HEMOCLOT™ Thrombin Time (T.T)

Intended Use

HEMOCLOT™ Thrombin Time (T.T.) kit is a clotting method for the in vitro quantitative determination of Thrombin Time on human citrated plasma, using manual or automated method.

Summary and Explanation

Technical The Thrombin Time is a coagulation assay measuring the time to convert fibrinogen to fibrin.

Clinical The Thrombin Time is a screening test to assess abnormalities of fibrinogen and to detect inhibitors against thrombin or fibrin. It can be useful for the evaluation of Disseminated Intravascular Coagulation (DIC) and liver disease.

A prolonged Thrombin Time can result from:

• Presence of antithrombin activity induced by therapy (eg Heparin, hirudin, argatroban, dabigatran).
• Presence of high concentrations of Fibrin/Fibrinogen degradation products.
• Qualitative (dysfibrinogenemia) or quantitative abnormalities of Fibrinogen (deficiency, DIC, fibrinolysis, hepatic disorders including cirrhosis).The Thrombin Time is normal in presence of a Factor XIII deficiency.

Principle

The HEMOCLOT™ Thrombin Time (T.T.) kit is a reagent for Thrombin Time (TT). It measures the clotting time (CT) induced by a controlled and constant amount of bovine thrombin, in presence of calcium, on citrated plasma. The time required for the formation of a stable clot is measured in seconds.

Reagents

R Bovine Thrombin, highly purified, and calcium, lyophilized. Contains BSA and stabilizers.

REF CK011K ➔ 6 vials of 2 mL.

REF CK011L ➔ 6 vials of 8 mL.

The bovine Thrombin concentration (about 1.0 NIH/mL) can vary from lot to lot and is adjusted for each lot in order to offer a high sensitivity of Thrombin Time assay to low concentrations of Unfractionated Heparin (UFH) and Low Molecular Weight Heparin (LMWH).