| Popis: |
Dorothy M Adcock,1 Mazi Rasulnia,2 Natalia Holot,3 David L Cooper3 1Laboratory Corporation of America Holdings, Burlington, NC, 2M Consulting LLC, Birmingham, AL, 3Clinical, Medical, and Regulatory Affairs,Novo Nordisk Inc., Plainsboro, NJ, USA Introduction: Diagnosis and management of hemophilia require accurate and precise measurements of factor activity levels. Activity is traditionally measured via one-stage (OS) clot-based assay; however, chromogenic substrate (CS) assays may be needed for certain cases. A survey was performed to understand assay-related knowledge gaps among hematologists and laboratory professionals. Methods: Separate web-based surveys were administered to hematologists who manage hemophilia and to laboratory professionals and queried practice patterns, knowledge of/attitudes toward CS assays, and interest in continuing education. Results: A total of 51 hematologists participated in this study; 67% managed hemophilia patients for ≥10 years and 24% were affiliated with a hemophilia treatment center (HTC). Most (80%) stated familiarity with general assay interpretation. Majorities of non-HTC and HTC respondents agreed that CS assays are more accurate than OS assays (62%/67%), although non-HTC hematologists indicated less understanding of when to order a CS assay (49%/67%). Fewer non-HTC respondents expressed concerns regarding the reliability of OS assays for diagnosis (38%/67%) and monitoring (38%/75%). Most (80%) expressed an interest in factor assay education, especially on available assays, efficacy, and best practices (39%). A total of 57 laboratory professionals participated, averaging 10 years in their current position; most (88%) were hospital based. More performed OS (72%) than CS (10%) or both (17%) assays; only 11% reported confidence with the interpretation of CS results. Few expressed concerns regarding the reliability of OS for diagnosis (9%) or monitoring (12%). Reported barriers to CS use included infrequent need (68%), lack of US Food and Drug Administration (FDA) approval (61%), and need for validation work (56%). Most (70%) were interested in CS assay education; top interests included advantages over traditional assays, general information on CS assays, and indications for testing (each 18%). Conclusion: Future educational efforts may focus on limitations of OS assays, indications for CS assay diagnosis/monitoring, and support for clinic-laboratory dialog. Keywords: hemophilia, factor activity assay, chromogenic substrate assay, coagulation factor VIII, coagulation factor IX, monitoring |
