Innovin®, Thromborel® S Always on Target for PT Determination. Doctors depend on precise and accurate results to provide optimal care for their patients.Always on Target for PT Determination. and the DADE BEHRING reagents Innovin® and Thromborel® S meet the high standards required for reliable testing. and X) Innovin® • Recombinant human tissue factor and synthetic phospholipids • High factor sensitivity • Excellent precision and stability • Clear. VII. V. The Prothrombin Time test is of great clinical importance in the diagnosis of acquired or inherited disorders of the extrinsic coagulation system..0 • Excellent heparin insensitivity Thromborel® S • Human placental thromboplastin • High factor sensitivity • Excellent precision and stability • Good lot-to-lot consistency • Reliable therapeutic range • First standardized thromboplastin • Over 850 batches of constant quality . no sedimentation • Good lot-to-lot consistency • Reliable therapeutic range • ISI values approx. Innovin® and Thromborel® S are indicated for the following applications: • Detection of inherited and acquired deficiencies of the extrinsic coagulation system • Monitoring of oral anticoagulant therapy • Analysis of specific coagulation factors (II. 1. VII and X.Innovin®.. which indicates excellent correlation with the WHO standard...) . Due to its recombinant source it is possible to guarantee that it contains no infectious contaminants such as HIV or hepatitis. precise results Innovin® and Thromborel® S are both calibrated against the presently validated standard to be used for human thromboplastin preparations according to the WHO guidelines. Economy Innovin® and Thromborel® S show excellent stability. Particularly. The ISI values for Innovin® and Thromborel® S are stated (for the most common instruments) in the lotdependent table values. A deficiency of one or more factors leads to a prolongation of the prothrombin time. minimizing the thrombotic or bleeding risks. Both reagents can be used for the determination of derived fibrinogen.0. 2 U/ml and 0. Factor Sensitivity Minimizing the risks in the Oral Anticoagulant Therapy Control Innovin® and Thromborel® S show excellent sensitivity to a reduction in factors II. better than other conventional reagents. 1. the high factor VII sensitivity allows the proper adjustment in the oral anticoagulant therapy. Innovin® and Thromborel® S assure exact control of the transition from heparin to coumarin treatment. (Derived Fibrinogen for Thromborel® S is not approved in the US yet. The use of ISI values allows the assay results to be expressed in INR (following the WHO recommendations for monitoring the oral anticoagulant therapy). Heparin Insensitivity Safe transition from heparin to coumarin treatment Innovin® and Thromborel® S are insensitive to heparin up to approx. Thromborel® S Standardization For patient safety. V. for both reagents. sensitivity and reproducibility. The sensitivity of each lot. avoiding reagent waste and allowing cost savings.6 U/ml respectively. The INR is intended to eliminate the differences between PT reagents when results are expressed as a percentage of normal or in seconds. Because such levels of heparin do not affect the measurements. is calculated and stated in ISI. Innovin® and Thromborel® S ISI values are approx. Accuracy and Precision Innovin® and Thromborel® S have excellent lot-to-lot consistency. Security Innovin® is manufactured under controlled conditions. 1 70-130% 15-36%** .6 U/ml plasma PT Calibration Plasmas 1-4 ✔ Calibration set for Thromborel® S ✔ No dilution of fibrinogen ✔ Optimal distribution of calibration points PT Calibration Plasma Kit A-D* ✔ Calibration set for calibrating INR and % of norm. synthetic phospholipids and calcium in stabilized HEPES buffer system Approx. (15ºC) . (37ºC) Opened vial: 48 h.0 INR Closed vial: 5 days (2-8ºC) Opened vial: 48 h. 24 h.Always on Target for PT Determination Product Information: PT Reagents and Calibrators Innovin® Components ISI value Reference range OAC therapeutic range Stability after reconstitution Heparin-insensitivity Calibrators: Recombinant human tissue factor. 