Method and kit for monitoring anticoagulant therapy

1 . A method for measuring and monitoring a combined effect of an anticoagulant drug on coagulation factors II and X in a patient taking the anticoagulant drug, the method comprising:

obtaining a test sample from the patient;

mixing factor VII into one or more coagulation reagents that activate factor X through factor VII and bypasses factor IX;

adding the one or more coagulation reagents with the factor VII to the test sample; and

determining blood clotability of the test sample by measuring an influence of factors II and X.

2 . The method of claim 1 , wherein the one or more coagulation reagents include thromboplastin.

3 . The method of claim 1 , wherein the test sample is plasma obtained from the patient.

4 . The method of claim 3 , wherein the one or more coagulation reagents are pre-mixed with a calcium reagent and with factor VII.

5 . The method of claim 1 , wherein the factor VII is provided as purified factor VII.

6 . The method of claim 1 , wherein the test sample is un-anticoagulated whole blood.

7 . The method of claim 1 further comprising the step of adjusting a dose of anticoagulant drug to reach a recommended therapeutic international normalized ratio (INR) of a predefined target, by either increasing the dose to maximize an antithrombotic effect of the anticoagulant drug or decreasing the dose to minimize risk of abnormal bleeding caused by over-anticoagulation.

8 . The method of claim 1 , wherein the anticoagulant drug is an oral anticoagulant.

9 . The method of claim 1 further comprising the step of diluting the test sample with buffer or saline solution.

10 . The method of claim 1 , wherein the one or more coagulation reagents are diluted with water, a saline aqueous solution or buffered aqueous solution.

11 . The method of claim 1 , wherein at least one component of the one or more coagulation reagents is lyophilized, and wherein the method further comprises a step of reconstituting the at least one component.