Comparison of ELISA diagnostic kits used in China for hepatitis C virus IgG antibody detection / 中华实验和临床病毒学杂志

ABSTRACT

<p><b>OBJECTIVE</b>To compare the commercial diagnostic reagent available in China for hepatitis C virus ( HCV) IgG antibody detection in order to provide some useful information for HCV prevention.</p><p><b>METHODS</b>The HCV-IgG detection reagents produced by six different Enterprises named A, B, C, D, E and F were chosen and applied to detect 160 HCV specious sera samples. HCV-IgG reagent from ABBOTT was adopted as gold-standard and the samples in gray zone were determined by RIBA method finally.</p><p><b>RESULTS</b>160 sera samples comprised 88 positive samples and 72 negative samples. The total conformity ranged from 88.13% to 98.13% and the Youden indexes ranged from 0.74 to 0.96 when the reagents from six different Enterprises were compared with gold-standard. The highest conformity was 98.13%, observed in D reagent with the highest Youden index of 0.96.</p><p><b>CONCLUSION</b>The total conformity rates were more than 88% when the HCV-IgG antibody detection reagents from six different Enterprises were compared with ABBOTT reagent. It was highly conformable. However, some reagent proved to be less conformable in negative samples detection.</p>