Comparative Study of Anti-HCV by New HCV EIA, Immunoblotting and RT-PCR in Korean Blood Donors / 대한수혈학회지

ABSTRACT

A newly developed third generation enzyme immunoassay(Lucky HCD 3.0 EIA) for hepatitis C virus(HCV) antibodies was added with the envelope(E1E2)/NS4 fusion proteins and expanded NS5 proteins as well as the core/NS3 fusion proteins. Authors evaluated the HCD 3.0 EIA with the previously available second generation EIA(HCD 2.0) in 10,435 Red Cross blood donors. Among 10,435 donors who were screened for the presence of HCV antibodies by HCD 2.0 assay, 22(0.21%) sera were repeatedly reactive. All of these sera were tested for further testing. Only 13 of all tested sera were reactive by HCD 3.0 EIA, and nine sera were not reactive. Nine of 13 HCD 3.0 positive sera were reactive by recombinant immunoblot assay(Lucky-Confirm). Also seven of these 13 sera had detectable HCV genomic RNA by reverse transcriptase-polymerase chain reaction(RT-PCR). None of nine HCD 3.0 negative samples had detectable immunoblot assay and HCV genomic RNA. It is concluded that the new HCV EIA can decrease a significant false positivity of second generation EIA in a blood donor population. This new assay correlates well with detection of HCV-RNA by RT-PCR and identifies donors who are truly infected.