Method for diagnosis of thrombotic disorders
AssigneesThe Scripps Research Institute, The Regents of the University of California
InventorsJohn H. Griffin, Samuel I. Rapaport, Dzung T. Le
Life of this patent
Estimating the term…
Abstract
The present invention provides an in vitro method useful for the diagnosis of a thrombotic disorder in a subject, having or at risk of having the disorder. Specifically, the disorder exemplified herein is associated with APC resistant Factor V and Va. The clotting time of a test sample is analyzed in the presence and absence of APC and compared with a standard reference sample in order to diagnose the subject.
Claims30
An in vitro method for diagnosing a subject as having or as being at risk for having a thrombotic disorder associated with activated protein C (APC)-resistant factor V or Va, the method comprising:
- a) contacting a test sample comprising a coagulation factor V or Va-containing specimen from the subject with a procoagulant reagent, factor V-deficient plasma to provide coagulation factors other than factors V or Va, calcium sufficient to initiate clotting, and APC in a test reaction;
- and
- b) comparing the clotting time for the test reaction to the clotting time for a control reaction carried out under the same conditions as the test reaction, but with a control sample comprising a coagulation factor V or Va-containing specimen from an individual not having or not at risk of having a thrombotic disorder associated with APC-resistant factor V or Va, wherein:
- i) detection of a decreased clotting time in the test reaction relative to the control reaction indicates a diagnosis of a thrombotic disorder associated with APC-resistant factor V or Va;
- and
- ii) detection of a similar clotting time in the test reaction relative to the control reaction indicates that the subject does not have or is not at risk of developing a thrombotic disorder associated with APC-resistant factor V or Va.
An in vitro method for diagnosing a subject as having or as being at risk for having a thrombotic disorder associated with activated protein C (APC)-resistant factor V or Va, the method comprising:
- a) contacting a first test sample comprising a coagulation factor V or Va-containing specimen from the subject with a procoagulant reagent, factor V-deficient plasma to provide coagulation factors other than factors V or Va, calcium sufficient to initiate clotting, and APC in a first test reaction;
- b) contacting a second test sample comprising a coagulation factor V or Va-containing specimen from the subject with a procoagulant reagent, factor V-deficient plasma to provide coagulation factors other than factors V or Va, and calcium sufficient to initiate clotting in a second test reaction;
- c) determining the clotting time difference for the first and second test samples;
- and
- d) comparing the clotting time difference for the first and second test samples with the clotting time difference for first and second control reactions carried out under the same conditions as the first and second test reactions, but with a control sample comprising a coagulation factor V or Va-containing specimen from an individual not having or not at risk of having a thrombotic disorder associated with APC-resistant factor V or Va, wherein:
- i) detection of a decrease in the clotting time difference for the test reactions relative to the clotting time difference for the control reactions indicates a diagnosis of a thrombotic disorder associated with APC-resistant factor V or Va;
- and
- ii) detection of a similar clotting time difference for the test reactions relative to the clotting time difference for the control reactions indicates that the subject does not have or is not at risk of developing a thrombotic disorder associated with APC-resistant factor V or Va.
Dependencies are inferred from the claim text.