Sensitivity and specificity of third-generation hepatitis C virus antibodydetection assays: an analysis of the literature

This study assessed the sensitivity and specificity of third-generation ser ological hepatitis C diagnostic tests from an analysis of the literature. T he literature analysis was run using criteria from McMaster University for the assessment of diagnostic tests. The selected studies were grouped accor ding to the type of population at high and low risk for hepatitis C virus ( HCV) infection and to the type of reference test. The homogeneity of the se nsitivity and the specificity was tested in each group using a Fisher's exa ct test. Of 132 studies, 10 were selected. When the estimates were homogene ous, summary point estimates and confidence intervals were computed; when t he estimates were heterogeneous, subgroup analysis was performed. The sensitivity of third-generation enzyme-linked immunosorbent assay (ELIS A3) was estimated at 98.9% (95% CI: 94-100%) in patients with chronic liver disease and at 97.2% (95% CI: 92-99%) in panels of sera. ELISA3 specificit y was found at 100% in patients with chronic liver disease. The sensitivity of the third generation recombinant immunoblot assay (RIBA3) was assessed at 78.8% (95% CI: 65-89%) in haemodialysed patients. This analysis provides evidence for the good sensitivity and specificity of ELISA3 assays particularly in high risk patient groups and confirms their use for screening in these populations. Further studies are needed to asses s properly RIBA3 in general population and in risk patients.