # Test Name: BAR ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.0 -2. ODC6315.0 -2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.0 -2.5 2.5 Fst.5 2. None Selected 8. H Lst.5 Process: CONC ∇ ∇ Test Name: Counts: BAR ∇ < > Type SEMI-QUANTITATIVE APPLICATION Calibration Type: 5AB ∇ Formula: EIA TYPE 1 ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.5 2. H Sample vol.5 # Test name BAR ∇ Sample type URI ∇ Page 1/2 System Reagent: OSR6315 Reagent ID: 315 Application BARBITURATES.0 -2.5 2.5 2.BARBITURATES. # # ο ∇ 4.5 2. OD L -2.0 -2. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name BAR ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -2. AU400/AU640 Semi-quantitative Reagent ID: 315 Specific test parameters Urine 1 -2. OD H ∇ Operation: Yes ∇ Test No 2.0 1-Point Cal. L -2.5 2.: ODC6314. # # ο ∇ 3. L -2.5 2. # # # # ∇ ο 3. None Selected 8. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0 1 1 60 Day μL High B B 0 3000 0 0 Hour Sample Volume Pre-Dilution Rate Rgt. # # # # ∇ ο 5.OD Dilution 0 μL Min.5 ∇ Type: Urine < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6315 Reagent ID: 315 Application Operation Yes ∇ BARBITURATES.5 ∇ OD Range Low High -2. No.0 2.5 -2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.01 2009-08 . ODC6316. ODC6317 and ODC6318 ф AU680 <Point Cal. # # ο ∇ 3.0 2.5 -2.5 2.0 -2.5 2. AU2700/AU5400 Semi-quantitative Reagent ID: 315 Parameters General LIH BAR Dilution -2.5 + ∇ 1-Point Cal.0 2.2 61 61 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. # # ο ∇ 6.5 -2. # # # # ∇ ο 6. # # ο ∇ 4.5 2. Volume R1(R1-1) 4. ∇ ∇ ∇ 3000 0 Sec. Point: ο with CONC-0 Slope Check: # ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. SEMI-QUANTITATIVE APPLICATION Calibration Type: 5AB ∇ Formula: EIA TYPE 1 ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. Nos.5 2. 7.5 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE1 ∇ + ∇ 24 570 RATE1 + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.5 2. # # ο ∇ 5.0 -2.5 -2.BARBITURATES.: ODC6314.0 Last L -2. # # # # # CONC † † † † † Factor/OD-L -2. Not within expected values µg/L Decimal Places Calibration Specific ISE BAR ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > EIA TYPE 1 Type Urine Counts: ∇ # ο ∇ Calibration Specific General ISE Type Urine Counts: # Process: CONC ∇ ∇ Test Name: BAR ∇ < > Use Serum Cal. # # ο ∇ 7.OD Reagent OD Limit First Low Last Low 0 μL OD Limit 2.0 -2.0 -2.0 2.0 2. ODC6315.5 R2(R2-1) ф 660 Onboard Stability Period Last Last 27 61 μL Dilution 0 Name Sec.0 Reagent OD limit: First L -2. # # # # ∇ ο 4. For No.0 High High Max. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ∇ ο 1.0 Factor/OD-H 2. No demographics 8. † DAU Negative & Multi-Drug Calibrators Cat. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 None ∇ ο with Conc-0 Hour Hour DAU BSOSR6315.0 Dynamic Range: L 0 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine LIH BAR ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # BAR ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2.0 -2. # # # # ∇ ο 2. AU680/AU480 Semi-quantitative Application System Reagent: OSR6315 Specific Test Parameters General LIH ISE Urine Max OD H 2.0 -2.5 2.2 1 61 μL ∇ μL Range ∇ Operation: Yes ∇ Test Name: BAR ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 100 NO % ∇ 4.5 2. Cap the R2 Buffer bottle and let stand approximately for 5 minutes at 15…25°C. The amount of active enzyme formed and resultant absorbance change are proportional to the amount of drug present in the sample. To avoid the possible build-up of azide compounds. drug in the sample competes with drug conjugated to one inactive fragment of β-galactosidase for antibody binding site. 1. This material and its container must be disposed of as hazardous waste. Chronic benzodiazepine use can cause physical dependence. buffer salts. Clinical consideration and professional judgement should be applied to any drug of abuse test result. These fragments spontaneously reassociate to form fully active enzyme that.8 recognition of samples containing benzodiazepine metabolites. stabiliser. ensuring that all the lyophilised material from the R1 Lyo bottle is transferred into the R1 Buffer bottle. cleaves a substrate. inhibiting the reassociation of inactive β-galactosidase fragments. and preservative. NOTE 3: The R1 and R2 solutions must be at the reagent compartment temperature of the analyser before performing the assay. NOTE 5: Do not freeze reconstituted reagents.. NOTE 4: To ensure reconstituted R1 stability. psychosis. which has been genetically engineered into two inactive fragments. in more severe cases. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. unopened.01 2009-08 DAU .. NOTE 1: The components supplied in this kit are intended for use as an integral unit. NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the appropriate reagent bottle. irritability. Mix again.67 g/L chlorophenol red-β-D-galactopyranoside. muscle tension. To improve the sensitivity of the assay. 2 Test Principle This assay is based on the bacterial enzyme β-galactosidase. particularly when using a preliminary positive result. Safety Phrases: S36. and. flush waste-pipes with water after the disposal of undiluted reagent.. Ensure the reagent is homogeneous before use. A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded.. generating a colour change that can be measured spectrophotometrically. detergent. Cap the R1 Buffer bottle and let stand approximately for 5 minutes at 15…25°C.3 of insomnia.4 anticonvulsants.N-bis[2-ethanesulfonic acid] buffer. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. S60. protect from prolonged. Wear suitable protective clothing. stabiliser. up to the stated expiry date when stored at 2. Reagent Preparation Prepare the following solutions using cold reagents and buffers. Mix by gentle inversion. reagents stored on board the instrument are stable for 60 days. and preservative. 2.N-bis[2-ethanesulfonic acid] buffer.Benzodiazepines OSR6316 2 x 16 mL 2x 2 x 16 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the qualitative and semi-quantitative assay of benzodiazepines in human urine on Beckman Coulter analysers. hallucinations. Dispose of all waste material in accordance with local guidelines. ensuring that all the lyophilised material from the R2 Lyo bottle is transferred into the R2 Buffer bottle. Detach the R2 Lyo bottle and adapter from the R2 Buffer bottle and discard. A more specific alternative chemical method must be used to obtain a confirmed 1 analytical result. Piperazine-N. Contains sodium azide. induce. Avoid the formation of foam.8°C) immediately prior to preparation of the solutions. Storage and Stability The reagents are stable. and preservative.3. Summary Benzodiazepines belong to a broad class of CNS-depressant drugs known as sedatives/hypnotics. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. If drug is not present in the sample. 3-5 Although widely prescribed. Refer to Safety Data Sheets for further information. antibody binds to drug conjugated on the inactive fragment.6 mg/L sheep polyclonal antibodies reactive to benzodiazepine. agitation. R1 (Enzyme acceptor solution): Connect the R1 Lyo bottle to the R1 Buffer bottle using one of the enclosed adapters. They are prescribed as anxiolytics. leaving the inactive enzyme fragments free to form active enzyme. 0.01 BLOSR6316. continuous exposure to bright light. buffer salts. and no active enzyme will be formed. The R2 working solution (enzyme donor) should be yellow-orange in colour.8°C. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. R22 Harmful if swallowed. If drug is present in the sample. benzodiazepines are also abused. In the assay. with withdrawal symptoms 2. Mix by gentle inversion. muscle relaxers. 13. it binds to antibody. and maintain anesthesia.7 µg/L enzyme donor conjugated to a benzodiazepine derivative. and seizures. 6 Reagent Composition R1 Buffer R1 Lyo R2 Buffer R2 Lyo Piperazine-N. Once reconstituted. Prepare the R2 solution before the R1 solution to minimise possible contamination. Remove the kit from refrigerated storage (2. EN. Record the reconstitution date on the bottle label. Avoid the formation of foam. thereby increasing the 7. sleeping agents. Record the reconstitution date on the bottle label. For in vitro diagnostic use only. and are also widely used for preanesthetic medication and to supplement. The assay provides only a preliminary analytical test result. Mix again.171 g/L enzyme acceptor. Ensure the reagent is homogeneous before use. 9. an optional enzyme is added to hydrolyse glucuronide metabolites of benzodiazepines. buffer salts. in the assay format. and preservative. Do not mix components from different lots. Detach the R1 Lyo bottle and adapter from the R1 Buffer bottle and discard. R2 (Enzyme donor solution): Connect the R2 Lyo bottle to the R2 Buffer bottle using one of the enclosed adapters. Quality Control Each laboratory should establish its own control frequency. 200 µg/L Cut-off: DAU Speciality Control. Samples producing a response value less than the value of the calibrator are considered negative.01 .4 2. Precision The following data was obtained on an AU640 using the DAU Primary and Secondary Multi-drug Calibrators and two levels of controls corresponding to ± 25% of each cut-off. use the following calibrators: Calibrator Name Cat.9 10. Data obtained in your laboratory may differ from these values. Obtain another sample for testing if adulteration of the sample is suspected. Following calibration. Major preventative maintenance was performed on the analyser or a critical part was replaced. It is recommended that two levels of controls be run. Values obtained for the controls should fall within specified limits. Samples producing a response value equal to or greater than the response value of the calibrator are considered positive. DAU Secondary Cut-off Multidrug Calibrator. DAU Primary Cut-off Multi-drug Calibrator. If any trends or sudden shifts in values are detected. 200 µg/L or 300 µg/L. Good laboratory practice suggests that controls be run each day patient samples are measured and each time calibration is performed. Centrifuge specimens with high turbidity before testing. GC/MS is generally accepted as a rigorous confirmation technique for all drugs since it provides the best level of 1 confidence in the result. and the DAU High Multi-drug Calibrator. Nitrazepam (ng/mL = µg/L) DAU Primary Cut-off Multi-drug Calibrator ODC6315 300 DAU Secondary Cut-off Multi-drug Calibrator ODC6316 200 Semi-quantitative evaluation For semi-quantitative analysis of samples. ODC0007. Calibration Qualitative evaluation For qualitative analysis of samples use either of the following Cut-off calibrators: Calibrator Name Cat.9 2.0 9.0 15.9 11 DAU BLOSR6316. Treat human urine as potentially infectious material.7 3. mA/min SD %CV SD %CV 150 324 3.5 1. the other 25% below the selected cut-off.1 9. for acceptability using the software options Routine. The Beckman Coulter system automatically flags each positive sample with the letter P and each negative sample with the letter N. one 25% above the selected cut-off. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions.3 4. Care should be taken when interpreting concentration results since there are many other factors that may influence a urine test result such as fluid intake and other biological factors. Quality control material The controls required are dependent on which assay is being performed 300 µg/L Cut-off: DAU Multi-drug Control.4 0. The setting sheet contains separate applications for semi-quantitative and qualitative assays. While confirmation techniques other than GC/MS may be adequate for some drugs of abuse. DAU Intermediate Multi-drug Calibrator. ODC0006.Specimen Urine: Collect urine samples in clean glass or plastic containers. No. No. Data contained within this section is representative of performance on Beckman Coulter systems.3 4. the resulting curve should be visually reviewed. DAU Negative Calibrator ODC6314 DAU Secondary Cut-off Multi-drug Calibrator ODC6316 DAU Primary Cut-off Multi-drug Calibrator ODC6315 DAU Intermediate Multi-drug Calibrator ODC6317 DAU High Multi-drug Calibrator ODC6318 Nitrazepam (ng/mL = µg/L) 0 200 300 800 5000 The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard.7 1. Chain of custody recommendations should 10 be applied if applicable. review all operating parameters. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice.01 2009-08 EN. Calculation Qualitative results The DAU Multi-drug Calibrator.1 300 375 3. 9 Samples can be stored at 15…25°C for a maximum of 7 days after which storage at 2…8°C is recommended. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.1 1.0 15. Primary or Secondary cut-off is used as a reference in distinguishing between positive and negative samples. Calibration Monitor. Benzodiazepines Qualitative Assay n=60 Within run Total µg/L Mean. Confirm a positive result by a more specific method based on an alternative chemical principle. on the Beckman Coulter analyser.0 200 346 3.6 3.9 250 373 3.1 375 401 4. Calibration Curve. Six replicates of each sample were analysed twice daily over 5 days.8 1. Expected Values Specific Performance Characteristics Results should always be negative with respect to the chosen cut-off i. Semi-quantitative results Relative concentrations of benzodiazepines can be established by calibrating the assay with the DAU Negative Calibrator.e. Adulteration of urine samples can affect the test results.8 225 346 5.7 14.5 1. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. 000 Oxaprozin 10. yielded the following percent cross-reactivity results: Compound Concentration Tested (µg/L) Nitrazepam 300 Alprazolam 138 α-OH-Alprazolam 163 Bromazepam 300 Chlordiazepoxide 2. µg/L SD %CV 150 147 7.0 11.3 5. Specificity The following parent compounds and metabolites when tested with the Benzodiazepines assay.3 4.5 Method Comparison Patient urine samples were used to compare this Benzodiazepines assay on the AU640 against another commercially available screening assay.000 Prazepam 150 EN.9 3.0 23.2 5.5 4. 300 µg/L cut-off protocol.1 Interfering Substances No interference was observed from the following substances added to the normal endogenous concentrations found in urine when tested with the Benzodiazepines assay (< 10% of baseline): Substance Concentration Substance Concentration Acetone ≤ 10 g/L Haemoglobin ≤ 3 g/L Ascorbic acid ≤ 1.000 Lormetazepam 163 Medazepam 200 Nordiazepam 150 Oxazepam 275 Oxazepam glucuronide 10.5 Total SD 9.6 250 260 9.083 Clobazam 400 Clonazepam 188 Clorazepate 325 Delorazepam 150 Demoxepam 1.Benzodiazepines Semi-quantitative Assay n=60 Within run µg/L Mean.900 Desalkylflurazepam 138 Diazepam 110 Estazolam 125 Flunitrazepam 188 Flurazepam 150 Halazepam 200 Lorazepam 208 Lorazepam glucuronide 10. technical or procedural errors).0 4.5 %CV 6.8 3.9 3. It is calculated as the absolute mean plus three standard deviations of 25 replicates of the Negative Kit Calibrator.3 7.5 g/L Human serum albumin ≤ 5 g/L Creatinine ≤ 5 g/L Oxalic acid ≤ 1 g/L Ethanol ≤ 10 g/L Riboflavin ≤ 75 mg/L Galactose ≤ 100 mg/L Sodium chloride ≤ 60 g/L ≤ 5 g/L Urea ≤ 40 g/L γ-globulin Glucose ≤ 30 g/L Other substances and/or factors not listed may interfere with the test and cause false results (e.g.01 % Cross-Reactivity 100 205 188 110 13 62 140 84 184 14 210 247 220 135 189 145 122 1 165 135 211 107 1 2 184 BLOSR6316.4 10.8 225 194 6.2 30. Cut-off 200 µg/L 300 µg/L LDL µg/L on AU640 2.6 300 281 11.01 2009-08 DAU .7 8.8 200 187 6.6 4.4 5.0 375 405 22. Results were as follows: 200 µg/L cut-off Qualitative Assay + Comparative Screening Method + 44 0 Comparative Screening Method + 300 µg/L cut-off Qualitative Assay + 40 0 - 0 83 - 0 93 200 µg/L cut-off Semi-quantitative Assay + Comparative Screening Method + 44 0 Comparative Screening Method + 300 µg/L cut-off Semi-quantitative Assay + 40 0 - 0 83 - 0 93 Sensitivity The lowest detectable level (LDL) represents the lowest measurable level of benzodiazepines that can be distinguished from zero.3 11. Compound Concentration Tested (µg/L) Temazepam 175 Temazepam glucuronide 10,000 Triazolam 138 α-OH-Triazolam 150 % Cross-Reactivity 144 1 191 193 Structurally unrelated compounds were tested with the Benzodiazepines assay, 300 µg/L cut-off protocol, and gave a negative response when tested at the concentrations listed below. Compound Concentration (µg/L) Acetaminophen** 500,000 Acetylsalicylic acid 500,000 Amoxicillin 100,000 Amphetamine 500,000 Benzoylecgonine 500,000 Captopril 500,000 Cimetidine 500,000 Codeine 500,000 Digoxin 100,000 EDDP 500,000 EMDP 100,000 Enalapril 500,000 Fluoxetine 500,000 Ibuprofen 500,000 Levothyroxine 50,000 Methadone 100,000 Methamphetamine 500,000 Morphine 100,000 Nifedipine 500,000 Phencyclidine 250,000 Phenobarbital 500,000 Propoxyphene 500,000 Ranitidine 500,000 Salicyluric acid 500,000 Secobarbital 500,000 Sertraline 250,000 9 10,000 11-nor -∆ -THC-COOH Tolmetin 500,000 Verapamil 500,000 ** Paracetamol Limitations In view of the cross-reactivity profile of the Benzodiazepines assay, semi-quantitative results may not correlate with the levels of individual drugs/metabolites in the sample. Setting Sheet Footnotes # † * 1. 2. 3. 4. 5. 6. 7. User defined ¤ Analyser default value Calibrator Cat. No.: ODC6315 or ODC6316 Calibrator Cat. Nos.: ODC6314, ODC6315, ODC6316, ODC6317 and ODC6318 Selected cut-off value Bibliography Hawks RL. Analytical methodology. In: Hawks RL, Chiang CN, eds. Urine testing for drugs of abuse. NIDA Research Monograph. 1986;73:30-41. Katzung BG, ed. Basic and clinical pharmacology. 5th ed. Norwalk, Conn: Appleton & Lange, 1992. Julien RM. A primer of drug action. 6th ed. New York, NY: W.H. Freeman & Co; 1992. Goodman and Gilman’s The Pharmacological basis of therapeutics. 8th ed. New York, NY: Pergamon Press, 1990. Adams EH. Prevalence of prescription drug abuse: Data from the National Institute on Drug Abuse. NY State J Med 1991;91(suppl 11):32s-36s. Henderson DR, Friedman SB, Harris JD, et al. CEDIA™, a new homogeneous immunoassay system. Clin Chem 1986; 32: 1637-1641. Beck O, Lafolle P, Hjemdahl P et al. Detection of Benzodiazepine Intake in Therapeutic Doses by Immunoanalysis of Urine: Two Techniques Evaluated and Modified for Improved Performance. Clin Chem. 1992;38:271-275. 8. Simonsson P, Liden A, Lindberg S. Effect of a-Glucuronidase on Urinary Benzodiazepine Concentrations Determined by Flourescence Polarization Immunoassay. Clin Chem.1995;41:920-923. 9. Notice of mandatory guidelines for federal workplace drug testing program: Final guidelines. Federal Register 1988;69 (Apr11):11983. 10. Torre RDL, Segura J, Zeeuw RD, Williams J. Recommendations for the reliable detection of illicit drugs in urine in the European Union, with special attention to the workplace. Ann Clin Biochem 1997;34:339-344. 11. United Kingdom laboratory guidelines for legally defensible workplace drug testing: Urine Drug Testing. Ver 1.0. 2001. 38pp. DAU BLOSR6316.01 2009-08 EN.01 BENZODIAZEPINES, AU400/AU640 Qualitative Reagent ID: 316 Specific test parameters Urine Max OD H 2.5 2.5 2.5 99999 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil. Fst Fst 24 Lst Lst Main 570 Sub 660 RATE + 27 ∇ ∇ ∇ First H Last H H Fst. H Lst. H Sample vol. Reagent 1 vol Reagent 2 vol 2 87 87 Dil. vol Dil. vol Dil. vol 0 0 0 μL μL μL Max. OD H ∇ Operation: Yes ∇ Test No 2.5 2.5 2.5 # Test name BNZ ∇ Sample type URI ∇ Page 1/2 System Reagent: OSR6316 Reagent ID: 316 Application BENZODIAZEPINES, AU600 Qualitative Application System Reagent: OSR6316 Specific Test Parameters General LIH ISE Range Test Name: BNZ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. ∇ ∇ ∇ Sec. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period Select using Space key, or select from list displayed by Guide key Test No Flag L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name BNZ ∇ Sample type URI ∇ 570 RATE + First 24 First Last Last 27 Wave Method Reaction Point 1 Point 2 Min. OD L -2.0 Reagent OD limit Fst. L -2.0 Lst. L -2.0 Dynamic range L -99999 Correlation factor H A B Rate 99999 1 0 ¤ NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.0 Reagent OD limit: First L -2.0 Last L -2.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: 60 Specific Test Parameters General LIH ISE Urine * # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L * Age Y Y Y Y Y Y Level H * Test Name: BNZ ∇ < > Type: Level L: * Level H: Value/Flag: Flag ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name BNZ ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L -99999 # Conc Factor/OD-H 99999 ∇ Calibration Specific General ISE Urine # Factor/OD-H 99999 Process: CONC ∇ ∇ QUALITATIVE APPLICATION Test Name: Counts: BNZ ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. No. # OD CONC † Factor/OD-L -99999 1-Point Cal. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † DAU Multi-Drug Calibrator Cat. No.: ODC6315 (300 µg/L cut-off), ODC6316 (200 µg/L cut-off) * Selected cut-off value BSOSR6316.01 2009-08 # User defined † DAU Multi-Drug Calibrator Cat. No.: ODC6315 (300 µg/L cut-off), ODC6316 (200 µg/L cut-off) * Selected cut-off Value DAU BENZODIAZEPINES, AU2700/AU5400 Qualitative Reagent ID: 316 Parameters General LIH BNZ Dilution -2.0 -2.0 -2.0 High High Max.OD Dilution 0 μL Min.OD Reagent OD Limit First Low Last Low 0 μL OD Limit 2.5 2.5 2.5 ∇ Type: Urine < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6316 Reagent ID: 316 Application Operation Yes ∇ BENZODIAZEPINES, AU680/AU480 Qualitative Application System Reagent: OSR6316 Specific Test Parameters General LIH ISE Urine Max OD H 2.5 2.5 2.5 R2(R2-1) ф 660 Onboard Stability Period Last Last 27 70 μL Dilution 0 Name Sec. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A μL -99999 1 1 60 Day High B B 0 99999 0 0 Hour Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) 1.6 1 70 μL ∇ μL Range ∇ Operation: Yes ∇ Test Name: BNZ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 100 NO % ∇ 1.6 70 70 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. ∇ ∇ ∇ 99999 0 Sec. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE ∇ + ∇ 24 570 RATE + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.0 Reagent OD limit: First L -2.0 Last L -2.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine LIH BNZ ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: * BNZ ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: * Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ∇ ο 1. # # # # ∇ ο 2. # # # # ∇ ο 3. # # # # ∇ ο 4. # # # # ∇ ο 5. # # # # ∇ ο 6. 7. No demographics 8. Not within expected values µg/L* Decimal Places Calibration Specific ISE BNZ ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ # ο ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Type Urine Counts: Factor/OD-H 99999 # Process: CONC ∇ ∇ Test Name: BNZ ∇ < > Use Serum Cal. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. No. # OD CONC † Factor/OD-L -99999 ∇ Factor Range Low High -99999 99999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ None ∇ 1-Point Cal. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # † * ф User defined. DAU Multi-Drug Calibrator Cat. No.: ODC6315 (300 µg/L cut-off) ODC6316 (200 µg/L cut-off) Selected cut-off values AU680 Hour Hour DAU BSOSR6316.01 2009-08 BENZODIAZEPINES, AU400/AU640 Semi-quantitative Reagent ID: 316 Specific test parameters Urine 1 -2.0 -2.0 -2.0 0 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil. H 5000 Fst Fst 24 Lst Lst First H Last H 2.5 2.5 Main 570 Sub 660 RATE1 + 27 ∇ ∇ ∇ Max OD H 2.5 Fst. H Lst. H Sample vol. Reagent 1 vol Reagent 2 vol 2 87 87 Dil. vol Dil. vol Dil. vol 0 0 0 μL μL μL Max. OD H ∇ Operation: Yes ∇ Test No 2.5 2.5 2.5 # Test name BNZ ∇ Sample type URI ∇ Page 1/2 System Reagent: OSR6316 Reagent ID: 316 Application BENZODIAZEPINES, AU600 Semi-quantitative Application System Reagent: OSR6316 Specific Test Parameters General LIH ISE Range Test Name: BNZ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. ∇ ∇ ∇ Sec. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key, or select from list displayed by Guide key Test No # L # # # # # # M M M M M M # # # # # # ∇ H # # # # # # M→ M→ M→ M→ M→ M→ # Test name BNZ ∇ Sample type URI ∇ On-board stability period 570 RATE1 + First 24 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. OD L -2.0 Reagent OD limit Fst. L -2.0 Lst. L -2.0 Dynamic range L 0 Correlation factor 5000 1 0 ¤ NO % ∇ 60 Specific Test Parameters General LIH ISE Urine # # # # # # # Age Y Y Y Y Y Y ∇ Range Page 2/2 Level L # Age Y Y Y Y Y Y Level H # Test Name: BNZ ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name BNZ ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -2.0 -2.0 -2.0 -2.0 -2.0 # Conc Factor/OD-H 2.5 2.5 2.5 2.5 2.5 ∇ Calibration Specific General ISE Urine # Factor/OD-H 2.5 2.5 2.5 2.5 2.5 Process: CONC ∇ ∇ Test Name: Counts: BNZ ∇ < > Type SEMI-QUANTITATIVE APPLICATION Calibration Type: 5AB ∇ Formula: EIA TYPE 1 ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. No. # # # # # OD CONC † † † † † Factor/OD-L -2.0 -2.0 -2.0 -2.0 -2.0 1-Point Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † DAU Negative & Multi-Drug Calibrators Cat. Nos.: ODC6314, ODC6316, ODC6315, ODC6317 and ODC6318 # User defined † DAU Negative & Multi-Drug Calibrators Cat. Nos.: ODC6314, ODC6316, ODC6315, ODC6317 and ODC6318 DAU BSOSR6316.01 2009-08 BENZODIAZEPINES, AU2700/AU5400 Semi-quantitative Reagent ID: 316 Parameters General LIH BNZ Dilution -2.0 -2.0 -2.0 High High Max.OD Dilution 0 μL Min.OD Reagent OD Limit First Low Last Low 0 μL OD Limit 2.5 2.5 2.5 ∇ Type: Urine < > ∇ ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6316 Reagent ID: 316 Application Operation Yes ∇ BENZODIAZEPINES, AU680/AU480 Semi-Quantitative Application System Reagent: OSR6316 Specific Test Parameters General LIH ISE Urine Max OD H 2.5 2.5 2.5 R2(R2-1) ф 660 Onboard Stability Period Last Last 27 70 μL Dilution 0 Name Sec. Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0 1 1 60 Day μL High B B 0 5000 0 0 Hour Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) 1.6 1 70 μL ∇ μL Range ∇ Operation: Yes ∇ Test Name: BNZ ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 100 NO % ∇ 1.6 70 70 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. ∇ ∇ ∇ 5000 0 Sec. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE1 ∇ + ∇ 24 570 RATE1 + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.0 Reagent OD limit: First L -2.0 Last L -2.0 Dynamic Range: L 0 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine LIH BNZ ∇ < > ISE HbA1c Range ∇ Test Name: Parameters General Test Name: # BNZ ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ∇ ο 1. # # # # ∇ ο 2. # # # # ∇ ο 3. # # # # ∇ ο 4. # # # # ∇ ο 5. # # # # ∇ ο 6. 7. No demographics 8. Not within expected values µg/L Decimal Places Calibration Specific ISE BNZ ∇ Test Name: < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > EIA TYPE 1 Type Urine Counts: ∇ # ο ∇ Calibration Specific General ISE Type Urine Counts: # Process: CONC ∇ ∇ Test Name: BNZ ∇ < > Use Serum Cal. SEMI-QUANTITATIVE APPLICATION Calibration Type: 5AB ∇ Formula: EIA TYPE 1 ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. No. # # # # # CONC † † † † † Factor/OD-L -2.0 -2.0 -2.0 -2.0 -2.0 Factor/OD-H 2.5 2.5 2.5 2.5 2.5 ∇ OD Range Low High -2.0 2.5 -2.0 2.5 -2.0 2.5 -2.0 2.5 -2.0 2.5 + ∇ 1-Point Cal. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. † DAU Negative & Multi-Drug Calibrators Cat. Nos.: ODC6314, ODC6316, ODC6315, ODC6317 and ODC6318 ф AU680 Hour Hour DAU BSOSR6316.01 2009-08 Cocaine OSR6317 2 x 16 mL 2x 2 x 16 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the qualitative and semi-quantitative assay of the cocaine metabolite benzoylecgonine in human urine on Beckman Coulter analysers. For in vitro diagnostic use only. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed 1 analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when using a preliminary positive result. Summary Cocaine (benzoylmethylecgonine), is derived from the plant species Erythroxylon coca, which is widely grown in South America. Cocaine abuse can produce euphoria, arousal, garrulousness, alertness, anxiety, insomnia, hyperactivity, paranoia, severe psychosis, and even 2,5,6 suicide. 3,5,6 Cocaine is rapidly metabolised, with less than 5% excreted unchanged in the urine. The two major metabolites, which result from enzymatic and 3,5-8 nonenzymatic hydrolysis, are benzoylecgonine and ecgonine methyl ester. The metabolite benzoylecgonine may be detected in urine for up to 9,10 3 weeks after long term, heavy use of cocaine. 2-4 Test Principle11 This assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a colour change that can be measured spectrophotometrically. In the assay, drug in the sample competes with drug conjugated to one inactive fragment of β-galactosidase for antibody binding site. If drug is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If drug is not present in the sample, antibody binds to drug conjugated on the inactive fragment, inhibiting the reassociation of inactive β-galactosidase fragments, and no active enzyme will be formed. The amount of active enzyme formed and resultant absorbance change are proportional to the amount of drug present in the sample. Reagent Composition R1 Buffer R1 Lyo R2 Buffer R2 Lyo Piperazine-N,N-bis[2-ethanesulfonic acid] buffer, 0.54 mg/L mouse monoclonal antibodies reactive to benzoylecgonine, buffer salts, stabiliser, and preservative. 0.171 g/L enzyme acceptor, buffer salts, detergent and preservative. Piperazine N,N-bis[2-ethanesulfonic acid] buffer; buffer salts, and preservative. 15.38 µg/L enzyme donor conjugated to benzoylecgonine, 1.67 g/L chlorophenol red-β-D-galactopyranoside, stabiliser, and preservative. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. Contains sodium azide. R22; Harmful if swallowed. Safety Phrases: S36, S60. Wear suitable protective clothing. This material and its container must be disposed of as hazardous waste. Dispose of all waste material in accordance with local guidelines. To avoid the possible build-up of azide compounds, flush waste-pipes with water after the disposal of undiluted reagent. Refer to Safety Data Sheets for further information. Reagent Preparation Prepare the following solutions using cold reagents and buffers. Remove the kit from refrigerated storage (2…8°C) immediately prior to preparation of the solutions. Prepare the R2 solution before the R1 solution to minimise possible contamination. R2 (Enzyme donor solution): Connect the R2 Lyo bottle to the R2 Buffer bottle using one of the enclosed adapters. Mix by gentle inversion, ensuring that all the lyophilised material from the R2 Lyo bottle is transferred into the R2 Buffer bottle. Avoid the formation of foam. Detach the R2 Lyo bottle and adapter from the R2 Buffer bottle and discard. Cap the R2 Buffer bottle and let stand for approximately 5 minutes at 15…25°C. Mix again. Record the reconstitution date on the bottle label. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. Ensure the reagent is homogeneous before use. R1 (Enzyme acceptor solution): Connect the R1 Lyo bottle to the R1 Buffer bottle using one of the enclosed adapters. Mix by gentle inversion, ensuring that all the lyophilised material from the R1 Lyo bottle is transferred into the R1 Buffer bottle. Avoid the formation of foam. Detach the R1 Lyo bottle and adapter from the R1 Buffer bottle and discard. Cap the R1 Buffer bottle and let stand for approximately 5 minutes at 15…25°C. Mix again. Record the reconstitution date on the bottle label. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. Ensure the reagent is homogeneous before use. NOTE 1: The components supplied in this kit are intended for use as an integral unit. Do not mix components from different lots. NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the appropriate reagent bottle. The R2 working solution (Enzyme Donor) should be yellow-orange in colour. A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded. NOTE 3: The R1 and R2 solutions must be at the reagent compartment storage temperature of the analyser before performing the assay. NOTE 4: To ensure reconstituted R1 stability, protect from prolonged, continuous exposure to bright light. NOTE 5: Do not freeze reconstituted reagents. Storage and Stability The reagents are stable, unopened, up to the stated expiry date when stored at 2...8°C. Once re-constituted, reagents stored on board the instrument are stable for 60 days. EN.01 BLOSR6317.01 2009-08 DAU Specimen Urine: Collect urine samples in clean glass or plastic containers. Centrifuge specimens with high turbidity before testing. Treat human urine as potentially infectious material. Obtain another sample for testing if adulteration of the sample is suspected. Adulteration of urine samples can affect the test results. Samples can be stored at 15…25°C for a maximum of 7 days after which storage at 2…8°C is recommended. Chain of custody recommendations should 13 be applied if applicable. 12 Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. The setting sheet contains separate applications for semi-quantitative and qualitative assays. Calibration Qualitative evaluation For qualitative analysis of samples use either of the following Cut-off calibrators: Calibrator Name DAU Primary Cut-off Multi-drug Calibrator DAU Secondary Cut-off Multi-drug Calibrator Cat. No. ODC6315 ODC6316 Benzoylecgonine (ng/mL = µg/L) 300 150 Semi-quantitative evaluation For semi-quantitative analysis of samples, use the following calibrators: Calibrator Name DAU Negative Calibrator DAU Secondary Cut-off Multi-drug Calibrator DAU Primary Cut-off Multi-drug Calibrator DAU Intermediate Multi-drug Calibrator DAU High Multi-drug Calibrator Cat. No. ODC6314 ODC6316 ODC6315 ODC6317 ODC6318 Benzoylecgonine (ng/mL = µg/L) 0 150 300 2000 5000 The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values; Major preventative maintenance was performed on the analyser or a critical part was replaced. Following calibration, the resulting curve should be visually reviewed, on the Beckman Coulter analyser, for acceptability using the software options Routine, Calibration Monitor, Calibration Curve. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Quality Control Each laboratory should establish its own control frequency. Good laboratory practice suggests that controls be run each day patient samples are measured and each time calibration is performed. It is recommended that two levels of controls be run; one 25% above the cut-off; the other 25% below the cut-off. Values obtained for the controls should fall within specified limits. If any trends or sudden shifts in values are detected, review all operating parameters. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Quality control material The controls required are dependent on which assay is being performed. 300 µg/L Cut-off: DAU Multi-drug Control, ODC0006. 150 µg/L Cut-off: DAU Speciality Control, ODC0007. Calculation Qualitative results The DAU Multi-drug Calibrator, Primary or Secondary Cut-off is used as a reference in distinguishing between positive and negative samples. Samples producing a response value equal to or greater than the response value of the calibrator are considered positive. Samples producing a response value less than the response value of the calibrator are considered negative. The Beckman Coulter system automatically flags each positive sample with the letter P and each negative sample with the letter N. Semi-quantitative results Relative concentrations of cocaine can be established by calibrating the assay with the DAU Negative Calibrator, DAU Secondary Cut-off Multi-drug Calibrator, DAU Primary Cut-off Multi-drug Calibrator, DAU Intermediate Multi-drug Calibrator, and the DAU High Multi-drug Calibrator. Care should be taken when interpreting concentration results since there are many other factors that may influence a urine test result such as fluid intake and other biological factors. Confirm a positive result by a more specific method based on an alternative chemical principle. While confirmation techniques other than GC/MS may be adequate for some drugs of abuse, GC/MS is generally accepted as a rigorous confirmation technique for all drugs since it provides the best level of 1 confidence in the result. Expected Values Qualitative Procedure 13 Results should always be negative with respect to the chosen cut-off i.e. 300 µg/L or 150 µg/L. