Calibrator for use in test methods for detecting a defective...

C - Chemistry – Metallurgy – 12 – Q

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C12Q 1/56 (2006.01) G01N 33/96 (2006.01)

Patent

CA 2162432

The invention relates to a plasma which can be used as a calibrator in coagulation tests which detect the degradation of factor V by activated protein C (APC), to the preparation of such a plasma and to its use. The problem with calibrators in current coagulation tests is the requirement for a reference concentration calibrator for APC-resistant factor V in activated protein C time tests. The calibrator of the present invention solves this problem as it provides a plasma composition with beneficial qualities such as shortened clotting time in an activated protein C time test. The calibrator of the present invention contains human plasma diluted with non-human animal plasma, or factor V-containing fractions of non-human plasma. The non-human animal factor V in the calibrator of the present invention cannot be cleaved by human activated protein C, and retains markedly high factor V activity, thus reducing the APCT.

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