The outcome of a study to investigate reported assay discrepancies using human coagulation factor VIII chromogenic kits has been published in the online journal Pharmeuropa Bio & Scientific Notes.
The study confirmed a significant discrepancy between the commercial chromogenic kits on the market at the time of the study. Important conclusions were drawn, including the need for laboratories to perform Factor X activation curves for each new chromogenic kit to allow accurate determination of Factor VIII potencies in therapeutic concentrates.
The study (coded BSP112) was run under the aegis of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM), a joint programme funded by the European Union and the Council of Europe.
Download the full article free of charge here: Assay discrepancies using human coagulation factor VIII chromogenic kits: Results from a plasma-derived factor VIII collaborative study (BSP112).