Recombinant FIX Fc fusion protein activity assessment with the one-stage clotting assay: A multicenter, assessor-blinded, prospective study in Japan (J-Field Study).

ABSTRACT:

Introduction

The one-stage clotting assay is used to measure factor IX (FIX) activity in patients' plasma samples and in FIX products for hemophilia treatment. However, the diversity of reagents and instruments has resulted in significant FIX assay variability.

Methods

The accuracy of the one-stage clotting assay to measure recombinant FIX Fc fusion protein (rFIXFc) activity was evaluated by major Japanese hemophilia treatment centers and commercial laboratories that measure factor IX activity for a majority of hemophilia B patients in Japan. Plasma-derived FIX (pdFIX) and recombinant FIX (rFIX) products were used as comparators. FIX-deficient plasma was spiked with four levels of FIX products based on label potency and measured under blinded conditions by routine one-stage

SUBMITTER: Fukutake K 

PROVIDER: S-EPMC7078902 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature