Validation of a factor VIII inhibitor screening assay to guide Bethesda testing in hemophilia A

Abstract: BACKGROUND: The development of factor VIII (FVIII) inhibitors is one of the most serious complications in the management of hemophilia A, as it significantly reduces the effectiveness of replacement therapy and increases morbidity. Although the Bethesda assay is considered the gold standard for inhibitor quantification, it is time-consuming and resource-intensive. Therefore, an accurate and reliable screening approach is essential to identify patients who truly need further evaluation.