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

ABSTRACT

BACKGROUND: Hepatitis C virus (HCV) core antigen is a serological marker of current HCV infection. OBJECTIVES: The aim of this study was mainly to evaluate the performance characteristics of the ARCHITECT HCV core antigen assay with specimens from US plasma donors and injecting drug users. STUDY DESIGN: A 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. RESULTS: HCV 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. CONCLUSIONS: HCV core antigen testing may be reliably used to identify current HCV infection.