PICT ANTICOAGULANT MONITORING 1. PEFAKIT PICT. Clotting Assay. PEFAKIT PiCT. PEFAKIT PICT Calibrators UFH. PEFAKIT PICT Controls UFH

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1 PEFAKIT PiCT PEFAKIT PICT Calibrators UFH PEFAKIT PICT Controls UFH PEFAKIT PICT Calibrators LMWH Clotting Assay PICT 1. PEFAKIT PICT Package size kit 80 3 vials of PiCT Activator (2mL) 3 vials of PiCT Start Reagent (2 ml) Plasma based functional assay for the determination of Factor Xa and factor IIa inhibitors. PiCT relies on the activation of plasma directly at the level of the pro-thrombinase complex, resulting in a fine-tuned analytical output directly linked to antithrombotic drug content. RVV-V (a specific FV activator from aboia russelli) activates FV. In the presence of added phospholipids (mimicking platelet membranes or other negatively charged surfaces), a defined amount of FXa and calcium is added and the prothrombinase is rapidly formed. ue to the FV preactivation by means of RVV-V prothrombinase formation becomes solely dependent on the activity of FXa and FIIa in the sample. 5 PEFAKIT PICT Controls LMWH PiCT test principle Prothrombinase complex Phospholipids RVV-V Traditional coagulation tests such as aptt, PT, ECT, TT or anti-xa assays are of limited use for the monitoring of antithrombotic drugs since different assays are required for monitoring of different anticoagulants. Intrinsic pathway Ca ++ FXa / FVa FV Extrinsic pathway The most commonly used test, aptt, broadly used to monitor heparin, lacks consistency, results varying with reagent, instrument and drug. Chromogenic assays represent the gold standard in most cases, but require special instrumentation. A universal test adaptable to standard instruments would simplify monitoring antithrombotic therapy and minimize investment to the hemostasis lab by eliminating the need for adopting new tests as new antithrombotic drugs enter the market. Inhibition (LMWH) Prothrombin Fibrinogen Thrombin Fibrin Inhibition (UFH/hirudin) Clotting time 54

2 2. PEFAKIT PICT CALIBRATORS UFH 4. PEFAKIT PICT CALIBRATORS LMWH x 2 x 1.0 ml 3 vials of UFH Calibrator 1 (1 ml) 3 vials of UFH Calibrator 2 (1 ml) M x 2 x 1.0 ml 3 vials of LMWH Calibrator 1 (1 ml) 3 vials of LMWH Calibrator 2 (1 ml) M Calibrator plasmas for quantification of unfractionated heparins (UFH) with Pefakit PiCT. This kit contains vials of plasma with no UFH anticoagulant activity (CAL1, 0 IU/ml) and vials of plasma with high UFH anticoagulant activity (CAL2) calibrated against WHO UFH standard. Calibrator plasmas for the quantification of low molecular weight heparins (LMWH) with Pefakit PiCT This kit contains vials of plasma with no LMWH anticoagulant activity (CAL1, 0 IU/ml) and vials of plasma with high LMWH anticoagulant activity (CAL2) calibrated against WHO LMWH standard. 3. PEFAKIT PICT CONTROLS UFH 5. PEFAKIT PICT CONTROLS LMWH x 2 x 1.0 ml 3 vials of UFH Control 1 (1 ml) 3 vials of UFH Control 2 (1 ml) M x 2 x 1.0 ml 3 vials of LMWH Control 1 (1mL) 3 vials of LMWH Control 2 (1 ml) M Control plasmas for quantification of unfractionated heparins (UFH) with Pefakit PiCT Pefakit PiCT Controls UFH contains vials of plasma with low and high UFH anticoagulant activity (C1, C2). Unfractionated heparin (UFH) Control plasmas for the quantification of low molecular weight heparins (LMWH) with Pefakit PiCT Pefakit PiCT Controls LMWH contains vials of plasma with low and high LMWH anticoagulant activity (C1, C2). Low molecular weight heparin (LMWH) Clotting time on BCS (s) r 2 = ,0 0,5 1,0 1,5 2,0 UFH (UI/mL) Clotting time on BCS (s) r 2 = ,0 0,2 0,4 0,6 0,8 1,0 1,2 1,4 1,6 LMWH in UI / ml 55

