Assays on the Ceveron 100 Series Instruments For

Assays on the Ceveron 100 Series Instruments For Research Use Only M

Clotting Chromogenic D-Dimer Thrombin Generation Quenching Mode M

Clotting Assays PT a. PTT Fibrinogen Thrombin. Time Extrinsic Factor Assays – Factor II, V, VII, X Intrinsic Factor Assays – Factor VIII, IX, XII, PK, M HMWK Lupus Anticoagulant testing Factor VIII Inhibitor Kit Protein C Protein S APC Resistance Direct Thrombin Inhibitors

Fletcher & Fitzgerald Factor Assays � Fletcher Factor – Prekallikrein ◦ 5205006 Fletcher Trait Plasma �Deficient in prekallikrein � Fitzgerald Factor – HMW Kininogen M ◦ 5204006 Fitzgerald Trait Plasma �Deficient in HMW kininogen � Assayed values in Coagulation Reference � Control values in Control A, Control N � Protocols in Ceveron s 100

Chromogenic Assays �Factor VIII: Chromogenic �C 1 INH �Protein C M �Antithrombin �Plasminogen �Antiplasmin �Anti- Xa assays

Anticoagulant Monitoring �Anti-Xa ◦ ◦ ◦ assays Apixaban Arixtra Edoxaban M Orgaran Rivaroxaban Heparin – LMW and UF �Direct Thrombin Inhibitors ◦ Dabigatran ◦ Argatroban

Turbidimetric �Techno. LEIA D-Dimer ◦ Latex Enhanced immunoassay M

Flexible Protocols �Open channels �Adjustable parameters �Ideal for non-human specimen testing M �Research applications �Pediatric specimens

Technofluor Factor XIII • Quantitative Activity Assay • Results in less than 30 minutes • Lot Stable Calibration Curve • No blank measurement. Mneeded • Na Citrate specimen • Excellent open vial reagent stability • 3 days on board Ceveron s 100 • 1 month stored at 2 -8 degrees C • 2 months stored at -20 degrees C

Technofluor Factor XIII • Thrombin activated FXIIIa cleaves quencher molecule • Dark quencher (2, 4 dinitrophenyl) is released • Fluorescence of N-terminal couple dye is measured • Fluorescent signal is proportional to the Factor XIII activity M

Technofluor Factor XIII Method Comparison • Excellent correlation with Ammonia Release and Antigenic Methods • ≥ 0. 95 M

Technofluor Factor XIII Superior Performance � Linearity 1 -150% � Reference Range 47 – 136% � LOD 0. 8% � CV’s within run < 4. 9% M � CV’s between runs <9. 2% � Limited Interferences ◦ ◦ ◦ Fibrinogen up to 6. 5 g/L (650 mg/d. L) Ammonia up to 2 m. M RF up to 600 mg/d. L Hemoglobin up to 500 mg/d. L Bilirubin up to 18 mg/d. L Lipemia up to 1400 mg/d. L

Technofluor ADAMTS-13 Activity � Quantitative activity assay � Fully automated � Less than 25 minutes � Lot stable calibration curve � Na Citrate specimen M � Excellent Open Vial Stability ◦ 3 days on board analyzer ◦ 1 month at 2 -8 degrees C ◦ 2 months at -20 degrees C � Calibrated against WHO International Standard

Technofluor ADAMTS-13 Activity • ADAMTS-13 in sample cleaves a v. WF 73 based substrate • Dark quencher (2, 4 dinitrophenyl) is released • Fluorescence of N-terminal couple dye is measured • Fluorescence is emitted proportional to the ADAMTS-13 in specimen M

Technofluor ADAMTS-13 Method Comparison • Excellent correlation to ADAMTS-13 chromogenic ELISA method • R = 0. 972 M

Technofluor ADAMTS-13 Superior Performance �Linearity 1 -125% �Reference range 60 -121% �LOD 0. 4% M �Imprecision Data

Technofluor ADAMTS-13 Limited Interferences • • • Hemoglobin up to 500 mg/d. L Bilirubin up to 18 Mmg/d. L Lipemia up to 1400 mg/d. L RF up to 600 mg/d. L v. WF up to 6 IU/m. L

Questions? Diapharma Technical Support Team 800 -447 -3846 M