{"title":"Verification and Implementation of a Bovine Chromogenic Factor VIII Assay for Hemophilia A Patients on Emicizumab Therapy.","authors":"Tlangelani V Masia, Susan Louw","doi":"10.7754/Clin.Lab.2024.240521","DOIUrl":null,"url":null,"abstract":"<p><strong>Backround: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>The TriniCHROM FVIII:C assay is compatible with routine automated coagulation analysers and delivers accurate FVIII and FVIII inhibitor levels.</p>","PeriodicalId":10384,"journal":{"name":"Clinical laboratory","volume":"70 12","pages":""},"PeriodicalIF":0.7000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical laboratory","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.7754/Clin.Lab.2024.240521","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
Clinical Laboratory is an international fully peer-reviewed journal covering all aspects of laboratory medicine and transfusion medicine. In addition to transfusion medicine topics Clinical Laboratory represents submissions concerning tissue transplantation and hematopoietic, cellular and gene therapies. The journal publishes original articles, review articles, posters, short reports, case studies and letters to the editor dealing with 1) the scientific background, implementation and diagnostic significance of laboratory methods employed in hospitals, blood banks and physicians'' offices and with 2) scientific, administrative and clinical aspects of transfusion medicine and 3) in addition to transfusion medicine topics Clinical Laboratory represents submissions concerning tissue transplantation and hematopoietic, cellular and gene therapies.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