3 Clotting Assay IRECT THROMBIN INHIBITORS 1.TECHNOCLOT TI Package size kit 2 x 20 tests 2 vials of Reagent 1 (R1): Normal Plasma, lyophilized (2 ml) 2 vials of Reagent 2 (R2): bovine thrombine (2 ml) TECHNOCLOT TI is used for the determination of anticoagulant activity of the direct thrombin inhibitor (TI) dabigatran in human citrated plasma. 1 2 TECHNOCLOT TI TECHNOVIEW abigatran cal set abigatran is the active component of the oral anticoagulant pro-drug, abigatran Etexilate which has been approved for various indications under the tradename Pradaxa.For measuring dabigatran in plasma, in a first step the diluted patient sample is mixed with normal human plasma reagent R1. Clotting is then initiated by adding the thrombin reagent R2. The clotting time measured is directly related to the concentration of the assayed dabigatran in the sample plasma. 3 TECHNOVIEW abigatran low control 4 TECHNOVIEW abigatran high control 5 TECHNOVIEW Argatroban Cal set 6 TECHNOVIEW Argatroban Low Control 7 TECHNOVIEW Argatroban High Control Test principle NEW abigatran time (s) r 2 = ng/ml Very good reproducibility abigatran ng/ml Argatroban time (s) r 2 = µg/ml Argatroban μg/ml intra-assay inter-assay intra-assay inter-assay Mean CV % TECHNOCLOT TI is used for the determination of anticoagulant activity of the direct thrombin inhibitor (TI) dabigatran in human citrated plasma. abigatran is the active component of the oral anticoagulant pro-drug, abigatran Etexilate which has been approved for various indications under the tradename Pradaxa.For measuring dabigatran in plasma, in a first step the diluted patient sample is mixed with normal human plasma reagent R1. Clotting is then initiated by adding the thrombin reagent R2. The clotting time measured is directly related to the concentration of the assayed dabigatran in the sample plasma. ng/ml iabagran abigatran: No interference with heparin 0,18 0 U/mL 0.8 U/mL 0,12 1 U/mL 0, U/mL 0,00 abigatran Control Low + UFH µg/ml Argatroban Argatroban: No interference with heparin U/mL 0.8 U/mL U/mL U/mL 0.00 Argatroban Control Low + LMWH 56

