A Review of Factor VIII and Factor IX Assay Methods for Monitoring Extended Half-Life Products in Hemophilia A and B

Clinical trials have used a variety of coagulation factor assay methods to assess treatment with recombinant Factor VIII (rFVIII) and recombinant Factor IX (rFIX) extended half-life (EHL) products. However, diagnostic laboratories may use different reagent combinations for routine use or for field trials of EHL products. The focus of this review is on the choice of one-stage clotting and chromogenic Factor VIII and Factor IX methods and the influence that assay principle and components may have on results, including the effects of different activated partial thromboplastin time reagents and factor-deficient plasma. Our aim is to tabulate the findings for each method and reagent group to give laboratories practical guidance as to how the reagent combinations used in their local laboratory compare to others, for the various EHLs available.