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems. Data obtained in your laboratory may differ from these values. Precision The following data was obtained on an AU640 using the DAU Primary and Secondary Multi-drug Calibrators and two levels of controls corresponding to ± 25% of each cut-off. Six replicates of each sample were analysed twice daily over 5 days. Cocaine Qualitative Assay n=60 µg/L Mean, mA/min 112.5 274 150 296 187.5 328 225 333 300 366 375 394 DAU Within run SD %CV 2.2 0.8 2.1 0.7 2.6 0.8 3.7 1.1 3.8 1.1 3.8 1.0 Total SD 3.8 4.7 5.1 4.9 5.4 5.6 %CV 1.4 1.6 1.6 1.5 1.5 1.4 BLOSR6317.01 2009-08 EN.01 Cocaine Semi-quantitative Assay n=60 Within run µg/L Mean, µg/L SD %CV 112.5 120 2.7 2.3 150 149 3.2 2.2 187.5 217 5.6 2.6 225 228 8.1 3.5 300 316 19.6 6.2 375 528 30.3 5.7 Total SD 3.3 4.7 8.2 9.5 25.6 43.2 %CV 2.8 3.2 3.8 4.2 8.1 8.2 Method Comparison Patient urine samples were used to compare this Cocaine assay on the AU640 against another commercially available screening assay. Results were as follows: 150 µg/L cut-off Qualitative Assay + Comparative Screening Method + 79 0 Comparative Screening Method + 300 µg/L cut-off Qualitative Assay + 53 0 - 0 71 - 0 94 150 µg/L cut-off Semi-quantitative Assay + Comparative Screening Method + 79 0 Comparative Screening Method + 300 µg/L cut-off Semi-quantitative Assay + 53 0 - 0 71 - 0 94 Sensitivity The lowest detectable level (LDL) represents the lowest measurable level of cocaine that can be distinguished from zero. It is calculated as the absolute mean plus three standard deviations of 25 replicates of the Negative Kit Calibrator. Cut-off 150 µg/L 300 µg/L LDL µg/L on AU640 4.3 4.9 Interfering Substances No interference was observed from the following substances added to the normal endogenous concentrations found in urine when tested with the Cocaine assay (< 10% of baseline): Substance Concentration Substance Concentration Acetone ≤ 10 g/L Haemoglobin ≤ 3 g/L Ascorbic acid ≤ 1.5 g/L Human serum albumin ≤ 5 g/L Creatinine ≤ 5 g/L Oxalic acid ≤ 1 g/L Ethanol ≤ 10 g/L Riboflavin ≤ 75 mg/L Galactose ≤ 100 mg/L Sodium chloride ≤ 60 g/L ≤ 5 g/L Urea ≤ 20 g/L γ-globulin Glucose ≤ 15 g/L Other substances and/or factors not listed may interfere with the test and cause false results (e.g. technical or procedural errors). Specificity The following parent compounds and metabolites when tested with the Cocaine assay, 300 µg/L cut-off protocol, yielded the following percent crossreactivity results: Concentration % CrossCompound Tested (µg/L) Reactivity Benzoylecgonine 300 100 Cocaethylene 312 57 Cocaine 315 54 Ecgonine 10,000 1.1 Ecgonine methyl ester 10,000 < 0.1 Structurally unrelated compounds were tested with the Cocaine assay, 300 µg/L cut-off protocol, and gave a negative response when tested at the concentrations listed below. Compound Acetaminophen** Acetylsalicylic acid Amoxicillin Amphetamine Captopril Chlordiazepoxide Cimetidine Codeine Diazepam Digoxin Enalapril Fluoxetine Ibuprofen Levothyroxine (T4) EN.01 Concentration (µg/L) 500,000 500,000 100,000 500,000 500,000 100,000 500,000 500,000 500,000 100,000 500,000 500,000 500,000 50,000 BLOSR6317.01 2009-08 DAU Compound Methadone Methamphetamine Morphine Nifedipine Phencyclidine Phenobarbital Propoxyphene Ranitidine Salicyluric acid Secobarbital 9 11-nor -∆ -THC-COOH Verapamil ** Paracetamol Concentration (µg/L) 500,000 500,000 100,000 500,000 500,000 500,000 500,000 500,000 500,000 500,000 10,000 500,000 Setting Sheet Footnotes # † * 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. User defined ¤ Analyser default value Calibrator Cat. No.: ODC6315 or ODC6316 Calibrator Cat. Nos.: ODC6314, ODC6315, ODC6316, ODC6317 and ODC6318 Selected cut-off value Hawks RL. Analytical methodology. In: Hawks, RL,Chiang, CN, eds. Urine Testing for Drugs of Abuse. NIDA Research Monograph 1986, 73: 30-41. Gawin FH, Ellinwood EH Jr. Cocaine and other stimulants: Actions, abuse, and treatment. N. Engl. J. Med. 1988,318: 1173-1182. Jatlow, Pl. Drugs of abuse profile: Cocaine. Clin. Chem. 1987, 33 (suppl): 66B-71B. Bouknight LG, Bouknight RR. Cocaine - A particularly addictive drug. Postgrad. Med. 1988; 83:115-124,131. Benowitz, NL, Clinical pharmacology and toxicology of cocaine. Pharmacol. & Toxicol. 1993;72:3-12. Jones RT. The pharmacology of cocaine. In: Grabowski, J. ed. Cocaine: Pharmacology, Effects and Treatment of Abuse. NIDA Research Monograph. 1984;50:34-53. Ambre J. Urinary excretion of cocaine and metabolites in humans: A kinetic analysis of published data. J. Anal. Toxicol. 1985;9:241-245. Ambre J, Ruo Tl, Nelson J, Belknap S. Urinary excretion of cocaine, benzoylecgonine and ecgonine methyl ester in humans. J. Anal. Toxicol. 1988;12:301-306. Weiss RD. Gawin, FH. Protracted elimination of cocaine metabolites in long-term, high-dose cocaine abusers. Am. J. Med. 1988, 85: 879-880. Burke WM, et al. Prolonged presence of metabolite in urine after compulsive cocaine use. J. Clin. Psychiatry. 1990;51:145-148. Henderson DR, Friedman SB, Harris JD et al. CEDIATM, a new homogeneous immunoassay system. Clin. Chem. 1986; 32:1637-1641. Notice of Mandatory Guidelines For Federal Workplace Drug Testing Program: Final Guidelines, Federal Register. 1988;69 [Apr. 11]:11983. Torre RDL, Segura J, Zeeuw RD, Williams J. Recommendations for the reliable detection of illicit drugs in urine in the European Union, with special attention to the workplace. Ann Clin Biochem 1997;34:339-344. Bibliography . DAU BLOSR6317.01 2009-08 EN.01 COCAINE, AU400/AU640 Qualitative Reagent ID: 317 Specific test parameters Urine ∇ Max OD H 2.5 Main ∇ ∇ ∇ 570 Sub 2.5 2.5 99999 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil. Fst Fst 24 Lst Lst 660 RATE + 27 Fst. H Lst. H First H Last H H Sample vol. Reagent 1 vol Reagent 2 vol μL μL μL 4 87 87 Dil. vol Dil. vol Dil. vol 0 0 0 Max. OD H ∇ Operation: Yes Test No ∇ 2.5 2.5 2.5 ∇ # Test name COC Sample type URI Page 1/2 System Reagent: OSR6317 Reagent ID: 317 Application COCAINE, AU600 Qualitative Application System Reagent: OSR6317 Specific Test Parameters General LIH ISE Range Test Name: COC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 4 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. ∇ ∇ ∇ Sec. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period Select using Space key, or select from list displayed by Guide key Test No ∇ Flag ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name COC Sample type URI ∇ 570 RATE + First 24 First Last Last 27 Wave Method Reaction Point 1 Point 2 Min. OD L -2.0 Reagent OD limit Fst. L -2.0 Lst. L -2.0 Dynamic range L -99999 Correlation factor H A B Rate 99999 1 0 ¤ NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.0 Reagent OD limit: First L -2.0 Last L -2.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: 60 Specific Test Parameters General LIH ISE Urine ∇ * Range Page 2/2 Level L * Level H * Test Name: COC ∇ < > Type: Level L: * Level H: Value/Flag: Flag ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name COC ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L -99999 # Conc Factor/OD-H 99999 ∇ Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 99999 # QUALITATIVE APPLICATION Test Name: Counts: COC ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. No. # OD CONC † Factor/OD-L -99999 1-Point Cal. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † DAU Multi-Drug Calibrator Cat. No.: ODC6315 (300 µg/L cut-off), ODC6316 (150 µg/L cut-off) * Selected cut-off value BSOSR6317.01 2009-08 # User defined † DAU Multi-Drug Calibrator Cat. No.: ODC6315 (300 µg/L cut-off), ODC6316 (150 µg/L cut-off) * Selected cut-off value DAU COCAINE, AU2700/AU5400 Qualitative Reagent ID: 317 Parameters General LIH COC ∇ Dilution μL -2.0 -2.0 -2.0 High High Max.OD μL Min.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.5 2.5 2.5 < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6317 Reagent ID: 317 Application Operation Yes COCAINE, AU680/AU480 Qualitative Application System Reagent: OSR6317 Specific Test Parameters General LIH ISE Urine ∇ Max OD H 2.5 2.5 2.5 R2(R2-1) μL Name Sec. 660 Onboard Stability Period Last Last 27 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 1 1 60 Day μL 61 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) μL ∇ μL 2.8 1 61 Range Operation: ∇ Yes Test Name: COC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H -99999 H B 60 100 NO % ∇ 2.8 61 61 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. Sec. 660 ∇ ∇ ∇ ∇ 99999 0 99999 High B B 0 0 0 Hour Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE ∇ + ∇ 24 570 RATE + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.0 Reagent OD limit: First L -2.0 Last L -2.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine ∇ LIH COC ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: * COC ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: * Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 2. ∇ # # # # ο 3. ∇ # # # # ο 4. ∇ # # # # ο 5. ∇ # # # # ο 6. ∇ 7. No demographics 8. Not within expected values µg/L* Decimal Places Calibration Specific ISE COC ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ Factor Range Low High -99999 99999 ∇ # ο ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Type Urine ∇ Counts: Factor/OD-H 99999 # Process: CONC ∇ Test Name: COC ∇ < > Test Name: Use Serum Cal. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. No. # OD CONC † Factor/OD-L -99999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration # None ∇ 1-Point Cal. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. † DAU Multi-Drug Calibrator Cat. No.: ODC6315 (300 µg/L cut-off) ODC6316 (150 µg/L cut-off) * Selected cut-off value ф AU680 <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour DAU BSOSR6317.01 2009-08 COCAINE, AU400/AU640 Semi-quantitative Reagent ID: 317 Specific test parameters Urine ∇ 1 -2.0 Main ∇ ∇ ∇ 570 Sub -2.0 -2.0 0 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil. H 5000 Fst Fst 24 Lst Lst First H Last H 2.5 2.5 660 RATE1 + 27 Max OD H 2.5 Fst. H Lst. H Sample vol. Reagent 1 vol Reagent 2 vol μL μL μL 4 87 87 Dil. vol Dil. vol Dil. vol 0 0 0 Max. OD H ∇ Operation: Yes Test No ∇ 2.5 2.5 2.5 ∇ # Test name COC Sample type URI Page 1/2 System Reagent: OSR6317 Reagent ID: 317 Application COCAINE, AU600 Semi-quantitative Application System Reagent: OSR6317 Specific Test Parameters General LIH ISE Range Test Name: COC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 4 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. ∇ ∇ ∇ Sec. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key, or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name COC Sample type URI ∇ On-board stability period 570 RATE1 + First 24 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. OD L -2.0 Reagent OD limit Fst. L -2.0 Lst. L -2.0 Dynamic range L 0 Correlation factor 5000 1 0 ¤ NO % ∇ 60 Specific Test Parameters General LIH ISE Urine ∇ # Range Page 2/2 Level L # Level H # Test Name: COC ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name COC ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -2.0 -2.0 -2.0 -2.0 -2.0 # Conc Factor/OD-H 2.5 2.5 2.5 2.5 2.5 ∇ Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 2.5 2.5 2.5 2.5 2.5 # Test Name: Counts: COC ∇ < > Type SEMI-QUANTITATIVE APPLICATION Calibration Type: 5AB ∇ Formula: EIA TYPE 1 ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. No. # # # # # OD CONC † † † † † Factor/OD-L -2.0 -2.0 -2.0 -2.0 -2.0 1-Point Cal. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † DAU Negative & Multi-Drug Calibrators Cat. Nos.: ODC6314, ODC6316, ODC6315, ODC6317 and ODC6318 # User defined † DAU Negative & Multi-Drug Calibrators Cat. Nos.: ODC6314, ODC6316, ODC6315, ODC6317 and ODC6318 DAU BSOSR6317.01 2009-08 COCAINE, AU2700/AU5400 Semi-quantitative Reagent ID: 317 Parameters General LIH COC ∇ Dilution μL -2.0 -2.0 -2.0 High High Max.OD μL Min.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.5 2.5 2.5 < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6317 Reagent ID: 317 Application Operation Yes COCAINE, AU680AU480 Semi-quantitative Application System Reagent: OSR6317 Specific Test Parameters General LIH ISE Urine ∇ Max OD H 2.5 2.5 2.5 R2(R2-1) μL Name Sec. 660 Onboard Stability Period Last Last 27 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0 1 1 60 Day μL High B B 0 5000 0 0 Hour 61 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. Volume R1(R1-1) μL ∇ μL 2.8 1 61 Range Operation: ∇ Yes Test Name: COC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 100 NO % ∇ 2.8 61 61 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. ∇ ∇ ∇ 5000 0 Sec. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE1 ∇ + ∇ 24 570 RATE1 + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.0 Reagent OD limit: First L -2.0 Last L -2.0 Dynamic Range: L 0 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine ∇ LIH COC ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # COC ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 2. # # ο ∇ 3. # # ο ∇ 4. # # ο ∇ 5. # # ο ∇ 6. # # ο ∇ 7. None Selected 8. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ∇ # # # # ο 2. ∇ # # # # ο 3. ∇ # # # # ο 4. ∇ # # # # ο 5. ∇ # # # # ο 6. ∇ 7. No demographics 8. Not within expected values µg/L Decimal Places Calibration Specific ISE COC ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > EIA TYPE 1 Type Urine Counts: ∇ # ο ∇ Calibration Specific General ISE Type Urine ∇ Counts: # Process: CONC ∇ Test Name: COC ∇ < > Test Name: Use Serum Cal. SEMI-QUANTITATIVE APPLICATION Calibration Type: 5AB ∇ Formula: EIA TYPE 1 ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal. No. # # # # # CONC † † † † † Factor/OD-L -2.0 -2.0 -2.0 -2.0 -2.0 Factor/OD-H 2.5 2.5 2.5 2.5 2.5 ∇ OD Range Low High -2.0 2.5 -2.0 2.5 -2.0 2.5 -2.0 2.5 -2.0 2.5 + ∇ 1-Point Cal. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. † DAU Negative & Multi-Drug Calibrators Cat. Nos.: ODC6314, ODC6316, ODC6315, ODC6317 and ODC6318 ф AU680 <Point Cal. For No. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour DAU BSOSR6317.01 2009-08 stabiliser and preservative. One benefit of measuring EDDP instead of methadone. protect from prolonged. Mix by gentle inversion. The R2 working solution (enzyme donor) should be yellow-orange in colour. EN. R22.3-diphenylpyrrolidine) in human urine on Beckman Coulter analysers.5-dimethyl-3. R1 (Enzyme acceptor solution): Connect the R1 lyo bottle to the R1 buffer bottle using one of the enclosed adapters.8°C. Record the reconstitution date on the bottle label. NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the appropriate reagent bottle. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. cleaves a substrate.N-bis [2-ethanesulfonic acid] buffer. Contains sodium azide. Safety Phrases: S36. If drug is present in the sample. The amount of active enzyme formed and resultant absorbance change are proportional to the amount of drug present in the sample. Dispose of all waste material in accordance with local guidelines. Enzyme donor conjugated to an EDDP derivative. drug in the sample competes with drug conjugated to one inactive fragment of β-galactosidase for antibody binding site. Enzyme acceptor. buffer salts. Do not mix components from different lots. ensuring that all the lyophilised material from the R2 lyo bottle is transferred into the R2 buffer bottle.01 BLOSR6318. Detach the R1 lyo bottle and adapter from the R1 buffer bottle and discard. Piperazine-N. it binds to antibody. monoclonal antibodies reactive to EDDP. since the drug was not ingested and therefore never metabolised. NOTE 1: The components supplied in this kit are intended for use as an integral unit. Refer to Safety Data Sheets for further information.EDDP OSR6318 2 x 16 mL 2x 2 x 16 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the qualitative and semi-quantitative assay of EDDP (2-ethylidine-1. In the assay. Cap the R1 buffer bottle and let stand for approximately 5 minutes at 15…25°C. R2 (Enzyme donor solution): Connect the R2 lyo bottle to the R2 buffer bottle using one of the enclosed adapters. For in vitro diagnostic use only. Avoid the formation of foam. Ensure the reagent is homogeneous before use. Harmful if swallowed. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. Mix again. Specimen Urine: Collect urine samples in clean glass or plastic containers. These fragments spontaneously re-associate to form fully active enzyme that. detergent. chlorophenol red-β-D-galactopyranoside. ensuring that all the lyophilised material from the R1 lyo bottle is transferred into the R1 buffer bottle. Storage and Stability The reagents are stable. is that individuals in methadone maintenance programs sometimes divert their methadone into the 8 illicit drug market and then spike their urine sample with a small quantity of methadone to cover the diversion. buffer salts. antibody binds to drug conjugated on the inactive fragment. Their urine sample may test positive for methadone but would not test positive for EDDP. up to the stated expiry date when stored at 2. and no active enzyme will be formed. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. and preservative. inhibiting the re-association of inactive β-galactosidase fragments. Reagent Composition R1 Buffer R1 Lyo R2 Buffer R2 Lyo Piperazine-N. Record the reconstitution date on the bottle label.3-diphenylpyrrolidine (EDDP) is the primary metabolite of methadone.. Mix by gentle inversion. generating a colour change that can be measured spectrophotometrically. Methadone is a synthetic opiate agonist that is often used in detoxification programs as an oral substitute for heroin or other morphine-like drugs to suppress withdrawal symptoms and/or to maintain chronic 3-7 relapsing heroin addicts. Once reconstituted. S60. flush waste-pipes with water after the disposal of undiluted reagent.01 2009-08 DAU . Summary 2-Ethylidine-1. If drug is not present in the sample.. stabiliser.5-dimethyl-3. which has been genetically engineered into two inactive fragments. Prepare the R2 solution before the R1 solution to minimise possible contamination. Mix again. leaving the inactive enzyme fragments free to form active enzyme. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. To avoid the possible build-up of azide compounds. This material and its container must be disposed of as hazardous waste. A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded. continuous exposure to bright light.N-bis [2-ethanesulfonic acid] buffer. NOTE 4: To ensure reconstituted R1 stability. Avoid the formation of foam. reagents stored on board the instrument are stable for 60 days. Detach the R2 lyo bottle and adapter from the R2 buffer bottle and discard. Cap the R2 buffer bottle and let stand for approximately 5 minutes at 15…25°C. Reagent Preparation Remove the kit from refrigerated storage (2…8°C) immediately prior to preparation of the solutions. in the assay format. buffer salts. and preservative. NOTE 5: Do not freeze reconstituted reagents. The assay provides only a preliminary analytical test result. Clinical consideration and professional judgement should be applied to any drug of abuse test result particularly when using a preliminary positive result. Ensure the reagent is homogeneous before use. A more specific alternative chemical method must be used to obtain a confirmed 1 analytical result. Wear suitable protective clothing. NOTE 3: The R1 and R2 solutions must be at the reagent compartment temperature of the analyser before performing the assay. unopened. and preservative. 2 Test Principle9 This assay is based on the bacterial enzyme β-galactosidase. Centrifuge specimens with high turbidity before testing.1 DAU BLOSR6318. GC/MS is generally accepted as a rigorous confirmation technique for all drugs since it provides the best level of 1 confidence in the result. While confirmation techniques other than GC/MS may be adequate for some drugs of abuse. Precision The following data was obtained on an AU640 using an DAU Multi-drug Cut-off Calibrator and two levels of controls corresponding to ± 25% of the cut-off. Good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed.01 .2 4. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.4 4. DAU Intermediate Multi-drug Calibrator. If any trends or sudden shifts in values are detected. The Beckman Coulter system automatically flags each positive sample with the letter P and each negative sample with the letter N.9 6. one 25% above the cut-off. Semi-quantitative results Relative concentrations of EDDP can be established by calibrating the assay with the DAU Negative Calibrator. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. Specific Performance Characteristics Data contained within this section is representative of performance on Beckman Coulter systems.5 10. The setting sheet contains separate applications for semi-quantitative and qualitative assays. Adulteration of urine samples can affect the test results. 11 Chain of custody recommendations should be applied if applicable. review all operating parameters. Six replicates of each sample were analysed twice daily over 5 days.4 4.01 2009-08 EN. Samples producing a response value less than the response value of the calibrator are considered negative. on the Beckman Coulter analyser. Care should be taken when interpreting concentration results since there are many other factors that may influence a urine test result such as fluid intake and other biological factors.7 % CV 4. 10 Samples can be stored at 15…25°C for a maximum of 7 days after which storage at 2…8°C is recommended. Data obtained in your laboratory may differ from these values. Primary or Secondary Cut-off is used as a reference in distinguishing between positive and negative samples. Expected Values Results should be negative with respect to the cut-off (100 µg/L). Calibration Monitor. ODC6315 ODC6316 EDDP (ng/mL = µg/L) 100 100 Semi-quantitative evaluation For semi-quantitative analysis of samples.0 Total SD 3.6 6.5 1. ODC6314 ODC6315 or ODC6316 ODC6317 ODC6318 EDDP (ng/mL = µg/L) 0 100 500 2000 The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard.4 1.0 3.3 Total SD 8. µg/L 75 76 100 99 125 157 Within run SD % CV 3. DAU Secondary Cut-off Multi-drug Calibrator or DAU Primary Cut-off Multi-drug Calibrator. Following calibration. Treat human urine as potentially infectious material. It is recommended that two levels of controls be run.4 9. Obtain another sample for testing if adulteration of the sample is suspected.4 Within run SD % CV 3.3 3.4 8. Calibration Curve. No.1 4. Quality Control Each laboratory should establish its own control frequency. Calculation Qualitative results The DAU Multi-drug Calibrator. Confirm a positive result by a more specific method based on an alternative chemical principle. Samples producing a response value equal to or greater than the response value of the calibrator are considered positive.1 % CV 3. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. No. with the exception of subjects on methadone treatment programs where positive results are anticipated. the resulting curve should be visually reviewed. the other 25% below the cut-off.4 4.6 9.2 3. Major preventative maintenance was performed on the analyser or a critical part was replaced. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. use the following calibrators: Calibrator Name DAU Negative Calibrator DAU Primary Cut-off Multi-drug Calibrator or DAU Secondary Cut-off Multi-drug Calibrator DAU Intermediate Multi-drug Calibrator DAU High Multi-drug Calibrator Cat. Calibration Qualitative evaluation For qualitative analysis of samples use either of the following Cut-off calibrators: Calibrator Name DAU Primary Cut-off Multi-drug Calibrator DAU Secondary Cut-off Multi-drug Calibrator Cat. ODC0007. Quality control material DAU Multi-drug Control. mA/min 75 265 100 289 125 317 EDDP Semi-quantitative Assay n=60 µg/L Mean. ODC0006 or DAU Speciality Control.1 4. for acceptability using the software options Routine. EDDP Qualitative Assay n=60 µg/L Mean. and the DAU High Multi-drug Calibrator.4 1. Values obtained for the controls should fall within specified limits. 01 2009-08 DAU .000 Enalapril 500.000 Benzoylecgonine 100.000 Fluoxetine 500. Results were as follows: 100 µg/L cut-off Qualitative Assay + Comparative Screening Method + 44 2* Comparative Screening Method 100 µg/L cut-off Semi-quantitative Assay + + 44 0 - 0 70 - 0 72 * These samples were tested by GC/MS and were found to contain 95 µg/L and 97 µg/L EDDP.000.000 Ibuprofen 500.000 Digoxin 100.000 Acetylsalicylic acid 500. Specificity The following parent compounds and metabolites when tested with the EDDP assay yielded the following percent cross-reactivity results: Concentration % Cross Compound Tested (µg/L) Reactivity EDDP 100 100.000 Amoxicillin 500.000 Doxylamine 500.016 α-levo-acetylmethadol 1.Method Comparison Patient urine samples were used to compare this EDDP assay on the AU640 against another commercially available screening assay.000 ** Paracetamol Limitations Setting Sheet Footnotes # † User defined ¤ Analyser default value System Calibrator Cat.000 Dextromethorphan 175.: ODC6314.000 0.000 Disopyramide 1.000 Captopril 500.000 Codeine 100.000 Morphine 100.000 Levothyroxine 500.g. technical or procedural errors). The lowest detectable level represents the lowest measurable level of EDDP that can be distinguished from zero. It is calculated as the absolute mean plus three standard deviations of 25 replicates of the Negative Kit Calibrator.000 0.000 Propoxyphene 100.000 Cimetidine 500. No.330 11-nor -∆ -THC-COOH Verapamil 500.000.000 Chlordiazepoxide 100.0 EMDP 200. Discrepant samples were investigated using a confirmatory GC/MS reference method. (e.000 9 9. (ODC6315 or ODC6316).000. 12 EN.000 Ranitidine 500. ODC6317 and ODC6318 A high methadone sample may produce a positive EDDP result during GC/MS due to conversion of methadone to EDDP.000 Salicyluric acid 500.000 0.000 Phenobarbital 100.000.000 Diazepam 100. Interfering Substances No significant interference (< 10%) was observed with the following substances: Substance Acetone Ascorbic acid Creatinine Ethanol Galactose γ-globulin Glucose Concentration ≤ 10 g/L ≤ 15 g/L ≤ 5 g/L ≤ 10 g/L ≤ 100 mg/L ≤ 5 g/L ≤ 10 g/L Substance Haemoglobin Human serum albumin Oxalic acid Riboflavin Sodium chloride Urea Concentration ≤ 3 g/L ≤ 5 g/L ≤ 1 g/L ≤ 75 mg/L ≤ 60 g/L ≤ 13 g/L Other substances and/or factors not listed may interfere with the test and cause false results. Nos.000 Secobarbital 100. Concentration Compound Tested (µg/L) Acetaminophen** 500. Sensitivity The lowest detectable level (LDL) on an AU640 was estimated at 8 µg/L.000 Structurally unrelated compounds were tested with the EDDP assay and gave a negative response when tested at the concentrations listed below.000 Nifedipine 500.000 Methamphetamine 100.000 Diphenhydramine 500.01 BLOSR6318.001 α-levo-dinoracetylmethadol 1.004 Methadone 600.000 0.: ODC6315 or ODC6316 System Calibrator Cat.000 0.000 Amphetamine 100.000 α-levo-noracetylmethadol 1. DAU BLOSR6318.BIBLIOGRAPHY 1. In: Hawks RL. Disposition of toxic drugs and chemicals in man.01 2009-08 EN. Montvale. NJ: Medical Economics Data Production Co. AHFS drug information. Basic and clinical pharmacology. 6th ed.34:339-344. Goldman FR. St. Diversion of methadone: Illicit methadone use among applicants to two metropolitan drug abuse programs. 11. 10. Katzung BG. Notice of mandatory guidelines for federal workplace drug testing program: Final guidelines.73:30-41.32:1637-1641. CEDIA™.23:615-619. 1978. CT: Appleton & Lange. Zeeuw RD. et al.01 . 12. Facts and comparisons: Loose-leaf drug information service. Segura J. Urine Testing for Drugs of Abuse. Torre RDL. 1990. 1988. Ann Clin Biochem 1997. Recommendations for the reliable detection of illicit drugs in urine in the European Union. 49th ed. Henderson DR. 5. Analytical methodology. 3.13:855862. Federal Register. Galloway FR. Hawks RL. Int J Addict. Bellet NF. 8. Cravey RH. A primer of drug action. Clin Chem. 1995. Chiang CN. Methadone conversion to EDDP during GC-MS analysis of urine samples. 1986.69 (Apr11):11983. 7. with special attention to the workplace. Chicago:Year Book Medical Publishers. 4. eds. Thistel CI. 2. Harris JD. Friedman SB.1992. NIDA Research Monograph. J Anal Toxicol. Norwalk. Physician’s desk reference. American Hospital Formularly Service. MO: Facts and Comparisons. 1999. NY: WH Freeman. 6. 9. Williams J.1989. 1995. 3rd ed. 1986. Louis. Julien RM. Baselt RC. a new homogeneous immunoassay system. 5th ed. 1988. No. vol 0 0 0 Max. # # ο ∇ 2. vol Dil.5 99999 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil. OD L -2. # # ο ∇ 7.5 2. No. # # ο ∇ 6.0 Reagent OD limit: First L -2. AU400/AU640 Qualitative Reagent ID: 318 Specific test parameters Urine ∇ Max OD H 2. Fst Fst 24 Lst Lst 660 RATE + 27 Fst. H First H Last H H Sample vol.5 ∇ # Test name EDDP Sample type URI Page 1/2 System Reagent: OSR6318 Reagent ID: 318 Application EDDP. L -2.: ODC6315 or ODC6316 DAU BSOSR6318. OD H ∇ Operation: Yes Test No ∇ 2. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # 100 Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name EDDP ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L -99999 # Conc Factor/OD-H 99999 ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 99999 # Test Name: Counts: EDDP ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. vol Dil. # # ο ∇ 4. No.5 2. L -2. None Selected 8.EDDP.: ODC6315 or ODC6316 # User defined † DAU Multi-Drug Calibrator Cat.0 Reagent OD limit Fst. ∇ ∇ ∇ Sec.0 Lst.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: 60 Specific Test Parameters General LIH ISE Urine ∇ 100 Range Page 2/2 Level L 100 Level H 100 Test Name: EDDP ∇ < > Type: Level L: Level H: Value/Flag: Flag ∇ Normal Ranges: Age L Sex Year 1. H Lst. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period Select using Space key.0 Dynamic range L -99999 Correlation factor H A B Rate 99999 1 0 ¤ NO % ∇ Pre-Dilution Rate: 1 Min OD L -2. # # ο ∇ 3.01 2009-08 . Reagent 1 vol Reagent 2 vol μL μL μL 8 87 87 Dil. AU600 Qualitative Application System Reagent: OSR6318 Specific Test Parameters General LIH ISE Range Test Name: EDDP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 8 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.5 2.5 Main ∇ ∇ ∇ 570 Sub 2. or select from list displayed by Guide key Test No ∇ Flag ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name EDDP Sample type URI ∇ 570 RATE + First 24 First Last Last 27 Wave Method Reaction Point 1 Point 2 Min. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † DAU Multi-Drug Calibrator Cat.0 Last L -2. # OD CONC † Factor/OD-L -99999 1-Point Cal. # # ο ∇ 5. 660 Onboard Stability Period Last Last 27 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A μL -99999 1 1 60 Day High B B 0 99999 0 0 Hour 61 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. # # ο ∇ 6.6 61 61 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. Volume R1(R1-1) μL ∇ μL 5. # OD CONC † Factor/OD-L -99999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal.0 High High Max. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined.5 2.EDDP.: ODC6315 or ODC6316 ф AU680 <Point Cal. No demographics 8.6 1 61 Range Operation: ∇ Yes Test Name: EDDP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 100 NO % ∇ 5.5 2. ∇ ∇ ∇ 99999 0 Sec. ∇ # # # # ο 4. # # ο ∇ 4. ∇ # # # # ο 5.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine ∇ LIH EDDP ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # EDDP ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 2. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. # # ο ∇ 2. For No. ∇ # # # # ο 2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.5 R2(R2-1) μL Name Sec.0 Last L -2. No. AU680/AU480 Qualitative Application System Reagent: OSR6318 Specific Test Parameters General LIH ISE Urine ∇ Max OD H 2.5 < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6318 Reagent ID: 318 Application Operation Yes EDDP. # # ο ∇ 7. ∇ # # # # ο 3. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE ∇ + ∇ 24 570 RATE + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.5 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour DAU BSOSR6318.0 Reagent OD limit: First L -2. ∇ # # # # ο 6. ∇ 7.0 -2. AU2700/AU5400 Qualitative Reagent ID: 318 Parameters General LIH EDDP ∇ Dilution μL -2. Not within expected values µg/L* Decimal Places Calibration Specific ISE EDDP ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ Factor Range Low High -99999 99999 ∇ # ο ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Type Urine ∇ Counts: Factor/OD-H 99999 # Process: CONC ∇ Test Name: EDDP ∇ < > Test Name: Use Serum Cal. # # ο ∇ 5. † DAU Multi-Drug Calibrator Cat. None Selected 8.01 2009-08 . No. # # ο ∇ 3. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.0 -2.OD μL Min. OD L -2.5 2. None Selected 8. H 2000 Fst Fst 24 Lst Lst First H Last H 2.01 2009-08 # User defined † DAU Negative & Multi-Drug Calibrators Cat. H Sample vol. # # # # OD CONC † † † † Factor/OD-L -2.5 Fst.EDDP.5 2. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 12 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. Nos.0 Lst.: ODC6314.5 2.0 -2. vol 0 0 0 Max.0 0 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil.0 Dynamic range L 0 Correlation factor 2000 1 0 ¤ NO % ∇ 60 Specific Test Parameters General LIH ISE Urine ∇ # Range Page 2/2 Level L # Level H # Test Name: EDDP ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. OD H ∇ Operation: Yes Test No ∇ 2.5 # Test Name: Counts: EDDP ∇ < > Type SEMI-QUANTITATIVE APPLICATION Calibration Type: 4AB ∇ Formula: EIA TYPE 1 ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.0 -2. L -2.5 660 RATE1 + 27 Max OD H 2. (ODC6315 or ODC6316). vol Dil. ODC6317 and ODC6318 BSOSR6318. Reagent 1 vol Reagent 2 vol μL μL μL 8 87 87 Dil.5 ∇ Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 2.5 2. # # ο ∇ 4. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † DAU Negative & Multi-Drug Calibrators Cat.0 Main ∇ ∇ ∇ 570 Sub -2.5 2.0 -2. ∇ ∇ ∇ Sec.0 -2.0 -2.: ODC6314. # # ο ∇ 5. L -2. # # ο ∇ 2. (ODC6315 or ODC6316). H Lst. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. No.0 1-Point Cal. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name EDDP ∇ 4AB ∇ POLYGONAL OD ∇ Conc † † † † Count Process Factor/OD-L -2. # # ο ∇ 6. AU400/AU640 Semi-quantitative Reagent ID: 318 Specific test parameters Urine ∇ 1 -2.5 2. vol Dil. # # ο ∇ 3. ODC6317 and ODC6318 DAU .5 2.0 -2. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name EDDP Sample type URI ∇ On-board stability period 570 RATE1 + First 24 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min.5 2. AU600 Semi-quantitative Application System Reagent: OSR6318 Specific Test Parameters General LIH ISE Range Test Name: EDDP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 8 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.0 # Conc Factor/OD-H 2.0 Reagent OD limit Fst. # # ο ∇ 7.5 ∇ # Test name EDDP Sample type URI Page 1/2 System Reagent: OSR6318 Reagent ID: 318 Application EDDP.0 -2. No.5 2. 6 61 61 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. † DAU Negative and Multi-Drug Calibrators Cat. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. 660 Onboard Stability Period Last Last 27 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0 1 1 60 Day μL High B B 0 2000 0 0 Hour 61 Dilution 0 Sample Volume Pre-Dilution Rate Rgt.01 2009-08 .: ODC6314.0 -2. ∇ # # # # ο 3.0 2.0 -2. SEMI-QUANTITATIVE APPLICATION Calibration Type: 4AB ∇ Formula: EIA TYPE 1 ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal. # # ο ∇ 4.5 2.0 2. AU680/AU480 Semi-quantitative Application System Reagent: OSR6318 Specific Test Parameters General LIH ISE Urine ∇ Max OD H 2.0 2. # # # # CONC † † † † Factor/OD-L -2.0 Dynamic Range: L 0 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine ∇ LIH EDDP ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # EDDP ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. No. ∇ ∇ ∇ 2000 0 Sec.5 2.0 High High Max. # # ο ∇ 6.0 Reagent OD limit: First L -2.0 Last L -2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour DAU BSOSR6318. Volume R1(R1-1) μL ∇ μL 5.EDDP. # # ο ∇ 2. AU2700/AU5400 Semi-quantitative Reagent ID: 318 Parameters General LIH EDDP ∇ Dilution μL -2. ∇ # # # # ο 4. ∇ # # # # ο 5. ODC6317 and ODC6318 ф AU680 <Point Cal. # # ο ∇ 5.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.0 Factor/OD-H 2.5 + ∇ 1-Point Cal.5 -2.5 2.5 ∇ OD Range Low High -2. # # ο ∇ 3. No demographics 8. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.0 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE1 ∇ + ∇ 24 570 RATE1 + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2. Nos.5 2.5 R2(R2-1) μL Name Sec.5 2.0 -2. ∇ # # # # ο 2. Not within expected values µg/L Decimal Places Calibration Specific ISE EDDP ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > EIA TYPE 1 Type Urine Counts: ∇ # ο ∇ Calibration Specific General ISE Type Urine ∇ Counts: # Process: CONC ∇ Test Name: EDDP ∇ < > Test Name: Use Serum Cal.5 2.0 -2.OD μL Min.6 1 61 Range Operation: ∇ Yes Test Name: EDDP ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 100 NO % ∇ 5. ∇ 7.5 -2. None Selected 8. ODC6316). (ODC6315. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 4AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. For No. # # ο ∇ 7.5 < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6318 Reagent ID: 318 Application Operation Yes EDDP.5 2.5 -2. ∇ # # # # ο 6.0 -2. Do not mix components from different lots. Detach the R1 lyo bottle and adapter from the R1 buffer bottle and discard. buffer salts.Methadone OSR6319 2 x 16 mL 2x 2 x 16 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the qualitative and semi-quantitative assay of methadone in human urine on Beckman Coulter analysers. and preservative. Wear suitable protective clothing. NOTE 4: To ensure reconstituted R1 stability.. Detach the R2 lyo bottle and adapter from the R2 buffer bottle and discard. R22. Prepare the R2 solution before the R1 solution to minimise possible contamination. resulting in its cumulative effects and slow elimination. up to the stated expiry date when stored at 2. and no active enzyme will be formed. R2 (Enzyme donor solution): Connect the R2 lyo bottle to the R2 buffer bottle using one of the enclosed adapters. S60. EN.N-bis [2-ethanesulfonic acid] buffer. stabiliser. To avoid the possible build-up of azide compounds. generating a colour change that can be measured spectrophotometrically. Mix again. stabiliser and preservative. flush waste-pipes with water after the disposal of undiluted reagent. continuous exposure to bright light.. In the assay. Contains sodium azide. If drug is present in the sample. leaving the inactive enzyme fragments free to form active enzyme. and preservative. Reagent Composition R1 Buffer R1 Lyo R2 Buffer R2 Lyo Piperazine-N. