[Evaluation on the anti-hepatitis C virus enzyme-linked immunosorbent diagnostic kits].
Ten different anti-HCV ELISA kits, four manufactured from abroad (ABBOTT, Innogenetics, Murex, Monolisa) and six in China, were evaluated by China national anti-HCV panel(100 positive, 98 negative) and Boston Biomedical Inc. (BBI) anti-HCV mixted titer performance panel(23 positive and 2 negative). The detective rates in 100 China national anti-HCV positive panel were 98% by ABBOTT EIA 2.0, 96% by BHY, SKH and XWK, 95% by BBS and HHM, 97% by SCJ, and that in 23 BBI anti-HCV positive panel were 100% by ABBOTT EIA2.0, but 91% by Murex, 87% by Innogenetics and Monolisa, 74% by BHY, 87% by SKH, 83% by XWK and HHM, 70% by BBS, 91% by SCJ. The specificity for all negative panels were similar in all kits. According to the results of HCV RIBA test (Ortho HCV RIBA 2.0), the structural antigens contained in all kits were almost the same, but the antigenicity of HCV nonstructural proteins were different, in the kits made in China they were lower than that made from abroad.
Zhou
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National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050.
Qi
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Gu
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D000914:Antibodies, Viral / Q000097:blood*; D001782:Blood Donors; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005069:Evaluation Studies as Topic; D016174:Hepacivirus / Q000276:immunology / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis*; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards*
D000914:Antibodies, Viral; D011933:Reagent Kits, Diagnostic