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Product Name :


High Sensitivity Prothrombin Time

International Sensitivity Index

Target ISI Value: 1.0 to 1.4 (Actual value on vial)

Intended Use

The PT reagent is an in vitro diagnostic assay intended for use in performing the

one stage prothrombin time (PT) test on the Mispa Clog Plus Analyzer.


The prothrombin time is the method of choice for monitoring oral anticoagulation

therapy (1) and is a fundamental screening test for acquired or inherited bleeding

disorders. During oral anti-coagulation therapy, the activity of vitamin Kdependant clotting factors (II, VII, IX, X, Protein C and Protein S) is reduced and

PT time is increased. The test is used for quantitative determination of blood

clotting factors in the extrinsic (VII) and common pathways (II, V and X) of



The capacity of blood to form a fibrin clot by way of the extrinsic hemostatic

pathway requires thromboplastin, calcium, factors I, II, V, VII and X (4,5). The PT

reagent provides a source of tissue thromboplastin and calcium that specifically

activate factor VII in the extrinsic coagulation pathway. The factors involved in

the intrinsic coagulation pathway are bypassed (6). Therefore, deficiencies of

intrinsic pathway factors (VIII, IX and XII) are not detected using the PT test.


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