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes before use. 2. Mix by gentle inversion. Cap the R1 buffer bottle and let stand approximately for 5 minutes at 15…25°C. buffer salts and preservative. Dispose of all waste material in accordance with local guidelines.01 2009-08 DAU . Ensure the reagent is homogeneous before use NOTE 1: The components supplied in this kit are intended for use as an integral unit. Refer to Safety Data Sheets for further information. It has a high binding 2 affinity for tissue protein. Mix again. NOTE 5: Do not freeze reconstituted reagents. These fragments spontaneously reassociate to form fully active enzyme that. inhibiting the reassociation of inactive β-galactosidase fragments. NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the appropriate reagent bottle. If drug is not present in the sample. Ensure the reagent is homogeneous before use. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. Mix by gentle inversion. 3. 3-5. NOTE 3: The R1 and R2 solutions must be at the reagent compartment temperature of the analyser before performing the assay. particularly when using a preliminary positive result. 1. 7 The pharmacological activity of methadone is very similar to that of morphine but differs in that it gives reliable effects when administered orally. For in vitro diagnostic use only. 7 overall abuse potential is comparable to that of morphine. reagents stored on board the instrument are stable for 60 days.01 BLOSR6319. 7 Methadone is well absorbed from the gastrointestinal tract and can be detected in plasma within 30 minutes after oral ingestion. Once reconstituted.N-bis [2-ethanesulfonic acid] buffer. The assay provides only a preliminary analytical test result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. unopened. in the assay format. cleaves a substrate. A more specific alternative chemical method must be used to obtain a confirmed 1 analytical result. ensuring that all the lyophilised material from the R2 lyo bottle is transferred into the R2 buffer bottle. Clinical consideration and professional judgement should be applied to any drug of abuse test result.171 g/L enzyme acceptor. Piperazine-N. Reagent Preparation Prepare the following solutions using cold reagents and buffers. protect from prolonged. 0.8 mg/L mouse monoclonal antibodies reactive to methadone. This material and its container must be disposed of as hazardous waste. Avoid the formation of foam. 0. Safety Phrases: S36. detergent. buffer salts. Harmful if swallowed. It is used as an 2-7 oral substitute for heroin or other morphine-like drugs to suppress withdrawal symptoms and/or to temporarily maintain chronic relapsing heroin addicts. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. Its 4. it binds to antibody. Avoid the formation of foam. A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded. The amount of active enzyme formed and resultant absorbance change are proportional to the amount of drug present in the sample. drug in the sample competes with drug conjugated to one inactive fragment of β-galactosidase for antibody binding site. Summary Methadone is a synthetic diphenylheptane-derivative opiate agonist which was first synthesised by German chemists during World War ll.67 g/L chlorophenol red-β-D-galactopyranoside. 3 Test Principle8 This assay is based on the bacterial enzyme β-galactosidase. The R2 working solution (enzyme donor) should be yellow-orange in colour. 2. R1 (Enzyme acceptor solution): Connect the R1 lyo bottle to the R1 buffer bottle using one of the enclosed adapters. Storage and Stability The reagents are stable.8°C. ensuring that all the lyophilised material from the R1 lyo bottle is transferred into the R1 buffer bottle.0154 mg/L enzyme donor conjugated to methadone derivative. Cap the R2 buffer bottle and let stand approximately for 5 minutes at 15…25°C. Remove the kit from refrigerated storage (2…8°C) immediately prior to preparation of the solutions. antibody binds to drug conjugated on the inactive fragment. Record the reconstitution date on the bottle label. Record the reconstitution date on the bottle label. which has been genetically engineered into two inactive fragments. 5 7. Following calibration. If any trends or sudden shifts in values are detected.0 1.9 1.0 4. Semi-quantitative results Relative concentrations of methadone can be established by calibrating the assay with the DAU Negative Calibrator. No. is used as a reference in distinguishing between positive and negative samples.3 3. Values obtained for the controls should fall within specified limits. Six replicates of each sample were analysed twice daily over 5 days.2 2. one 25% above the cut-off.7 1. Calibration Curve. Samples producing a response value less than the response value of the calibrator are considered negative. Data obtained in your laboratory may differ from these values.01 .4 Total SD 5. ODC0006. Quality Control Each laboratory should establish its own control frequency. Data contained within this section is representative of performance on Beckman Coulter systems. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. containing 300 µg/L methadone. Expected Values Specific Performance Characteristics Results should always be negative with respect to the cut-off i. Obtain another sample for testing if adulteration of the sample is suspected. GC/MS is generally accepted as a rigorous confirmation technique for all drugs since it provides the best level of 1 confidence in the result. Adulteration of urine samples can affect the test results.4 Total SD 5.9 %CV 2.3 8.3 1.6 7. ODC6314 ODC6319 ODC6320 ODC6321 Methadone (ng/mL = µg/L) 0 300 600 1000 The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard. Treat human urine as potentially infectious material. on the Beckman Coulter analyser. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. Confirm a positive result by a more specific method based on an alternative chemical principle.2 4. It is recommended that two levels of controls be run. Methadone Qualitative Assay n=60 µg/L Mean.3 BLOSR6319.0 1. Quality control material DAU Multi-drug Control. Calculation Qualitative results The DAU Methadone Cut-off Calibrator.3 2. 300 µg/L with the exception of subjects on methadone treatment programs where positive results are anticipated. Chain of custody recommendations should 10 be applied if applicable. mA/min 225 307 300 371 375 441 Methadone Semi-quantitative Assay n=60 µg/L Mean. DAU Methadone Cut-off Calibrator.4 1.Specimen Urine: Collect urine samples in clean glass or plastic containers. Major preventative maintenance was performed on the analyser or a critical part was replaced. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.2 5. Good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. The Beckman Coulter system automatically flags each positive sample with the letter P and each negative sample with the letter N. Samples producing a response value equal to or greater than the response value of the calibrator are considered positive.9 Within run SD %CV 3.8 2. DAU Methadone Intermediate Calibrator and the DAU Methadone High Calibrator. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. ODC6319 Methadone (ng/mL = µg/L) 300 Semi-quantitative evaluation For semi-quantitative analysis of samples.1 0. 9 Samples can be stored at 15…25°C for a maximum of 7 days after which storage at 2…8°C is recommended. Precision The following data was obtained on an AU640 using the DAU Methadone Cut-off Calibrator and two levels of controls corresponding to ± 25% of the cutoff.01 2009-08 %CV 1. review all operating parameters. use the following calibrators: Calibrator Name DAU Negative Calibrator DAU Methadone Cut-off Calibrator DAU Methadone Intermediate Calibrator DAU Methadone High Calibrator Cat. for acceptability using the software options Routine. Calibration Qualitative evaluation For qualitative analysis of samples use the following Cut-off calibrator: Calibrator Name DAU Methadone Cut-off Calibrator Cat.e. Centrifuge specimens with high turbidity before testing. Care should be taken when interpreting concentration results since there are many other factors that may influence a urine test result such as fluid intake and other biological factors. No. the resulting curve should be visually reviewed.0 10. The setting sheet contains separate applications for semi-quantitative and qualitative assays. Calibration Monitor. µg/L 225 240 300 313 375 398 DAU 11 Within run SD %CV 2. the other 25% below the cut-off. While confirmation techniques other than GC/MS may be adequate for some drugs of abuse.6 EN. 000 500.000 500. Interference No interference was observed from the following substances added to the normal endogenous concentrations found in urine when tested with the Methadone assay. Results were as follows: 300 µg/L cut-off Qualitative Assay + Comparative Screening Method + 62 0 0 71 Comparative Screening Method + 300 µg/L cut-off Semi-quantitative Assay + 62 0 0 71 Sensitivity The lowest detectable level on an AU640 analyser was calculated as 20.65 0. ODC6320 and ODC6321 EN.000 500. Specificity The following parent compounds and metabolites when tested with the DAU Methadone assay.000 25. ODC6319. Nos.000 500.000 % Cross Reactivity 2.03 0.000 100.000 500.: ODC6319 System Calibrator Cat.000 100. yielded the following percent cross-reactivity results: Compound Alpha-Methadol EDDP EMDP LAAM Methadol Methadone Morphine-3-Glucuronide Norpropoxyphenen Propoxyphene Compound Acetaminophen** Acetylsalicylic acid Amoxicillin Amphetamine Benzoylecgonine Captopril Chlordiazepoxide Cimetidine Codeine Diazepam Digoxin Enalapril Fluoxetine Ibuprofen Levothyroxine Methamphetamine Morphine Nifedipine Phencyclidine Phenobarbital Ranitidine Salicyluric acid Secobarbital Tolmetin 9 11-nor-∆ -THC-COOH Verapamil ** Paracetamol Concentration Tested (µg/L) 33.000 Structurally unrelated compounds were tested with the Methadone assay and gave a negative response when tested at the concentrations listed below.000 500.03 Concentration (µg/L) 500.000 500. Substance Acetone Ascorbic acid Creatinine Ethanol Galactose γ-globulin Glucose Concentration ≤ 10 g/L ≤ 15 g/L ≤ 5 g/L ≤ 10 g/L ≤ 100 mg/L ≤ 5 g/L ≤ 30 g/L Substance Haemoglobin Human serum albumin Oxalic acid Riboflavin Sodium chloride Urea Concentration ≤ 3 g/L ≤ 5 g/L ≤ 1 g/L ≤ 75 mg/L ≤ 60 g/L ≤ 20 g/L Other substances and/or factors not listed may interfere with the test and cause false results (e.000 500.000 500.50 100 0.000 100.333 500.01 BLOSR6319.000 500.7 µg/L.000 500.000 300 100. It is calculated as the absolute mean plus three standard deviations of 25 replicates of the Negative Kit Calibrator. No.000 500.000 10.01 0.000 50.000 500.000 500.48 1.03 1. technical or procedural errors).000 500.000 500.: ODC6314.Method Comparison Patient urine samples were used to compare this Methadone OSR6319 assay on the AU640 against another commercially available screening assay.000 500.02 0.000 500.000 500.000 500.000 500. Setting Sheet Footnotes # † User defined ¤ Analyser default value System Calibrator Cat.000 20.01 2009-08 DAU .000 100.000 100. The lowest detectable level (LDL) represents the lowest measurable level of methadone that can be distinguished from zero.g. eds. Julien RM. 1986. St.34:339-344.01 2009-08 EN. Henderson DR. 1988. 1986. Goodman and Gilman’s the Pharmacological Basis of Therapeutics. Clin Chem. American Hospital Formulary Service. Analytical methodology. 1992.0. Torre RDL. 1991. 9. 5. 8th ed. Ann Clin Biochem 1997. Facts and comparisons: Loose-leaf drug information service. Williams J.01 . Segura J. NY: WH Freeman. 49th ed. 5th ed. In: Hawks RL. United Kingdom laboratory guidelines for legally defensible workplace drug testing: Urine Drug Testing. Federal Register. 8. AHFS drug information. 1990. 11. 32:1637-1641. 1988. with special attention to the workplace. A Primer of Drug Action. 7. DAU BLOSR6319. 4. CT: Appleton & Lange. Louis.1995.38pp. Harris JD. Ver 1. Montvale. Urine Testing for Drugs of Abuse. 6. Hawks RL. Friedman SB. 2. Recommendations for the reliable detection of illicit drugs in urine in the European Union. a new homogeneous immunoassay system. New York. Katzung BG. Zeeuw RD. 2001.73:30-41. Basic and Clinical Pharmacology. Chiang CN. 3. Norwalk. CEDIA™. et al. NJ: Medical Economics Data Production Co. New York. 6th ed. 69(Apr 11):11983. MO: Facts and comparisons. Notice of mandatory guidelines for federal workplace drug testing program: Final guidelines. NIDA Research Monograph.BIBLIOGRAPHY 1. 10. NY: Pergamon Press. Physician’s Desk Reference. 1995. : ODC6319 DAU BSOSR6319. AU400/AU640 Qualitative Reagent ID: 319 Specific test parameters Urine ∇ Max OD H 2. None Selected 8.5 Main ∇ ∇ ∇ 570 Sub 2.0 Reagent OD limit: First L -2.5 ∇ # Test name MTD Sample type URI Page 1/2 System Reagent: OSR6319 Reagent ID: 319 Application METHADONE. OD L -2. vol Dil. No.5 2. vol Dil. ∇ ∇ ∇ Sec.0 Last L -2.0 Reagent OD limit Fst. # OD CONC † Factor/OD-L -99999 1-Point Cal. # # ο ∇ 3. H Lst. vol 0 0 0 Max.01 2009-08 . # # ο ∇ 2.5 2.METHADONE. No.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: 60 Specific Test Parameters General LIH ISE Urine ∇ 300 Range Page 2/2 Level L 300 Level H 300 Test Name: MTD ∇ < > Type: Level L: Level H: Value/Flag: Flag ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 4. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † DAU Methadone Calibrator Cat. Reagent 1 vol Reagent 2 vol μL μL μL 4 87 87 Dil.0 Lst. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # 300 Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name MTD ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L -99999 # Conc Factor/OD-H 99999 ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 99999 # Test Name: Counts: MTD ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration # ∇ Cal. L -2. # # ο ∇ 5. or select from list displayed by Guide key Test No ∇ Flag ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name MTD Sample type URI ∇ 570 RATE + First 24 First Last Last 27 Wave Method Reaction Point 1 Point 2 Min. AU600 Qualitative Application System Reagent: OSR6319 Specific Test Parameters General LIH ISE Range Test Name: MTD ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 4 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. No. H First H Last H H Sample vol. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period Select using Space key.5 2.5 99999 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil. OD H ∇ Operation: Yes Test No ∇ 2. L -2. Fst Fst 24 Lst Lst 660 RATE + 27 Fst.0 Dynamic range L -99999 Correlation factor H A B Rate 99999 1 0 ¤ NO % ∇ Pre-Dilution Rate: 1 Min OD L -2. # # ο ∇ 7. # # ο ∇ 6.: ODC6319 # User defined † DAU Methadone Calibrator Cat. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. † DAU Methadone Calibrator Cat.5 R2(R2-1) μL Name Sec.OD μL Min. ∇ 7. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE ∇ + ∇ 24 570 RATE + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2. ∇ # # # # ο 5. No. # # ο ∇ 4. AU680/AU480 Qualitative Application System Reagent: OSR6319 Specific Test Parameters General LIH ISE Urine ∇ Max OD H 2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. For No.0 Reagent OD limit: First L -2. Not within expected values µg/L Decimal Places Calibration Specific ISE MTD ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ Factor Range Low High -99999 99999 ∇ # ο ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Type Urine ∇ Counts: Factor/OD-H 99999 # Process: CONC ∇ Test Name: MTD ∇ < > Test Name: Use Serum Cal. ∇ # # # # ο 2.5 2. ∇ # # # # ο 3. # # ο ∇ 2.0 -2. ∇ # # # # ο 4. Volume R1(R1-1) μL ∇ μL 2.8 61 61 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.METHADONE.0 -2. None Selected 8.0 Last L -2.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine ∇ LIH MTD ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # MTD ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. ∇ # # # # ο 6.5 2.8 1 61 Range Operation: ∇ Yes Test Name: MTD ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 100 NO % ∇ 2.0 High High Max. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. # # ο ∇ 5. # # ο ∇ 7. No. ∇ ∇ ∇ 99999 0 Sec. # # ο ∇ 6.5 2. 660 Onboard Stability Period Last Last 27 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A μL -99999 1 1 60 Day High B B 0 99999 0 0 Hour 61 Dilution 0 Sample Volume Pre-Dilution Rate Rgt.: ODC6319 ф AU680 <Point Cal.5 < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6319 Reagent ID: 319 Application Operation Yes METHADONE. AU2700/AU5400 Qualitative Reagent ID: 319 Parameters General LIH MTD ∇ Dilution μL -2. # OD CONC † Factor/OD-L -99999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal. No demographics 8. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.5 2. # # ο ∇ 3. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour DAU BSOSR6319.01 2009-08 . 0 Dynamic range L 0 Correlation factor 1000 1 0 ¤ NO % ∇ 60 Specific Test Parameters General LIH ISE Urine ∇ # Range Page 2/2 Level L # Level H # Test Name: MTD ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.METHADONE. vol Dil. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name MTD ∇ 4AB ∇ POLYGONAL OD ∇ Conc † † † † Count Process Factor/OD-L -2. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † DAU Negative & Multi-Drug Calibrator Cat. Nos. ODC6319. # # ο ∇ 3. L -2. Nos.: ODC6314.5 2.5 2. # # ο ∇ 6. Reagent 1 vol Reagent 2 vol μL μL μL 4 87 87 Dil.0 Reagent OD limit Fst.01 2009-08 .0 -2.0 -2.0 -2.0 0 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil.5 2.5 2. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name MTD Sample type URI ∇ On-board stability period 570 RATE1 + First 24 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. vol Dil.5 2. H Sample vol.5 # Test Name: Counts: MTD ∇ < > Type SEMI-QUANTITATIVE APPLICATION Calibration Type: 4AB ∇ Formula: EIA TYPE 1 ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. H 1000 Fst Fst 24 Lst Lst First H Last H 2.0 -2.0 Lst.5 Fst. # # ο ∇ 5.0 Main ∇ ∇ ∇ 570 Sub -2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key. L -2. OD H ∇ Operation: Yes Test No ∇ 2. H Lst.0 -2.5 2. ∇ ∇ ∇ Sec. # # ο ∇ 4.5 2. OD L -2. None Selected 8. ODC6320 and ODC6321 # User defined † DAU Negative & Multi-Drug CalibratorsCat.0 -2.5 2. AU600 Semi-quantitative Application System Reagent: OSR6319 Specific Test Parameters General LIH ISE Range Test Name: MTD ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 4 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.: ODC6314.5 ∇ Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 2. # # ο ∇ 2.0 1-Point Cal. vol 0 0 0 Max.5 660 RATE1 + 27 Max OD H 2. # # # # OD CONC † † † † Factor/OD-L -2. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 12 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. AU400/AU640 Semi-quantitative Reagent ID: 319 Specific test parameters Urine ∇ 1 -2. ODC6320 and ODC6321 DAU BSOSR6319. ODC6319.0 # Conc Factor/OD-H 2.5 2. # # ο ∇ 7.0 -2. No.5 ∇ # Test name MTD Sample type URI Page 1/2 System Reagent: OSR6319 Application METHADONE. ∇ # # # # ο 4. SEMI-QUANTITATIVE APPLICATION Calibration Type: 4AB ∇ Formula: EIA TYPE 1 ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration # Cal.5 2.0 2.8 1 61 Range Operation: ∇ Yes Test Name: MTD ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 100 NO % ∇ 2. None Selected 8. ODC6319.0 Dynamic Range: L 0 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine ∇ LIH MTD ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # MTD ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.0 Factor/OD-H 2. Volume R1(R1-1) μL ∇ μL 2. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 4AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. † DAU Negative & Multi-Drug Calibrator Cat.0 -2. AU680/AU480 Semi-quantitative Application System Reagent: OSR6319 Specific Test Parameters General LIH ISE Urine ∇ Max OD H 2.5 2.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2. ∇ # # # # ο 6. # # ο ∇ 4.0 -2. # # ο ∇ 3.8 61 61 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. ∇ 7. # # ο ∇ 5. # # ο ∇ 2.01 2009-08 .0 Reagent OD limit: First L -2. ODC6320 and ODC6321 ф AU680 <Point Cal. # # ο ∇ 6.0 High High Max. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour DAU BSOSR6319.5 2.5 -2. ∇ # # # # ο 5. AU2700/AU5400 Semi-quantitative Reagent ID: 319 Parameters General LIH MTD ∇ Dilution μL -2.5 -2. Not within expected values µg/L Decimal Places Calibration Specific ISE MTD ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > EIA TYPE 1 Type Urine Counts: ∇ # ο ∇ Calibration Specific General ISE Type Urine ∇ Counts: # Process: CONC ∇ Test Name: MTD ∇ < > Test Name: Use Serum Cal.5 R2(R2-1) μL Name Sec.0 -2.0 2. ∇ # # # # ο 2. # # ο ∇ 7. For No.0 2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.5 + ∇ 1-Point Cal.5 2. 660 Onboard Stability Period Last Last 27 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0 1 1 60 Day μL High B B 0 1000 0 0 Hour 61 Dilution 0 Sample Volume Pre-Dilution Rate Rgt.5 < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6319 Reagent ID: 319 Application Operation Yes METHADONE. ∇ # # # # ο 3. No. Nos.5 2.5 2.: ODC6314. # # # # CONC † † † † Factor/OD-L -2. ∇ ∇ ∇ 1000 0 Sec.OD μL Min.5 ∇ OD Range Low High -2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt. No demographics 8.METHADONE.5 -2.0 2.0 -2.0 Last L -2.0 -2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE1 ∇ + ∇ 24 570 RATE1 + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.5 2. inhibiting the reassociation of inactive β-galactosidase fragments. 2. 2. Safety Phrases: S36. Prepare the R2 solution before the R1 solution to minimise possible contamination. however. leaving the inactive enzyme fragments free to form active enzyme. Avoid the formation of foam. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Mix by gentle inversion.5 Both have widely accepted medical uses. R1 (Enzyme acceptor solution): Connect the R1 Lyo bottle to the R1 Buffer bottle using one of the enclosed adapters. Morphine and codeine are naturally occurring alkaloids of opium. protect from prolonged. To avoid the possible build-up of azide compounds. Refer to Safety Data Sheets for further information. unopened. the main site of metabolism being the liver.3 2. NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the appropriate reagent bottle. Dispose of all waste material in accordance with local guidelines. Once reconstituted. Do not mix components from different lots. it binds to antibody. Reagent Composition R1 Buffer R1 Lyo R2 Buffer R2 Lyo Citrate buffer.. This material and its container must be disposed of as hazardous waste. Detach the R1 Lyo bottle and adapter from the R1 Buffer bottle and discard. Wear suitable protective clothing.67 g/L chlorophenol red-β-D-galactopyranoside. 1. buffer salts. Detach the R2 Lyo bottle and adapter from the R2 Buffer bottle and discard. and preservative. both drugs are sometimes abused. ensuring that all the lyophilised material from the R1 Lyo bottle is transferred into the R1 Buffer bottle. 23. Reagent Preparation Prepare the following solutions using cold reagents and buffers. and preservative. Contains sodium azide.Opiates OSR6320 2 x 16 mL 2x 2 x 16 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the qualitative and semi-quantitative assay of opiates in human urine on Beckman Coulter analysers. Record the reconstitution date on the bottle label. The amount of active enzyme formed and resultant absorbance change are proportional to the amount of drug present in the sample. Ensure the reagent is homogeneous before use NOTE 1: The components supplied in this kit are intended for use as an integral unit.01 2009-08 DAU . Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. R22 Harmful if swallowed. Remove the kit from refrigerated storage (2…8°C) immediately prior to preparation of the solutions. NOTE 3: The R1 and R2 solutions must be at the reagent compartment temperature of the analyser before performing the assay.8°C. which has been genetically engineered into two inactive fragments. 7 Opiates (morphine.3 µg/L enzyme donor conjugated to morphine. S60. and preservative. Clinical consideration and professional judgement should be applied to any drug of abuse test result. and no active enzyme will be formed. up to the stated expiry date when stored at 2. These fragments spontaneously reassociate to form fully active enzyme that. Cap the R1 Buffer bottle and let stand for approximately 5 minutes at 15…25°C. 0.01 BLOSR6320. antibody binds to drug conjugated on the inactive fragment. For in vitro diagnostic use only. codeine and heroin) are rapidly metabolised by the body. buffer salts. stabiliser. Mix again. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minute.171 g/L enzyme acceptor. EN.4 Test Principle8 This assay is based on the bacterial enzyme β-galactosidase. 3 mg/L monoclonal antibodies reactive to opiates. R2 (Enzyme donor solution): Connect the R2 Lyo bottle to the R2 Buffer bottle using one of the enclosed adapters. Ensure the reagent is homogeneous before use. in the assay format. The R2 working solution (Enzyme Donor) should be yellow-orange in colour.. Mix again. A more specific alternative chemical method must be used to obtain a confirmed 1 analytical result. A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded. NOTE 4: To ensure reconstituted R1 stability. Phosphate buffer. 4. stabiliser. Record the reconstitution date on the bottle label. Avoid the formation of foam. drug in the sample competes with drug conjugated to one inactive fragment of β-galactosidase for antibody binding site. principally as analgesics. NOTE 5: Do not freeze reconstituted reagents. ensuring that all the lyophilised material from the R2 Lyo bottle is transferred into the R2 Buffer bottle. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. detergent. If drug is not present in the sample. Summary Opium is obtained from the unripe pods of the opium poppy Papaver somniferum. continuous exposure to bright light. cleaves a substrate. generating a colour change that can be measured spectrophotometrically. buffer salts and preservative. In the assay. Heroin is a compound synthesised from 6 morphine and is the most commonly abused opiate. The assay provides only a preliminary analytical test result. particularly when using a preliminary positive result. If drug is present in the sample. Mix by gentle inversion. reagents stored on board the instrument are stable for 60 days. flush waste-pipes with water after the disposal of undiluted reagent. Cap the R2 Buffer bottle and let stand approximately for 5 minutes at 15…25°C. Storage and Stability The reagents are stable. Treat human urine as potentially infectious material.9 EN. No.8 0.6 2. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. Data obtained in your laboratory may differ from these values. The setting sheet contains separate applications for semi-quantitative and qualitative assays.2 DAU Total SD 9.8 6. mA/min SD %CV SD %CV 225 279 1.5 3. ODC6314 ODC6316 ODC6317 ODC6318 Morphine (ng/mL = µg/L) 0 300 800 2000 The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. It is recommended that two levels of controls be run. on the Beckman Coulter analyser. Six replicates of each sample were analysed twice daily over 5 days.7 Opiates Semi-quantitative Assay n=60 Within run µg/L Mean.7 14.8 5.9 4. review all operating parameters. 9 Samples can be stored at 15…25°C for a maximum of 7 days after which storage at 2…8°C is recommended.7 375 368 2. While confirmation techniques other than GC/MS may be adequate for some drugs of abuse. Quality Control Material DAU Speciality Control.7 3.4 300 283 5. Calculation Qualitative results The DAU Secondary Cut-off Multi-drug Calibrator is used as a reference in distinguishing between positive and negative samples. DAU Intermediate Multi-drug Calibrator. Values obtained for the controls should fall within specified limits.0 1. 300 µg/L. Chain of custody recommendations should 10 be applied if applicable. Semi-quantitative results Relative concentrations of opiates can be established by calibrating the assay with the DAU Negative Calibrator. The Beckman Coulter system automatically flags each positive sample with the letter P and each negative sample with the letter N. DAU Secondary Cut-off Multi-drug Calibrator. Care should be taken when interpreting concentration results since there are many other factors that may influence a urine test result such as fluid intake and other biological factors.7 1.01 . the other 25% below the cut-off. Adulteration of urine samples can affect the test results.01 2009-08 %CV 4. Quality Control Each laboratory should establish its own control frequency. Obtain another sample for testing if adulteration of the sample is suspected.3 1. No. Confirm a positive result by a more specific method based on an alternative chemical principle. the resulting curve should be visually reviewed. ODC0007. Calibration Qualitative evaluation For qualitative analysis of samples use either of the following Cut-off calibrators: Calibrator Name DAU Secondary Cut-off Multi-drug Calibrator Cat. and the DAU High Multi-drug Calibrator. Major preventative maintenance was performed on the analyser or a critical part was replaced.e.2 BLOSR6320. Expected Values Specific Performance Characteristics Results should always be negative with respect to the cut-off i.9 2. µg/L SD %CV 225 194 4. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. use the following calibrators: Calibrator Name DAU Negative Calibrator DAU Secondary Cut-off Multi-drug Calibrator DAU Intermediate Multi-drug Calibrator DAU High Multi-drug Calibrator Cat. GC/MS is generally accepted as a rigorous confirmation technique for all drugs since it provides the best level of 1 confidence in the result. 10 Data contained within this section is representative of performance on Beckman Coulter systems.5 1. Following calibration. one 25% above the cut-off. Calibration Curve. Good laboratory practice suggests that controls be run each day patient samples are measured and each time calibration is performed. ODC6316 Morphine (ng/mL = µg/L) 300 Semi-quantitative evaluation For semi-quantitative analysis of samples.9 0. Samples producing a response value equal to or greater than the response value of the calibrator are considered positive. Samples producing a response value less than the response value of the calibrator are considered negative. Precision The following data was obtained on an AU640 using the DAU Secondary Multi-drug Calibrator and two levels of controls corresponding to ± 25% of the cut-off.9 375 364 7. Calibration Monitor. Opiates Qualitative Assay n=60 Within run Total µg/L Mean. If any trends or sudden shifts in values are detected.5 12.2 300 326 2.Specimen Urine: Collect urine samples in clean glass or plastic containers.6 0. Centrifuge specimens with high turbidity before testing. for acceptability using the software options Routine. Compound Acetaminophen** Acetylsalicylic acid Amoxicillin Amphetamine Benzoylecgonine Captopril Chlordiazepoxide Cimetidine Diazepam Digoxin Enalapril Fluoxetine Ibuprofen Levothyroxine Methadone Methamphetamine Nifedipine Phencyclidine Phenobarbital Propoxyphene Ranitidine Salicyluric acid Secobarbital 9 11-nor -∆ -THC-COOH Verapamil ** Paracetamol Concentration (µg/L) 500.000 100.6 Morphine-3-glucuronide 300 81 Morphine-6-glucuronide 300 47 6-Monoacetylmorphine 300 81 Merperidine 150.000 500.000 500.000 500.000 50.000 3..000 500.000 1.000 EN.000 500.000 500.000 100.000 500.000 100.01 2009-08 DAU .000 500.000 500.000 100. Results were as follows: 300 µg/L cut-off Qualitative Assay + Comparative Screening Method + 72 0 Comparative Screening Method + 300 µg/L cut-off Semi-quantitative Assay + 72 0 - 0 60 - 0 60 Sensitivity The lowest detectable level (LDL) represents the lowest measurable level of opiate that can be distinguished from zero.2 Oxymorphone 20.000 500. technical or procedural errors). It is calculated as the absolute mean plus three standard deviations of 25 replicates of the Negative Kit Calibrator.000 500. Specificity The following parent compounds and metabolites when tested with the Opiates assay yielded the following percent cross-reactivity results: Concentration % Cross Compound Tested (µg/L) Reactivity Morphine 300 100 Codeine 300 125 Diacetylmorphine 300 53 Dihydrocodeine 300 50 Hydrocodone 300 48 Hydromorphone 300 57 Imipramine 20.000 500.000 100.g.000 500.9 Oxycodone 10.000 500.000 500.Method Comparison Urine samples were assayed with Opiates assay on an Beckman Coulter analyser using another commercially available method for Opiates as a reference.1 High concentrations of rifampicin or floxin may cause a false positive result.000 500. Cut-off 300 µg/L LDL µg/L on AU640 18 Interfering Substances No interference was observed from the following substances added to the normal endogenous concentrations found in urine when tested with the Opiates assay (< 10% of baseline): Substance Acetone Ascorbic acid Creatinine Ethanol Galactose γ-globulin Glucose Concentration ≤ 10 g/L ≤ 15 g/L ≤ 5 g/L ≤ 10 g/L ≤ 100 mg/L ≤ 5 g/L ≤ 30 g/L Substance Haemoglobin Human serum albumin Oxalic acid Riboflavin Sodium chloride Urea Concentration ≤ 3 g/L ≤ 5 g/L ≤ 1 g/L ≤ 75 mg/L ≤ 60 g/L ≤ 60 g/L Other substances and/or factors not listed may interfere with the test and cause false results (e.000 1.000 500.000 0.01 BLOSR6320.000 10. Structurally unrelated compounds were tested with the Opiates assay and gave a negative response when tested at the concentrations listed below. Metabolism and excretion rate of morphine in humans after morphine administration. 1991. Hasselström J. Urine Testing for Drugs of Abuse. Krasell WG. Clin Chem. et al. Henderson DR.34:339-344. 1995. Detection of 6-acetylmorphine in urine as an indicator of recent heroin exposure. I.01 . 5. Zeeuw RD. 13: 1-23. Federal Register. Foster City. Excretion of codeine and morphine following ingestion of poppy seeds. DAU BLOSR6320. 69(Apr 11):11983. J Anal Toxicol. ODC6316. Welch P. Walsh TD. In: Hawks RL. Mitchell JM. 15-17. Opium and its derivations. Calif: Chemical Toxicology Institute. Struempler RE. In view of the cross-reactivity profile of the Opiates assay. Clin Pharmacokinet. and ingestion of products containing poppy seeds can cause a positive test result. a new homogeneous immunoassay system. 1987. Morphine pharmacokinetics and metabolisim in humans: Enterophepatic cycling and relative contribution of metabolitics to active opioid concentrations. Clin Ther. Ther Drug Monit. Forensic drug testing for opiates.24:344-354. 4th ed. 1993. eds.Limitations Poppy seeds can contain opiates. 7. Cravey RH. Ann Clin Biochem 1997. 15:49-53. ODC6317 and ODC6318 Bibliography Hawks RL. 9. Clin Chem 1986. Torre RDL. Glare PA. Clinical pharmacokinetics of morphine. Recommendations for the reliable detection of illicit drugs in urine in the European Union. with special attention to the workplace. 1. Paul BD. Säwe J. 2. drug and assay considerations and detection times. ll. (4:B46-B4B) Basell RC. Analytical methodology. Mitchell JM. Concentrations of morphine and codeine in serum and urine ingestion of poppy seeds.1197-99. 73: 30-41. 11. Hayes LW. 1988. Balant LP. Paul BD. 4. 1991. Cone EJ. 32:1634-1641. 11. Disposition of Toxic Drugs and Chemicals in Man. semi-quantitative results may not correlate with the levels of individual drugs/metabolites in the sample. 33:806-808.: ODC6314. Segura J. 1987. J Anal Toxicol. 3. 6.01 2009-08 EN. Balant-Gorgia AE. 8. 10. Nos. Welch P. Mueggler PA. Friedman SB. CEDIA™. No. Harris JD. 12. Williams J. J Anal Toxicol. 1991. Notice of mandatory guidelines for federal workplace drug testing program: Final guidelines. Chiang CN. NIDA Research Monograph 1986. 1992. Cone EJ.: ODC6316 Calibrator Cat. Forensic drug testing for opiates.12 Setting Sheet Footnotes # † User defined ¤ Analyser default value Calibrator Cat. 5 ∇ # Test name OPI Sample type URI Page 1/2 System Reagent: OSR6320 Reagent ID: 320 Application OPIATES.5 2. # OD CONC † Factor/OD-L -99999 1-Point Cal. # # ο ∇ 7.0 Lst. No. No. vol 0 0 0 Max. vol Dil.5 99999 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil. vol Dil.0 Reagent OD limit: First L -2. AU600 Qualitative Application System Reagent: OSR6320 Specific Test Parameters General LIH ISE Range Test Name: OPI ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. # # ο ∇ 6.0 Reagent OD limit Fst. OD H ∇ Operation: Yes Test No ∇ 2. ∇ ∇ ∇ Sec. # # ο ∇ 2.01 2009-08 . None Selected 8.5 2.: ODC6316 DAU BSOSR6320.0 Dynamic range L -99999 Correlation factor H A B Rate 99999 1 0 ¤ NO % ∇ Pre-Dilution Rate: 1 Min OD L -2. # # ο ∇ 3.: ODC6316 # User defined † DAU Multi-Drug Calibrator Cat. Reagent 1 vol Reagent 2 vol μL μL μL 2 87 87 Dil. L -2. No.