Clinical utility and impact of the use of the chromogenic vs one-stage factor activity assays in haemophilia A and B.

Abstract

Treatment of haemophilia A/B patients comprises factor VIII (FVIII) or factor IX (FIX) concentrate replacement therapy, respectively. FVIII and FIX activity levels can be measured in clinical laboratories using one‐stage activated partial thromboplastin time (aPTT)‐based clotting or two‐stage chromogenic factor activity assays. We discuss strengths and limitations of these assays, providing examples of clinical scenarios to highlight some of the challenges associated with their current use for diagnostic and monitoring purposes. Substantial inter‐laboratory variability has been reported for one‐stage assays when measuring the activity of factor replacement products due to the wide range of currently available aPTT reagents, calibration standards, factor‐deficient plasmas, assay conditions and instruments. Chromogenic activity assays may avoid some limitations associated with one‐stage assays, but their regulatory status, perceived higher cost, and lack of laboratory expertise may influence their use. Haemophilia management guidelines recommend the differential application of one or both assays for initial diagnosis and disease severity characterisation, post‐infusion monitoring and replacement factor potency labelling. Efficient communication between clinical and laboratory staff is crucial to ensure application of the most appropriate assay to each clinical situation, correct interpretation of assay results and, ultimately, accurate diagnosis and optimal and safe treatment of haemophilia A or B patients.