4 2. TECHNOVIEW ABIGATRAN CAL SET x 1.0 ml 4 vials of plasma (1 ml) Set of 4 calibrators with different concentrations of abigatran. The TECHNOVIEW ABIGATRAN Calibrator is prepared from citrated plasmas supplemented with different concentrations of abigatran using the TECHNOCLOT TI. 3. TECHNOVIEW ABIGATRAN LOW CONTROL x 1.0 ml 5 vials of plasma (1 ml) Control plasma with low concentration of abigatran ( 150 ng/ml). The TECHNOVIEW ABIGATRAN Low Control Plasma is prepared from citrated plasmas supplemented with a low concentrations of abigatran around 150 ng/ml. 4. TECHNOVIEW ABIGATRAN HIGH CONTROL x 1.0 ml 5 vials of plasma (1 ml) Control plasma with high concentration of abigatran ( 300 ng/ml). The TECHNOVIEW ABIGATRAN High Control Plasma is prepared from citrated plasmas supplemented with a high concentrations of abigatran around 300 ng/ml. The TECHNOVIEW abigatran Calibrator and Control Plasma Sets listed below are plasmas for calibration and quality control of the corresponding anticoagulant measurement, titrated and optimised using the TECHNOCLOT TI. 5. TECHNOVIEW ARGATROBAN CAL SET x 1.0 ml 5 vials of plasma (1 ml) Set of 4 calibrators with different concentrations of Argatroban (0 to 2 µg/ml). The TECHNOVIEW ARGATROBAN Calibrator is prepared from citrated plasmas supplemented with different concentrations of Argatroban using the TECHNOCLOT TI. 6. TECHNOVIEW ARGATROBAN LOW CONTROL x 1.0 ml 5 vials of plasma (1 ml) Control plasma with low concentration of Argatroban ( 0.7 µg/ml) The TECHNOVIEW ARGATROBAN Low Control Plasma is prepared from citrated plasmas supplemented with a low concentrations of Argatroban around 0.7 µg/ml. 7. TECHNOVIEW ARGATROBAN HIGH CONTROL x 1.0 ml 5 vials of plasma (1 ml) Control plasma with high concentration of Argatroban ( 1.2 µg/ml). The TECHNOVIEW ARGATROBAN High Control Plasma is prepared from citrated plasmas supplemented with a high concentrations of Argatroban around 1.2 µg/ml. The TECHNOVIEW Argatroban Calibrator and Control Plasma Sets listed below are plasmas for calibration and quality control of the corresponding anticoagulant measurement, titrated and optimised using the TECHNOCLOT TI. 57

5 1. TECHNOCHROM ANTI-Xa Chromogenic Assay ANTI-Xa Package size kit 80 1 vial of Reagent 1 (4 ml) 1 vial of Reagent 2 (4 ml) 1 vial of Reagent 3 (20 ml) M ANTI-Xa 1 TECHNOCHROM anti-xa UFH 2 Technoview UFH cal set 3 Technoview UFH cont low 4 Technoview UFH cont high LMW 5 Technoview LMW cal set A system of reagents for the chromogenic determination of direct and indirect Xa inhibitors in human citrated plasma. TECHNOCHROM anti-xa assay is based on the inhibition of activated factor X (FXa) by Antithrombin (AT) in the presence of heparin as measured by a chromogenic FXa substrate. The amount of pna, released by enzymatic hydrolysis, is measured at 405 nm. There is an inverse relationship between the amount of heparin present in the sample and colour development. Information Anticoagulant Linearity etection limit Fondaparinux (Arixtra ) μg/mL 0.07μg/mL LMWH IU/mL 0.05 IU/mL UFH IU/mL 0.06 IU/mL anaparoid (Orgaran ) IU/mL 0.08 U/mL Rivaroxaban (Xarelto ) ng/ml 10 ng/ml Technoview LMW cont low Technoview LMW cont medium Technoview LMW cont high 58

6 2. TECHNOVIEW UFH CAL SET 5. TECHNOVIEW LMW CAL SET x 1.0 ml Set of 5 plasmas for calibration of unfractionated Heparin (UFH) Calibrators are prepared from citrated plasmas supplemented with different concentrations of unfractionated Heparin x 1.0 ml Set of 5 plasmas for calibration of Low Molecular Weight (LMW) Heparin measurements titrated and optimised using anti-xa assays. Calibrator plasmas are prepared from citrated plasmas supplemented with different concentrations of LMW Heparin. 6. TECHNOVIEW LMW CONT LOW 3. TECHNOVIEW UFH CONT LOW x 1.0 ml Set of low control plasmas for quality control of unfractionated Heparin (UFH) Control plasmas are prepared from citrated plasmas supplemented with 0.2 IU/mL of unfractionated Heparin x 1.0 ml Set of low control plasmas for the quality control of Low Molecular Weight (LMW) Heparin Control Low plasmas are prepared from citrated plasmas supplemented with 0.4 IU/mL of LMW Heparin. 7. TECHNOVIEW LMW CONT MEIUM 4. TECHNOVIEW UFH CONT HIGH x 1.0 ml Set of high control plasmas for quality control of unfractionated Heparin (UFH) x 1.0 ml Set of medium control plasmas for the quality control of Low Molecular Weight (LMW) Heparin Control Medium plasmas are prepared from citrated plasmas supplemented with 0.9 IU/mL of LMW Heparin. Control plasmas are prepared from citrated plasmas supplemented with 0.5 IU/mL of unfractionated Heparin. Heparin is the most frequently used antithrombotic therapeutic drug. The biological activity of this sulfated glycosaminoglycan resides in its ability to accelerate (up to 2000-fold) the inhibitory effect of antithrombin (AT) on the coagulation proteases. 8. TECHNOVIEW LMW CONT HIGH x 1.0 ml Set of high control plasmas for the quality control of Low Molecular Weight (LMW) Heparin LMW Control High plasmas are prepared from citrated plasmas supplemented with 1.3 IU/mL of LMW Heparin. 59