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: 60 Specific Test Parameters General LIH ISE Urine ∇ 300 Range Page 2/2 Level L 300 Level H 300 Test Name: OPI ∇ < > Type: Level L: Level H: Value/Flag: Flag ∇ Normal Ranges: Age L Sex Year 1.5 2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period Select using Space key. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. Fst Fst 24 Lst Lst 660 RATE + 27 Fst. OD L -2. # # ο ∇ 5. H First H Last H H Sample vol. L -2.OPIATES. or select from list displayed by Guide key Test No ∇ Flag ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name OPI Sample type URI ∇ 570 RATE + First 24 First Last Last 27 Wave Method Reaction Point 1 Point 2 Min.0 Last L -2. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † DAU Multi-Drug Calibrator Cat. H Lst. AU400/AU640 Qualitative Reagent ID: 320 Specific test parameters Urine ∇ Max OD H 2. # # ο ∇ 4. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # 300 Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name OPI ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L -99999 # Conc Factor/OD-H 99999 ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 99999 # Test Name: Counts: OPI ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal.5 Main ∇ ∇ ∇ 570 Sub 2. 0 -2. # OD CONC † Factor/OD-L -99999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal.5 2. No.5 2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 ∇ ο with Conc-0 Hour Hour DAU BSOSR6320. ∇ # # # # ο 5. ∇ # # # # ο 4. ∇ # # # # ο 3.01 2009-08 . # # ο ∇ 5.6 70 70 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.0 Reagent OD limit: First L -2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE ∇ + ∇ 24 570 RATE + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2. AU680/AU480 Qualitative Application System Reagent: OSR6320 Specific Test Parameters General LIH ISE Urine ∇ Max OD H 2. No demographics 8. AU2700/AU5400 Qualitative Reagent ID: 320 Parameters General LIH OPI ∇ Dilution μL -2.5 R2(R2-1) μL Name Sec. # # ο ∇ 7. # # ο ∇ 2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.6 1 70 Range Operation: ∇ Yes Test Name: OPI ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 100 NO % ∇ 1. Volume R1(R1-1) μL ∇ μL 1. 660 Onboard Stability Period Last Last 27 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A μL -99999 1 1 60 Day High B B 0 99999 0 0 Hour 70 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. # # ο ∇ 6.0 Last L -2.: ODC6316 ф AU680 <Point Cal.0 High High Max. † DAU Multi-Drug Calibrator Cat.5 < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6320 Reagent ID: 320 Application Operation Yes OPIATES. ∇ 7.OD μL Min. No. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # 300 Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine ∇ LIH OPI ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: 300 OPI ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 2. # # ο ∇ 3. ∇ # # # # ο 6.OPIATES.5 2. ∇ ∇ ∇ 99999 0 Sec.0 -2. None Selected 8. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. Point: ο with CONC-0 Slope Check: # ∇ # ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. For No. # # ο ∇ 4. Not within expected values µg/L Decimal Places Calibration Specific ISE OPI ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ Factor Range Low High -99999 99999 ∇ # ο ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Type Urine ∇ Counts: Factor/OD-H 99999 # Process: CONC ∇ Test Name: OPI ∇ < > Test Name: Use Serum Cal. ∇ # # # # ο 2. H Sample vol. ODC6316. H 2000 Fst Fst 24 Lst Lst First H Last H 2. OD L -2.5 ∇ # Test name OPI Sample type URI Page 1/2 System Reagent: OSR6320 Reagent ID: 320 Application OPIATES. # # ο ∇ 2.0 -2. Reagent 1 vol Reagent 2 vol μL μL μL 2 87 87 Dil. vol 0 0 0 Max. No.5 # Test Name: Counts: OPI ∇ < > Type SEMI-QUANTITATIVE APPLICATION Calibration Type: 4AB ∇ Formula: EIA TYPE 1 ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal. ODC6317 and ODC6318 # User defined † DAU Negative & Multi-Drug Calibrators Cat.0 -2. ODC6316. L -2.0 Reagent OD limit Fst.0 Main ∇ ∇ ∇ 570 Sub -2.5 ∇ Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 2.5 2.0 -2.5 2. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † DAU Negative & Multi-Drug Calibrator Cat.5 2.: ODC6314. # # ο ∇ 3.OPIATES.5 2. # # ο ∇ 7. Nos.5 2. AU600 Semi-quantitative Application System Reagent: OSR6320 Specific Test Parameters General LIH ISE Range Test Name: OPI ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 2 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. AU400/AU640 Semi-quantitative Reagent ID: 320 Specific test parameters Urine ∇ 1 -2.0 -2.5 Fst. # # ο ∇ 5. None Selected 8.0 Dynamic range L 0 Correlation factor 2000 1 0 ¤ NO % ∇ 60 Specific Test Parameters General LIH ISE Urine ∇ # Range Page 2/2 Level L # Level H # Test Name: OPI ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.0 -2.0 -2. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name OPI ∇ 4AB ∇ POLYGONAL OD ∇ Conc † † † † Count Process Factor/OD-L -2. # # ο ∇ 4. # # ο ∇ 6.5 2.0 # Conc Factor/OD-H 2. H Lst. vol Dil. L -2. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 12 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.5 2. ∇ ∇ ∇ Sec.5 2.5 660 RATE1 + 27 Max OD H 2.: ODC6314.01 2009-08 .0 -2. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name OPI Sample type URI ∇ On-board stability period 570 RATE1 + First 24 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min.0 1-Point Cal. vol Dil.0 0 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil. Nos.0 Lst. # # # # OD CONC † † † † Factor/OD-L -2. OD H ∇ Operation: Yes Test No ∇ 2.5 2. ODC6317 and ODC6318 DAU BSOSR6320. ∇ ∇ ∇ 2000 0 Sec. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE1 ∇ + ∇ 24 570 RATE1 + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.0 2. # # ο ∇ 2. SEMI-QUANTITATIVE APPLICATION Calibration Type: 4AB ∇ Formula: EIA TYPE 1 ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 ∇ Advanced Calibration: # Cal.0 Last L -2.5 -2.OD μL Min.5 R2(R2-1) μL Name Sec.5 2.5 2. No. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1. ODC6316.5 -2.5 -2. ∇ 7. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour DAU BSOSR6320. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: ICF: Calibration Stability Period: Calibration Type: 4AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. ∇ # # # # ο 2.5 + ∇ 1-Point Cal. # # ο ∇ 6.5 2. ∇ # # # # ο 4. # # ο ∇ 7.0 2. For No.0 -2. ODC6317 and ODC6318 ф AU680 <Point Cal.0 High High Max.5 2.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2. # # ο ∇ 5.5 2.6 1 70 Range Operation: ∇ Yes Test Name: OPI ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 100 NO % ∇ 1.0 Factor/OD-H 2.0 -2. † DAU Negative & Multi-Drug Calibrators Cat. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.5 2. Volume R1(R1-1) μL ∇ μL 1.OPIATES.: ODC6314.5 ∇ OD Range Low High -2.0 -2. # # # # CONC † † † † Factor/OD-L -2. # # ο ∇ 3. None Selected 8.6 70 70 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.0 Reagent OD limit: First L -2. ∇ # # # # ο 5. AU680/AU480 Semi-quantitative Application System Reagent: OSR6320 Specific Test Parameters General LIH ISE Urine ∇ Max OD H 2. # # ο ∇ 4.5 2. Nos. Not within expected values µg/L Decimal Places Calibration Specific ISE OPI ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > EIA TYPE 1 Type Urine Counts: ∇ # ο ∇ Calibration Specific General ISE Type Urine ∇ Counts: # Process: CONC ∇ Test Name: OPI ∇ < > Test Name: Use Serum Cal.5 < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6320 Reagent ID: 320 Application Operation Yes OPIATES.0 2. 660 Onboard Stability Period Last Last 27 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0 1 1 60 Day μL High B B 0 2000 0 0 Hour 70 Dilution 0 Sample Volume Pre-Dilution Rate Rgt.0 -2. ∇ # # # # ο 6.0 -2.0 2. ∇ # # # # ο 3.01 2009-08 .0 Dynamic Range: L 0 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine ∇ LIH OPI ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # OPI ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. No demographics 8. AU2700/AU5400 Semi-quantitative Reagent ID: 320 Parameters General LIH OPI ∇ Dilution μL -2. 9 12. and. Approximately 70% of a 4 THC dose is excreted in faeces and urine within 72 hours of administration.42 µg/L enzyme donor conjugated to 11-nor-Δ -THC-COOH. and no active enzyme will be formed.3 Test Principle6 This assay is based on the bacterial enzyme β-galactosidase. Avoid the formation of foam. inhibiting the re-association of inactive β-galactosidase fragments. where it may remain in the body for several days or even weeks. These fragments spontaneously re-associate to form fully active enzyme that. which has been genetically engineered into two inactive fragments. Prepare the R2 solution before the R1 solution to minimise possible contamination. buffer salts. Mix again. To avoid the possible build-up of azide compounds. cleaves a substrate. Mix by gentle inversion. Mix by gentle inversion. Reagent Preparation Prepare the following solutions using cold reagents and buffers. even hallucinations. Dispose of all waste material in accordance with local guidelines. 0. 3-(N-morpholino)propanesulfonic acid buffer. NOTE 2: Avoid cross-contamination of reagents by matching reagent caps to the appropriate reagent bottle. In the assay. 1. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. leaving the inactive enzyme fragments free to form active enzyme. Avoid the formation of foam. THC acts as a mild 2. particularly when using a preliminary positive result. ensuring that all the lyophilised material from the R2 Lyo bottle is transferred into the R2 Buffer bottle. 9 Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. of which Δ -tetrahydrocannabinol (THC) is the primary psychoactive compound. These drugs contain at least 61 cannabinoids (a 9 2. and preservative. Ensure the reagent is homogeneous before use NOTE 1: The components supplied in this kit are intended for use as an integral unit. and preservative. 2. buffer salts. Ensure the reagent is homogeneous before use R1 (Enzyme Acceptor Solution): Connect the R1 Lyo bottle to the R1 Buffer bottle using one of the enclosed adapters. Mix again. This material and its container must be disposed of as hazardous waste. Heavy chronic THC users who stop taking the drug may show positive urine tests for a month or longer. R2 (Enzyme Donor Solution): Connect the R2 Lyo bottle to the R2 Buffer bottle using one of the enclosed adapters. EN. 3 class of chemicals unique to the cannabis plant). NOTE 3: The R1 and R2 solutions must be at the reagent compartment temperature of the analyser before performing the assay. A dark red or purple-red colour indicates that the reagent has been contaminated and must be discarded. If drug is not present in the sample. protect from prolonged. R22 Harmful if swallowed. The amount of active enzyme formed and resultant absorbance change are proportional to the amount of drug present in the sample. ensuring that all the lyophilised material from the R1 Lyo bottle is transferred into the R1 Buffer bottle.171 g/L enzyme acceptor.01 BLOSR6322. buffer salts. heightened sensations. and the rate of release of stored 5 2. detergent and preservative. antibody will bind to drug conjugated on the inactive fragment. NOTE 4: To ensure reconstituted R1 stability. If drug is present in the sample. 9 2-5 transformed by liver enzymes to over 24 metabolites. Summary Marijuana and hashish come from the hemp plant Cannabis sativa. Safety Phrases: S36. in higher doses. it will bind to antibody. Do not mix components from different lots. 5 It is rapidly THC is highly fat soluble and therefore readily stored in fatty tissues. The concentrations of THC metabolites in urine are influenced by several factors: the frequency of prior use. the timing of urine specimen collection in relation to the last exposure to THC. Remove the kit from refrigerated storage (2…8°C) immediately prior to preparation of the solutions. Clinical consideration and professional judgement should be applied to any drug of abuse test result. 0. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. Place the bottle directly into the reagent compartment of the analyser or into refrigerated storage (2…8°C) and let stand for at least 30 minutes. Wear suitable protective clothing.56 mg/L monoclonal antibodies reactive to 11-nor-Δ -THC-COOH. Refer to Safety Data Sheets for further information. flush waste-pipes with water after the disposal of undiluted reagent. which grows throughout the world. The assay provides only a preliminary analytical test result. generating a colour change that can be measured spectrophotometrically.01 2009-08 DAU . Contains sodium azide. stabiliser.THC OSR6322 2 x 16 mL 2x 2 x 16 mL 2x R1 Buffer R1 Lyo R2 Buffer R2 Lyo Intended Use Homogeneous enzyme immunoassay for the qualitative and semi-quantitative assay of cannabinoids (THC) in human urine on Beckman Coulter analysers. For in vitro diagnostic use only. NOTE 5: Do not freeze reconstituted reagents. A more specific alternative chemical method must be used to obtain a confirmed 1 analytical result. 4 sedative-hypnotic that may produce euphoria. The R2 working solution (enzyme donor) should be yellow-orange in colour. Record the reconstitution date on the bottle label. 2. drug in the sample competes with drug conjugated to one inactive fragment of β-galactosidase for antibody binding site. continuous exposure to bright light. Cap the R2 Buffer bottle and let stand approximately for 5 minutes at 15…25°C. the primary one being 11-nor-Δ -tetrahydrocannabinol-9-carboxylicacid. in the assay format. Record the reconstitution date on the bottle label. S60. Detach the R2 Lyo bottle and adapter from the R2 Buffer bottle and discard.67 g/L chlorophenol red-β-D-galactopyranoside. Cap the R1 Buffer bottle and let stand approximately for 5 minutes at 15…25°C. stabiliser and preservative. 5 cannabinoids from fatty tissues. 3. Detach the R1 Lyo bottle and adapter from the R1 Buffer bottle and discard. stabiliser. Reagent Composition R1 Buffer R1 Lyo R2 Buffer R2 Lyo 3-(N-morpholino)propanesulfonic acid buffer. Samples producing a response value equal to or greater than the response value of the calibrator are considered positive. one 25% above the cut-off. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. control and sample to be tested. If any trends or sudden shifts in values are detected. Test Procedure Refer to the appropriate User’s Guide and the accompanying Instrument Setting Sheet for analyser-specific assay instructions. Quality control material The controls required are dependent on which assay is being performed.. 50 µg/L Cut-off: DAU THC 50 Control. Calibration Qualitative evaluation For qualitative analysis of samples use either of the following calibrators: Calibrator Name DAU THC 25 Calibrator DAU THC 50 Calibrator Cat. Specimen Urine: Collect urine samples in clean glass or plastic containers. ODC0008. for acceptability using the software options Routine. Dispense ≥ 600 µL of each calibrator. Expected Values Specific Performance Characteristics Results should always be negative with respect to the chosen cut-off i. Adulteration of urine samples can affect the test results. Major preventative maintenance was performed on the analyser or a critical part was replaced. up to the stated expiry date when stored at 2.8°C.. Data contained within this section is representative of performance on Beckman Coulter systems. The Beckman Coulter system automatically flags each positive sample with the letter P and each negative sample with the letter N. 25 µg/L Cut-off: DAU THC 25 Control. Care should be taken when reporting concentration results since there are many other factors that may influence a urine test result such as fluid intake and other biological factors. No. Confirm a positive result by a more specific method based on an alternative chemical principle. Data obtained in your laboratory may differ from these values. on the Beckman Coulter analyser. use the following calibrators: Calibrator Name DAU Negative Calibrator DAU THC 25 Calibrator DAU THC 50 Calibrator DAU THC 75 Calibrator DAU THC 100 Calibrator Cat.e. 50 µg/L or 25 µg/L. Values obtained for the controls should fall within specified limits. DAU THC 25 Calibrator. DAU THC 75 Calibrator. Centrifuge specimens with high turbidity before testing. Six replicates of each sample were analysed twice daily over 5 days. Semi-quantitative results Relative concentrations of cannabinoids can be established by calibrating the assay with the DAU Negative Calibrator.01 2009-08 EN. reagents stored on board the instrument are stable for 60 days. Once reconstituted. ODC0009. 7 Samples can be stored at 15…25°C for a maximum of 7 days after which storage at 2…8°C is recommended. While confirmation techniques other than GC/MS may be adequate for some drugs of abuse. and the DAU THC 100 Calibrator. The setting sheet contains separate applications for semi-quantitative and qualitative assays. the resulting curve should be visually reviewed. Calculation Qualitative results The DAU THC 25 or THC 50 Calibrators are used as a reference in distinguishing between positive and negative samples. Precision The following data was obtained on an AU640 using the DAU THC 25 and 50 Calibrators and two levels of controls corresponding to ± 25% of each cutoff. Calibration Curve. Treat human urine as potentially infectious material. Following calibration. GC/MS is generally accepted as a rigorous confirmation technique for all drugs since it provides the best level of 1 confidence in the result. review all operating parameters. ODC6322 ODC6323 11-nor-Δ -THC-COOH (ng/mL = µg/L) 25 50 9 Semi-quantitative evaluation For semi-quantitative analysis of samples. Good laboratory practice suggests that controls be run each day patient samples are measured and each time calibration is performed. Chain of custody recommendations should 8 be applied if applicable. It is recommended that two levels of controls be run. Obtain another sample for testing if adulteration of the sample is suspected.01 . Recalibrate the assay when the following occur: Change in reagent bottle or significant shift in control values. Quality Control Each laboratory should establish its own control frequency. Calibration Monitor. DAU THC 50 Calibrator. No. 8 DAU BLOSR6322. unopened.Storage and Stability The reagents are stable. Samples producing a response value less than the response value of the calibrator are considered negative. ODC6314 ODC6322 ODC6323 ODC6324 ODC6325 11-nor-Δ -THC-COOH (ng/mL = µg/L) 0 25 50 75 100 9 The calibrator values provided in the calibrator package insert are traceable to a primary gravimetric standard. the other 25% below the cut-off. 4 78 2.6 3.7 15. Sensitivity The lowest detectable level (LDL) represents the lowest measurable level of THC that can be distinguished from zero. It is calculated as the absolute mean plus three standard deviations of 25 replicates of the Negative Kit Calibrator.01 2009-08 DAU .2 2.0 4.5 Interfering Substances No interference was observed from the following substances added to the normal endogenous concentrations found in urine when tested with the THC assay (< 10% of baseline): Substance Acetone Ascorbic acid Creatinine Ethanol Galactose γ -globulin Glucose Concentration ≤ 10 g/L ≤ 15 g/L ≤ 5 g/L ≤ 10 g/L ≤ 100 mg/L ≤ 10 g/L ≤ 30 g/L Substance Haemoglobin Human serum albumin Oxalic acid Riboflavin Sodium chloride Urea Concentration ≤ 3 g/L ≤ 10 g/L ≤ 1 g/L ≤ 75 mg/L ≤ 60 g/L ≤ 60 g/L Other substances and/or factors not listed may interfere with the test and cause false results (e.1 1.5 Within run SD 1.9 Method Comparison Patient urine samples were used to compare this THC assay on the AU640 against another commercially available screening assay.2 SD 2.5 16.3 5. Cut-off 25 µg/L 50 µg/L LDL µg/L on AU640 1.9 5. 50 μg/L cut-off protocol. yielded the following percent crossreactivity results: Compound 9 11-nor-Δ -THC-COOH 8 11-nor-Δ -THC-COOH 9 Δ -THC 9 11-OH-Δ -THC 9 8β -OH-Δ -THC 9 8β 11-di-OH-Δ -THC 9 1-Δ -THC-Glucuronide Cannabinol Cannabidiol Concentration Tested (µg/L) 50 40 500 125 1.7 3.THC Qualitative Assay n=60 µg/L Mean. technical or procedural errors).000 % Cross-Reactivity 100 125 10.5 0.5 2.9 < 0.0 1.8 8.1 1.1 1.8 11.2 2.8 1.0 3.1 15.3 1.1 3.5 0.8 %CV 0. mA/min 19 315 25 389 31 483 38 338 50 411 62 523 THC Semi-quantitative Assay n=60 µg/L Mean.000 5000 62 1.2 µg/L and 22.000 1. Specificity The following parent compounds and metabolites when tested with the DAU THC assay.3 0.1 SD 9. µg/L 19 26 25 31 31 35 38 39 50 49 62 62 Within run SD 2.8 1.9 4.01 BLOSR6322.2 1. Discrepant samples were investigated using a confirmatory GC/MS reference method.8 %CV 4.7 0.6 Total %CV 3.9 8.7 0.2 2.4 1.7 2.7 4.1 EN.2 0.g.7 2.9 1.0 Total %CV 8. Results were as follows: 25 µg/L cut-off Qualitative Assay + Comparative Screening Method + 56 0 Comparative Screening Method + 50 µg/L cut-off Qualitative Assay + 24 0 - 0 68 - 0 88 25 µg/L cut-off Semi-quantitative Assay + Comparative Screening Method + 24 0 Comparative Screening Method + 50 µg/L cut-off Semi-quantitative Assay + 24 0 - 0 88 - 2* 86 9 * These samples were tested by GC/MS and the following results were found to contain 21.1 5.8 µg/L of 11-nor-Δ -THC-COOH.7 1.5 2.9 1.4 6.4 43 2. Urine Testing for Drugs of Abuse. with special attention to the workplace. Julien RM. Chem. control and sample to be tested. Boca Raton. Henderson. NIDA Research Monograph 1986.000 Nifedipine 500. and Behavior. 73: 84-92. Segura J. Chiang. Chiang CN. CN. et al. 1986. No.34:339-344.: ODC6322 (25 µg/L Cut-off) or ODC6323 (50 µg/L Cut-off) System Calibrator Cat. Cocaine. Sample volume for 25 µg/L cut-off protocol: 5. 8.000 Chlordiazepoxide 100.000 Captopril 500. eds.01 . 1992. A Primer for Drug Action.: ODC6314.000 Verapamil 500. Designer Drugs: Chemistry. Torre RDL. 50 µg/L cut-off protocol.000 Digoxin 100. Marijuana. New York. Setting Sheet Footnotes # † ‡ § * 1.000 Tolmetin 500. eds. Federal Register. Barnett G. 3rd ed. 1989. eds. ODC6324 and ODC6325 Sample volume for 25 µg/L cut-off protocol: 8µl.Structurally unrelated compounds were tested with the DAU THC assay. and gave a negative response when tested at the concentrations listed below. Chiang CN. Analytical methodology. RL. Disposition of Toxic Drugs and Chemicals In Man. Bibliography DAU BLOSR6322.000 A metabolite of the anti-HIV drug Sustiva (formerly known as DMP 266) may cause false positive results in the THC assay. Sample volume for 50 µg/L protocol: 4 µL. RL. 1994.000 Secobarbital 500. Williams J. FL: CRC Press Inc. 4. Barnett G.000 Levothyroxine 50. 6.000 Benzoylecgonine 500. Nos. 2. lll: Year Book Medical Publishers.000 Enalapril 500. Harris JD.000 Codeine 500. Cravey RH. Recommendations for the reliable detection of illicit drugs in urine in the European Union. 7.000 Ranitidine 500.000 Propoxyphene 500.110 (June 9): 11983.01 2009-08 EN. Hawks RL. Urine Testing for Drugs of Abuse.8 µL.Pharmacology.000 Salicyluric acid 500.000 Diazepam 500. NY: WH Freeman & Co.000 Fluoxetine 500.In: Hawks RL. Dispense ≥ 600 µL of each calibrator.000 Amoxicillin 100. a new homogeneous immunoassay system. SB. User defined ¤ Analyser default value System Calibrator Cat. Selected cut-off value Hawks. ODC6323. Chicago. Baselt RC. Ann Clin Biochem 1997.000 Methadone 500. ** Paracetamol ™ Limitations In view of the cross-reactivity profile of the THC assay. 73: 30-41. Chiang CN. In: Redda KK. Friedman. ODC6322.6µL. Clin.000 Amphetamine 500. Compound Concentration (µg/L) Acetaminophen** 500.000 Phencyclidine 500. Examples of specific drug assays.000 Acetylsalicylic acid 500. Marijuana pharmacokinetics and pharmacodynamics. DR.000 Cimetidine 500. 1989. 5. Notice of mandatory guidelines for federal workplace drug testing program: Revised mandatory guidelines. 3. 6th ed. 1986. NIDA Research Monograph.000 Methamphetamine 500.000 Ibuprofen 500. Sample volume for 50 µg/L protocol: 2. In: Hawks. Walker CA.000 Morphine 100.32: 1637-1641. Zeeuw RD. semi-quantitative results may not correlate with the levels of individual drugs/metabolites in the sample. CEDIA™.000 Phenobarbital 500. OD L -2. Sample volume for 50 µg/L protocol : 4µL Dispense >600µL of each calibrator. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name THC ∇ AB ∇ Y=AX+B OD ∇ Conc † Count Process Factor/OD-L -99999 # Conc Factor/OD-H 99999 ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 99999 # Test Name: Counts: THC ∇ < > Type Calibration Type: AB ∇ Formula: Y=AX+B ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None 999 ∇ Advanced Calibration: # ∇ Cal. Sample volume for 50 µg/L protocol : 4µL Dispense >600µL of each calibrator. vol 0 0 0 Max. H Lst.5 Main ∇ ∇ ∇ 570 Sub 2. No. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat. ∇ ∇ ∇ Sec.0 Last L -2.5 2.01 2009-08 # † * ‡ User defined System Calibrator Cat. # # ο ∇ 3. L -2.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: 60 Specific Test Parameters General LIH ISE Urine ∇ * Range Test Name: THC ∇ < > Type: Level L: * Level H: Value/Flag: Flag ∇ Normal Ranges: Age L Sex Year 1. # # ο ∇ 6. # OD CONC † Factor/OD-L -99999 1-Point Cal.0 Dynamic range L -99999 Correlation factor H A B Rate 99999 1 0 ¤ NO % ∇ Pre-Dilution Rate: 1 Min OD L -2. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: On-board stability period 570 RATE + First 24 First Last Last 27 Wave Method Reaction Point 1 Point 2 Min. # # ο ∇ 5.5 2.0 Reagent OD limit: First L -2. DAU . Fst Fst 24 Lst Lst 660 RATE + 27 Fst. # # ο ∇ 7. L -2.0 Reagent OD limit Fst. H First H Last H H Sample vol. vol Dil. # # ο ∇ 2. AU600 Qualitative Application System Reagent: OSR6322 Specific Test Parameters General LIH ISE Range Test Name: THC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume ‡ 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri. control and sample to be tested.: ODC6322 (25µg/L cut-off) or ODC6323 (50µg/L cut-off) Selected cut-off value Sample volume for 25 µg/L cut-off protocol : 8µL.5 2.0 Lst.THC. No. or select from list displayed by Guide key Test No ∇ Flag ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name THC Sample type URI ∇ Level L * Page 2/2 Level H * 0 Sample Pre-dil. AU400/AU640 Qualitative Reagent ID: 322 Specific test parameters Urine ∇ Max OD H 2. # # ο ∇ 4.5 99999 B 60 Linearity Fst No lag time NO % Sec % ∇ Select using Space key. control and sample to be tested. vol Dil.: ODC6322 (25µg/L cut-off) or ODC6323 (50µg/L cut-off) Selected cut-off value ‡ Sample volume for 25 µg/L cut-off protocol : 8µL. Reagent 1 vol Reagent 2 vol μL μL μL ‡ 87 87 Dil. None Selected 8. BSOSR6322. Point: ο with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 8 Formula 1 Selection calibrator Cal No Point 1 # ∇ Point 2 ∇ Point 3 ∇ Point 4 ∇ Point 5 ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 ∇ Operation: Yes Test No ∇ ∇ # Test name THC Sample type URI Page 1/2 System Reagent: OSR6322 Reagent ID: 322 Application THC. No. OD H 2. OD μL Min. ∇ 7. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.5 2. ∇ # # # # ο 4.8µL Dispense > 600µL of each calibrator.0 -2. No.01 2009-08 .0 -2. # # ο ∇ 3. 660 Onboard Stability Period Last Last 27 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A μL -99999 1 1 60 Day High B B 0 99999 0 0 Hour 61 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. ∇ # # # # ο 6. System Calibrator Cat.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: ∇ Point 3: ∇ Point 4: ∇ Point 5: ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ User defined. ∇ # # # # ο 2. Sample volume for 50µg/L protocol : 2. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE ∇ + ∇ 24 570 RATE + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2. ∇ ∇ ∇ 99999 0 Sec. # OD CONC † Factor/OD-L -99999 Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: None ∇ 999 ∇ Advanced Calibration: # None ∇ 1-Point Cal. No. # # ο ∇ 7. Not within expected values µg/L Decimal Places Calibration Specific ISE THC ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > Y=AX+B Type Urine Counts: ∇ Factor Range Low High -99999 99999 ∇ # ο ∇ QUALITATIVE APPLICATION Calibration Specific General ISE Type Urine ∇ Counts: Factor/OD-H 99999 # Process: CONC ∇ Test Name: THC ∇ < > Test Name: Use Serum Cal. No demographics 8. For No.5 2. Volume R1(R1-1) μL ∇ μL § 1 61 Range Operation: ∇ Yes Test Name: THC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 100 NO % ∇ § 61 61 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.5 2.THC. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour DAU BSOSR6322.0 Reagent OD limit: First L -2.: ODC6322 (25µg/L cut-off) or ODC6323 (50µg/L cut-off) Selected cut-off value Sample volume for 25µg/L cut-off protocol : 5.5 2.0 High High Max.0 Dynamic Range: L -99999 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine ∇ LIH THC ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: * THC ∇ < > Type: Specific Test Parameters Calculated Test Type: High * Urine ∇ Range Level L: * Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1. AU2700/AU5400 Qualitative Reagent ID: 322 Parameters General LIH THC ∇ Dilution μL -2. ∇ # # # # ο 3. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level * Specificl Ranges: From To Sex Year Month Year # # # # ο 1. Calibration Type: AB ∇ Formula: Y=AX+B ∇ Cal. AU680/AU480 Qualitative Application System Reagent: OSR6322 Specific Test Parameters General LIH ISE Urine ∇ Max OD H 2. Ф AU680 # † * § <Point Cal. # # ο ∇ 2. # # ο ∇ 4.0 Last L -2.6µL. None Selected 8. ∇ # # # # ο 5. # # ο ∇ 6.5 < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6322 Reagent ID: 322 Application Operation Yes THC. # # ο ∇ 5. control and sample to be tested.5 R2(R2-1) μL Name Sec. OD L -2.5 2. Out of Range L # # # # # # # # Unit: µg/L Decimal places: # Panic value H # # # # # # # # Month # # # # # # Age H Year # # # # # # Month # # # # # # Value/flag Normal range Sex 1 # ∇ 2 # ∇ 3 # ∇ 4 # ∇ 5 # ∇ 6 # ∇ 7 Non select 8 Out of range L H Panic Value: # # L # # # # # # # # L # H # # # # # # # # H # Select the function using the Function key or the Mouse Calibration specific Test No # Test name THC ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -2. ODC6324 and ODC6325 Dispense >600µL of each calibrator.01 2009-08 # User defined † System Calibrator Cat. ODC6324 and ODC6325 Dispense >600µL of each calibrator. AU600 Semi-quantitative Application System Reagent: OSR6322 Specific Test Parameters General LIH ISE Range Test Name: THC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume 4 87 87 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.5 2.5 ∇ # Test name THC Sample type URI Page 1/2 System Reagent: OSR6322 Reagent ID: 322 Application THC. vol 0 0 0 Max.0 -2. ODC6323. vol Dil. L -2. ODC6322.5 2.5 660 RATE1 + 27 Max OD H 2. ODC6322. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: A 1 On-board stability period: Select using Space key.5 2.0 0 B 60 Linearity Fst No lag time NO % Sec % ∇ 0 Sample Pre-dil. H 100 Fst Fst 24 Lst Lst First H Last H 2.THC. # # ο ∇ 6.: ODC6314.0 -2.5 2.0 Lst.0 -2.0 Dynamic range L 0 Correlation factor 100 1 0 ¤ NO % ∇ 60 Specific Test Parameters General LIH ISE Urine ∇ # Range Page 2/2 Level L # Level H # Test Name: THC ∇ < > Type: Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.5 Fst.0 1-Point Cal. AU400/AU640 Semi-quantitative Reagent ID: 322 Specific test parameters Urine ∇ 1 -2.5 ∇ Calibration Specific General ISE Urine ∇ Process: CONC ∇ Factor/OD-H 2. No. L -2. ODC6323.0 -2. # # ο ∇ 5.0 # Conc Factor/OD-H 2.0 Main ∇ ∇ ∇ 570 Sub -2. # # ο ∇ 7.5 2.5 2. OD H ∇ Operation: Yes Test No ∇ 2. DAU . vol Dil. ∇ ∇ ∇ Sec. control and sample to be tested.0 -2. or select from list displayed by Guide key Test No ∇ # ∇ H M M M M M M # # # # # # # # # # # # M→ M→ M→ M→ M→ M→ Age Y Y Y Y Y Y # # # # # # # # # # # # Age Y Y Y Y Y Y L # Test name THC Sample type URI ∇ On-board stability period 570 RATE1 + First 24 First Last Last 27 Pre-Dilution Rate: Min OD L Reagent OD limit: First L Last L Dynamic Range: L Correlation Factor: Wave Method Reaction Point 1 Point 2 H A B Rate Min. BSOSR6322. H Sample vol. Nos.0 -2.5 2.0 -2.: ODC6314.5 2. # # # # # OD CONC † † † † † Factor/OD-L -2.0 Reagent OD limit Fst.5 # Test Name: Counts: THC ∇ < > Type SEMI-QUANTITATIVE APPLICATION Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + 999 ∇ Advanced Calibration: # ∇ Cal.0 -2. None Selected 8.0 -2. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined ¤ Analyser default value † System Calibrator Cat. H Lst. Nos. control and sample to be tested. Reagent 1 vol Reagent 2 vol μL μL μL 4 87 87 Dil. # # ο ∇ 2.5 2. Point: ο With CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal. # # ο ∇ 3. # # ο ∇ 4.5 2. 8 1 61 Range Operation: ∇ Yes Test Name: THC ∇ < > Type: Sample: Reagents: Volume R1 Volume R2 Volume First H Last H H B 60 100 NO % ∇ 2. 660 Onboard Stability Period Last Last 27 ф Dynamic Range Low Correlation Factor A ∇nm Factor for Maker A 0 1 1 60 Day μL High B B 0 100 0 0 Hour 61 Dilution 0 Sample Volume Pre-Dilution Rate Rgt. ODC6322.0 Last L -2.0 -2. # # ο ∇ 3. # # ο ∇ 6.5 2. ODC6324 and ODC6325 Dispense > 600µL of each calibrator. ∇ # # # # ο 5. 660 ∇ Wavelength: Method: Reaction slope: Measuring Point 1: Measuring Point 2: Linearity : No Lag Time: Common Rgt.5 < > ∇ ∇ Type: Urine ISE HbA1c Range Test Name: Specific Test Parameters Calculated Test System Reagent: OSR6322 Reagent ID: 322 Application Operation Yes THC. # # ο ∇ 2. For No.5 -2. SEMI-QUANTITATIVE APPLICATION Calibration Type: 5AB ∇ Formula: POLYGONAL ∇ OD Slope Check Allowance Range Check ο Reagent Blank ο Calibration Advanced Calibration Operation Interval (RB/ACAL) Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + ∇ 999 Advanced Calibration: # Cal.5 -2.5 -2. ∇ # # # # ο 2.5 + ∇ 1-Point Cal. ∇ # # # # ο 3.5 -2. Volume R1(R1-1) μL ∇ μL 2.5 ∇ OD Range Low High -2.5 2. # # ο ∇ 5.0 2. No demographics 8. # # # # # CONC † † † † † Factor/OD-L -2.0 -2.0 High High Max. ODC6323.5 2. Not within expected values µg/L Decimal Places Calibration Specific ISE THC ∇ < Low # # # # # # # # # High # # # # # # # # Calibration Parameters STAT Table Calibration > POLYGONAL Type Urine Counts: ∇ # ο ∇ Calibration Specific General ISE Type Urine ∇ Counts: # Process: CONC ∇ Test Name: THC ∇ < > Test Name: Use Serum Cal.0 2. Ф AU680 <Point Cal. Nos.0 Factor/OD-H 2. control and sample to be tested.OD Reagent OD Limit First Low Last Low Dilution 0 0 OD Limit 2.5 2. ∇ # # # # ο 6. # # ο ∇ 7.0 Reagent OD limit: First L -2. AU680/AU480 Semi-quantitative Application System Reagent: OSR6322 Specific Test Parameters General LIH ISE Urine ∇ Max OD H 2. Out of Range L # # # # # # # # Unit: Unit Parameters Calibrators General Month # # # # # # Age H Year # # # # # # H # # # # # # # # Decimal places: # Month # # # # # # Panic Value Low # High # L µg/L H Month # # # # # # Panic Value: # # Value/Flag: # Low ∇ Level # Specificl Ranges: From To Sex Year Month Year # # # # ο 1.5 R2(R2-1) μL Name Sec.0 -2. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ Hour Hour DAU BSOSR6322. No.OD μL Min.0 -2. ∇ 7.5 2. None Selected 8. Point: ο with CONC-0 Slope Check: # ∇ # Use Master Curve ∇ ∇ ο Lot Calibration OD Range Low High Stability Reagent Blank 999 Day 0 Calibration 999 Day 0 MB Type Factor: 1-Point Calibration Point None ∇ ο with Conc-0 ∇ MB Type Factor: Calibration Stability Period: Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ # User defined. # # ο ∇ 4.5 2.0 Dynamic Range: L 0 Correlation Factor: A 1 On-board stability period: Specific Test Parameters General LIH ISE Urine ∇ LIH THC ∇ < > ISE HbA1c Test Name: Parameters General Range Test Name: # THC ∇ < > Type: Specific Test Parameters Calculated Test Type: High # Urine ∇ Range Level L: # Level H: Value/Flag: # ∇ Normal Ranges: Age L Sex Year 1.8 61 61 μL μL μL Dilution Dilution Dilution 0 0 0 μL μL μL Pri.0 2.0 2.0 -2. ∇ # # # # ο 4. AU2700/AU5400 Semi-quantitative Reagent ID: 322 Parameters General LIH THC ∇ Dilution μL -2.0 -2. ∇ ∇ ∇ 100 0 Sec.: ODC6314. † System Calibrator Cat. Type Wavelength Pri Method Reaction Slope Measuring Point1 First Measuring Point2 First Linearity Limit Lag Time Check Noneф 570 ∇nm RATE1 ∇ + ∇ 24 570 RATE1 + First 24 First Last Last 27 NO % ∇ Pre-Dilution Rate: 1 Min OD L -2.THC.01 2009-08 .0 2.5 2.5 2. 