A novel immuno-assay is being evaluated for the measurement of Factor VIII. Current procedure measures a rate assay which is subject to much artefact. The hypothesis is that the new assay will give a reading of absolute quantities of FVIII which will provide a more suitable indicator of FVIII content for clotting factor manufacturers, physicians and patients.
Remnant samples collected in a clinical laboratory are assayed with the new procedure and compared with the standard functional activated partial thromboplastin time (APTT) assay. A PK study in seven study subjects with hemophilia A is being carried out using five different commercially licensed factor VIII concentrates and the blood samples drawn for the PK analysis are being measured for FVIII with the novel assay and compared with the standard APTT assay. The concentrates used in the PK studies are also being applied to the two assay systems to determine each product's specific activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
7
There is no intervention. This is a study of the differences in assays.
Department of Biochemistry University of Vermont
Burlington, Vermont, United States
The level of Factor VIII in pMols
Time frame: 48 hours
The possible role of VWF, factor concentrate type and non-inhibitory antibody presence or absence on the FVIII antigen levels
Time frame: 48 hours
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