Method for monitoring anticoagulant therapy

Abstract

A method of measuring the combined activity of both and only coagulation factors II and X for the purpose of monitoring anticoagulant therapy, and kits for using the method. This is based on the hypothesis that the combined activity of factor II and factor X (FII and FX) more accurately reflects clottability and the antithrombotic effect of VKA anticoagulants in patients than conventional methods (eg PT, P&P). The method involves mixing of test plasma from a human to be tested with specially prepared plasma deficient in both and only coagulation factors II and X but with normal levels of other factors (referred to herein as Fiix-deficient plasma or Fiix plasma), in order to correct for any possible deficiency in other coagulation factors than FII and FX in the test sample. By adding a coagulation reagent and calcium, the generation of thrombin or fibrin can be measured. Kits of the invention comprise a coagulation reagent, calcium and specially made plasma that is deficient in both and only factor II and factor FX. The kit components are suitably lyophilised.

Dependencies are inferred from the claim text.