63100 MU 9194 Na Electrode 63102 63101 MU 9196 Cl Electrode 63103 Part No. Test Principle1 The ISE module for Na . ISE Buffer ISE Mid Standard ISE Reference ISE Low Serum Standard ISE High Serum Standard ISE Low/High Urine Standard ISE Internal Reference ISE Na+/K+ Selectivity Check 4 x 2000 mL 4 x 2000 mL 4 x 1000 mL 4 x 100 mL 4 x 100 mL 4 x 100 mL 2 x 25 mL 2 x 25 mL + Reagent used in conjunction with the ISE module of Beckman Coulter AU analysers for the quantitative (indirect) determination of Sodium (Na ). K . When compared to an internal reference. Dispose of all waste material in accordance with local guidelines. EN. Use of any other products may result in inaccurate measurement of routine samples and/or damage to the electrodes.1 mol/L ISE Mid-Standard + Na + K Cl Preservatives ISE Reference Potassium Chloride Preservatives 4.13 mmol/L 3. proper body pH. in enzyme reactions. contains formaldehyde. An electrical potential is developed according to the Nernst Equation for a specific ion. cofactors. and regulation of appropriate heart and muscle functions. For in vitro diagnostic use only. Safety Phrases: S24. Refer to Safety Data Sheets for further information.02 2009-11 ISE .ISE REAGENTS / STANDARDS 66320 66319 66318 66317 66316 66315 66314 66313 Intended Use Summary1 Electrolytes affect most metabolic processes. Wear suitable gloves. S60: Avoid contact with skin. + + - Contents. and Cl employs crown ether membrane electrodes for sodium and potassium and a molecular oriented PVC membrane for chloride that are specific for each ion of interest in the sample. Reagent Preparation The reagents and standards are ready for use. They serve to maintain osmotic pressure and hydration of various body fluid compartments. Reagents / Standards Concentration of active ingredients: ISE Low Serum Standard + Na 130 mmol/L + K 3. S37.01 BL66320. plasma and urine. Electrode Order No. This material and its container must be disposed of as hazardous waste. Part No. Electrolytes are also involved in oxidation-reduction reactions and participate as essential parts or. ISE Mid Standard: Irritant.3 mmol/L 0.00 mol/L ISE Low/High Urine Standard + Na (Low) 50 mmol/L (High) 200 mmol/L + K (Low) 10 mmol/L (High) 100 mmol/L Cl (Low) 50 mmol/L (High) 180 mmol/L Preservatives ISE Internal Reference Potassium Chloride 3. May cause sensitization by skin contact. this electrical potential is translated into voltage and then into the ion concentration of the sample.1 mmol/L ISE High Serum Standard + Na 160 mmol/L + K 6 mmol/L Cl 120 mmol/L Preservatives ISE Na Selectivity Check + Na 150 mmol/L Preservatives ISE K Selectivity Check + K 5 mmol/L Preservatives + + 1. + Potassium (K ) and Chloride (Cl ) concentrations in human serum. Precautions and Warnings Hazard Warnings and Risk Phrases: ISE Buffer. R43. MU 9197 MU 9195 Electrode Ref Electrode K Electrode See User’s Guide for further information.5 mmol/L Cl 85 mmol/L Preservatives ISE Buffer Triethanolamine Preservatives 0. The products listed are required to calibrate and calculate results for the ISE Module.3 mol/L Silver Chloride Saturated Preservatives ISE Configuration The ISE unit consists of the following measuring devices: Order No. Recalibrate the assay every day. Turbid urine samples should be cleared by centrifugation. results should always be assessed in conjunction with the patient's medical history. Calibration: Application Serum/plasma Urine Standard ISE Low Serum Standard & ISE High Serum Standard ISE Low/High Urine Standard Cat. 66315. 4 Stable in serum/plasma as follows: Chloride Potassium Sodium 7 days when stored at 2…25°C 6 weeks when stored at 2…25°C 2 weeks when stored at 2…25°C 5 Urine: Collect 24-hour urine without additives . Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. No.1 mmol/L 3. 66314 and 66313 should have the caps replaced immediately after each use.02 2009-11 EN. Potassium from red cells will diffuse into serum/plasma giving falsely elevated results. sex. or when the following occur: Change in lot number of ISE Buffer (66320). 63101. For diagnostic purposes. 66317 66316 66315 The ISE standard values are traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 2201 for Sodium and Chloride and the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 2202 for Potassium. 24h Adult Adult 101 – 109 mmol/L 110 – 250 mmol/day Expected values may vary with age. 24h Potassium Serum Plasma Urine. 63103).Storage and Stability 66314 should be stored at 15…25°C. 3 Care should be taken when interpreting results from patients with hyperlipidemia and hyperproteinemia due to the electrolyte exclusion effect. clinical examinations and other findings. unopened up to the stated expiry date when stored at 2…25°C. ISE Mid-Standard (66319) or ISE Reference (66318). Test Procedure Refer to User’s Guide for operation and calibration procedure. Do not acidify. Major preventative maintenance was performed on the analyser or a critical part was replaced. Some precipitation may be present in the ISE Internal Reference Solution. Each laboratory should establish its own guidelines for corrective action to be taken if controls do not recover within the specified limits. Note: 66317. Each laboratory should verify the transferability of the expected values to its own population. sample type. Significant shift in control values. 63102. ISE BL66320. These target values should fall within the corresponding acceptable ranges given in the relevant product literature. and if necessary determine its own reference interval according to good laboratory practice. 66316. Urine: All control materials with values determined by this method may be used. ODC0003 and ODC0004 or other control materials with values determined by this method may be used.5 – 5. 66314 is stable for 90 days when stored at 15…25°C.5 mmol/L 25 – 125 mmol/day Chloride 8 Serum or plasma Urine. Specimen2. Only use lithium heparinised plasma. potassium and chloride values of each sample. Reference Intervals7 Sodium Serum or plasma Urine. Gross lipemia causes pseudohyponatremia therefore grossly lipemic specimens should be cleared by ultracentrifugation. diet and geographical location. If any trends or sudden shifts in values are detected. The results obtained by any individual laboratory may vary from the given mean value. 24h Adult Adult Adult Adult Adult 136 – 146 mmol/L 40 – 220 mmol/day 3. The following reagents and standards are stable. Potassium and Chloride. Change in ISE electrodes (63100. review all operating parameters. Quality Control: Serum and Plasma: Controls Cat. This does not affect the performance of the reagent however the reagent should be thoroughly mixed before use. However. Once open. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Separate from cells immediately by centrifugation and do not allow serum/plasma to remain on the cells after centrifugation. Calculation The Beckman Coulter analysers automatically compute the sodium.3 Serum/plasma: Haemolysed and grossly lipemic samples should be avoided. once opened they are stable when stored at 2…25°C as follows: 66320 66319 66318 66317 ISE Buffer ISE Mid Standard ISE Reference ISE Low Serum standard 2 months 1 month 2 months 90 days 66316 66315 66313 ISE High Serum Standard ISE Low/High Urine Standard + + ISE Na /K Selectivity Check 90 days 90 days 90 days Reagents and standards should be allowed to equilibrate to room temperature prior to use. Stable in urine as follows: Chloride 4 Potassium Sodium 4 6 6 1 week when stored at 2…25°C 2 months when stored at 2…8°C 45 days when stored at 15…25°C 45 days when stored at 2…25°C Refer to Young for a comprehensive list of preanalytical factors associated with Sodium.01 .4 – 4. No. Siggaard-Anderson O. 1997. 9. AU600. Philadelphia: WB Saunders Company. Fukutani S. and preservation of urine specimens. Electrolytes.03 0.04 0. Scott MG.200 mmol/L 15 – 400 mmol/L Precision The following data was obtained on an AU2700 using a serum pool analysed over 10 days. Zawta B.977 0. EN.64 0.39.06 0. Tietz NW. ed.5 – 7.48 1.58 0. Young DS.01 BL66320.1995:124pp. 2nd ed. Use of anticoagulants in diagnostic laboratory investigations and stability of blood. LeGrys VA. Tietz NW.Specific performance characteristics Data contained within this section is representative of performance on Beckman Coulter systems. 2000.0 Potassium AU400 Method 2 0. AU5400 are linear in serum.0 – 125.89 0. Philadelphia: WB Saunders Company.49 0.400 mmol/L 2. Pennsylvania: NCCLS.71 Sodium (Na ) + Potassium (K ) Chloride (Cl ) + The following data was obtained on an AU2700 using a urine pool analysed over 10 days.65 0. Ehret W. approved guideline.02 2009-11 ISE .43 Total SD 0.78 1. 2nd ed.0 Chloride AU400 Method 2 1. 1987:614-624.44 0. Fundamentals of clinical chemistry. 3rd ed.22 CV% 0. Tietz textbook of clinical chemistry.991 238 1.562-564.0 .Effects of Drugs on Clinical Laboratory Tests.63 Total SD 1.41.10.0 mmol/L Cl 50 – 200 mmol/L Urine + Na + K Cl 10 .962. 1987:948. Fundamentals of clinical chemistry. AU2700. Linearity The ISE Module on AU400.0 9 Interfering Substances Certain anticoagulants. Effects of preanalytical variables on clinical laboratory tests. AACC.016 -2. Ashwood ER. n = 60 Mean mmol/L 138 4. Results of linear regression analysis were as follows: Y Method X Method Slope Intercept Correlation Coeff (r) No.2:26. Matsubara A. drugs and organophilic compounds may affect electrolyte determinations. Logan NM. of samples Range (mmol/L) Sodium AU400 Method 2 1.0 .977 233 80. 2.73 0. Urinalysis and collection. Pruden EL. AACC Press. 502-504.024 -2. Heil W. Clin Chem Lab Med 2008. Ichihara K. 2001.981 239 118. ed. et al. AU640.107 0. 5. In: Teitz NW.Electrolytes and blood gases.29 1.8 90 n = 60 Mean mmol/L 166 100 245 Within Run SD CV% 0.68 0.965pp.302 0. eds. 1999. NCCLS Document GP16-A2.1061-1062. Philadelphia:WB Saunders Company. 3. Siggaard-Anderson O.64 Within Run SD CV% 0. BIBLIOGRAPHY 1. Determination of reference intervals for 26 commonly measured biochemical analytes with consideration of long-term within-individual variation. Washington. Wisser H. Schmitt Y. 5th ed.0 – 157. transportation. Töpfer G. 6. Refer to Young for further information on interfering substances. WHO/DIL/LAB/99. 8.48 0.30 2. Philadelphia: WB Saunders Company.76 0.1 Rev. Clinical guide to laboratory tests. Sodium (Na ) + Potassium (K ) Chloride (Cl ) + Method Comparison Patient serum samples were used to compare this ISE module on the AU400 against another commercially available ISE module. Tietz NW.46:691-98. AACC Press.48pp. In: Burtis CA. 4. Appendix. Young DS. preservatives. Data obtained in your laboratory may differ from these values.29 0.428 0. NCCLS. plasma and serum samples. ed. 7. In: Teitz NW. Heusel JW.9 CV% 0. plasma or urine samples as follows: Serum + Na 50 – 200 mmol/L + K 1. . Refer to Safety Data Sheets for further information Calibrator Preparation The calibrators are ready for use. 2 x 7.01 BLODC6413. Safety Phrases: S36. . The Antibiotic TDM Multi-Calibrator values are traceable to a primary gravimetric standard. For in vitro diagnostic use only.5 mL 2 x 5. flush waste-pipes with water after the disposal of undiluted reagent.01 2009-08 Calibrator . The calibrators are stable. tightly capped immediately after each use and stored at 2…8°C. Wear suitable protective clothing. To avoid the possible build-up of azide compounds. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. provided they are free from contamination. Value Assignment Refer to table of assigned values. S60. the calibrators are stable for 60 days. contains sodium azide.ANTIBIOTIC TDM MULTI-CALIBRATOR ODC6413 Intended Use The Antibiotic TDM Multi-Calibrator is intended to be used with the Gentamycin reagent OSR6420 for the quantitative determination of gentamycin on Beckman Coulter analysers. Storage and Stability Do not freeze. Calibrator Composition Buffer based matrix containing bovine serum albumin. EN. Gently invert each vial several times. Once open. unopened. It is recommended to record the date the calibrator was opened on the bottle label. to ensure a homogeneous mixture. up to the stated expiry date when stored at 2…8°C. R22: Harmful if swallowed. preservative and variable amounts of gentamycin.0 mL Calibrator 1 Calibrator 2 (blue cap) (red cap) Contents. Test Procedure Refer to relevant product instructions for use. This material and its container must be disposed of as hazardous waste. Dispose of all waste material in accordance with local guidelines. prior to each use. . Once open.org/ejifcc/vol13no3/130301003..42:1676-82. provided they are free from contamination. Turner WE. Clin Chem 1996. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. Scand J Clin Lab Invest Suppl 1990. EN. this product should be handled as a potentially infectious material. Storage and Stability The calibrators are stable.ifcc. Calibrator Composition Liquid human serum matrix containing variable amounts of human apolipoprotein A1. The Apo A1 and B Calibrator values have been assigned using WHO International reference materials SP1-01 and SP3-07 respectively by immunoturbidimetry. Precautions and Warnings To avoid the possible build-up of azide compounds. et al. prior to each use. and Lipoprotein(a).3 Refer to table of means and ranges. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Dispose of all waste material in accordance with local guidelines. Patterson DG Jr. Maggio VL. Marcovina SM. Calibrator Preparation The calibrators are ready for use. Henderson LO. flush waste-pipes with water after the disposal of calibrator. up to the stated expiry date when stored at 2…8°C. BIBLIOGRAPHY 1. . . Gently invert each vial several times. Biological materials of human origin contained in this product were tested for Anti-HCV.01 BLODR3005. Dati F. human apolipoprotein B and preservative. to ensure a homogeneous mixture.2. Barr JR. Value Assignment1. Tate J.01 2009-08 Calibrator . 2. Reference Materials for the Standardization of the Apolipoproteins A-I and B. Albers JJ. unopened. For in vitro diagnostic use only. Apolipoprotein assays: standardization and quality control.APO A1 & B CALIBRATOR ODR3005 2 x 1 mL 2 x 1 mL 2 x 1 mL Calibrator 1 Calibrator 2 Calibrator 3 (White Cap) (Yellow Cap) (Red Cap) Intended Use The Apo A1 & B Calibrator is a liquid human serum based matrix calibrator intended to be used with the Apo A1 and Apo B reagents (OSR6142 & OSR6143 respectively) for the quantitative determination of Apo A1 & Apo B on Beckman Coulter analysers. Isotope dilution-mass spectrometric quantification of specific proteins: model application with apolipoprotein A-I. tightly capped immediately after each use. eJIFCC vol 13 no 3: http://www. Contents.htm. the calibrators are stable for 30 days. and stored at 2…8°C..198:58-65. Cooper GR. 3. Test Procedure Refer to relevant product instructions for use. . Gently invert each vial several times. Turner WE. For in vitro diagnostic use only. and stored at 2…8°C. 2. Precautions and Warnings To avoid the possible build-up of azide compounds. Calibrator Composition Liquid human serum matrix containing variable amounts of human apolipoprotein A1. the calibrators are stable for 30 days. Value Assignment1.3 Please refer to table of assigned values. provided they are free from contamination.. Apolipoprotein assays: standardization and quality control. Scand J Clin Lab Invest Suppl 1990. eJIFCC vol 13 no 3: http://www.198:58-65.Apo A1 & B Calibrator ODR3022 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL Calibrator 1 Calibrator 2 Calibrator 3 Calibrator 4 Calibrator 5 (White Cap) (Yellow Cap) (Orange Cap) (Red Cap) (Black Cap) Intended Use The Apo A1 & B Calibrator is a liquid human serum based matrix calibrator intended to be used with the Apo A1 and Apo B reagents (OSR6142 & OSR6143 respectively) for the quantitative determination of Apo A1 & Apo B on Beckman Coulter analysers. Biological materials of human origin contained in this product were tested for Anti-HCV. Patterson DG Jr.2. Dispose of all waste material in accordance with local guidelines. The Apo A1 and B Calibrator values have been assigned using WHO International reference materials SP1-01 and SP3-07 respectively by immunoturbidimetry. Storage and Stability The calibrators are stable. 3. Test Procedure Refer to relevant product instructions for use. Clin Chem 1996. flush waste-pipes with water after the disposal of calibrator. prior to each use. BIBLIOGRAPHY 1. up to the stated expiry date when stored at 2…8°C. Albers JJ. Reference Materials for the Standardization of the Apolipoproteins A-I and B. Isotope dilution-mass spectrometric quantification of specific proteins: model application with apolipoprotein A-I. EN. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. et al. to ensure a homogeneous mixture.ifcc. Cooper GR. Once open. human apolipoprotein B and preservative.htm Barr JR.01 BLODR3022. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. tightly capped immediately after each use. Henderson LO. Dati F. Calibrator Preparation The calibrators are ready for use. and Lipoprotein(a). Marcovina SM. Maggio VL. this product should be handled as a potentially infectious material. unopened.42:1676-82. Tate J.01 2009-08 Calibrator .org/ejifcc/vol13no3/130301003. Contents. . 01 2009-08 Calibrator . Test Procedure Refer to relevant product instructions for use. by immunoturbidimetry. Protein standardization IV: value transfer procedure for the assignment of serum protein values from a reference preparation to a target material. Olesen Larsen S. Bentzon MW. EN. ASO Calibrator 6 x 1 mL Contents. st The ASO Calibrator value has been assigned using the WHO NIBSC 1 International standard for Anti-Streptolysin O. For in vitro diagnostic use only.Clin Chem Lab Med 2001. the calibrator is stable for 30 days. and stored at 2…8°C. Precautions and Warnings To avoid the possible build-up of azide compounds.2 Refer to table of assigned values.39:1110-1122 Spaun J. prior to each use. Blirup-Jensen S. AST. up to the stated expiry date when stored at 2…8°C.01 BLODR3013. It is recommended to record the date the calibrator was opened on the bottle label. . Once open. this product should be handled as a potentially infectious material. provided it is free from contamination. BIBLIOGRAPHY 1. flush waste-pipes with water after the disposal of calibrator. Hewitt LF. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. Larsen M. Dispose of all waste material in accordance with local guidelines. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents.24:271-79. Calibrator Composition Liquid human serum matrix containing human anti-streptolysin O and preservatives. Biological materials of human origin contained in this product were tested for Anti-HCV. unopened. Johnson AM. Gently invert each vial several times. tightly capped immediately after each use. to ensure a homogeneous mixture. Calibrator Preparation The calibrator is ready for use. International standard for anti-streptolysin-O. 2. Value Assignment1. Storage and Stability The calibrator is stable.ASO Calibrator ODR3013 Intended Use The ASO Calibrator is a liquid human serum based matrix calibrator intended to be used with the ASO reagent OSR6194 for the quantitative determination of anti-streptolysin O on beckman coulter analysers. Bull Wld Hlth Org 1961. . The Bicarbonate Calibrator values are traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 351. 3 x 25 mL 3 x 25 mL Calibrator 1 Calibrator 2 Contents. EN. Storage and Stability The calibrators are stable. unopened. Dispose of all waste material in accordance with local guidelines. It is recommended to record the date the calibrator was opened on the bottle label.Routine. Test Procedure Refer to relevant product instructions for use. Calibration Curve.Bicarbonate Calibrator ODC0019 Intended Use The Bicarbonate Calibrator is an aqueous preparation of sodium carbonate intended to be used with the Bicarbonate reagent OSR6190 for the quantitative determination of bicarbonate on Beckman Coulter analysers. provided they are free from contamination. tightly capped immediately after each use. for acceptability using the software options . on the Beckman Coulter analyser.01 BLODC0019. up to the stated expiry date when stored at 15…25°C. Calibrator Composition Buffer based matrix containing variable amounts of sodium carbonate and preservative. the calibrators are stable for 30 days. Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. Calibrator Preparation The calibrators are ready for use. and stored at 15…25°C.01 2009-08 Calibrator . Value Assignment For the value assigned to the calibrator please refer to the bottle label. For in vitro diagnostic use only. Calibration Monitor. the resulting curve should be visually reviewed. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Once open. Note: Following calibration. . As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. unopened. the control is stable for 5 days when stored at 2…8°C. Record the date the calibrator was reconstituted on the bottle label. With the rubber stopper back in place. Avoid foaming. Continue mixing until the solution is homogeneous and all lyophilized material is reconstituted.01 BLODR30034.0 mL. The CK-MB Calibrator value has been standardised against the CKtotal IFCC Reference Method with addition of antibody. dissolve the contents completely by gently mixing for 30 minutes. avoiding any loss of lyophilised material. For in vitro diagnostic use only. Calibrator Preparation 1. Biological materials of human origin contained in this product were tested for Anti-HCV. Add 1. Precautions and Warnings Dispose of all waste material in accordance with local guidelines.CK-MB CALIBRATOR ODR30034 Intended Use The CK-MB Calibrator is a lyophilised human serum calibrator designed for calibration of the CK-MB reagent OSR61155 on Beckman Coulter analysers. Value Assignment Refer to table of assigned values. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. 6 x 1 mL (White Cap) Contents. 5. 2. Carefully remove the cap and rubber stopper from the bottle. up to the stated expiry date when stored at 2…8°C.0 mL of sterile deionised water at 15…25°C to the lyophilised material using a volumetric pipette calibrated to deliver exactly 1. Calibrator Composition Lyophilised human serum containing creatine kinase-MB isoenzyme. Once open. Test Procedure Refer to relevant product instructions for use. 8 hours when stored at 15…25°C or 4 weeks when stored at –20°C when frozen once. this product should be handled as a potentially infectious material. EN. 4. performed manually and calculated via molar absorption coefficient ε.01 2009-08 Calibrator . providing it is free from contamination and is tightly capped immediately after each use. Storage and Stability The CK-MB calibrator is stable. 3. . S60.CORE TDM MULTI-CALIBRATOR ODC6411 Intended Use The Core TDM Multi-Calibrator is intended to be used with the reagents listed in the table below for the quantitative determination of carbamazepine. phenytoin. the calibrators are stable for 60 days. Storage and Stability Do not freeze. For in vitro diagnostic use only. unopened. This material and its container must be disposed of as hazardous waste. phenobarbital. phenobarbital. Dispose of all waste material in accordance with local guidelines. The calibrators are stable. tightly capped immediately after each use and stored at 2…8°C. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful.5 mL 2 x 5. OSR6412 OSR6415 2 x 7. flush waste-pipes with water after the disposal of undiluted reagent. preservative and variable amounts of carbamazepine.01 2009-08 Calibrator . R22: Harmful if swallowed. up to the stated expiry date when stored at 2…8°C. Gently invert each vial several times. Test Procedure Refer to relevant product instructions for use. theophylline and valproic acid. Refer to Safety Data Sheets for further information. theophylline and valproic acid on Beckman Coulter analysers. The Core TDM Multi-Calibrator values are traceable to a primary gravimetric standard.01 BLODC6411. It is recommended to record the date the calibrator was opened on the bottle label. Once open.0 mL Calibrator 1 Calibrator 2 (Blue Cap) (Red Cap) Contents. OSR6414 OSR6413 OSR6411 Reagent Theophylline Valproic acid Cat. Wear suitable protective clothing. No. To avoid the possible build-up of azide compounds. Calibrator Composition Buffer based matrix containing bovine serum albumin. phenytoin. Calibrator Preparation The calibrators are ready for use. provided they are free from contamination. contains sodium azide. EN. Reagent Carbamazepine Phenobarbital Phenytoin Cat. Safety Phrases: S36. Value Assignment Refer to table of assigned values. to ensure a homogeneous mixture. prior to each use. No. . 1 2 The CRP Calibrator (Latex) values have been assigned using the IFCC (International Federation of Clinical Chemistry) standard CRM 470 by immunoturbidimetry. BIBLIOGRAPHY 1. Blirup-Jensen S. Bienvenu J. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. Once open. provided they are free from contamination. Johnson AM. Storage and Stability The calibrators are stable. Johnson AM. prior to each use. this product should be handled as a potentially infectious material. Protein standardization IV: value transfer procedure for the assignment of serum protein values from a reference preparation to a target material. Test Procedure Refer to relevant product instructions for use. Gently invert each vial several times. to ensure a homogeneous mixture. tightly capped immediately after each use. For in vitro diagnostic use only. Carlström A.1993. Contents. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents.01 2009-08 Calibrator . flush waste-pipes with water after the disposal of calibrator. For the zero calibrator saline should be used. Precautions and Warnings To avoid the possible build-up of azide compounds. 2. unopened. Dispose of all waste material in accordance with local guidelines. Baudner S. the calibrators are stable for 90 days. Milford Ward A. and stored at 2…8°C. EN. up to the stated expiry date when stored at 2…8°C.39:1110-1122. Calibrator Composition Liquid human serum matrix containing variable amounts of human CRP and preservative. Value Assignment Refer to table of assigned values.Clin Chem Lab Med 2001. CRM 470. Biological materials of human origin contained in this product were tested for Anti-HCV.01 BLODC0027.CRP Latex Calibrator Highly Sensitive Set ODC0027 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL Calibrator 1 Calibrator 2 Calibrator 3 Calibrator 4 Calibrator 5 (Yellow Cap) (Cream Cap) (Yellow/Green Cap) (Pink Cap) (Red Cap) Intended Use The CRP Calibrator (Latex) is a liquid human serum based matrix calibrator intended to be used with the Highly Sensitive application of the CRP Latex reagent OSR6199 for the quantitative determination of CRP on Beckman Coulter analysers. The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins. EUR 15243 EN. Larsen M. Calibrator Preparation The calibrators are ready for use. Blirup-Jensen S. et al. . to ensure a homogeneous mixture. Blirup-Jensen S. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. tightly capped immediately after each use. CRM 470. Value Assignment Refer to table of assigned values. For in vitro diagnostic use only.Clin Chem Lab Med 2001. prior to each use. BIBLIOGRAPHY 1. provided they are free from contamination. Calibrator Composition Liquid human serum matrix containing variable amounts of human CRP and preservative. Johnson AM. 1 2 The CRP Calibrator (Latex) values have been assigned using the IFCC (International Federation of Clinical Chemistry) standard CRM 470 by immunoturbidimetry. flush waste-pipes with water after the disposal of calibrator. Protein standardization IV: value transfer procedure for the assignment of serum protein values from a reference preparation to a target material.01 BLODC0026. Gently invert each vial several times. Dispose of all waste material in accordance with local guidelines. Baudner S. the calibrators are stable for 90 days. unopened. Contents.39:1110-1122.1993. Larsen M. up to the stated expiry date when stored at 2…8°C. Test Procedure Refer to relevant product instructions for use. The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins. this product should be handled as a potentially infectious material. Johnson AM. Milford Ward A.01 2009-08 Calibrator . EUR 15243 EN. Once open. Carlström A. Storage and Stability The calibrators are stable. Biological materials of human origin contained in this product were tested for Anti-HCV. Blirup-Jensen S. Calibrator Preparation The calibrators are ready for use. For the zero calibrator saline should be used. 2. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive.CRP Latex Calibrator Normal Set ODC0026 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL Calibrator 1 Calibrator 2 Calibrator 3 Calibrator 4 Calibrator 5 (Cream Cap) (Blue Cap) (Red Cap) (Brown Cap) (Green Cap) Intended Use The CRP Calibrator (Latex) is a liquid human serum based matrix calibrator intended to be used with the Normal application of the CRP (Latex) reagent OSR6199 for the quantitative determination of CRP on Beckman Coulter analysers. and stored at 2…8°C. et al. EN. Bienvenu J. Precautions and Warnings To avoid the possible build-up of azide compounds. . Biological materials of human origin contained in this product were tested for Anti-HCV. 6. With the rubber stopper back in place.5 mL 2 x 0. up to the stated expiry date when stored at 2…8°C. S60. Avoid foaming during the preparation of dilutions. Carefully remove the cap from the D-Dimer Calibrator 2 and rubber stopper from the bottle. 4. 28 days at 2…8°C or 30 days when stored at -20 °C when frozen once. For in vitro diagnostic use only. To avoid the possible build-up of azide compounds. Once reconstituted. providing it is free from contamination and is tightly capped immediately after use. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Prepare calibrator using doubling dilutions as described on the lot specific value sheet enclosed with the D-Dimer calibrator (ODR3033). 3.25°C. 2 x 2. Value Assignment Refer to table of assigned values.01 BLODR3033. Safety Phrases: S36. R52/53: Harmful to aquatic organisms may cause long-term adverse effects in the aquatic environment.. Exercise the normal precautions required for handling all laboratory reagents. this product should be handled as a potentially infectious material.D-DIMER CALIBRATOR ODR3033 Intended Use The D-Dimer Calibrator is a lyophilised calibrator in a human serum matrix intended to be used with the D-Dimer OSR60135 for the quantitative determination of D-Dimer in human plasma on Beckman Coulter analysers. 5. Safety data sheet available for professional user on request. Record the date the calibrator was reconstituted on the bottle label. Test Procedure Refer to relevant product instructions for use. avoiding any loss of lyophilised material. Refer to special instructions/safety data sheets. contains sodium azide. Calibrator 2 is stable for 1 day at 15. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. Dispose of all waste material in accordance with local guidelines. 2. EN. unopened.5 mL.01 2009-08 Calibrator . Calibrator Preparation 1.. dissolve the contents completely by gently mixing for 30 minutes. R22: Harmful if swallowed. This material and its container must be disposed of as hazardous waste. Storage and Stability The calibrators are stable. flush waste-pipes with water after the disposal of calibrator material.5 mL of sterile deionised water at 15…25°C to the lyophilised material using a volumetric pipette calibrated to deliver exactly 0.5 mL Calibrator 1 Calibrator 2 (blue cap) (blue cap) Contents. Wear suitable protective clothing. The D-Dimer assay has been calibrated against another commercially available immuno-turbidimetric assay which reports results in µg FEU/mL. Add 0. S61: Avoid release to the environment. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. Avoid foaming. D-Dimer Calibrator 1 is ready for use. Calibrator Composition Calibrator 1: Calibrator 2: Liquid human serum matrix Lyophilised human serum containing D-Dimer and preservative. . BIBLIOGRAPHY EN. It is recommended to record the date the calibrator was opened on the bottle label. Test Procedure Refer to relevant instructions for use. up to the stated expiry date when stored at 2…8°C. Fed. for acceptability using the software options . hepatitis B. Amphetamines/Ecstasy Barbiturates Benzodiazepines Cocaine Opiate OSR6323 OSR6315 OSR6316 OSR6317 OSR6320 1 x 5 mL (Black Cap) The semi-quantitative DAU applications provide only a preliminary analytical test result. Council Directive (2000/54/EC). Analyte Amphetamines/Ecstasy Barbiturates Benzodiazepines Cocaine Opiate Cat No: OSR6323 OSR6315 OSR6316 OSR6317 OSR6320 Cal Point 1 ODC6314 ODC6314 ODC6314 ODC6314 ODC6314 Cal Point 2 ODC6316 ODC6316 ODC6316 ODC6316 ODC6316 Cal Point 3 ODC6315 ODC6315 ODC6315 ODC6315 ODC6326 Cal Point 4 ODC6326 ODC6326 ODC6326 ODC6326 ODC6317 Cal Point 5 ODC6317 ODC6317 ODC6317 ODC6317 ODC6318 Cal Point 6 ODC6318 ODC6318 ODC6318 ODC6318 N/A Contents.1030. Gently invert each vial several times. Please refer to the enclosed settings for details on changes to the “Calibration Specific” parameters. The calibrator should be used in conjunction with the other DAU Multi-Drug calibrators and placed in the following order for each of the designated analytes.Routine.56:64175-64182. Occupational Exposure to Bloodborne Pathogens. User defined Beckman Coulter System Calibrator Cat Nos : Calibration stability period Department of Labor. Occupational Safety and Health Administration. For in vitro diagnostic use only. prior to each use. flush waste-pipes with water after the disposal of calibrator. Materials of human origin were tested for HIV 1 and 2. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. 1991. the values of which have been verified by GC/MS. L262 from Oct 17. The calibrator values have been assigned using a primary gravimetric standard. Storage and Stability The calibrators are stable. of the Europ. Communities. Where the DAU Low Intermediate Multi-Drug Calibrator ODC6326 is used there is no change to the “Specific Test Parameters”.DAU LOW INTERMEDIATE MULTI-DRUG CALIBRATOR ODC6326 Intended Use The DAU Low Intermediate Multi-Drug Calibrator is a human urine based liquid calibrator intended to be used with DAU reagents listed in the table below for the semi-quantitative determination of drugs of abuse in human urine on Beckman Coulter analysers. provided they are tightly capped immediately after each use. Setting Sheet Footnotes # † ¥ 1. Calibrator Composition The DAU Calibrator is human urine based containing the following constituents: d-Methamphetamine Benzoylecognine Secobarbital Morphine Nitrazepam Preservative Precautions and Warnings To avoid the possible build-up of azide compounds. and hepatitis C. Value Assignment Refer to table below for values assigned to the DAU Low Intermediate Multi-Drug Calibrator. Calibrator Preparation The calibrator is ready for use. as no test method can rule out the potential risk of infection with absolute certainty. Final Rule. However. Register. Calibration Curve. Calibration Monitor. No. Once open. ODC6326 DAU Calibrator Low Intermediate AMPH µg/L 1500 AMPH/ECST µg/L 1500 BARB µg/L 500 BENZ µg/L 500 COC µg/L 500 OPIAT µg/L 500 Note: Following semi-quantitative calibration. to ensure a homogeneous mixture. unopened. 2000. the calibrators are stable for 60 days. on the Beckman Coulter analyser. and stored at 2…8°C. the resulting curve should be visually reviewed. This calibrator is sold separately and may be used with any reagent lot. Official J. 29 CFR Part 1910. however where greater accuracy is required especially in that region of the calibration curve between the Intermediate Calibrator ODC6317 and the preceding cut-off calibrator. Dispose of all waste material in accordance with local guidelines.01 BLODC6326.01 2009-08 Calibrator . In the event of 1. Beckman Coulter recommends the use of this Low Intermediate Multi-Drug Calibrator ODC6326. The findings were negative.2 exposure the directives of the responsible health authorities should be followed. the material must be handled just as carefully as the patient sample. 2. . 0 -2. AU400/AU640 Semi-quantitative Reagent ID: 320 System Reagent: OSR6320 Calibration Specific General ISE Test Name: OPI POLYGONAL ∇ Counts: # ∇ Type Urine < > ∇ Process: CONC ∇ AMPHETAMINES/ECSTASY. OSR6317 Calibration Specific General ISE Urine Calibration Type: 5AB ∇ Formula: Process: CONC ∇ OD Factor/OD-H 2.0 -2.0 -2.0 -2. OSR6316.0 -2.5 # ∇ Reagent ID: 323.: ODC6314.0 -2. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: AU600 Semi-quantitative Application Test No # Test name OPIATES. 315. Point MB type factor Calibrator stability period OD Conc † † † † † † 999 Cal type 13 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 ∇ Point 7 ∇ 1-point cal.5 2. ODC6317 and ODC6318 Calibrator BSODC6326. ODC6317 and ODC6318 Select the function using the Function key or the Mouse # User defined † System Calibrator Cat. ODC6315. BARBITURATES. Point: MB Type Factor: with CONC-0 Slope Check: + ∇ Advanced Calibration: # 999 ∇ Calibration Stability Period: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: Cal. 316.01 2009-08 .0 -2.: ODC6314.0 Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: ∇ Advanced Calibration: 999 # ∇ 1-Point Cal.5 ∇ Calibration specific Test No Count Process ∇ Factor/OD-L -2. ODC6316.5 # Conc # Test name # ∇ 6AB ∇ POLYGONAL ∇ SEMI-QUANTITATIVE APPLICATION Cal type 14 Formula 3 Selection calibrator Cal No Point 1 # ∇ Point 2 # ∇ Point 3 # ∇ Point 4 # ∇ Point 5 # ∇ Point 6 # ∇ Point 7 ∇ 1-point cal.0 Factor/OD-H 2. Nos. OSR6315.0 -2.5 2.5 2.0 # Conc Factor/OD-H 2.0 Factor/OD-H 2.BENZODIAZEPINES.0 -2. # # # # # CONC † † † † † Factor/OD-L -2. ODC6316.5 2.0 -2. 317 Test Name: Counts: # ∇ < > Type Calibration Type: 6AB ∇ Formula: POLYGONAL ∇ Cal.5 2. No. point MB type factor Calibrator stability period 999 Select the function using the Function key or the Mouse # User defined † System Calibrator Cat. # # # # # # + OD CONC † † † † † † Factor/OD-L -2.0 -2.5 2. ODC6326.5 2.5 2. AU600 Semi-quantitative Application Calibration specific OPI ∇ 5AB ∇ POLYGONAL OD ∇ Conc † † † † † Count Process Factor/OD-L -2.0 -2.5 2.5 2. COCAINE.5 2.5 2. AU400/AU640 Semi-quantitative Application Application System Reagent: OSR6323.5 2.5 2.OPIATES.5 2.0 -2.0 -2.5 2.5 2. Nos.5 1-Point Cal.0 -2. No.0 -2.5 2.0 -2.0 -2. ODC6326. