Performance evaluation of two chemiluminescence immunoassay reagents for HCV antibody in blood donors screening
10.13303/j.cjbt.issn.1004-549x.2021.02.007
- VernacularTitle:两种化学发光免疫分析试剂用于血液筛查丙肝抗体的检测性能评价
- Author:
Jianfeng CHEN
1
;
Le CHANG
2
;
Hong LIU
1
;
Wenchao LI
1
;
Peng LI
1
Author Information
1. Blood Center of Shandong Province, Jinan 250014, China
2. National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology
- Publication Type:Journal Article
- Keywords:
HCV antibody;
chemiluminescence immunoassay;
enzyme-linked immunosorbent assay;
blood screening
- From:
Chinese Journal of Blood Transfusion
2021;34(2):123-127
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 Aim of this study was to evaluate performance of two chemiluminescence immunoassay (CLIA) reagents for hepatitis C virus antibodies (anti-HCV) detection, focusing on the feasibility of blood screening for blood donors. 【Methods】 The sero-panel samples from NCCL and the donor samples were tested with CLIA, ECLIA and two ELISA (A: double antigen sandwich method, B: indirect method) reagents synchronously to evaluate their performances respectively, and the sensitivity, specificity and CV of the four reagents were compared. 【Results】 CLIA, ECLIA, A and B reagents showed sensitivities of 99.06%(315/318), 99.69%(317/318), 99.06%(315/318) and 99.69%(317/318), and clinical specificities was 99.06%(315/318), 99.69%(317/318), 99.06%(315/318) and 99.69%(317/318), respectively. Between-run and within-run precision for ECLIA reagent ranged (both CV<8%) was better than two ELISA reagents (between-run: CV <15% and within-run: CV <20%), and the CLIA reagent also met the requirement in blood screening (CVs <14%). 【Conclusion】 This ECLIA reagent showed high sensitivity and good reproducibility together with acceptable specificity in routine sample screening, which proved its further application in blood screening. This CLIA reagent has high specificity and the same sensitivity as indirect ELISA reagent. This CLIA reagent could be used in combination with other reagents with high sensitivity to screen anti-HCV in blood donors.
