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Updated: May 9, 2026
A Protocol for Analyzing Hepatitis C Virus Replication
Published on: June 26, 2014
[Establishment of the evaluation reference system for domestic anti-hepatitis C virus diagnostic enzyme immunoassay
Xiaobin Niu1, Xinming Wang, Gongcheng Liu
1Department of Clinical Laboratory, Henan Hospital of Traditional Chinese Medicine, Zhengzhou 450002, China.
Objective:
To establish the evaluation reference for domestic anti-hepatitis C virus (HCV) enzyme immunoassay (EIA) diagnostic kits.
Methods:
4833 serum samples which were collected from different provinces of China were screened with 5 domestic anti-HCV EIA kits and redetected with 2 foreign anti-HCV EIA kits. Then the selected samples were confirmed with Chiron RIBA HCV 3.0 SIA and real-time quantitative PCR reagents. The confirmed positive samples were examined for HCV genotypes. The positive samples (classified as low, medium and high titers), negative samples, mixed-titer positive dilution samples and special samples were selected for preparing the evaluation reference for anti-HCV diagnostic reagent kits.
Results:
The established evaluation reference consisted of 30 positive serum samples including high, medium and low titers, and 10 single band samples confirmed by RIBA, and 6 dilution samples to evaluate the sensitivity, and 30 confirmed negative samples including some high negative value samples and interferential samples.
Conclusion:
The evaluation reference samples could offer dependable detection results, and covered abundant antibody repertoire, thus providing important reference for the improvement of the qualities of domestic anti-HCV EIA kits.