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ MB Type Factor: 1-Point Calibration Point 999 999 None ∇ with Conc-0 Day Day 0 0 Hour Hour MB Type Factor: 1-Point Calibration Point None ∇ with Conc-0 # User defined. ODC6326.5 Allowance Range Check -2.5 Reagent Blank -2.5 2. Nos.0 -2.5 -2. ODC6317 and ODC6318 Calibrator BSODC6326.0 ∇ Advanced Calibration: # ∇ 1-Point Cal.0 2.5 2.0 2. No. Point: with CONC-0 Slope Check: MB Type Factor: Calibration Stability Period: AU680/AU480 Semi-quantitative Application Parameters Calibrators General Calibration Specific ISE OPI ∇ < > Test Name: OPIATES.0 -2. For No.0 2.5 Allowance Range Check -2.5 2.0 2. ODC6316. ODC6316.5 2.5 Advanced Calibration Operation # # ∇ ∇ Interval (RB/ACAL) Lot Calibration # ∇ # Lot Calibration ∇ Calibration Type: 6AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: # † ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ Calibration Type: 5AB ∇ Formula: <Calibrator Parameters> Calibrator OD Conc Point 1: # † ∇ Point 2: # † ∇ Point 3: # † ∇ Point 4: # † ∇ Point 5: # † ∇ Point 6: ∇ Point 7 ∇ Point 8 ∇ Point 9 ∇ Point 10 ∇ <Point Cal.5 2. No. # # # # # # OD CONC † † † † † † Factor/OD-L -2. For No.0 -2.5 2. AU2700/AU5400 Semi-quantitative Application Calibration Specific General ISE Test Name: Type Urine Calibration Type: 5AB ∇ Formula: POLYGONAL Counts: # OD ∇ # Factor/OD-H 2.0 2. ODC6315.0 -2.01 2009-08 . Calibration Specific Calibration Parameters STAT Table Calibration ISE Test Name: # ∇ < > Type Urine Type POLYGONAL Urine ∇ Use Serum Cal. Point: MB Type Factor: Calibration Stability Period: with CONC-0 Slope Check: + ∇ Advanced Calibration: # 999 ∇ 999 Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: Cal.5 -2.0 2. † System Calibrator Cat.0 2.5 Reagent Blank -2.: ODC6314.0 -2.0 -2.0 -2.0 -2. COCAINE. † System Calibrator Cat.0 Factor/OD-H 2.5 Calibration -2.0 2. AU2700/AU5400 Semi-quantitative Application Calibration Specific General ISE Test Name: # ∇ < > Calibration Type: 6AB ∇ Formula: POLYGONAL ∇ Counts: Point 1: Point 2: Point 3: Point 4: Point 5: Point 6: Point 7: + Cal. AU680/AU480 Semi-quantitative Application Calibration Parameters STAT Table Calibration Parameters Calibrators General ∇ Use Serum Cal. POLYGONAL + ∇ Counts: # ∇ ∇ ODRange Low High Slope Check -2. BARBITURATES. # # # # # CONC † † † † † Factor/OD-L -2.0 -2.5 -2.0 2.5 Calibration Advanced Calibration Operation Interval (RB/ACAL) Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration + ∇ SEMI-QUANTITATIVE APPLICATION Counts: # ∇ ∇ OD Range Low High Slope Check -2. ODC6326. of Correction Points Master Curve> Calibrator OD Conc Point-1 ∇ Point-2 ∇ 999 999 Day Day 0 0 Hour Hour Use Master Curve ∇ ∇ OD Range Low High Stability Reagent Blank Calibration <Point Cal. Nos.AMPHETAMINES/ECSTASY. ODC6317 and ODC6318 # User defined.: ODC6314.5 2.BENZODIAZEPINES.5 2.5 1-Point Cal.5 Process: CONC ∇ ∇ Process: CONC ∇ OPI ∇ Type Urine < > ∇ OPIATES.0 2.0 2.5 -2.5 2. In the event of exposure the 1. the resulting curve should be visually reviewed. To avoid the possible build-up of azide compounds. contains sodium azide. 17. 2. Cat. preservative and stabiliser. L262 from Oct. to ensure a homogeneous mixture. Calibration Curve. The findings were negative. The calibrator values have been assigned using a primary gravimetric standard. Register. of the Europ.56:64175-64182.Routine. on the Beckman Coulter analyser. The calibrators are stable. up to the stated expiry date when stored at 2…8°C. No. tightly capped immediately after each use. the material must be handled just as carefully as the patient sample. Official J. R22: Harmful if swallowed. 29 CFR Part 1910.01 BLODC6319. 1991. S60. Wear suitable protective clothing.1030. Occupational Safety and Health Administration. Council Directive (2000/54/EC).DAU METHADONE CALIBRATORS ODC6319 ODC6320 ODC6321 Intended Use The DAU Methadone Calibrators are human urine based liquid calibrators intended to be used with the Methadone reagent OSR6319 for the qualitative and semi-quantitative determination of methadone in human urine on Beckman Coulter analysers. However. Test Procedure Refer to relevant product instructions for use. Calibrator Composition Human urine containing methadone. and hepatitis C. BIBLIOGRAPHY 1. This material and its container must be disposed of as hazardous waste. the values of which have been verified by GC/MS. Refer to Safety Data Sheets for further information. Gently invert each vial several times. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. unopened. Dispose of all waste material in accordance with local guidelines. for acceptability using the software options . Calibration Monitor.01 2009-08 Calibrator . No. Fed. the calibrators are stable for 60 days. For in vitro diagnostic use only. Once open. Safety Phrases: S36. flush waste-pipes with water after the disposal of calibrator.2 directives of the responsible health authorities should be followed. Final Rule. and stored at 2…8°C. ODC6319 ODC6320 ODC6321 DAU Methadone Calibrator DAU Methadone Cut-off Calibrator DAU Methadone Intermediate Calibrator DAU Methadone High Calibrator μg/L 300 600 1000 Note: Following semi-quantitative calibration. 2000. Communities. EN. Department of Labor. Materials of human origin were tested for HIV 1 and 2. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. prior to each use. DAU Methadone Cut-off Calibrator DAU Methadone Intermediate Calibrator DAU Methadone High Calibrator 1 x 5 mL 1 x 5 mL 1 x 5 mL (yellow cap) (green cap) (red cap) Contents. Occupational Exposure to Bloodborne Pathogens. Calibrator Preparation The calibrators are ready for use. as no test method can rule out the potential risk of infection with absolute certainty. Value Assignment Refer to table below for values assigned to the DAU Methadone Calibrators. hepatitis B. Storage and Stability Do not freeze. It is recommended to record the date the calibrator was opened on the bottle label. provided they are free from contamination. . Safety Phrases: S36. No. Materials of human origin were tested for HIV 1 and 2. The calibrators are stable. However.DAU MULTI-DRUG CALIBRATORS ODC6315 ODC6316 ODC6317 ODC6318 Intended Use The DAU Multi-Drug Calibrators are human urine based liquid calibrators intended to be used with DAU reagents listed in the table below for the qualitative and semi-quantitative determination of drugs of abuse in human urine on Beckman Coulter analysers. Communities. 2. prior to each use. S60. 17. Wear suitable protective clothing. Once open. Cat. Council Directive (2000/54/EC). Calibrator Composition The DAU Calibrator is human urine based. to ensure a homogeneous mixture.1030. In the event of exposure the 1. Value Assignment Refer to table below for values assigned to the DAU Multi-Drug Calibrators. This material and its container must be disposed of as hazardous waste. unopened. OSR6323 OSR6315 OSR6316 OSR6317 OSR6318 OSR6320 DAU Primary Cut-off Multi-Drug Calibrator DAU Secondary Cut-off Multi-Drug Calibrator DAU Intermediate Multi-Drug Calibrator DAU High Multi-Drug Calibrator 1 x 5 mL 1 x 5 mL 1 x 5 mL 1 x 5 mL (yellow cap) (white cap) (green cap) (red cap) Contents. flush waste-pipes with water after the disposal of calibrator material. EN. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice. Dispose of all waste material in accordance with local guidelines. R22: Harmful if swallowed. the resulting curve should be visually reviewed. up to the stated expiry date when stored at 2…8°C. Calibrator Preparation The calibrators are ready for use. Fed. The calibrator values have been assigned using a primary gravimetric standard. the calibrators are stable for 60 days. for acceptability using the software options . the values of which have been verified by GC/MS. Refer to Safety Data Sheets for further information. of the Europ. 29 CFR Part 1910. DAU Calibrator ODC6315 DAU Primary Cut-off Multi-drug Calibrator ODC6316 ODC6317 ODC6318 DAU Secondary Cut-off Multi-drug Calibrator DAU Intermediate Multi-drug Calibrator DAU High Multi-drug Calibrator Amphetamines/ Ecstacy µg/L 1000 500 3000 5000 Barbiturates Benzodiazepines Cocaine EDDP µg/L µg/L µg/L µg/L 300 300 300 100 200 800 3000 200 800 5000 150 2000 5000 100 500 2000 Opiates µg/L 300 800 2000 Note: Following semi-quantitative calibration. Reagent Amphetamines/Ecstasy Barbiturates Benzodiazepines Cocaine EDDP Opiates Cat. Final Rule. For in vitro diagnostic use only. Department of Labor.56:64175-64182. 1991. 2000. Official J. BIBLIOGRAPHY 1.Routine. Calibration Curve. Storage and Stability Do not freeze. It is recommended to record the date the calibrator was opened on the bottle label. Occupational Exposure to Bloodborne Pathogens. Test Procedure Refer to relevant product instructions for use. and hepatitis C. contains sodium azide.01 BLODC6315. Calibration Monitor. containing the following constituents: d-Methamphetamine Benzoylecgonine Secobarbital EDDP Nitrazepam Morphine Preservative Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. tightly capped immediately after each use and stored at 2…8°C. To avoid the possible build-up of azide compounds. No. The findings were negative.2 directives of the responsible health authorities should be followed.01 2009-08 Calibrator . No. on the Beckman Coulter analyser. Occupational Safety and Health Administration. L262 from Oct. as no test method can rule out the potential risk of infection with absolute certainty. Register. hepatitis B. provided they are free from contamination. the material must be handled just as carefully as the patient sample. Gently invert each vial several times. . OSR6323 OSR6315 OSR6316 OSR6317 OSR6318 OSR6319 OSR6320 OSR6322 1 x 5 mL (blue cap) Contents. To avoid the possible build-up of azide compounds. Gently invert vial several times. R22: Harmful if swallowed. Communities. Council Directive (2000/54/EC). to ensure a homogeneous mixture. Value Assignment No dectectable level has been found using GC/MS for the following analytes: Amphetamines/Ecstasy Barbiturates Benzodiazepines Cocaine EDDP Methadone Opiates THC Note: Following semi-quantitative calibration. and hepatitis C. Occupational Safety and Health Administration. tightly capped immediately after each use and stored at 2…8°C. the resulting curve should be visually reviewed. However. 17. the material must be handled just as carefully as the patient sample. unopened. hepatitis B. Dispose of all waste material in accordance with local guidelines. up to the stated expiry date when stored at 2…8°C. Reagent Amphetamines/Ecstasy Barbiturates Benzodiazepines Cocaine EDDP Methadone Opiates THC Cat. as no test method can rule out the potential risk of infection with absolute certainty. It is recommended to record the date the calibrator was opened on the bottle label. S60. 29 CFR Part 1910. Quality control procedures should be undertaken immediately following calibration in accordance with good laboratory practice.56:64175-64182.Routine. Wear suitable protective clothing. for acceptability using the software options . the calibrators are stable for 60 days. prior to each use. Fed. EN. 2000. Once open. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful.01 2009-08 Calibrator . For in vitro diagnostic use only. Calibrator Composition The DAU negative calibrator contains human urine and preservative. provided they are free from contamination. contains sodium azide. Materials of human origin were tested for HIV 1 and 2. BIBLIOGRAPHY 1. L262 from Oct. on the Beckman Coulter analyser. 1991.2 directives of the responsible health authorities should be followed. No. This material and its container must be disposed of as hazardous waste. 2. Final Rule. Calibrator Preparation The calibrator is ready for use. Department of Labor. The calibrator is stable. Refer to Safety Data Sheets for further information. Calibration Monitor. of the Europ. Calibration Curve. In the event of exposure the 1. Occupational Exposure to Bloodborne Pathogens. Storage and Stability Do not freeze. Safety Phrases: S36. The findings were negative.1030. Test Procedure Refer to relevant product instructions for use. Register.01 BLODC6314. No.DAU NEGATIVE CALIBRATOR ODC6314 Intended Use The DAU Negative Calibrator is a human urine based liquid calibrator intended to be used with DAU reagents listed in the table below for the semiquantitative determination of drugs of abuse in human urine on Beckman Coulter analysers. flush waste-pipes with water after the disposal of calibrator material. Official J. . No. up to the stated expiry date when stored at 2…8°C. Storage and Stability Do not freeze. In the event of exposure the 1. EN. The calibrators are stable. For in vitro diagnostic use only. 29 CFR Part 1910. The calibrator values have been assigned using a primary gravimetric standard. DAU THC 25 Calibrator DAU THC 50 Calibrator DAU THC 75 Calibrator DAU THC 100 Calibrator 1 x 15 mL 1 x 15 mL 1 x 15 mL 1 x 15 mL (white cap) (yellow cap) (black cap) (green cap) Contents. Safety Phrases: S36. Materials of human origin were tested for HIV 1 and 2.DAU THC CALIBRATORS ODC6322 ODC6323 ODC6324 ODC6325 Intended Use The DAU THC Calibrators are human urine based liquid calibrators intended to be used with the THC reagent OSR6322 for the qualitative and semiquantitative determination of THC in human urine on Beckman Coulter analysers. provided they are free from contamination. Once open.01 BLODC6322. However. as no test method can rule out the potential risk of infection with absolute certainty. This material and its container must be disposed of as hazardous waste. S60. to ensure a homogeneous mixture. prior to each use. R22: Harmful if swallowed. To avoid the possible build-up of azide compounds. 2000. 1991. and hepatitis C.01 2009-08 Calibrator .1030. Register. Official J. of the Europ. Calibrator Preparation The calibrators are ready for use. Department of Labor. BIBLIOGRAPHY 1. Wear suitable protective clothing. Fed. the values of which have been verified by GC/MS. Calibrator Composition Human urine containing 11-nor-Δ -tetrahydrocannabinol-9-carboxylic acid. Gently invert each vial several times. flush waste-pipes with water after the disposal of calibrator material.56:64175-64182. hepatitis B. contains sodium azide. tightly capped immediately after each use and stored at 2…8°C. 2. It is recommended to record the date the calibrator was opened on the bottle label. 17. Occupational Exposure to Bloodborne Pathogens. Dispose of all waste material in accordance with local guidelines. Council Directive (2000/54/EC). Communities. unopened. the material must be handled just as carefully as the patient sample. 9 Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. Occupational Safety and Health Administration. The findings were negative. Refer to Safety Data Sheets for further information. Final Rule. Value Assignment Refer to table for values assigned to the DAU THC Calibrators. Test Procedure Refer to relevant product instructions for use. preservative and stabilisers. the calibrators are stable for 60 days.2 directives of the responsible health authorities should be followed. L262 from Oct. . EN. prior to each use. These calibrators are gravimetrically prepared then verified by a commercially available process.5 mL Calibrator 1 Calibrator 2 Calibrator 3 Calibrator 4 Calibrator 5 Calibrator 6 Intended Use The Digitoxin Calibrator is a liquid human serum based matrix calibrator intended to be used with the Digitoxin reagent OSR6403 for the quantitative determination of digitoxin on Beckman Coulter analysers. and stored at 2…8°C. the calibrators are stable up to the stated expiry date. Gently invert each vial several times. to ensure a homogeneous mixture. Storage and Stability The calibrators are stable. unopened. Value Assignment Refer to table for values assigned to the Digitoxin Calibrator. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Dispose of all waste material in accordance with local guidelines. Calibrator Composition Liquid human serum matrix containing variable amounts of digitoxin and a preservative. Once open.5 mL 1 x 2. tightly capped immediately after each use. provided they are free from contamination. Precautions and Warnings To avoid the possible build-up of azide compounds. up to the stated expiry date when stored at 2…8°C.01 2009-08 Calibrator .5 mL 1 x 2.5 mL 1 x 2.Digitoxin Calibrator ODC6403 1 x 2. Contents.5 mL 1 x 2. flush waste-pipes with water after the disposal of calibrator. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive.01 BLODC6403. Calibrator Preparation The calibrators are ready for use. For in vitro diagnostic use only. Test Procedure Refer to relevant product instructions for use.5 mL 1 x 2. this product should be handled as a potentially infectious material. Biological materials of human origin contained in this product were tested for Anti-HCV. . Contents. Calibrator Composition Liquid human serum matrix containing variable amounts of digoxin and a preservative.5 mL 1 x 2. provided they are free from contamination. flush waste-pipes with water after the disposal of calibrator. Value Assignment Refer to table for values assigned to the Digoxin Calibrator. the calibrators are stable up to the stated expiry date. prior to each use. Storage and Stability The calibrators are stable.5 mL 1 x 2.5 mL 1 x 2.5 mL Calibrator 1 Calibrator 2 Calibrator 3 Calibrator 4 Calibrator 5 Calibrator 6 Intended Use The Digoxin Calibrator is a liquid human serum based matrix calibrator intended to be used with the Digoxin reagent OSR6404 for the quantitative determination of digoxin on Beckman Coulter analysers. Biological materials of human origin contained in this product were tested for Anti-HCV.5 mL 1 x 2. unopened. Calibrator Preparation The calibrators are ready for use.01 BLODC6404. tightly capped immediately after each use. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents.01 2009-08 Calibrator . up to the stated expiry date when stored at 2…8°C. Once open. Test Procedure Refer to relevant product instructions for use. to ensure a homogeneous mixture. Gently invert each vial several times. For in vitro diagnostic use only. and stored at 2…8°C. Precautions and Warnings To avoid the possible build-up of azide compounds. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. this product should be handled as a potentially infectious material. These calibrators are gravimetrically prepared then verified by a commercially available process.Digoxin Calibrator ODC6404 1 x 2.5 mL 1 x 2. Dispose of all waste material in accordance with local guidelines. EN. . for the quantitative determination of HbA1c (Hemoglobin A1c). and are traceable to the IFCC HbA1c reference method via IFCC HbA1c reference material.01 2009-08 Calibrator . the calibrators are stable up to the stated expiry date. Mauri P. Once open. unopened. Takei I. Paroni R. Kobold U. Hoezel W. Total Haemoglobin values assigned to the THb Calibrator are traceable to the IRMM Haemoglobin Cyanide Standard (BCR – 522). For calibration of the Total Hemoglobin reagent use Calibrator 1 only. Kobold U. Mosca A. Test Procedure Refer to relevant product instructions for use. Umemoto M. Clin Chem 2004. Miedema K. Calibrator Composition Calibrator Level 1 Sodium hydroxide 0. 50(1): 166-174.0 Hapten Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. Weykamp C. Hoshino T. in human blood on Beckman Coulter analysers. 2. WG. It is intended to be used with the HbA1c reagent OSR6192 and HbA1c APT reagent OSR61177.4%. 2.2 Refer to table of assigned values. Dispose of all waste material in accordance with local guidelines. Wiedmeyer H-M. Paroni R. The HbA1c calibrator values have been assigned by immunoturbidimetry using HbA1c OSR6192. pH 13 Surfactant. Finke A. 40(1): 78-89. Barr J. Value Assignment1. Miedema. provided they are free from contamination. Japan. Clin Chem Lab Med 2002. EN. Calibrator Preparation The HbA1c Calibrator is ready for use. John. and Sweden: A Method-Comparison Study. Umemoto M.HbA1c Calibrator ODR3032 1 x 8 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL Calibrator 1 Calibrator 2 Calibrator 3 Calibrator 4 Calibrator 5 Calibrator 6 Intended Use The HbA1c Calibrator is an aqueous hapten-containing solution. Weykamp C. up to the stated expiry date when stored at 2…8°C. Approved IFCC reference method for the Measurement of HbA1c in Human Blood. Goodall I. Barr JR. For in vitro diagnostic use only. Hoshino T. Theinpoint L. Thienpont L. Jeppsson J-O. Jeppsson J-O.5% Triton X-100 Chlorohemin Calibrator Levels 2 to 6 Bovine Serum Albumin Buffer. Mauri P. Storage and Stability The calibrators are stable. tightly capped immediately after each use and stored at 2…8°C. IFCC Reference System for Measurement of Hemoglobin A1c in Human Blood and the National Standardisation Schemes in the United States. Susanto F. Safety data sheet available for professional user on request. Hoelzel W. BIBLIOGRAPHY 1. Contents. pH 3. Mosca A. Little R. Gently invert each vial several times prior to each use to ensure a homogeneous mixture. For calibration of the HbA1c reagent use Calibrators 1 to 6.01 BLODR3032. a diabetic marker. . 2 x 3 mL Contents. To ensure stability. Calibrator Composition Lyophilised human serum containing human HDL-cholesterol. 2nd ed. Continue mixing until the solution is homogeneous and all lyophilized material is reconstituted. up to the stated expiry date when stored at 2…8°C. Precautions and Warnings Dispose of all waste material in accordance with local guidelines. Lippel K.01 BLODC0011. eds. Manual of laboratory operations. Dept.0 mL of sterile deionised water at 15…25°C to the lyophilised material using a volumetric pipette calibrated to deliver exactly 3. Karon J.S. Avoid foaming. Health and Human Services. Add 3. Storage and Stability The calibrator is stable.HDL-CHOLESTEROL CALIBRATOR ODC0011 Intended Use The HDL-Cholesterol Calibrator is a lyophilised human serum calibrator intended to be used with the HDL-Cholesterol reagent OSR6187 for the quantitative determination of HDL-cholesterol on Beckman Coulter analysers. 1982. In: Lipid Research Clinics Program. 3. unopened. MD: U. this product should be handled as a potentially infectious material. Beckman Coulter recommend that vials are tightly capped immediately after use and that care is taken to avoid contamination. With the rubber stopper back in place. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. The reconstituted and frozen calibrator is stable for 30 days when stored at -20°C. Calibrator Preparation 1. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents.01 2009-08 Calibrator . Biological materials of human origin contained in this product were tested for Anti-HCV. Bethesda. 2. It can be aliquoted and frozen once. Hainline A. 5. For in vitro diagnostic use only. Carefully remove the cap and rubber stopper from the bottle. dissolve the contents completely by gently mixing for 30 minutes. avoiding any loss of lyophilised material. 4. EN. Test Procedure Refer to relevant product instructions for use. Record the date the calibrator was reconstituted on the bottle label. Once reconstituted the calibrator is stable for 7 days when stored at 2…8°C. Lipid and lipoprotein analysis. Value Assignment Refer to table of assigned values 1 The HDL-Cholesterol Calibrator value is traceable to the US CDC (Centre for Disease Control) HDL-cholesterol reference method.0 mL. BIBLIOGRAPHY 1. . The reconstituted and frozen calibrator is stable for 30 days when stored at -20ºC. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents.0 mL.01 BLODC0012. Once reconstituted the calibrator is stable for 7 days when stored at 2…8ºC. To ensure stability. 4.0 mL of sterile deionised water at 15…25ºC to the lyophilised material using a volumetric pipette calibrated to deliver exactly 1. up to the stated expiry date when stored at 2…8ºC. Avoid foaming. For in vitro diagnostic use only. unopened. dissolve the contents completely by gently mixing for 30 minutes. Value Assignment Refer to table of assigned values. Beckman Coulter recommend that vials are tightly capped immediately after use and that care is taken to avoid contamination. BIBLIOGRAPHY 1. Calibrator Preparation 1. 41: 1414 – 20. Carefully remove the cap and rubber stopper from the bottle. 2 x 1 mL Contents.01 2009-08 Calibrator . Test Procedure Refer to relevant product instructions for use. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. Add 1. Precautions and Warnings Dispose of all waste material in accordance with local guidelines.LDL-CHOLESTEROL CALIBRATOR ODC0012 Intended Use The LDL-Cholesterol Calibrator is a lyophilised human serum calibrator intended to be used with the LDL-Cholesterol reagent OSR6183 for the quantitative determination of LDL-cholesterol on Beckman Coulter analysers. avoiding any loss of lyophilised material. this product should be handled as a potentially infectious material. Storage and Stability The calibrator is stable. 1 The LDL-Cholesterol Calibrator value is traceable to the US CDC (Centre for Disease Control) LDL-cholesterol reference method. National Cholesterol Education Program recommendations for measurement of low-density lipoprotein cholesterol: executive summary. Biological materials of human origin contained in this product were tested for Anti-HCV. The National Cholesterol Education Program Working Group on Lipoprotein Measurement. Ross JW. Calibrator Composition Lyophilised human serum containing human LDL-cholesterol. 2. Bachorik PS. It can be aliquoted and frozen once. Clin Chem 1995. 3. EN. With the rubber stopper back in place. Record the date the calibrator was reconstituted on the bottle label. . ® C4 OSR6160 ERM – DA470 ® Transferrin OSR6152 ERM – DA470 st ASO OSR6194 WHO NIBSC 1 International standard for Anti-Streptolysin O. flush waste-pipes with water after the disposal of calibrator material. Standard ® C3 OSR6159 ERM – DA470 for C3c.01 BLODR30037. Johnson AM. pH 7. Olesen Larsen S. Storage and Stability: The calibrator is stable.Clin Chem Lab Med 2001.24:271-79. Baudner S. Bienvenu J.01 2009-08 Calibrator . the calibrator is stable for 30 days. this product should be handled as a potentially infectious material. et al. Blirup-Jensen S. Gently invert each vial several times prior to each use to ensure a homogeneous mixture. EN. provided it is free from contamination.39:1110-1122. 4 x 2 mL Contents.MC Cal A ODR30037 Intended Use The MC Cal A is intended to be used for the quantitative determination of the immuno-turbidimetric reagents listed in the table below on Beckman Coulter Mastercurve enabled systems only. Biological materials of human origin contained in this product were tested for Anti-HCV. Larsen M. Bull Wld Hlth Org 1961. It is recommended to record the date the calibrator was opened on the bottle label. Dispose of all waste material in accordance with local guidelines. Transferrin Anti-Streptolysin O Complement 3 Complement 4 Also contains preservative. Calibrator Composition Variable amounts of the following human proteins in a liquid serum matrix. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. To avoid the possible build-up of azide compounds. up to the stated expiry date when stored at 2…8°C. For in vitro diagnostic use only. 3. International standard for anti-streptolysin-O. and stored at 2…8°C. AST. Johnson AM. Carlström A. Once open.1993. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. 1 2. Hewitt LF. No. Value Assignment Refer to table of assigned values for MC Cal A.0. Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. BIBLIOGRAPHY 1.3 The MC Cal A values have been assigned using the following reference materials by immuno-turbidimetry: Reagent Cat. tightly capped immediately after each use. Milford Ward A. CRM 470. The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins. Bentzon MW. Calibrator Preparation The calibrator is ready for use. Spaun J. 2. Blirup-Jensen S. EUR 15243 EN. unopened. Protein standardization IV: value transfer procedure for the assignment of serum protein values from a reference preparation to a target material. Test Procedure Refer to relevant product instructions for use. . 01 BLODR3024.01 2009-08 Calibrator . up to the stated expiry date when stored at 2…8°C. R22: Harmful if swallowed. provided they are free from contamination. This material and its container must be disposed of as hazardous waste. to ensure a homogeneous mixture. Safety Phrases: S36. Biological materials of human origin contained in this product were tested for Anti-HCV. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. unopened. For in vitro diagnostic use only. it is recommended to calibrate microalbumin separately to other serum assays. S60.Microalbumin Calibrator ODR3024 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL Calibrator 1 Calibrator 2 Calibrator 3 Calibrator 4 Calibrator 5 (White Cap) (Yellow Cap) (Orange Cap) (Red Cap) (Black Cap) Intended Use The Microalbumin calibrator is intended to be used with the Microalbumin reagent OSR6167 for the quantitative determination of albumin on Beckman Coulter analysers. Calibrator Composition Sodium chloride Human albumin Preservative 150 mmol/L Variable Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. Value Assignment1 Please refer to table of assigned values. Once open. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. Calibrator Preparation The calibrators are ready for use. To avoid the possible build-up of azide compounds. tightly capped immediately after each use. Wear suitable protective clothing. Refer to Safety Data Sheets for further information. Data on file at Beckman Coulter Biomedical Ltd. Test Procedure Refer to relevant product instructions for use. contains sodium azide. Dispose of all waste material in accordance with local guidelines. Limitations The microalbumin result of a urine sample may be elevated when it immediately follows a serum sample. flush waste-pipes with water after the disposal of calibrator. Storage and Stability The calibrators are stable. and stored at 2…8°C. The Microalbumin Calibrator values have been assigned using a primary albumin standard by immunoturbidimetry. BIBLIOGRAPHY 1. this product should be handled as a potentially infectious material. Contents. EN. Gently invert each vial several times. In order to eliminate this effect. the calibrators are stable for 30 days. prior to each use. . Dispose of all waste material in accordance with local guidelines. Iwasa M. Waterman MR. Kawai H. Radioimmunoassay for human myoglobin: methods and results in patients with skeletal muscle or myocardial disorders.3 Refer to table of assigned values. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Stone MJ. BIBLIOGRAPHY 1. the calibrators are stable for 30 days. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. up to the stated expiry date when stored at 2…8°C.Myoglobin Calibrator ODR3025 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL Calibrator 1 Calibrator 2 Calibrator 3 Calibrator 4 (White Cap) (Yellow Cap) (Orange Cap) (Red Cap) Intended Use The Myoglobin Calibrator is a buffer based matrix containing human myoglobin intended to be used with the Myoglobin reagent OSR6168 for the quantitative determination of myoglobin on Beckman Coulter analysers. Yagita M.0 % w/v 0. Gently invert each vial several times. Willerson JT. Gomez-Sanchez CE. to ensure a homogeneous mixture. 2. Test Procedure Refer to relevant product instructions for use.2. Kondo A. Contents. Hayashi T. Results in patients with acute myocardial infarction. Storage and Stability The calibrators are stable.4) BSA Sodium chloride Preservative Variable 10 mmol/L 1. unopened. Calibrator Preparation The calibrators are ready for use. J Lab Clin Med 1978.01 BLODR3025. Kenny MA. 3. J Clin Invest 1975. provided they are free from contamination. tightly capped immediately after each use. A radioimmunoassay for human serum myoglobin: method development and normal values.23:69-75. EN. this product should be handled as a potentially infectious material. Biological materials of human origin contained in this product were tested for Anti-HCV. prior to each use. and stored at 2…8°C.92:341-52. flush waste-pipes with water after the disposal of calibrator. Once open. Miyoshi K. The Myoglobin Calibrator values are traceable to a highly purified human cardiac myoglobin and values assigned using a commercially available RIA method by immunoturbidmetry.56:1334-9. Clin Chem 1977. Radioimmunoassay of myoglobin in human serum. Calibrator Composition Human myoglobin HEPES buffer (pH 7. Saito S.01 2009-08 Calibrator .9 % w/v Precautions and Warnings To avoid the possible build-up of azide compounds. For in vitro diagnostic use only. It is recommended to record the date the calibrator was opened on the bottle label. Rosano TG. Value Assignment1. . 1993. Johnson AM. Once open. Carlström A. Biological materials of human origin contained in this product were tested for Anti-HCV. tightly capped immediately after each use. Calibrator Preparation The calibrators are ready for use. Dispose of all waste material in accordance with local guidelines. The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins. Storage and Stability The calibrators are stable.01 BLODR3029. prior to each use. CRM 470. For in vitro diagnostic use only. provided they are free from contamination. BIBLIOGRAPHY 1. Test Procedure Refer to relevant product instructions for use. 1 2 The Prealbumin Calibrator values have been assigned using the IFCC (International Federation of Clinical Chemistry) standard CRM 470 by immunoturbidimetry. unopened.01 2009-08 Calibrator . HbsAg and Anti-HIV 1/2 on a single donor basis and were found to be non-reactive. up to the stated expiry date when stored at 2…8°C. Johnson AM. Value Assignment Refer to table of assigned values. Calibrator Composition Liquid human serum matrix containing variable amounts of human prealbumin and a preservative. the calibrators are stable for 30 days. EN. to ensure a homogeneous mixture. et al. Blirup-Jensen S. 2.39:1110-1122 Baudner S. this product should be handled as a potentially infectious material.Prealbumin Calibrator ODR3029 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL Calibrator 1 Calibrator 2 Calibrator 3 Calibrator 4 Calibrator 5 (White Cap) (Yellow Cap) (Orange Cap) (Red Cap) (Black Cap) Intended Use The Prealbumin Calibrator is a liquid human serum based matrix calibrator intended to be used with the Prealbumin reagent OSR6175 for the quantitative determination of prealbumin on Beckman Coulter analysers. Blirup-Jensen S. Bienvenu J.Clin Chem Lab Med 2001. flush waste-pipes with water after the disposal of calibrator. and stored at 2…8°C. Contents. EUR 15243 EN. Protein standardization IV: value transfer procedure for the assignment of serum protein values from a reference preparation to a target material. Larsen M. Gently invert each vial several times. Milford Ward A. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Precautions and Warnings To avoid the possible build-up of azide compounds. . NIBSC 64/2 . . Krag P.42:311-318. this product should be handled as a potentially infectious material. Anderson SG. Dispose of all waste material in accordance with local guidelines. Once open. provided they are free from contamination. Contents. by immunoturbidimetry. Value Assignment Refer to table of assigned values. Biological materials of human origin contained in this product were tested for Anti-HCV.RF Latex Calibrator ODC0028 1 x 1 mL 1 x 1 mL 1 x 1 mL 1 x 1 mL 1 x 1 mL Calibrator 1 Calibrator 2 Calibrator 3 Calibrator 4 Calibrator 5 (White Cap) (Blue Cap) (Green Cap) (Red Cap) (Orange Cap) Intended Use The RF Latex Calibrator is a liquid human serum based matrix calibrator intended to be used with the RF Latex reagent OSR61105 for the quantitative determination of Rheumatoid Factor on Beckman Coulter analysers. 1 The RF Calibrator values have been assigned using the WHO International reference material. Storage and Stability The calibrators are stable. the calibrators are stable for 3 months. to ensure a homogeneous mixture. Calibrator Preparation The calibrators are ready for use. Calibrator Composition Liquid human serum matrix containing variable amounts of human RF and preservative. up to the stated expiry date when stored at 2…8°C. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. BIBLIOGRAPHY 1. EN. International reference preparation of rheumatoid arthritis serum.01 BLODC0028. flush waste-pipes with water after the disposal of calibrator. Bull Wld Hlth Org 1970. and stored at 2…8°C. Test Procedure Refer to relevant product instructions for use. tightly capped immediately after each use. Houba V.01 2009-08 Calibrator . For in vitro diagnostic use only. Precautions and Warnings To avoid the possible build-up of azide compounds. prior to each use. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Gently invert each vial several times. unopened. Bentzon MW. . Storage and Stability The calibrators are stable. EUR 15243 EN. The material is prepared from human serum with the constituent values adjusted where necessary by the addition of analytical grade chemicals and appropriate serum proteins. 2. Once open. No. up to the stated expiry date when stored at 2…8°C. Spaun J. Baudner S. International collaborative study to evaluate a recombinant L ferritin preparation as an international standard. provided they are free from contamination. IgA OSR6144 / OSR61171 IFCC standard CRM 470. 