Emicizumab治疗的血友病a患者的牛显色因子VIII检测的验证和实施。

IF 0.7 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY Clinical laboratory Pub Date : 2024-12-01 DOI:10.7754/Clin.Lab.2024.240521

Tlangelani V Masia, Susan Louw

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引用次数: 0

摘要

背景：A型血友病患者可产生因子浓缩物抑制剂。Emicizumab是一种非因子治疗，尽管有抑制剂，但仍有疗效。对半蜜单抗治疗的FVIII活性评估需要牛显色试剂，如TriniCHROM FVIII:C。方法：对15例血友病患者和35例非血友病患者以及10例接受emicizumab治疗的患者进行FVIII水平检测，这些患者采用了血栓形成时间和TriniCHROM FVIII:C试剂。同时用两种试剂测定FVIII抑制剂水平。结果：在未暴露于emicizumab的患者中，这两种试剂获得了FVIII和FVIII抑制剂水平的可接受一致性（R²分别= 0.92和0.96）。到凝块时间FVIII测定过高估计了接受emicizumab治疗的患者的FVIII水平。显色FVIII检测在接受emicizumab治疗的患者中提供准确的内源性FVIII水平。结论：TriniCHROM FVIII:C检测与常规自动凝血分析仪兼容，并提供准确的FVIII和FVIII抑制剂水平。

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Verification and Implementation of a Bovine Chromogenic Factor VIII Assay for Hemophilia A Patients on Emicizumab Therapy.

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.

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来源期刊

Clinical laboratory 医学-医学实验技术

CiteScore

1.50

自引率

0.00%

发文量

494

审稿时长

3 months

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.