Real‐world assay variability between laboratories in monitoring of recombinant factor IX Fc fusion protein activity in plasma samples

摘要

Monitoring of factor IX (FIX) replacement therapy in haemophilia B relies on accurate coagulation assays. However, considerable interlaboratory variability has been reported for one‐stage clotting (OSC) assays. This study aimed to evaluate the real‐world, interlaboratory variability of routine FIX activity assays used in clinical haemostasis laboratories for the measurement of recombinant FIX Fc fusion protein (rFIXFc) activity.