Product Name :
P.T
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.
Summary
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
coagulation.
Principle
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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