Study on discrepancies in measured values of an extended half-life recombinant FⅧ product across different assay systems
10.3760/cma.j.cn114452-20250310-00144
- VernacularTitle:不同检测体系对一种长效重组凝血因子Ⅷ制剂测定值的差异性研究
- Author:
Yanyan SHAO
1
;
Yu LIU
1
;
Guanqun XU
1
;
Jing DAI
1
;
Xuefeng WANG
1
Author Information
1. 上海交通大学医学院附属瑞金医院检验科，上海200025
- Publication Type:Journal Article
- Keywords:
Hemophilia A;
Extended half-life recombinant factor Ⅷ;
One-stage clotting assay;
Chromogenic substrate assay;
Thrombin generation assay
- From:
Chinese Journal of Laboratory Medicine
2025;48(8):1015-1021
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the accuracy of one-stage clotting assay and chromogenic substrate assay for testing an extended half-life recombinant FⅧ and to explore standardized conversion models between methods.Methods:Observational study. FⅧ activity (FⅧ:C) in plasma samples with theoretical values of 1 000, 800, 600, 500, 400, and 300 IU/L was measured using both one-stage clotting assay (employing Siemens Actin FSL reagent, Werfen SynthASil reagent, Stago PTT-A reagent) and the chromogenic substrate assay from Hyphen Biomed. Differences in FⅧ:C measured by the various methods were compared using the SNK test. Recovery rates were calculated to evaluate the accuracy of each assay. Sample activity was verified using the thrombin generation assay (TGA). Correlations between activities determined by the different assay systems were assessed using linear regression analysis.Results:Observational study. FⅧ activity (FⅧ:C) in diluted plasma samples with theoretical values of 1 000, 800, 600, 500, 400, and 300 IU/L was measured using both one-stage clotting assay (employing Siemens Actin FSL reagent, Werfen SynthASil reagent, Stago PTT-A reagent) and the chromogenic substrate assay from Hyphen Biomed. Differences in FⅧ:C measured by the various methods were compared using the SNK test. Recovery rates were calculated to evaluate the accuracy of each assay. Sample activity was verified using the thrombin generation assay (TGA). Correlations between activities determined by the different assay systems were assessed using linear regression analysis.Conclusion:Some marked one-stage clotting assay system has limitations in the clinical detection of extended half-life recombinant FⅧ. While the chromogenic substrate assay provides more accurate results. The one-stage clotting assay values can undergo cross-assay correction for FⅧ:C using a standardized conversion coefficient, which can further elevate the accuracy of monitoring hemophilia treatment efficacy.
