Performance of ARCHITECT HCV core antigen test with specimens from US plasma donors and injecting drug users

Abstract

BackgroundHepatitis C virus (HCV) core antigen is a serological marker of current HCV infection. ObjectivesThe aim of this study was mainly to evaluate the performance characteristics of the ARCITECT HCV core antigen assay with specimens from US plasma donors and injecting drug users. Study designA total of 551 serum and plasma samples with known anti-HCV and HCV RNA status were tested for HCV core antigen using the Abbott ARCHITECT HCV core antigen test. ResultsHCV core antigen was detectable in 100% of US plasma donor samples collected during the pre-seroconversion phase of infection (anti-HCV negative/HCV RNA positive). Overall sensitivity of the HCV core antigen assay was 88.9–94.3% in samples collected after seroconversion. The correlation between HCV core antigen and HCV RNA titers was 0.959. ConclusionsHCV core antigen testing may be reliably used to identify current HCV infection.