Evaluation of sera with a low signal to cut-off ratio using two chemiluminescent assays for detecting Hepatitis C Virus, and their correlation with the detection of Viral RNA

Abstract Objective All commercial assays used to measure the presence of Hepatitis C virus (HCV) antibodies set cut-off points to categorise the results, but the problem of false positive results in screening hepatitis C sera is well known. The aim of this study was to evaluate the results obtained by two chemiluminescent assays in selected sera, and compare these results with the detection of viral RNA in the specimens studied. Material and methods Two hundred reactive sera (positive) were selected, although with a low signal to cut-off ratio (S/CO), were selected, using two chemiluminescent assays and were then subjected to genome amplification. Results and discussion Viral RNA could be only be detected in 8 (4%) of the selected specimens. Taking these results into account, we believe that the design of the current chemiluminescent assays do not provide sufficient specificity when they are used as the only tests for the diagnosis of hepatitis C.