8 h.0 to 1.0 80-130% 12-33% . (37ºC) Up to 0.5-2.5-2. 1. 1. 5 days (15-25ºC) . 2 U/ml plasma InnoCal Set* ✔ Calibration set for Innovin® ✔ No dilution of fibrinogen ✔ Optimal distribution of calibration points * not available in the US Thromborel® S Components ISI value Reference range OAC therapeutic range Stability after reconstitution Heparin-insensitivity Calibrators: Human placental thromboplastin and calcium chloride Approx. ✔ Easy determination of MNPT with plasma A * not available in the US ** typical values. (15ºC) Up to approx. for exact data see lot-dependent table of values Features Comparison • • • • Factor sensitivity Heparin insensitivity Lupus anticoagulant sensitivity Activator source Innovin® +++ +++ ++ Recombinant Thromborel® S ++ ++ Human placenta . 4. 4.0 INR Closed vial: 10 days (2-8ºC) . sensitive screening test for coagulation disorders in the domain of the extrinsic systems (factors II. Thromborel® S Thromborel® S is prepared from human placental tissue factor combined with calcium chloride and stabilizers. With Thromborel® S and the relevant deficient plasma. Innovin® contains no other clotting factors such as prothrombin. Due to its high sensitivity for these coagulation factors Thromborel® S is especially well suited to monitoring oral anticoagulant therapy. V. it is highly sensitive to factor deficiencies and plasma samples from patients treated with oral anticoagulants. VII and X.. Innovin® is also insensitive to therapeutic levels of heparin. VII and X).. calcium. even in the mildly pathological range. FVII or FX.. The Prothrombin Time measured with Thromborel® S is a rapid. . it is possible to determine activity of coagulation factors II. Therefore.Innovin®. Thromborel® S exhibits good correlation with the WHO international reference thromboplastin preparation. The sensitivity of Innovin® is very similar to the WHO human brain reference thromboplastin. In addition. Thromborel® S Product Description Innovin® Innovin® is prepared from purified recombinant human tissue factor produced in E. V. buffers and stabilizers. coli combined with synthetic phospholipids. The high sensitivity of Innovin® to coagulation factors and its insensitivity to therapeutic heparin make it beneficial in monitoring oral anticoagulant therapy. its high sensitivity allows differentiation of abnormal plasmas. 5 ml Accuracy controls 291070* 291071* 291072* ORKE35 ORKE65 OUPZ13 OUPZ21 * not available in the US Ci-Trol® 1 Ci-Trol® 2 Ci-Trol® 3 Control Plasma N Control Plasma N Control Plasma P Control Plasma P 10 x for 1. Germany www.0 ml 8 x for 10 ml 12 x for 20 ml 20 x for 10 ml Calibrators 291094* OQLZ11* OUUP11 * not available in the US PT Calibration Set Innovin PT Calibration Plasma Kit A-D PT Calibration Plasmas 1-4 4 x for 1.0 ml 20 x for 1.com .0 ml Precision controls OTXR21 B4244-10 B4244-20 B4244-30 Control Plasma U Ci-Trol® level 1** Ci-Trol® leveI 2** Ci-Trol® level 3** 30 x for 1.0 ml 10 x for 10 ml 12 x for 20 ml 8 x for 2.0 ml 6 x for 1.0 ml ** in conjunction with Dade Behring LabLink program Innovin® and Thromborel® S are registered trademarks of Dade Behring Inc. Information given in this brochure is accurate at the time of going to press.0 ml 8 x for 4.0 ml 20 x for 1.0 ml 4 x for 1.0 ml 10 x for 1.0 ml 30 x for 1.0 ml 10 x for 1.0 ml 30 x for 1. The details in the package insert are binding in each individual case 131 200 E 01/05 DADE BEHRING Höchster Strasse 70 65835 Liederbach.0 ml 20 x for 1.0 ml 2 x 4 x for 0.dadebehring.Order Information PT reagents B4212-40* B4212-50 B4212-100 OUHP13 OUHP23 OUHP35 OUHP47 OUHP43 * not available in the US Innovin® Innovin® Innovin® Thromborel® S Thromborel® S Thromborel® S Thromborel® S Thromborel® S 10 x for 4.0 ml 6 x for 1. and all affiliated companies.