Evaluation on performance index of different domestic and imported anti-HCV EIA kits

ObjectiveTo evaluate sensitivity and specificity of 6 domestic and imported anti-hepatitis C virus(HCV) enzyme immunoassay(EIA) kits by known HCV reference serum.MethodsThe anti-HCV positive and negative specimens selected from blood donors were set up as anti-HCV reference serum.The sensitivity,specificity,and coincidence rates of 2 imported(Murex and Ortho) and 4 domestic anti-HCV EIA kits were evaluated with the reference serum.The coincidence of the domestic kits with imported kits was analyzed.ResultsThe sensitivity of 6 anti-HCV EIA kits for the detection of reference serum were 92.16%,92.16%,90.2%,94.12%,90.2%,and 92.16% and the specificity was 94.44%,64.81%,90.74%,88.89%,96.3%,and 79.63%,respectively.The coincidence rates ranged from 85.71% to 93.33%。The coincidence of 4 domestic kits with Murex was better for the detection of reference serum,with a Kappa value of >0.6,and the coincidence rate of domestic kits with Murex was generally higher than that of with Ortho.ConclusionThe sensitivity of 4 improved domestic and imported anti-HCV EIA kits is similar,however,the specificity varies from each other.