Analysis of Anti-HCV Test Results Using ELISA Reagents from Different Companies

To explore the reason of conflict test results by using anti-HCV ELISA reagents from different companies,175 serum samples were tested by using anti-HCV reagents from four domestic and two foreign companies.17 samples with conflicted results and 1 sample with weak positive result in these 175 samples were tested by using anti-HCV sub-fragment ELISA reagents respectively.The results were statistically analyzed with SPSS13.0 software.The results showed that 85 samples were negative,38 were positive,and 52 had discordant results among the 175 samples tested by using reagents from 6 different companies.The results of 18 discordant resulting samples tested by anti-HCV sub-fragment reagent showed that the false negative rate of reagent I,II,III,IV,V and VI were 75%(9/12),25%(3/12),66.67%(8/12),33.33%(4/12),58.33%(7/12),33.33%(4/12),respectively.The false negative rate of the result obtained by reagent II plus reagent V combination test was 8.33%,which was significantly reduced.The different antigen components coated on test tubes was the important factor for conflicted detecting results.Therefore,preliminary screening and re-inspection using reagents coating with complementary antigen components is an important method for reducing false negative rate and for the safeguard of samples safety.