International collaborative calibration of the 2nd international standard for serum amyloid A
10.13200/j.cnki.cjb.004642
- VernacularTitle:血清淀粉样蛋白A第2代国际标准品的协作标定
- Author:
Ting YU
1
Author Information
1. *Division of In Vitro Diagnostics for Non⁃infectious Diseases, National Institutes for Food and Drug Control, Beijing 100050, China
- Publication Type:Journal Article
- Keywords:
Serum amyloid A(SAA);
International standard(IS);
Collaborative calibration;
Chemiluminescence immunoassay;
Latex immunoturbidimetric assay
- From:
Chinese Journal of Biologicals
2026;39(01):17-21+30
- CountryChina
- Language:Chinese
-
Abstract:
Objective To participate in the collaborative calibration study of the 2 nd international standard(IS) candidate(code: 23/148) for serum amyloid A(SAA).Methods According to the research plan of the Medicines and Healthcare products Regulatory Agency(MHRA), National Institutes for Food and Drug Control of China, on behalf of Chinese laboratories,organized 12 laboratories(including kit enterprises or testing institutions) for calibration using six chemilumine-scence immu noassay and six latex immunoturbidimetric assay detection kits.Results The SAA geometric mean of the immune potency submitted by Chinese laboratory was 56. 3 μg/ampoule[95% confidence interval(CI): 52. 2-60. 6 μg/ampoule, n = 12,geometric coefficient of variation(GCV): 12. 6%], with a median value of 53. 8 μg/ampoule(95% CI: 51. 9-61. 1 μg/ampoule).A total of 17 laboratories from six countries around the world participated in this study. After analysis, the geometric mean of the immune potency of SAA was 60. 9 μg/ampoule(95% CI: 54. 6-67. 9 μg/ampoule, n = 17, GCV: 23. 5%), with a median value of 55. 8 μg/ampoule(95% CI: 52. 0-60. 0 μg/ampoule).Conclusion After reviewed and approved by the World Health Organization(WHO) Expert Committee on Biological Standards, it is proposed that the candidate preparation coded23/148 is established as the 2 nd IS for SAA, with the median(56 μg/ampoule) as the final value. However, the above study data collectively demonstrates that commercial SAA immunoassays are poorly harmonized at the current time. Manufacturers may be adversely impacted as they transition to use 23/148. Recalibration needs to be performed when necessary, to improve the consistency of test results.