4. The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins. Blirup-Jensen S. Carlström A. Heath A. No. AST. Calibrator Composition Variable amounts of the following human proteins in a liquid serum matrix. Hewitt LF. Biological materials of human origin contained in this product were tested for Anti-HCV. Worwood M. Standard IgG OSR6145 / OSR61172 IFCC standard CRM 470. this product should be handled as a potentially infectious material. CRM 470. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. immunoglobulin A. Blirup-Jensen S.Clin Chem Lab Med 2001. Cook JD. Value Assignment Refer to table of assigned values for Serum Protein Multi-Calibrator. complement 3. Immunoglobulin G Transferrin Immunoglobulin A C-reactive protein Immunoglobulin M Anti-Streptolysin O Complement 3 Ferritin Complement 4 Also contains preservative Precautions and Warnings To avoid the possible build-up of azide compounds. Transferrin OSR6152 IFCC standard CRM 470. 1 2. unopened.01 BLODR3021. immunoglobulin M. Walker D.1993. Reagent IgG IgA IgM C3 C4 Cat. Johnson AM.43:1582-87. Gently invert each vial several times. Olesen Larsen S. Dispose of all waste material in accordance with local guidelines. Milford Ward A. prior to each use. No.01 2009-08 Calibrator . complement 4. rd Ferritin OSR6150 / OSR61138 / OSR61203 3 international standard for ferritin. Bull Wld Hlth Org 1961. transferrin. Larsen M.4 The Serum Protein Multi-Calibrator values have been assigned using the following reference materials by immuno-turbidimetry: Reagent Cat. Calibrator Preparation The calibrators are ready for use. Arosio P. the calibrators are stable for 30 days.3. Thorpe SJ. EN. OSR6145 / OSR61172 OSR6144 / OSR61171 OSR6146 / OSR61173 OSR6159 OSR6160 Reagent Transferrin CRP ASO Ferritin Cat.0. flush waste-pipes with water after the disposal of calibrator. IgM OSR6146 / OSR61173 IFCC standard CRM 470. Protein standardization IV: value transfer procedure for the assignment of serum protein values from a reference preparation to a target material. C3 OSR6159 IFCC standard CRM 470 for C3c. C-reactive protein.39:1110-1122. Bienvenu J. CRP OSR6147 IFCC standard CRM 470. C4 OSR6160 IFCC standard CRM 470. pH 7.Serum Protein Multi-Calibrator ODR3021 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL Calibrator 1 Calibrator 2 Calibrator 3 Calibrator 4 Calibrator 5 Calibrator 6 (White Cap) (Yellow Cap) (Orange Cap) (Red Cap) (Black Cap) (Green Cap) Intended Use The Serum Protein Multi-Calibrator is intended to be used with the immuno-turbidimetric reagents listed in the table below for the quantitative determination of immunoglobulin G. Clin Chem 1997. to ensure a homogeneous mixture. 3. Test Procedure Refer to relevant product instructions for use. recombinant NIBSC 94/572 BIBLIOGRAPHY 1. Johnson AM. st ASO OSR6194 WHO NIBSC 1 International standard for Anti-Streptolysin O. tightly capped immediately after each use and stored at 2…8°C. Bentzon MW. anti-Streptolysin O and ferritin on Beckman Coulter analysers. International standard for anti-streptolysin-O. OSR6152 OSR6147 OSR6194 OSR6150 / OSR61138 / OSR61203 Contents.24:271-79. For in vitro diagnostic use only. et al. . Test Procedure Refer to relevant product literature. the calibrators are stable for 30 days. EUR 15243 EN.Clin Chem Lab Med 2001. 3. tightly capped immediately after each use. It is recommended to record the date the calibrator was opened on the bottle label. Johnson AM. Poulik MD.Serum Protein Multi-Calibrator 2 ODR3023 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL 1 x 2 mL Calibrator 1 Calibrator 2 Calibrator 3 Calibrator 4 Calibrator 5 (White Cap) (Yellow Cap) (Orange Cap) (Red Cap) (Black Cap) Intended Use The Serum Protein Multi-Calibrator 2 is intended to be used with the Beckman Coulter immuno-turbidimetric reagents listed in the table below for the quantitative determination of α-1 acidglycoprotein. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. J Biol Stand 1985. Larsen M. No. α-1 antitrypsin. to ensure a homogeneous mixture. Storage and Stability The calibrators are stable. Baudner S. Esteve J. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. Carlström A. flush waste-pipes with water after the disposal of calibrator material. ceruloplasmin and haptoglobin on Beckman Coulter analysers.3 The Serum Protein Multi-Calibrator 2 values have been assigned using the following reference materials by immuno-turbidimetry: Reagent Cat. Vincent C. Standard OSR6162 IFCC standard CRM 470 α-1 acidglycoprotein OSR6163 IFCC standard CRM 470 α-1 antitrypsin st OSR6151 WHO 1 International Standard 1985 β-2 microglobulin Ceruloplasmin OSR6164 IFCC standard CRM 470 Haptoglobin OSR6165 IFCC standard CRM 470 BIBLIOGRAPHY 1. this product should be handled as a potentially infectious material. Forbes M. OSR6162 OSR6163 OSR6151 OSR6164 OSR6165 Contents.13:185-97.01 BLODR3023. Cooper EH. Once open. β-2 microglobulin. Deconninck I. EN. Johnson AM.1993. For in vitro diagnostic use only.0. No. 2. 1 2. Calibrator Preparation The calibrators are ready for use. et al. Blirup-Jensen S. α-1 acidglycoprotein α-1 antitrypsin β-2 microglobulin Ceruloplasmin Haptoglobin Also contains preservative Precautions and Warnings To avoid the possible build-up of azide compounds. A collaborative study of a preparation of normal human serum for use as a reference in the assay of beta 2 microglobulin. pH 7. unopened. The material is prepared from human serum with the constituent values adjusted where necessary by the addition of analytical grade chemicals and appropriate serum proteins.39:1110-1122. The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins. Dispose of all waste material in accordance with local guidelines. Biological materials of human origin contained in this product were tested for Anti-HCV. up to the stated expiry date when stored at 2…8°C. Protein standardization IV: value transfer procedure for the assignment of serum protein values from a reference preparation to a target material. and stored at 2…8°C.01 2009-08 Calibrator . Value Assignment Refer to table of assigned values for Serum Protein Multi-Calibrator 2. Reagent α-1 acidglycoprotein α-1 antitrypsin β-2 microglobulin Ceruloplasmin Haptoglobin Cat. Milford Ward A. Bienvenu J. Blirup-Jensen S. Calibrator Composition Variable amounts of the following human proteins in a liquid serum matrix. CRM 470. Gently invert each vial several times. provided they are free from contamination. et al. prior to each use. . Triglyceride. Cholinesterase. Tap the top of the vial before opening to dislodge any lyophilsate caught in the stopper. Precautions and Warnings Biological materials of human origin contained in this product were tested for Anti-HCV. 3. Lipase. 6. Dissolve the contents completely by gently mixing on a roller for 30 minutes. Please ensure that the lot number on the calibrator vial is the same as the one listed in the table of assigned values in the package insert. Dispose of all waste material in accordance with local guidelines.SYSTEM CALIBRATOR 66300 Intended Use The System Calibrator is a calibration serum intended to be used with Beckman Coulter System reagents on Beckman Coulter analysers. Lipase reagent is to be calibrated as normal in AB mode. For determination of Alkaline Phosphatase. Total Protein. HBDH. the calibrator is stable for 8 hours at 2…8°C. ** Bilirubin: The Stability of Bilirubin in the calibrator after freezing is 5 Days. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. it is recommended that the calibrator is used within 1 hour of reconstitution for calibrating Total and Non-prostatic Acid Phosphatase. Urea. 5. 2. With the addition of stabiliser. Continue mixing until the solution is homogeneous and all lyophilized material is reconstituted. Allow the vial to equilibrate to room temperature before opening to prevent condensation in the vial. 20°C). Since Bilirubin is light sensitive and total protection is not given by the brown bottle. it is recommended that the reconstituted serum be allowed stand for at least 2 hours at 2…8°C before use. Creatinine. Glucose. 3.01 2009-08 Calibrator . CK-NAC. Uric Acid. Iron.01 BL66300.8°C 8 hours 30 hours 1 week Exceptions Acid Phosphatase: In the absence of stabiliser. Record the date the vial was reconstituted on the bottle label. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. UIBC.0 mL weigh if unsure. Magnesium * When frozen once. AST. animal and plant origin. Stability of the components in the reconstituted calibrator in the absence of bacterial contamination are as follows: Alkaline Phosphatase. ** Bilirubin. LDH Albumin. Do not shake the vial as this will cause foaming. For in vitro diagnostic use only. -20°C * Not recommended 1 month 1 month 2. Stabiliser can be added to the calibrator to improve the stability of Acid Phosphatase. A fresh vial of calibrator should be used for each of these runs. it is recommended that 5 separate calibration events should be used.. Storage and Stability The calibrator is stable. storage of calibrator vials in the dark is recommended when calibrating Bilirubin. 1. Invert the vial 3 times and then leave to stand for 10 minutes. Always open the vial gently to prevent any loss of lyophilisate. 2. ALT. EN. Add to the vial fresh deionised water equilibrated to room temperature. *** Inorganic Phosphorous Calcium. Notes Important for Enzymes (Except Lipase) To provide a robust and easy approach to generate the analyser specific MB factor. Use a calibrated pipette that can accurately dispense 5.. Store at 2…8°C. (approx. Cholesterol. this product should be handled as a potentially infectious material. 4. Amylase. Value Assignment Calibration values have been determined using standardised procedures and Beckman Coulter System Reagents on Beckman Coulter analysers. The calibrator should not be frozen and reused. The calibrator must not be used to calibrate any other reagents if stabiliser has been added. unopened. GGT. 20 x 5 mL Contents Human serum with chemical additives and appropriate enzymes of human. *** Prior to lot 112 Inorganic Phosphorous stability was 1 week. The stabiliser is provided with the reagent kit and one drop of stabiliser should be added per 1mL of serum. Lactate. Calibrator Preparation 1. Test Procedure Refer to appropriate product literature. See product insert. When calculating the mean factor from the separate runs the data should be examined for obvious outliers which should be repeated and replaced. up to the stated expiry date when stored at 2…8°C. . EN. Calcium. Uric Acid. For in vitro diagnostic use only. unopened. Test Procedure Refer to relevant product instructions for use. The serum from each donor contributing urine for this product was tested and found to be non-reactive for Anti HCV. Precautions and Warnings To avoid the possible build-up of azide compounds. Dispose of all waste material in accordance with local guidelines. Creatinine. and stored at 2…8°C. Creatinine values may gradually decrease over the product shelf life. HbsAg and Anti-HIV 1/2. Calibration values have been determined using standardised procedures and Beckman Coulter System Reagents on Beckman Coulter analysers. Gently invert each vial several times.01 2009-08 Calibrator . the calibrator is stable for 60 days. Storage and Stability Do not freeze. Once open. Calibrator Composition Liquid human urine matrix containing Amylase. tightly capped immediately after each use. flush waste-pipes with water after the disposal of calibrator.Urine Calibrator ODC0025 Intended Use The Urine Calibrator is a liquid human urine calibrator intended to be used with the Beckman Coulter System Reagents listed below on Beckman Coulter analysers. It is recommended to record the date the calibrator was opened on the bottle label. Magnesium and preservative. this product should be handled as a potentially infectious material.01 BLODC0025. The calibrator is stable. to ensure a homogeneous mixture. As there is no known test method that can offer complete assurance that products containing human source material will not transmit infectious agents. Value Assignment Refer to table of assigned values. Inorganic Phosphorous. provided it is free from contamination. Please ensure that the lot number on the calibrator vial is the same as the one listed in the table of assigned values in this package insert. α-Amylase Calcium Glucose Inorganic Phosphorous Urea Uric Acid Creatinine Magnesium OSR6106 / OSR6182 OSR6113 / OSR6176 / OSR61117 OSR6121 OSR6122 OSR6134 OSR6136 OSR6178 / OSR61204 OSR6189 6 x 8 mL Contents. up to the stated expiry date when stored at 2…8°C. Glucose. Calibrator Preparation The calibrator is ready for use. prior to each use. Urea. . For in vitro diagnostic use only. 3. 8 hours when stored at 15…25°C or 4 weeks when stored at -20°C when frozen once. avoiding any loss of lyophilised material. the control is stable for 5 days when stored at 2…8°C. Once open. The results obtained by any individual laboratory may vary from the given mean value. With the rubber stopper back in place. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. Carefully remove the cap and rubber stopper from the bottle. Avoid foaming. Biological materials of human origin contained in this product were tested for Anti-HCV. These target values should fall within the corresponding acceptable ranges given in the enclosed table. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. The CK-MB Control value is traceable to a Beckman Coulter Master Calibrator. EN.0 mL.0 mL of sterile deionised water at 15…25°C to the lyophilised material using a volumetric pipette calibrated to deliver exactly 2. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Storage and Stability The CK-MB control serum is stable. If any trends or sudden shifts in values are detected. Add 2. 4.01 BLODR2041. Record the date the control was reconstituted on the bottle label. Control Composition Lyophilised human serum containing creatine kinase-MB isoenzyme. unopened. this product should be handled as a potentially infectious material. Test Procedure Refer to relevant product instructions for use. 2. Control Preparation 1. CK-MB Control Serum 9 x 2 mL Contents. up to the stated expiry date when stored at 2…8°C.01 2009-08 Control .CK-MB CONTROL SERUM ODR2041 Intended Use The CK-MB Control Serum is a lyophilised human serum control designed to monitor the accuracy and precision of the CK-MB reagent OSR6153 on Beckman Coulter analysers. review all operating parameters. Value Assignment Refer to table of means and ranges. dissolve the contents completely by gently mixing for 30 minutes. Precautions and Warnings Dispose of all waste material in accordance with local guidelines. providing it is free from contamination and is tightly capped immediately after each use. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. . 5. Value Assignment Refer to table of means and ranges. Continue mixing until the solution is homogeneous and all lyophilized material is reconstituted. Precautions and Warnings Dispose of all waste material in accordance with local guidelines. If any trends or sudden shifts in values are detected.0 mL.0 mL of sterile deionised water at 15…25°C to the lyophilised material using a volumetric pipette calibrated to deliver exactly 2.01 2009-08 Control . Control Preparation 1. With the rubber stopper back in place. the control is stable for 5 days when stored at 2…8°C. The CK-MB Control Serum Level 1 value has been standardised against the CKtotal IFCC Reference Method with addition of antibody. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. 8 hours when stored at 15…25°C or 4 weeks when stored at –20°C when frozen once. These target values should fall within the corresponding acceptable ranges given in the enclosed table. this product should be handled as a potentially infectious material. The results obtained by any individual laboratory may vary from the given mean value. Test Procedure Refer to relevant product instructions for use. 9 x 2 mL (White Cap) Contents. providing it is free from contamination and is tightly capped immediately after each use.CK-MB CONTROL SERUM LEVEL 1 ODR30035 Intended Use The CK-MB Control Serum Level 1 is a lyophilised human serum control designed to monitor the accuracy and precision of the CK-MB reagent OSR61155 on Beckman Coulter analysers. EN. unopened. dissolve the contents completely by gently mixing for 30 minutes. 3. For in vitro diagnostic use only. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. 4. avoiding any loss of lyophilised material. Add 2. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. review all operating parameters. performed manually and calculated via molar absorption coefficient ε. Biological materials of human origin contained in this product were tested for Anti-HCV. up to the stated expiry date when stored at 2…8°C. Once open.01 BLODR30035. Storage and Stability The CK-MB control serum is stable. Avoid foaming. Record the date the control was reconstituted on the bottle label. 2. Control Composition Lyophilised human serum containing creatine kinase-MB isoenzyme. Carefully remove the cap and rubber stopper from the bottle. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. . Test Procedure Refer to relevant product instructions for use. Value Assignment Refer to table of means and ranges. this product should be handled as a potentially infectious material. Biological materials of human origin contained in this product were tested for Anti-HCV. Precautions and Warnings Dispose of all waste material in accordance with local guidelines. Once open.01 BLODR30036. 2. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Avoid foaming. up to the stated expiry date when stored at 2…8°C. review all operating parameters. These target values should fall within the corresponding acceptable ranges given in the enclosed table. 3. unopened.0 mL. EN. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. For in vitro diagnostic use only. 9 x 2 mL (Black Cap) Contents. providing it is free from contamination and is tightly capped immediately after each use. Record the date the control was reconstituted on the bottle label. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. Control Composition Lyophilised human serum containing creatine kinase-MB isoenzyme. performed manually and calculated via molar absorption coefficient ε. With the rubber stopper back in place. 4. Continue mixing until the solution is homogeneous and all lyophilized material is reconstituted.0 mL of sterile deionised water at 15…25°C to the lyophilised material using a volumetric pipette calibrated to deliver exactly 2. Carefully remove the cap and rubber stopper from the bottle. 5. The results obtained by any individual laboratory may vary from the given mean value.CK-MB CONTROL SERUM LEVEL 2 ODR30036 Intended Use The CK-MB Control Serum Level 2 is a lyophilised human serum control designed to monitor the accuracy and precision of the CK-MB reagent OSR61155 on Beckman Coulter analysers. 8 hours when stored at 15…25°C or 4 weeks when stored at -20°C when frozen once. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. . Control Preparation 1. avoiding any loss of lyophilised material. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. the control is stable for 5 days when stored at 2…8°C. The CK-MB Control Serum Level 2 value has been standardised against the CKtotal IFCC Reference Method with addition of antibody. Storage and Stability The CK-MB control serum is stable. If any trends or sudden shifts in values are detected.01 2009-08 Control . dissolve the contents completely by gently mixing for 30 minutes. Add 2. . Control Preparation Allow the vial to equilibrate to room temperature before opening to prevent condensation in the vial. Lipase. Control Composition Lyophilised human serum with chemical additives and appropriate enzymes of human and animal origin. If any trends or sudden shifts in values are detected. Use a calibrated pipette that can accurately dispense 5. Urea & Uric Acid. These target values should fall within the corresponding acceptable ranges given in the enclosed table. AST. unopened. Each laboratory should establish its own control frequency. For in vitro diagnostic use only. however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. ALT. Once reconstituted the control is stable for 7 days. APO A1. Tap the top of the vial before opening to dislodge any lyophilisate caught in the stopper. provided it is free from contamination. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Triglyceride Albumin. Note: Bacterial contamination produces a characteristic odour and a decrease in the glucose level. CK-NAC. Dissolve the contents completely by gently mixing on a roller for 30 minutes. GLDH. Total Protein. UIBC. GLDH. ALT. Iron. APO A1. Glucose. HBDH. LDH. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. 20 x 5 mL (green cap) Contents. it is recommended that the reconstituted serum be allowed to stand for at least 2 hours at 2…8°C before use. HDL Cholesterol. Note: For determination of Alkaline Phosphatase. Lipase. Potassium. tightly capped immediately after each use and stored at 2…8°C. Creatinine. Precautions and Warnings Dispose of all waste material in accordance with local guidelines. up to the stated expiry date when stored at 2…8°C. Lithium. Calcium. LDH. 2…8°C 24 hours 24 hours 24 hours 2 days 7 days -20°C** 5 days 2 days 1 month 1 month 1 month 2…8°C 24 hours 24 hours 24 hours 2 days 7 days -20°C** 5 days 2 days 1 month 1 month 1 month * ACP stabiliser provided in the OSR6101 reagent kit should not be added to this control. APO B. (Approx. Cholesterol. 20°C). ** When frozen once. Total Protein. Creatinine. Amylase. Cholesterol.weigh if unsure. Calcium. Magnesium.01 BLODC0003. Storage and Stability The control is stable.Control Serum 1 ODC0003 Intended Use The Control Serum 1 is a lyophilised human serum control intended to be used in-conjunction with the Control Serum 2 ODC0004 to monitor the analytical performance of the Beckman Coulter system reagents listed in the enclosed table on Beckman Coulter analysers. IgG. Lactate. Triglyceride Albumin. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. Potassium.01 2009-08 Control . Glucose. Store at 2…8°C. CK-NAC. Please ensure that the lot number on the control vial is the same as the one listed in the enclosed table. Lithium. Inorganic Phosphorus. The results obtained by any individual laboratory may vary from the given mean value. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. UIBC. Chloride. Biological materials of human origin contained in this product were tested for Anti-HCV. AST. Lactate.0 mL. The following stabilities apply for Lot 0025 Reconstituted Stability Bilirubin-Total and Direct (Protect from light) Cholinesterase *ACP ALP. Do not shake the vial as this will cause foaming. Magnesium. Inorganic Phosphorus. Sodium. GGT. Note: These analyte concentrations are lot dependent and are listed in the enclosed table. Sodium. if observed discard the vial. Open the vial gently to prevent any loss of lyophilisate. The following stabilities apply from Lot 0027 onwards Reconstituted Stability Bilirubin-Total and Direct (Protect from light) Cholinesterase *ACP ALP. IgM. this product should be handled as a potentially infectious material. Test Procedure Refer to relevant product instructions for use. IgA. Amylase. Add to the vial. IgG. Urea & Uric Acid. fresh deionised water equilibrated to room temperature. Continue mixing until the solution is homogenous and all lyophilised material is reconstituted. IgA. Iron. IgM. HBDH. review all operating parameters. Chloride. Record the date the vial was reconstituted on the bottle label. Invert the vial 3 times and then leave to stand for 10 minutes. EN. The serum also contains preservatives and stabilisers. GGT. Richtlinien der Bundesärztekammer. When using the analyser quality control software for surveillance of assay performance the analyte specific standard deviations have to be determined by each laboratory.01 2009-08 EN.01 . 1 The ranges represent the maximum permissible deviation of a single determination according to Rilibäk. Value assignment has been carried out using the Beckman Coulter System. These standard deviations cannot be deduced from the stated acceptable ranges. For the analytes not listed in Rilibäk the ranges are given as +/-20% of the target mean value.Value Assignment Refer to table of means and acceptable ranges.32(6). These values represent the mean of either five-fold determinations from at least five independent series or three-fold determinations from at least eight independent series. Control BLODC0003. DG Klinische Chemie Mitteilungen 2001. BIBLIOGRAPHY 1. Lactate. APO B. Control Preparation 1. GLDH. review all operating parameters. ALT. Add to the vial. HDL Cholesterol. Note: Bacterial contamination produces a characteristic odour and a decrease in the glucose level. GGT. Total Protein. Iron. Total Protein. Record the date the vial was reconstituted on the bottle label. Biological materials of human origin contained in this product were tested for Anti-HCV. Dissolve the contents completely by gently mixing on a roller for 30 minutes. LDH. Inorganic Phosphorus. The serum also contains preservatives and stabilisers. Amylase. Sodium. Urea & Uric acid. 2…8°C 24 hours 24 hours 24 hours 2 days 7 days -20°C** 5 days 2 days 1 month 1 month 1 month 2…8°C 24 hours 24 hours 24 hours 2 days 7 days -20°C** 5 days 2 days 1 month 1 month 1 month * ACP stabiliser provided in the OSR6101 reagent kit should not be added to this control. if observed discard the vial. (Approx. 2. Magnesium. Creatinine. UIBC. Test Procedure Refer to relevant product instructions for use. CK-NAC. 20°C). fresh deionised water equilibrated to room temperature. IgG. IgA. Iron. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. The following stabilities apply for Lot 0026. GLDH. The results obtained by any individual laboratory may vary from the given mean value. this product should be handled as a potentially infectious material. Creatinine. Store at 2…8°C. Chloride. Use a calibrated pipette that can accurately dispense 5. APO B The following stabilities apply from Lot 0028 onwards Reconstituted Stability Bilirubin-Total and Direct (Protect from light) Cholinesterase *ACP ALP. Please ensure that the lot number on the control vial is the same as the one listed in the enclosed table. Lithium. AST. Precautions and Warnings Dispose of all waste material in accordance with local guidelines. HBDH. IgM. unopened. If any trends or sudden shifts in values are detected.01 BLODC0004. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. CK-NAC. tightly capped immediately after each use and stored at 2…8°C. it is recommended that the reconstituted serum be allowed to stand for at least 2 hours at 2…8°C before use. Chloride. Inorganic Phosphorus. APO A1. GGT. Glucose. Lipase. Triglyceride Albumin. Glucose. IgM. Lithium. ALT. Storage and Stability The control is stable. Reconstituted Stability Bilirubin-Total and Direct Bilirubin (Protect from light) Cholinesterase *ACP ALP. LDH. Lactate. provided it is free from contamination. Note: These analyte concentrations are lot dependent and are listed in the enclosed table. Cholesterol. Calcium. Cholesterol. Invert the vial 3 times and then leave to stand for 10 minutes. however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. IgG. Amylase. Lipase. up to the stated expiry date when stored at 2…8°C. Allow the vial to equilibrate to room temperature before opening to prevent condensation in the vial. Triglyceride Albumin. Potassium. Urea & Uric Acid. Magnesium. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. AST. Sodium. IgA.Control Serum 2 ODC0004 Intended Use The Control Serum 2 is a lyophilised human serum control intended to be used in-conjunction with the Control Serum 1 ODC0003 to monitor the analytical performance of the Beckman Coulter system reagents listed in the enclosed table on Beckman Coulter analysers. 5. 6. ** When frozen once. EN. Do not shake the vial as this will cause foaming. These target values should fall within the corresponding acceptable ranges given in the enclosed table. UIBC. Potassium.01 2009-08 Control . 3. Calcium.0 mL . Once reconstituted the control is stable for 7 days. Each laboratory should establish its own control frequency. Open the vial gently to prevent any loss of lyophilisate. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. APO A1. 20 x 5 mL (red cap) Contents. Control Composition Lyophilised human serum with chemical additives and appropriate enzymes of human and animal origin. For in vitro diagnostic use only.weigh if unsure 4. Continue mixing until the solution is homogenous and all the lyophilised material is reconstituted. Note: For determination of Alkaline Phosphatase. HBDH. Tap the top of the vial before opening to dislodge any lyophilisate caught in the stopper. 01 2009-08 EN.32(6). For the analytes not listed in Rilibäk the ranges are given as +/-20% of the target mean value. DG Klinische Chemie Mitteilungen 2001. When using the analyser quality control software for surveillance of assay performance the analyte specific standard deviations have to be determined by each laboratory. These standard deviations cannot be deduced from the stated acceptable ranges. 1 The ranges represent the maximum permissible deviation of a single determination according to Rilibäk. Control BLODC0004. Richtlinien der Bundesärztekammer.Value Assignment Refer to table of means and acceptable ranges. BIBLIOGRAPHY 1. These values represent the mean of either five-fold determinations from at least five independent series or three-fold determinations from at least eight independent series. Value assignment has been carried out using the Beckman Coulter System.01 . Carlström A. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins. BIBLIOGRAPHY 1. Gently invert each vial several times. tightly capped immediately after each use and stored at 2…8°C. EUR 15243 EN. The CRP concentrations of the control sera were measured using CRP Latex reagent OSR6199 with CRP Calibrator (Latex) ODR3031 and ODC0027 with reference to CRM470 as described in the appropriate calibrator leaflet. prior to each use. et al. Control 1 Control 2 2 x 3 mL 2 x 3 mL (white cap) (blue cap) Contents. Once open. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Value Assignment1 Refer to table of means and ranges. If any trends or sudden shifts in values are detected. to ensure a homogeneous mixture. Johnson AM. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Biological materials of human origin contained in this product were tested for Anti-HCV. unopened. Test Procedure Refer to relevant product instructions for use. Baudner S. These target values should fall within the corresponding acceptable ranges given in the enclosed table. For in vitro diagnostic use only. EN. Storage and Stability The controls are stable. Blirup-Jensen S. provided they are free from contamination.CRP (Latex) Control Serum ODC0013 Intended Use The CRP (Latex) Control Serum is a liquid human serum control designed to monitor the analytical performance of the sensitive and highly sensitive applications of the CRP Latex reagent OSR6199 on Beckman Coulter analysers. up to the stated expiry date when stored at 2…8°C. The results obtained by any individual laboratory may vary from the given mean value. Control Composition Liquid human serum matrix containing variable amounts of human CRP and preservatives.01 2009-08 Control . Milford Ward A. the controls are stable for 30 days. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. CRM 470. Dispose of all waste material in accordance with local guidelines. It is recommended to record the date the control was opened on the bottle label. Control Preparation The controls are ready for use. review all operating parameters. this product should be handled as a potentially infectious material. Precautions and Warnings To avoid the possible build-up of azide compounds. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Bienvenu J.01 BLODC0013. flush waste-pipes with water after the disposal of control material.1993. . Value Assignment Refer to table of means and ranges. To avoid the possible build-up of azide compounds. Safety Phrases: S36. flush waste-pipes with water after the disposal of control material. contains sodium azide. the controls are stable for 1 day at 15…25°C. providing it is free from contamination and is tightly capped immediately after use. Continue mixing until the solution is homogeneous and all lyophilised material is reconstituted. The results obtained by any individual laboratory may vary from the given mean value. 2. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. review all operating parameters. up to the stated expiry date when stored at 2…8°C. 3. Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful. 28 days at 2…8°C or 30 days when stored at -20°C when frozen once. EN. Record the date the control was reconstituted on the bottle label. Storage and Stability The controls are stable. S60. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration/blanking is performed. dissolve the contents completely by gently mixing for 30 minutes. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. avoiding any loss of lyophilised material. Control 1 Control 2 2 x 0. unopened. These target values should fall within the corresponding acceptable ranges given in the enclosed table. Safety data sheet available for professional user on request.01 2009-08 Control . Wear suitable protective clothing. Biological materials of human origin contained in this product were tested for Anti-HCV. If any trends or sudden shifts in values are detected. With the rubber stopper back in place. Avoid foaming. 4. Dispose of all waste material in accordance with local guidelines.5 mL of sterile deionised water at 15…25°C to the lyophilised material using a volumetric pipette calibrated to deliver exactly 0. 5. Once reconstituted.5 mL (Yellow Cap) (Orange Cap) Contents.01 BLODC0029. Control Composition Lyophilised human serum containing D-Dimer and preservatives. This material and its container must be disposed of as hazardous waste. Control Preparation 1. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. Add 0.5 mL.D-DIMER CONTROL ODC0029 Intended Use The D-Dimer Control is a lyophilised control in a human serum matrix intended to be used to monitor the analytical performance of the D-Dimer OSR60135 on Beckman Coulter analysers. The D-Dimer controls are traceable to the D-Dimer Calibrator (ODR3033). Carefully remove the cap and rubber stopper from the bottle. this product should be handled as a potentially infectious material. Test Procedure Refer to relevant product instructions for use. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. For in vitro diagnostic use only. Exercise the normal precautions required for handling all laboratory reagents. R22: Harmful if swallowed.5 mL 2 x 0. . 29 CFR Part 1910. The control values have been assigned using a primary gravimetric standard. to ensure a homogeneous mixture. and hepatitis C. 1815296/100099/100090 Microgenics Catalogue No. 1 2 1.1030. Official J.25 Propoxyphene* µg/L 225 375 BIBLIOGRAPHY Department of Labor.01 2009-08 Control . Dispose of all waste material in accordance with local guidelines. 2. OSR6323 OSR6315 OSR6316 OSR6317 OSR6318 OSR6319 Microgenics Catalogue No. flush waste-pipes with water after the disposal of control material. If any trends or sudden shifts in values are detected. containing the following constituents: d-Methamphetamine EDDP Propoxyphene Secobarbital Methadone Preservatives Nitrazepam Morphine Stabilisers Benzoylecgonine Phencyclidine Precautions and Warnings To avoid the possible build-up of azide compounds. In the event of exposure the 1. No. Reagent Amphetamines/Ecstasy Barbiturates Benzodiazepines Cocaine EDDP Methadone *Opiate 2K *PCP *Propoxyphene Cat. Amphetamines/ Ecstasy µg/L 750 1250 Barbiturates µg/L 225 375 Benzodiazepines µg/L 225 375 Cocaine µg/L 225 375 EDDP µg/L 75 125 Methadone µg/L 225 375 Opiates 2K* PCP* µg/L µg/L 1500 18. the controls are stable for 30 days. 17.DAU MULTI-DRUG CONTROL ODC0006 Intended Use The DAU Multi-Drug Control is a human urine based liquid control designed to monitor the analytical performance of the DAU reagents listed in the table below on Beckman Coulter analysers. No. Value Assignment Refer to table below for mean values assigned to the DAU Multi-Drug Control. Storage and Stability Do not freeze. prior to each use. the material must be handled just as carefully as the patient sample. 2000. the values of which have been verified by GC/MS. review all operating parameters. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Control Preparation The controls are ready for use. unopened. Register. Test Procedure Refer to relevant product instructions for use. The results obtained by any individual laboratory may vary from the given mean value.75 2500 31. provided they are free from contamination. Once open. Occupational Exposure to Bloodborne Pathogens. Materials of human origin were tested for HIV 1 and 2. Gently invert each vial several times. 1815784/100173/100172 Microgenics Catalogue No. The controls are stable. Communities. tightly capped immediately after each use and stored at 2…8°C. The findings were negative. However. EN. 1661523/100171/100170 DAU Multi-Drug Control DAU Multi-Drug Control 1 (low) 2 (high) 3 x 5 mL 3 x 5 mL * The tests listed are for use with Microgenics labelled reagents only. Fed. No. It is recommended to record the date the control was opened on the bottle label.56:64175-64182. of the Europ. Occupational Safety and Health Administration. 