P.141 A large-scale evaluation of a new method for hepatitis C virus (HCV) genotyping based on real-time PCR

Abstract

Background and aims: The diagnosis of ongoing hepatitis C virus (HCV) infection involves the detection of specific antibodies and of HCV-RNA. We aimed to assess the relationship between these two parameters in a representative sample of a population at high risk for HCV infection. Methods: Plasma and serum samples were respectively tested for HCV-RNA by a qualitative PCR (Cobas Amplicor HCV, Roche) and for HCV antibodies by a MEIA screening assay (AxSYM HCV 3.0, Abbott) and an immunoblot (Inno-LIA-III, Innogenetics). Results and conclusions: Out of 888 samples assayed, 579 (65.2%) were positive for HCV-RNA, while anti-HCV antibodies were detected respectively in 802 sera by AxSYM (90.3%) and in 783 by LIA (706 positive and 77 indeterminate, 88.2%). The anti-core antibodies displayed the best correlation with viremia, since they were present in 97.1% of the PCR+ samples, followed by anti-NS3 (90.2%) and anti-NS4 (89.6%). Only one HCV-RNA positive sample was negative by LIA and MEIA (early seroconversion). The AxSYM sample/cutoff (S/CO) values were directly correlated with the presence of HCV-RNA: a PCR positivity was found in 4.9% of samples with a S/CO ≤10, in 60.8% of samples with a S/CO between 11 and 50 and in 93.6% of cases with a S/CO >50, (P<0.005). The immunoblot adds little, on a single specimen, to the information yielded by the AxSYM screening test. A suitable diagnostic algorithm for HCV in high-risk settings could be the anti-HCV screening by MEIA and a qualitative assay for HCV-RNA on samples with low reactivity.