ABSTRACT
HCV core antigen is detectable in serum several weeks earlier than anti-HCV antibodies. Variability in early detection time is even more pronounced in certain groups of patients such as the hemodialysis and immunocompromised where the antibody response may take between 45-68 days to develop. Early detection of HCV core Ag in serum may represent an attractive, cost effective screening tool for such high risk patients. The current study aimed at evaluation of the analytical performance of the Abbott Architect HCV Chemiluminescenat Microparticle Immunoassay [CMIA] in comparison to the standard PCR detection of HCV RNA. In addition, the current study evaluated the possible clinical utility of HCV Ag kit in testing pooled samples from several patients. Samples from 44 HCV patients and 15 controls were analyzed using the CMIA HCV core Ag assay and quantitative PCR. Samples from positive HCV patients were pooled and analyzed using the HCV core Ag assay. The current study demonstrated a sensitivity of 81.0% and specificity of 97.0% for the ABBOTT HCV core Ag kit assay in detecting HCV positive cases compared to quantitative PCR assay. The most important finding of the current study is that HCV core Ag assays may have false negative results at low level viremia [low HCV copy numbers]. The current study does not support using HCV core Ag as a single test for screening possible HCV cases or using HCV core Ag assays on pooled samples. Bigger studies may be needed to strengthen the findings of the current study