Development of a new batch of the national reference panel for hepatitis C virus antibody detection reagents
10.13200/j.cnki.cjb.004749
- VernacularTitle:新批次丙型肝炎病毒抗体检测试剂国家参考品的研制
- Author:
Xinxin DUAN
- Publication Type:Journal Article
- Keywords:
Hepatitis C virus(HCV);
Antibody detection reagents;
ELISA;
National reference panel
- From:
Chinese Journal of Biologicals
2026;39(08):922-927+934
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo develop replacement batches for the national reference panel for hepatitis C virus(HCV) antibody detection reagents, so as to use them for quality evaluation and control of HCV antibody ELISA detection reagents.MethodsA total of 238 previously collected plasma samples were screened for HCV antibodies using indirect ELISA method and sandwich detection kit, and then confirmed by HCV antibody ELISA kit, chemiluminescence kit and Western blot kit.After centrifugation, the confirmed samples were divided into negative reference, positive reference, sensitivity(lowest limit of detection) reference and precision reference, and stored at ≤-20 ℃.Furthermore, the homogeneity and stability of the reference substance were evaluated, and 15 HCV antibody ELISA detection kits produced by 12 manufacturers were used for collaborative calibration to determine various quality standards.ResultsBased on the screening and confirmation results,65 plasma samples were selected to constitute the national reference panel for HCV antibody detection reagents, comprising30 negative(N1-N30), 30 positive(P1-P30), 4 sensitivity(lowest limit of detection)(L1-L4), and 1 precision(J) reference substances.The homogeneity and stability of the reference panel met all specified requirements.Among 15 ELISA detection kits for HCV antibody, two products achieved a negative compliance rate of 30/30, while the remaining 13 products achieved29/30.Eleven products demonstrated a positive compliance rate of 30/30, while the remaining four products achieved 29/30.All 15 products correctly identified the sensitivity samples(L1-L3 as positive, L4 as negative).Except for one kit for which no data were obtained and the CV could not be calculated, the CVs of precision verification of the other 14 kits were all below15%.ConclusionThe developed new batch of HCV antibody national reference panel has good homogeneity and stability,and all performance indicators meet the quality requirements of national reference, which can be used for the quality evaluation and lot release of HCV antibody ELISA detection reagents, possessing a great significance to promote the quality improvement of this kind of products and ensure blood safety.
