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New challenges and best practices for the laboratory monitoring of factor VIII and factor IX replacement

Several recombinant factor VIII and factor IX concentrates with extended half‐life (EHL) have recently been validated by clinical studies. The availability of these novel concentrates is expected to significantly facilitate the treatment of patients with hemophilia A and B. However, the modification applied to these molecules has introduced variations in their activity measurement in routine coagulation assays. Depending on the assays, underestimations of up to 10‐fold or overestimations of up to approximately 30‐fold in the measurements of the recovery have been reported in some factor concentrates. Such biases in monitoring may lead to major under‐ or overtreatment, as well as unnecessary searching for inhibitor antibodies. In this review, we discuss the guidelines and recommendations that allow the selection of optimal strategies to monitor patients treated with these novel factor concentrates. Based on the specificities of the assays and on local regulations, different chromogenic substrate assays in addition to one‐stage clotting assays may be validated to allow the accurate measurement of all novel products. An efficient communication between the clinical laboratory and the clinicians is essential to ensure that the appropriate assays are carried out in laboratories and that the clinicians correctly evaluate the data. Further laboratory and clinical studies are still required for the optimization of the laboratory assays that can be used in the measurement of novel factor VIII and factor IX concentrates with EHL.