Novel assays in the coagulation laboratory: a clinical and laboratory perspective

The ability to monitor Factor VIII (FVIII) and Factor IX (FIX) levels is integral to the clinical management of hemophilia A and B patients, respectively. Factor activity levels are checked during regular follow-up, post-infusion of factor concentrates, during pre- and post-operative assessments, and when the presence of an inhibitor is suspected. However, the ability to accurately and reproducibly measure factor activity levels with standard coagulation assays has been challenging due to the emergence of recombinant factor concentrates with extended half-lives. Similarly, special considerations must be given to the type of inhibitor assay used in patients with acquired hemophilia receiving recombinant porcine FVIII replacement. Alternative approaches to achieve hemostasis with clotting factor mimetics and interference of endogenous anticoagulants lack standardized assays for monitoring hemostatic efficacy. Laboratory assays measuring dynamic clotting parameters such as thrombin generation or whole blood viscoelasticity may provide a way forward, but have yet to enter routine clinical use. This review highlights the role of specialized coagulation assays in an era where multiple new hemostatic therapeutics for hemophilia are available, and underscores the need for clear communication between bedside and laboratory clinicians.