Development of novel automated screening method for detection of FVIII inhibitors
AssigneePrescient Medicine Holdings, Inc.
InventorsMatthew Stephen Evans, Keri Jon Donaldson, Mary Elaine Dye, Michael H. Creer
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Abstract
Disclosed herein are methods for determining the presence of a coagulation inhibitor in a patient. A patient curve associated with the patient sample and having a patient slope (Ps) and a a standard curve associated with a control sample and having a control slope (Cs) are generated, and the Ps and the Cs are compared to obtain a Ps/Cs parallelism ratio. A Ps/Cs parallelism ratio of less than a predetermined ratio is indicative of presence of a coagulation inhibitor in the patient sample.
Claims16
A method of treating a patient having a condition associated with the presence of a Factor VIII inhibitor in a patient sample, the method comprising:
- generating a patient curve associated with the patient sample, the patient curve having a patient slope (Ps);
- generating a standard curve associated with a control sample, the standard curve having a control slope (Cs),
- wherein the patient curve and the standard curve are generated by plotting a plurality of clotting time points for a series of dilutions of the patient sample and the control sample relative to a Factor VIII clotting activity;
- determining a Ps/Cs parallelism ratio as being less than 0.45;
- determining, with a sensitivity of 100%, the presence of the Factor VIII inhibitor in the patient sample, and administering to the patient at least one agent for treatment of the condition associated with the presence of the Factor VIII inhibitor,
- wherein the at least one agent comprises one or more of 1-deamino-8-d-arginine vasopressin;
- human factor VIII;
- porcine factor VIII;
- an FVIII bypassing agent;
- an activated prothrombin complex concentrate;
- a nonactivated prothrombin complex concentrate;
- factor Xa, VIIa, or a recombinant version thereof of the patient;
- an agent used for immunosuppression:
- an antifibrinolytic;
- or a target anticoagulant.
A method of treating a patient in having an autoimmune disorder associated with the presence of a Factor VIII inhibitor in a patient sample, the method comprising:
- generating a patient curve associated with the patient sample, the patient curve having a patient slope (Ps);
- generating a standard curve associated with a control sample, the standard curve having a control slope (Cs),
- wherein the patient curve and the standard curve are generated by plotting a plurality of clotting time points for a series of dilutions of the patient sample and the control sample relative to a Factor VIII clotting activity;
- determining a Ps/Cs parallelism ratio that is less than 0.45;
- determining the presence of the Factor VIII inhibitor in the patient sample with 100% sensitivity based on the determined Ps/Cs parallelism ratio;
- and
- administering to the patient one or more agents for treatment of the autoimmune disorder associated with the presence of the Factor VIII inhibitor, wherein the one or more agents include human factor VIII, porcine factor VIII, or an FVIII bypassing agent.
Dependencies are inferred from the claim text.