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Backround: Patients with hemophilia A can develop inhibitors to factor concentrates. Emicizumab, a nonfactor-based therapy, has efficacy despite inhibitors. FVIII activity assessment on emicizumab treatment requires a bovine chromogenic reagent such as TriniCHROM FVIII:C.
Methods: FVIII levels were measured in 15 patients with and 35 without hemophilia and 10 patients on emicizumab therapy with a time-to-clot and the TriniCHROM FVIII:C reagents. FVIII inhibitor levels were also determined with both reagents.
Results: Acceptable agreement of FVIII and FVIII inhibitor levels were obtained with the 2 reagents (R² = 0.92 and 0.96, respectively) in patients not exposed to emicizumab. The time-to-clot FVIII assay overestimated FVIII levels in patients on emicizumab therapy. The chromogenic FVIII assay delivered accurate endogenous FVIII levels in patients on emicizumab therapy.
Conclusions: The TriniCHROM FVIII:C assay is compatible with routine automated coagulation analysers and delivers accurate FVIII and FVIII inhibitor levels.
DOI: 10.7754/Clin.Lab.2024.240521
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