1991. as no test method can rule out the potential risk of infection with absolute certainty.2 directives of the responsible health authorities should be followed. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Contents. Final Rule. Control Composition The DAU Control is human urine based. hepatitis B. L262 from Oct.01 BLODC0006. For in vitro diagnostic use only. up to the stated expiry date when stored at 2…8°C. Council Directive (2000/54/EC). . No. If any trends or sudden shifts in values are detected.2 directives of the responsible health authorities should be followed.1030. Control Preparation The controls are ready for use. Official J. up to the stated expiry date when stored at 2…8°C. DAU Control 1 2 1. Gently invert each vial several times.5 187. as no test method can rule out the potential risk of infection with absolute certainty. Register. the material must be handled just as carefully as the patient sample. Test Procedure Refer to relevant product instructions for use.01 2009-08 Control .DAU SPECIALITY CONTROL ODC0007 Intended Use The DAU Speciality Control is a human urine based liquid control designed to monitor the analytical performance of the DAU reagents listed in the table below on Beckman Coulter analysers. The controls are stable. Value Assignment Refer to table below for mean values assigned to the DAU Speciality Control. Occupational Safety and Health Administration. EN. prior to each use. Storage and Stability Do not freeze.56:64175-64182. The results obtained by any individual laboratory may vary from the given mean value. and hepatitis C. The findings were negative. hepatitis B. 1991. Fed. flush waste-pipes with water after the disposal of control material.5 EDDP µg/L 75 125 Opiates µg/L 225 375 BIBLIOGRAPHY Department of Labor. of the Europ. Occupational Exposure to Bloodborne Pathogens. Final Rule.01 BLODC0007. 2000. review all operating parameters. unopened. L262 from Oct. The control values have been assigned using a primary gravimetric standard. 29 CFR Part 1910. In the event of exposure the 1. It is recommended to record the date the control was opened on the bottle label. tightly capped immediately after each use and stored at 2…8°C. 17. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. the controls are stable for 30 days. OSR6323 OSR6315 OSR6316 OSR6317 OSR6318 OSR6320 DAU Speciality Control DAU Speciality Control 1 (low) 2 (high) 3 x 5 mL 3 x 5 mL Contents. Council Directive (2000/54/EC). However. Communities. For in vitro diagnostic use only. containing the following constituents: d-Methamphetamine Secobarbital Nitrazepam Benzoylecgonine EDDP Morphine Preservative Stabilisers Precautions and Warnings To avoid the possible build-up of azide compounds. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. the values of which have been verified by GC/MS. Materials of human origin were tested for HIV 1 and 2. No. Control Composition The DAU Control is human urine based. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Dispose of all waste material in accordance with local guidelines. Reagent Amphetamines/Ecstasy Barbiturates Benzodiazepines Cocaine EDDP Opiates Cat. Once open. provided they are free from contamination. 2 Amphetamines/Ecstasy µg/L 375 625 Barbiturates µg/L 150 250 Benzodiazepines µg/L 150 250 Cocaine µg/L 112. to ensure a homogeneous mixture. . hepatitis B. to ensure a homogeneous mixture. It is recommended to record the date the control was opened on the bottle label. 1 (low) 2 (high) 1 (low) 2 (high) 1 x 15 mL 1 x 15 mL 1 x 15 mL 1 x 15 mL (white cap) (black cap) (white cap) (black cap) Contents. and hepatitis C. 2. To avoid the possible build-up of azide compounds. tightly capped immediately after each use and stored at 2…8°C. For in vitro diagnostic use only. Control Preparation The controls are ready for use. prior to each use. Test Procedure Refer to table for mean values assigned to the DAU THC Controls.2 directives of the responsible health authorities should be followed. Dispose of all waste material in accordance with local guidelines. provided they are free from contamination. Occupational Exposure to Bloodborne Pathogens. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. This material and its container must be disposed of as hazardous waste.01 2009-08 Control . contains sodium azide. The controls are stable. Council Directive (2000/54/EC). It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Control Composition Human urine containing 11-nor-Δ -tetrahydrocannabinol-9-carboxylic acid. Refer to relevant product instructions for use. the material must be handled just as carefully as the patient sample. No. up to the stated expiry date when stored at 2…8°C. Final Rule. The findings were negative. 2000. review all operating parameters. Gently invert each vial several times. Communities. unopened. However. Storage and Stability Do not freeze. Once open. Register. Wear suitable protective clothing. 17. of the Europ. The results obtained by any individual laboratory may vary from the given mean value. S60. Official J. R22: Harmful if swallowed. as no test method can rule out the potential risk of infection with absolute certainty. 1991. 29 CFR Part 1910. 9 Precautions and Warnings Hazard Warnings and Risk Phrases: Harmful.56:64175-64182. Department of Labor. flush waste-pipes with water after the disposal of control material. preservative and stabilisers. Materials of human origin were tested for HIV 1 and 2. EN.01 BLODC0008. Refer to Safety Data Sheets for further information. In the event of exposure the 1. the controls are stable for 60 days.1030.DAU THC CONTROLS ODC0008 DAU THC 25 Control ODC0009 DAU THC 50 Control Intended Use The DAU THC Controls are human urine based liquid controls designed to monitor the analytical preformance of the THC reagent OSR6322 on Beckman Coulter analysers. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. L262 from Oct. Safety Phrases: S36. BIBLIOGRAPHY 1. Fed. Occupational Safety and Health Administration. If any trends or sudden shifts in values are detected. . avoiding any loss of lyophilised material. Holding the Reconstitution Fluid dropper bottle vertically. Test Procedure Refer to relevant product instructions for use. Whole Blood Application Reconstituted controls should be placed on board the analyser without pre-treatment. 50(1): 166-174. Appearance of moisture in the bottle prior to reconstitution is an indication of deterioration of the material and renders the material unsatisfactory for use. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Hoshino T. antibodies to hepatitis C (HCV). Strictly follow the pre-treatment directions in the Instructions for Use of HbA1c Control (ODC0022). and are traceable to the IFCC HbA1c reference method via IFCC HbA1c reference material. Mauri P. Thienpont L. and incubate for 5 minutes at room temperature before use. Biological materials of human origin contained in this product have been tested and shown to be free from hepatitis B surface antigen (HbsAg). WG. 2.915 x IFCC) + 2. Kobold U. 40(1): 78-89. To avoid the possible build-up of azide compounds. Paroni R. Record the date the control was reconstituted on the bottle label. Mosca A.01 2009-08 Control EN. The reconstituted controls are stable at 15…25°C for 30 minutes and for 3 months when stored at 2…8°C. Little R. Dispose of all waste material in accordance with local guidelines. flush waste-pipes with water after the disposal of undiluted reagent. avoid foaming. discard the first drop to ensure a constant volume of the drops thereafter. Carefully remove the cap from the bottle. Barr JR. Approved IFCC reference method for the Measurement of HbA1c in Human Blood. IFCC Reference System for Measurement of Hemoglobin A1c in Human Blood and the National Standardisation Schemes in the United States. Haemolysate Application Before use. 5.HbA1c Control ODC0022 Intended Use The HbA1c Control is a lyophilised human blood control.25 mL) of the reconstitution fluid to the control bottle. Add six drops of fluid (0. review all operating parameters. The HbA1c control values have been assigned by immunoturbidimetry using HbA1c OSR6192 and HbA1c APT OSR61177. 3. This will ensure that any issues with the pre-treatment process or denaturant solution are identified and the performance of the Hba1c assay (OSR6192) is effectively monitored. patients’ samples can be processed with the minimum pre-treatment time of 5 minutes up to the maximum defined stability of the pre-treated sample of 8 hours at room temperature. swirl the control bottle several times and leave to stand at room temperature for 15 min. %HbA1c results are expressed in DCCT aligned units using the IFCC approved Master Equation (NGSP = (0. Mix thoroughly. and Sweden: A Method-Comparison Study. Theinpoint L. If at any time HbA1c controls are out of range. Jeppsson J-O. Control Composition Lyophilised whole blood of human origin HbA1c Level 1 lyophilised powder HbA1c Level 2 lyophilised powder Reconstitution Fluid 0. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. It is imperative that this step is controlled as accurately as possible. Umemoto M. John. Additional pre-treatment/QC recommendations for manual method: 1. Finke A. Jeppsson J-O. Control Preparation 1.2 Refer to table of means and ranges.15). OSR0004) [1:41 dilution]. Umemoto M. provided they are free from contamination. 4. Please note that only Hemoglobin Denaturant OSR0004 can be used with this method. Mauri P. and antibodies to Human Immunodeficiency Virus (HIV-1 and HIV-2). 3. Miedema. If any trends or sudden shifts in values are detected. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Hoelzel W. Storage and Stability The controls are stable. The results obtained by any individual laboratory may vary from the given mean value. pre-treat reconstituted controls by adding 25 µL of control to 1000 µL of Hemoglobin Denaturant (Cat No. These target values should fall within the corresponding acceptable ranges given in the enclosed table. Clin Chem 2004. 7. 2. Weykamp C. on Beckman Coulter analysers. Kobold U. 2 x Control 1 2 x Control 2 1 x 2 mL Lyo Lyo Reconstitution Fluid Contents. Clin Chem Lab Med 2002. Paroni R. tightly capped immediately after each use. Once a control has been assayed – discard it – never rerun pre-treated HbA1c controls. Wiedmeyer H-M. up to the stated expiry date when stored at 2…8°C. After 15 minutes. Takei I.Incubate controls with the denaturant at room temperature for exactly 5 minutes before placing onto the system. Continue mixing until the solution is homogenous and all lyophilised material is reconstituted. BIBLIOGRAPHY 1. Goodall I. For in vitro diagnostic use only.01 . Value Assignment1. Hoezel W. Mosca A. Weykamp C. discontinue the use of the current opened bottle of OSR0004 Hemoglobin Denaturant . BLODC0022. Carefully replace the cap. coat all surfaces of the control bottle by rotating and inverting the bottle. Barr J. 2. designed to monitor the accuracy and precision of HbA1c reagent OSR6192 and HbA1c APT reagent OSR61177. instead repeat the pre-treatment step. this product should be handled as a potentially infectious material. Susanto F. Miedema K. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Japan. Hoshino T. Once the effectiveness of the denaturant has been demonstrated in this manner for the minimum defined pre-treatment time. 6. unopened.09% Sodium Azide in saline Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. . 2.0 mL. 1982. EN. Bachorik PS. For in vitro diagnostic use only. To ensure stability. These target values should fall within the corresponding acceptable ranges given in the enclosed table.HDL/LDL-CHOLESTEROL CONTROL SERUM ODC0005 Intended Use The HDL/LDL-Cholesterol Control Serum is a lyophilised human serum control designed to monitor the analytical performance of the HDL and LDL Cholesterol reagents. Ross JW. Dept. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Guidelines on the measurement of low-density -lipoprotein cholesterol: executive summary. Control Preparation 1. Karon J. Health and Human Services. In: Lipid Research Clinics Program. Test Procedure Refer to relevant product instructions for use. 1. Value Assignment Refer to table of means and ranges. review all operating parameters. Bethesda. The reconstituted and frozen controls are stable for 30 days when stored at -20°C. this product should be handled as a potentially infectious material. Control Composition Lyophilised human serum containing human HDL-cholesterol and LDL-cholesterol. dissolve the contents completely by gently mixing for 30 minutes. Biological materials of human origin contained in this product were tested for Anti-HCV. Lippel K. Record the date the control was reconstituted on the bottle label. OSR6187 and OSR6183 respectively. Lipid and lipoprotein analysis. Precautions and Warnings Dispose of all waste material in accordance with local guidelines. Continue mixing until the solution is homogeneous and all lyophilized material is reconstituted. Hainline A. MD: U.01 2009-08 Control . for the National Cholesterol Education Program Working Group on Lipoprotein Measurement.44:1414-20. eds. With the rubber stopper back in place. If any trends or sudden shifts in values are detected. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. Once reconstituted the controls are stable for 7 days when stored at 2…8°C.2 The HDL/LDL-Cholesterol Control Sera values are traceable to the US CDC (Centre for Disease Control) HDL and LDL-cholesterol reference methods. 5. up to the stated expiry date when stored at 2…8°C. 4. 2. Storage and Stability The controls are stable. They can be aliquoted and frozen once. The results obtained by any individual laboratory may vary from the given mean value. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. 2nd ed.0 mL of sterile deionised water at 15…25°C to the lyophilised material using a volumetric pipette calibrated to deliver exactly 5. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. unopened. HbsAg and Anti-HIV 1/2 on a single donor basis and were found to be non-reactive. Avoid foaming. Clin Chem 1995. Add 5. avoiding any loss of lyophilised material. Beckman Coulter recommend that vials are tightly capped immediately after each use and that care is taken to avoid contamination.01 BLODC0005. Carefully remove the cap and rubber stopper from the bottle. 3. BIBLIOGRAPHY 1. Manual of laboratory operations. Control 1 Control 2 3 x 5 mL 3 x 5 mL Contents. on Beckman Coulter analysers.S. . Value Assignment Refer to table of means and ranges. EN. These target values should fall within the corresponding acceptable ranges given in the enclosed table. OSR6162 OSR6163 OSR6194 OSR6151 OSR6164 OSR6159 OSR6160 OSR6147/OSR61157 OSR6199 Reagent Ferritin Haptoglobin IgA IgG IgM Prealbumin RF Latex Transferrin Cat. Gently invert the vial several times prior to each use to ensure a homogeneous mixture. provided it is free from contamination. this product should be handled as a potentially infectious material. flush waste-pipes with water after the disposal of control material. review all operating parameters. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. No. Control Preparation The control is ready for use. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. containing the following constituents of human origin: α-1 acidglycoprotein Ferritin α-1 antitrypsin Haptoglobin Anti-Streptolysin O Immunoglobulin A Immunoglobulin G β-2 microglobulin Ceruloplasmin Immunoglobulin M Complement 3 Prealbumin Complement 4 Rheumatoid Factor C-reactive protein Transferrin Also contains preservatives and stabilisers. tightly capped immediately after each use and stored at 2…8°C. reagent and calibrator combinations that allow traceability to the relevant reference materials listed in the corresponding calibrator leaflets. Mean analyte values for ITA Control Serum have been assigned using appropriate variations in Beckman Coulter analyser. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.01 BLODC0014. Storage and Stability The control is stable. Control Composition The ITA Control Serum is human serum based. No. It is recommended to record the date the control was opened on the bottle label. The results obtained by any individual laboratory may vary from the given mean value. Once open. Precautions and Warnings To avoid the possible build-up of azide compounds. the control is stable for 30 days. unopened.01 2009-08 Control . Dispose of all waste material in accordance with local guidelines. up to the stated expiry date when stored at 2…8°C. Reagent α-1 acidglycoprotein α-1 antitrypsin ASO β-2 microglobulin Ceruloplasmin C3 C4 CRP CRP Latex Cat. OSR6150 / OSR61138 / OSR61203 OSR6165 OSR6144 / OSR61171 OSR6145 / OSR61172 OSR6146 / OSR61173 OSR6175 OSR61105 OSR6152 6 x 2 mL (yellow cap) Contents. Biological materials of human origin contained in this product were tested for Anti-HCV. For in vitro diagnostic use only. Test Procedure Refer to relevant product instructions for use. If any trends or sudden shifts in values are detected.ITA CONTROL SERUM 1 ODC0014 Intended Use The ITA Control Serum is a liquid human serum control intended to be used in-conjunction with ITA Control Sera ODC0015 and ODC0016 to monitor the analytical performance of the Beckman Coulter system reagents listed in the table below on Beckman Coulter analysers. . Control Composition The ITA Control Serum is human serum based. the control is stable for 30 days. For in vitro diagnostic use only. tightly capped immediately after each use and stored at 2…8°C. reagent and calibrator combinations that allow traceability to the relevant reference materials listed in the corresponding calibrator leaflets. this product should be handled as a potentially infectious material.ITA CONTROL SERUM 2 ODC0015 Intended Use The ITA Control Serum is a liquid human serum control intended to be used in-conjunction with ITA Control Sera ODC0014 and ODC0016 to monitor the analytical performance of the Beckman Coulter system reagents listed in the table below on Beckman Coulter analysers. Once open. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. No. Test Procedure Refer to relevant product instructions for use. Storage and Stability The control is stable. If any trends or sudden shifts in values are detected. review all operating parameters. Mean analyte values for ITA Control Serum have been assigned using appropriate variations in Beckman Coulter analyser. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. containing the following constituents of human origin: Ferritin α-1 acidglycoprotein Haptoglobin α-1 antitrypsin Anti-Streptolysin O Immunoglobulin A Immunoglobulin G β-2 microglobulin Ceruloplasmin Immunoglobulin M Complement 3 Prealbumin Complement 4 Rheumatoid Factor C-reactive protein Transferrin Also contains preservatives and stabilisers. EN.01 BLODC0015. These target values should fall within the corresponding acceptable ranges given in the enclosed table. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. up to the stated expiry date when stored at 2…8°C. flush waste-pipes with water after the disposal of control material. Control Preparation The control is ready for use. Dispose of all waste material in accordance with local guidelines. provided it is free from contamination. Reagent α-1 acidglycoprotein α-1 antitrypsin ASO β-2 microglobulin Ceruloplasmin C3 C4 CRP CRP Latex Cat. OSR6150 / OSR61138 / OSR61203 OSR6165 OSR6144 / OSR61171 OSR6145 / OSR61172 OSR6146 / OSR61173 OSR6175 OSR61105 OSR6152 6 x 2 mL (red cap) Contents. OSR6162 OSR6163 OSR6194 OSR6151 OSR6164 OSR6159 OSR6160 OSR6147 / OSR61157 OSR6199 Reagent Ferritin Haptoglobin IgA IgG IgM Prealbumin RF Latex Transferrin Cat. Gently invert the vial several times prior to each use to ensure a homogeneous mixture. The results obtained by any individual laboratory may vary from the given mean value. It is recommended to record the date the control was opened on the bottle label. unopened. Biological materials of human origin contained in this product were tested for Anti-HCV. Precautions and Warnings To avoid the possible build-up of azide compounds. No.01 2009-08 Control . Value Assignment Refer to table of means and ranges. . No. If any trends or sudden shifts in values are detected. tightly capped immediately after each use and stored at 2…8°C. Reagent α-1 acidglycoprotein α-1 antitrypsin ASO β-2 microglobulin Ceruloplasmin C3 C4 CRP CRP Latex Cat. the control is stable for 30 days. It is recommended to record the date the control was opened on the bottle label. OSR6162 OSR6163 OSR6194 OSR6151 OSR6164 OSR6159 OSR6160 OSR6147/OSR61157 OSR6199 Reagent Ferritin Haptoglobin IgA IgG IgM Prealbumin RF Latex Transferrin Cat. Control Composition The ITA Control Serum is human serum based. HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and were found to be non-reactive. Mean analyte values for ITA Control Serum have been assigned using appropriate variations in Beckman Coulter analyser. review all operating parameters. No. this product should be handled as a potentially infectious material. These target values should fall within the corresponding acceptable ranges given in the enclosed table. Biological materials of human origin contained in this product were tested for Anti-HCV. Dispose of all waste material in accordance with local guidelines. Storage and Stability The control is stable. reagent and calibrator combinations that allow traceability to the relevant reference materials listed in the corresponding calibrator leaflets. up to the stated expiry date when stored at 2…8°C. Test Procedure Refer to relevant product instructions for use. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents. Value Assignment Refer to table of means and ranges. containing the following constituents of human origin: Ferritin α-1 acidglycoprotein Haptoglobin α-1 antitrypsin Anti-Streptolysin O Immunoglobulin A Immunoglobulin G β-2 microglobulin Ceruloplasmin Immunoglobulin M Complement 3 Prealbumin Complement 4 Rheumatoid Factor C-reactive protein Transferrin Also contains preservatives and stabilisers. flush waste-pipes with water after the disposal of control material. Gently invert the vial several times prior to each use to ensure a homogeneous mixture. provided it is free from contamination. For in vitro diagnostic use only.01 2009-08 Control . unopened. Once open.ITA CONTROL SERUM 3 ODC0016 Intended Use The ITA Control Serum is a liquid human serum control intended to be used in-conjunction with ITA Control Sera ODC0014 and ODC0015 to monitor the analytical performance of the Beckman Coulter system reagents listed in the table below on Beckman Coulter analysers. EN.01 BLODC0016. The results obtained by any individual laboratory may vary from the given mean value. Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples are tested and each time calibration is performed. Precautions and Warnings To avoid the possible build-up of azide compounds. Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits. OSR6150 / OSR61138 / OSR61203 OSR6165 OSR6144 / OSR61171 OSR6145 / OSR61172 OSR6146 / OSR61173 OSR6175 OSR61105 OSR6152 6 x 2 mL (blue cap) Contents. Control Preparation The control is ready for use. It is therefore recommended that each laboratory generates analyte specific control target values and intervals based on multiple runs according to their requirements. . Avoid the formation of foam. Exercise the normal precautions required for handling all laboratory reagents. 4 x 54 mL Product Information Sodium Hydroxide Alkane Sulphonate Cumenesulphonic Acid Precautions and Warnings Hazard Warning and Risk Phrases: Xi Irritant. Safety data sheet available for professional user on request.01 BLODR20067.01 2009-08 Miscellaneous . S60. rinse immediately with plenty of water and seek medical advice. This material and its container must be disposed of as hazardous waste. Reagent Handling The Cleaning Solution is provided ready to use. In case of contact with eyes. R38 – R41. 37/39. Risk of serious damage to eyes. EN. Safety Phrases: S26. Wear suitable gloves and eye/face protection. Dispose of all waste material in accordance with local guidelines. Irritating to skin.CLEANING SOLUTION (For Contamination Avoidance) ODR20067 Intended Use Cleaning Concentrate. Storage and Stability Stable until the expiration date stated on the label when stored at 2 – 25°C. . Protect from Light.01 BLOE66039. Dispose of all waste material in accordance with local guidelines. Precautions and Warnings Hazard Warning and Risk Phrases: Irritant. seek medical advice immediately (show the label where possible). Safety data sheet available for professional user on request. Reagent Handling The Cleaning Solution is provided ready to use. S45 In case of accident or if you feel unwell. rinse immediately with plenty of water and seek medical advice. Safety Phrases: S26 In case of contact with eyes. S60 This material and its container must be disposed of as hazardous waste. Exercise the normal precautions required for handling all laboratory reagents. wash immediately with plenty of water. S28 After contact with skin. Avoid the formation of foam.CLEANING SOLUTION OE66039 Intended Use Cleaning Concentrate. EN. R31 Contact with acids liberates toxic gas. Storage and Stability Stable until the expiration date stated on the label when stored at 2 – 8°C. R36/38 Irritating to eyes and skin. S37 Wear suitable gloves. 6 x 500 mL Product Information Hypochlorite.01 2009-11 Miscellaneous . . Niederau CM. Hoshino T. Dispose of all waste material in accordance with local guidelines. Weykamp C. Finke A. avoid foaming. Mauri P. Umemoto M. 3. EN. Calibrators do not require pre-treatment. Discard any remaining unused aliquotted denaturant. Hoezel W. Reinauer H Glycohemoglobins In: Thomas L. Before use. up to the stated expiry date when stored at 2…8°C. Limitations Please note that only Hemoglobin Denaturant OSR0004 can be used with HbA1c OSR6192. Clin Chem Lab Med 2002. Clinical Laboratory Diagnostics. provided it is free from contamination.2 The HbA1c reagent OSR6192 is used as an indicator of the mean daily blood glucose concentration over the preceding two months. Data on file at Beckman Coulter Biomedical Ltd. Paroni R. Bibliography 1. Contents.40(1):78-89.. For in vitro diagnostic use only. the whole blood samples must be hydrolysed by the protease present in the Hemoglobin Denaturant.01 2009-08 Miscellaneous . Hemoglobin Denaturant OSR0004 is not suitable for use with HbA1c APT OSR61177. tightly capped immediately after each use and stored at 2…8°C. Handling the denaturant OSR0004: Never use discoloured or turbid denaturing solution and always store this reagent at 2…8°C.4 Preservative Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents. Specimen K2-EDTA or NH4-heparinised blood. 2 x 250 mL Summary1. Reagent Preparation The Hemoglobin Denaturant OSR0004 is ready for use. Thienpont L. Barr J. Test Procedure Refer to relevant product instructions for use. Kobold U. Use and assessment of clinical laboratory results. Once open. Storage and Stability3 Hemoglobin Denaturant is stable. unopened. 2. Mosca A. ed. Prior to measurement of HbA1c using OSR6192. 1998:142-148. Miedema K. Pour off the amount of denaturant needed to pre-treat samples into a clean container – recap and return the opened denaturant bottle to storage at 2…8°C Only pipette from this aliquot – Do not pipette directly from the opened bottle of denaturant. Run treated samples using the HbA1c reagent OSR6192. Approved IFCC reference method for the Measurement of HbA1c in Human Blood. pre-treat samples and controls manually by adding 25µL of whole blood to 1000µL of Hemoglobin Denaturant [1:41 dilution] mix thoroughly.Hemoglobin Denaturant OSR0004 Intended Use The Hemoglobin Denaturant Reagent is intended for use in the pretreatment of samples for the HbA1c reagent OSR6192. Frankfurt/Main: TH-Books Verlagsgesellschaft mbH.01 BLOSR0004. and incubate for 5 minutes at room temperature before use. Jeppsson J-O. Reagent Composition Porcine Pepsin Buffer pH 2. Hemoglobin Denaturant is stable up to the stated expiry date. . see following table).9 % Precautions and Warnings Exercise the normal precautions required for handling all laboratory reagents.0800 0. Test Principle Patient samples are diluted with the LIH reagent and the absorbance is measured at 6 wavelengths. 16 x 48 mL R1 Summary A number of diseases and pre-analytical conditions can result in increased concentrations of chromogens like bilirubin. ICT: Bilirubin and HEM: Haemoglobin) and the approximate concentration of the interferent (e.04010. Specimen Serum and Plasma.2000 >0.9 100 – 199 200 – 299 10 – 19.0150 0 22 4 0. Flag N + ++ +++ ++++ +++++ Approximate Concentration of Chromatic Substance LIP (mg/dL Intralipid) ICT (mg/dL Bilirubin) HEM (mg/dL Haemoglobin) < 40 < 2. Once open.9 200 – 299 300 – 500 20 – 40 300 – 500 > 500 > 40 > 500 If a particular sample is marked with one or more of the above flags.2000 Visual Assessment Miscellaneous EN.g. ++. The users of these test systems should evaluate the sample quality and identify potentially interfering substances in these samples. Dispose of all waste material in accordance with local guidelines. This verification can be done with the aid of the reagent specific information from the ‘Interfering Substances’ section of the relevant IFU. Method Concordance Lipaemia Patient serum samples were used to compare the Lipaemia Index of this LIH reagent OSR62166 on the AU2700 against a bichromatic turbidity test and against a visual assessment of the sample by three independent observers.LIH OSR62166 Intended Use Photometric test for the semi-quantitative assessment of lipaemia/turbidity. reagent stored on board the instrument is stable for 90 days. Contents.5 < 50 40 – 99 2. haemoglobin and lipids/turbidity in body fluids. ++++.0400 0 8 3 0.01 2009-08 .: +. For in vitro diagnostic use only. With the LIH reagent this assessment can be done on the AU Chemistry System.0 – 9. These flags characterise the kind of chromatic substance (LIP: Lipaemia/turbidity. If one or more chromogen in a potentially interfering concentration is present in a sample. Storage and Stability The reagent is stable unopened up to the stated expiry date when stored at 2…25°C. The results are summarised in the following tables. Flag +++++ ++++ +++ ++ + N Frequency of Lipaemia flags 0 14 0 0 6 1 2 1 LIP AU2700 +ve -ve 3 288 -ve 52 29 +ve 1 476 ≤0. icterus and haemolysis (LIH) in human serum and plasma on Beckman Coulter analysers. Calibration No calibration required.08010. Test Procedure Refer to the appropriate User Guide and analyser configuration screen for analyser-specific assay instructions for the sample type as listed in the Intended Use statement. users should verify if the kind or the level of the chromogen is a potential risk to the accuracy of the test results of that sample.5 – 4.9 50 – 99 100 – 199 5. Chromogens can interfere with photometric tests. Reagent Preparation The reagent is ready for use and can be placed directly on board the instrument.1200 Turbidity OD 0.01 BLOSR6x166. Reagent Composition in the Test Sodium chloride Preservatives 0. applicable flags will be generated and reported along with the results of the analyses performed on that sample. The manufacturers of clinical reagents are responsible for the characterisation of the interference performance of the supplied test systems. Calculation The Beckman Coulter analysers automatically compute the LIH status of each sample.01510. It is recommended that serum/plasma should be physically separated from contact with cells within two hours from the time of collection. Use samples undiluted.12010. and this evaluation is normally done by visual assessment. Icterus Patient serum samples were used to compare the Icterus Index of this LIH reagent OSR62166 on the AU2700 against the Bilirubin reagent OSR6112 and against a visual assessment of the sample by three independent observers. D. • If severe turbidity. or turbidity. B." Textbook of Clinical Chemistry. PA (1995). LDH/HBDH in these samples may be increased by 10 to 20%. The results are summarised in the following tables. Approved Guideline. "Specimen Collection and Processing. Washington.C. W. Saunders. NCCLS publication H18-A. Sources of Biological Variation.e. PA (1991). B. The results are summarised in the following tables.0-19. AACC Press. W.9 20. a genuine HEM + may be reported as HEM ++ Both interference effects are linear with the Bilirubin and Intralipid concentration. W. Procedures for the Handling and Processing of Blood Specimens. Villanova. 3rd Edition.99 5.e. D. Philadelphia. Young DS. PA (1994). Friedman RB and Young DS. Flag +++++ ++++ +++ ++ + N Frequency of Icterus flags 11 1 4 3 ICT AU2700 +ve -ve 7 283 -ve 74 5 +ve 5 449 < 2. Philadelphia.C." 3rd Edition. Saunders. • If the visual assessment shows no apparent abnormality consider these samples as normal. Tietz NW. icterus and/or haemolysis is observed consider these samples as LIP+++++.0-39.50-4. "Clinical Guide to Laboratory Tests.01 2009-08 EN. Bibliography • • • • • • Tietz NW.5 1 12 1 2.99 10. Miscellaneous BLOSR6x166. National Committee for Clinical Laboratory Standards. "Clinical Diagnosis and Management by Laboratory Methods. B. • In rare cases mild haemolysis (20 to 50 mg/dL) may generate ABN flags. PA (1990)." 18th Edition.00-9. (1997). ICT+++++ and/or HEM+++++. Philadelphia. Henry JB ed. Effects of Disease on Clinical Laboratory Tests. 2nd Edition. Limitations The integrity of all indices should be visually verified if ABN flags are obtained.01 . Flag +++++ ++++ +++ ++ + N Frequency of Haemolysis flags 0 15 24 30 8 26 50-99 100-199 200-299 300-499 Haemoglobin Concentration (mg/dL) HEM AU2700 10 3 +ve -ve 1 288 -ve 86 4 +ve 359 < 50 ≥ 500 Visual Assessment Interfering Substances Results of studies conducted to evaluate the susceptibility of the method to interference were as follows: Lipaemia index: no interference up to 40 mg/dL or 684 µmol/L Bilirubin no interference up to 5 g/L haemoglobin ® Bilirubin index: no interference up to 500 mg/dL Intralipid no interference up to 5 g/L haemoglobin Haemolysis index: 40 mg/dL Bilirubin can have a negative effect on the HEM index by a maximum of 2 classes – i. Washington. (1997). of the sample and the triglyceride concentration. Effects of Preanalytical Variables on Clinical Laboratory Tests. Please note that there is a poor correlation between the Lipaemia index. AACC Press. a genuine HEM +++ may be reported as HEM + ® 500 mg/dL Intralipid can have a positive effect on the HEM index by a maximum of 1 class – i. Saunders. 2nd Edition.9 Bilirubin Concentration (mg/dL) 2 20 4 15 10 ≥ 40 Visual Assessment Haemolysis Patient serum samples were used to compare the Haemolysis Index of this LIH reagent OSR62166 on the AU2700 against the Total Hemoglobin reagent OSR6192 (without predilution) and against a visual assessment of the sample by three independent observers. 2000 1.0400 0.7000 + ++ +++ ++++ +++++ Lipemia 0.0 Reagents 1 vol. AU2700/AU5400 Application System Reagent: OSR62166 Specific Test Parameters General LIH ISE Range Test Name: 96. vol.1100 0.1200 0.4300 0. LIH 96.1100 0.2100 0.8500 1.0800 0.1700 ++ 0.7000 1.7000 ++++ 0.0000 1.6 20 90 μL μL Days µL < Level > < Lip > < Ict > < Hem > + 0. LIH Reagent ID: 166 LIH.2100 0. AU400/AU640 Application System Reagent: OSR62166 Reagent ID: 166 Specific Test Parameters General LIH ISE Range Test Name: Use Test Name: 96. AU600 Application System Reagent: OSR62166 Reagent ID: 166 Specific Test Parameters General LIH Test Name: ISE 96.2000 1.0150 0.LIH. 2.0800 0.6 20 90 Dilution Dilution μL μL 0 100 µL µL Level Lipemia: Icterus: Hemolysis: + 0.8500 1.0150 0. LIH Sample: Volume Reagents: R1 Volume Onboard Stability Period: Level Lipemia: Icterus: Hemolysis: 2.1100 0.1700 0.8500 1.7000 0 100 ∇ µL Sample vol. LIH LIH.3500 +++ 0.3500 0.7000 + 0.0400 0. 25 ONBOARD STBLTY PERIOD μL μL µL µL Dil.0000 +++++ 0.0 25 90 μL μL Dilution Dilution 0 125 µL µL Sample: Volume Reagents: R1 Volume Onboard Stability Period: 1. Dil.0400 0.3500 Miscellaneous BSOSR62166.4300 0.0150 0. LIH Use Test Name: 96.0000 +++++ 0.7000 1.3500 +++ 0.4300 0.0800 0.1200 0.2000 Icterus 0.1700 ++ 0.7000 1.7000 1.2100 0.2100 0. AU680/AU480 Application Reagent ID: 166 HbA1c Calculated Tests LIH Reagent Dedicated Range System Reagent: OSR62166 Specific Test Parameters Test No: 96 Name LIH Use Test No: 96 Name LIH Dilution Dilution 0 LIH Judgement Level +++ 0.0150 0. 0 125 90 Sample: Volume Reagents: R1 Volume Onboard Stability Period: 1.7000 Hour Hemolysis 0.1700 ++ 0.7000 ++++ 0.2000 1.1100 0.4300 0.7000 ++++ 0.0400 0.1200 0.0000 +++++ 0.8500 1.7000 LIH.1200 0.0800 0.01 2009-08 . vol. . This material and its container must be disposed of as hazardous waste. Irritating to skin. After contact with skin.01 BLOSR0001. Safety Phrases: S26-28a-37/39-60: In case of contact with eyes. Wear suitable gloves and eye/face protection. rinse immediately with plenty of water and seek medical advice.Wash Solution OSR0001 ODR2000 Intended Use Cleaning Concentrate.01 2009-08 Miscellaneous . R38 – R41. 6x2L 4x5L Precautions and Warnings Hazard Warnings and Risk Phrases: Xi Irritant. Risk of serious damage to eyes. wash immediately with plenty of water. EN.