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To establish the evaluation reference for domestic anti-hepatitis C virus (HCV) enzyme immunoassay (EIA) diagnostic kits. 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. 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. 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.


Xiaobin Niu, Xinming Wang, Gongcheng Liu, Yongwei Li. Establishment of the evaluation reference system for domestic anti-hepatitis C virus diagnostic enzyme immunoassay kits]. Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology. 2013 Jul;29(7):761-4

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PMID: 23837990

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