FVIII inhibitor assay
AssigneeTechnoclone Herstellung von Diagnostika und Arzneimitteln GmbH
InventorsHubertus Wilhelmus Verbruggen, Nikolaus Binder
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Abstract
The present invention relates to an improved method for determining the amount of FVIII inhibitors in a patient sample, comprising the provision of a patient plasma sample, a normal pool plasma samples, and a control plasma sample which is FVIII/VWF deficient, inactivating all clotting factors present in the samples, addition of recombinant FVIII (rFVIII) to the control plasma sample, combination of the patient plasma sample with the control plasma sample with rFVIII to obtain a test mixture, and of the normal plasma pool sample with the control plasma sample with rFVIII to obtain a control mixture, incubation of the test mixture and the control mixture for less than 30 minutes, and analyzing the mixtures for residual rFVIII activity in the absence of VWF.
Claims17
A method of testing for FVIII inhibitors in a patient sample, the method comprising the following steps:
- a. providing a previously obtained patient plasma sample,
- b. providing a buffered normal pool plasma sample,
- c. providing a control plasma sample which is clotting factor VIII (FVIII)/von Willebrand Factor (VWF) deficient,
- d. heat treating the samples provided in steps a) to c),
- e. adding recombinant FVIII (rFVIII) to the control plasma sample,
- f. combining the patient plasma sample and the control plasma sample with rFVIII to obtain a test mixture,
- g. combining the normal pool plasma sample and the control plasma sample with rFVIII to obtain a control mixture,
- h. incubating the test mixture and the control mixture for less than 30 minutes, and
- i. analyzing the mixtures for residual rFVIII activity in the absence of VWF.
Dependencies are inferred from the claim text.