7 1. TECHNOVIEW ORGARAN CAL SET Lyophilized plasmas ANTI-Xa x 1.0 ml Set of 5 plasmas for calibration of Sodium anaparoid (Orgaran ) measurements titrated and optimised using anti-xa assays. Calibrator plasma is prepared from citrated plasmas supplemented with different concentrations of Sodium anaparoid (Orgaran ). Orgaran Arixtra 4 5 Technoview Orgaran cal set Technoview Orgaran cont low Technoview Orgaran cont high Technoview Arixtra cal set Technoview Arixtra cont low 2. TECHNOVIEW ORGARAN CONT LOW x 1.0 ml Set of low control plasmas for the quality control of Sodium anaparoid (Orgaran ) Control Low plasmas are prepared from citrated plasmas supplemented with 0.50 IU/mL of Sodium anaparoid (Orgaran ). 6 Technoview Arixtra cont high 3. TECHNOVIEW ORGARAN CONT HIGH Sodium anaparoid (Orgaran ) is a polysaccharide anticoagulant, used as an alternative therapy to Heparin or low molecular weight Heparin (LMWH), when these latter drugs are contraindicated. TECHNOVIEW Orgaran Calibrator plasmas are prepared from citrated plasmas supplemented with different concentrations of Sodium anaparoid (Orgaran ). The plasma contains stabilizers but no bactericide additives x 1.0 ml Set of high control plasmas for the quality control of Sodium anaparoid (Orgaran ) Control High plasmas are prepared from citrated plasmas supplemented with 1.0 IU/mL of Sodium anaparoid (Orgaran ). 60

8 4. TECHNOVIEW ARIXTRA CAL SET x 1.0 ml Set of 5 plasmas for calibration and the quality control of Arixtra (Fondaparinux sodium) measurements, titrated and optimised using anti-xa assays. Calibrator plasma is prepared from citrated plasmas supplemented with different concentrations of Fondaparinux sodium Sodium (Arixtra ). 5. TECHNOVIEW ARIXTRA CONT LOW x 1.0 ml Set of low control plasmas for the quality control of Arixtra (Fondaparinux sodium) Control plasmas are prepared from citrated plasmas supplemented with 0.5 µg/ml of Fondaparinux sodium (Arixtra). 6. TECHNOVIEW ARIXTRA CONT HIGH Arixtra can be used as an anticoagulant for curative or preventive indications. Measuring the Arixtra concentration in patient s plasma allows monitoring the therapy and adjusting drug dosage. TECHNOVIEW Arixtra Calibrator plasmas are prepared from citrated plasmas supplemented with different concentrations of Fondaparinux sodium (Arixtra) x 1.0 ml Set of high control plasmas for the quality control of Arixtra (Fondaparinux sodium) High Control plasmas are prepared from citrated plasmas supplemented with 1.5 µg/ml of Fondaparinux sodium (Arixtra ). 61

