Soluble thrombomodulin-based one-stage assay for vitamin-K dependent coagulation-inhibiting proteins

Abstract

The present invention provides a novel one-stage assay which uses soluble thrombomodulin for directly determining the functional status in plasma of the vitamin K-dependent coagulation-inhibiting proteins, protein C and protein S. The method comprises combining a blood plasma test sample and a coagulation-activating substance in a calcium-free solution, then adding soluble thrombomodulin and calcium ions to initiate a coagulation reaction, measuring the time required for the test plasma sample to clot, comparing the measured clot time to that of standard control plasma samples, including protein C- and protein S-deficient plasma controls, and then using the compared clot time values for determining the functional status of protein C and protein S in the individual from whom the test plasma sample was taken. The functional status of the vitamin K-dependent coagulation-inhibiting proteins is used to determine the risk of thrombosis in the host individual.

Dependencies are inferred from the claim text.