9 Rivaroxaban Technoview Rivaroxaban cal set Technoview Rivaroxaban cont low Technoview Rivaroxaban cont medium Technoview Rivaroxaban cont high Apixaban Technoview Apixaban cal set Technoview Apixaban cont low Technoview Apixaban cont high Lyophilized plasmas ANTI-Xa NEW 7. TECHNOVIEW RIVAROXABAN CAL SET x 1.0 ml x 1.0 ml Set of 5 plasmas for calibration of rivaroxaban Calibrator plasmas are prepared from citrated plasmas supplemented with different concentrations of rivaroxaban. The plasma contains stabilizers but no bactericide additives. 8. TECHNOVIEW RIVAROXABAN CONT LOW x 1.0 ml Set of low control plasmas to be used for the quality control of rivaroxaban Control Low Plasmas are prepared from citrated plasmas supplemented with around 60 ng/ml of rivaroxaban. 9. TECHNOVIEW RIVAROXABAN CONT MEIUM x 1.0 ml Set of medium control plasmas to be used for the quality control of rivaroxaban Control Medium Plasmas are prepared from citrated plasmas supplemented with around 110 ng/ml of rivaroxaban. 62 Rivaroxaban is an oral anticoagulant invented and manufactured by Bayer. In a number of countries it is marketed as Xarelto. 10. TECHNOVIEW RIVAROXABAN CONT HIGH x 1.0 ml Set of high control plasmas to be used for the quality control of rivaroxaban Control High Plasmas are prepared from citrated plasmas supplemented with around 300 ng/ml of rivaroxaban.

10 11. TECHNOVIEW APIXABAN CAL SET x 1.0 ml Set of calibration plasmas to be used for calibration of apixaban Calibrator plasma is prepared from citrated plasmas supplemented with different concentrations of apixaban. 12. TECHNOVIEW APIXABAN CONT LOW x 1.0 ml TECHNOVIEW Apixaban Control Plasma is a set of low control plasmas to be used for the quality control of apixaban Control Low Plasmas are prepared from citrated plasmas supplemented with around 120 ng/ml of apixaban. 13. TECHNOVIEW APIXABAN CONT HIGH x 1.0 ml TECHNOVIEW Apixaban Control Plasma is a set of high control plasmas to be used for the quality control of apixaban High Control plasmas are prepared from citrated plasmas supplemented with around 300 ng/ml of apixaban. Apixaban is an anticoagulant for the treatment of venous thromboembolic events. It is a direct factor Xa inhibitor. Measuring the Apixaban concentration in patients plasma allows monitoring the therapy and adjusting drug dosage. 63

11 Frozen Plasmas ANTI-Xa 1. CONTROL HNF / UFH CTHNF1 CTHNF2 Set of control plasmas for quality control of unfractionated Heparin (UFH) Control UFH plasmas are prepared from citrated plasmas supplemented with 2 different concentrations of WHO UFH standard chosen by customer Control HNF / UFH Control HBPM / LMWH Control ORGARAN 2. CONTROL HBPM / LMWH CTHBPM1 CTHBPM2 Features & benefits Supplemented with standard from european pharmacopoeia. Set of high control plasmas for the quality control of Low Molecular Weight (LMW) Heparin Control LMWH plasmas are prepared from citrated plasmas supplemented with 2 different concentrations of WHO LMWH standard chosen by customer. 64 Rapidly frozen in liquid Nitrogen Without any bovine additives No alteration due to lyophilization Ready to use in a couple of minutes Plasmas found negative for FA required tests Colour code for each plasma product Conditioned in plastic tubes, adaptable on STAR analyzers Can be stored up to 3 years at -40 C / -80 C 3. CONTROL ORGARAN CTO1-08 CTO2-08 Set of control plasmas for the quality control of Sodium anaparoid (Orgaran ) Control ORGARAN plasmas are prepared from citrated plasmas supplemented with 2different concentrations of Sodium anaparoid (Orgaran ).