The ultimate goal of blood donor screening for anti-hepatitis C virus (hCV) antibodies is the specific exclusion of viral carriers from the blood donor population. Recently, a thirdgeneration anti-HCV screening (Lucky HCD 3.0) and immunoblot
assay
(Lucky Confirm) using antigens derived from the core and different nonstructural regions (NS3, NS4 and NS5) of the HCV viral genome were developed. To evaluated the usefulness of these assays, anti-HCV reaction patterns of the RIBA-2 and the
presence of
HCV-RNA detected by reverse transcriptase-polymerase chain reaction (RT-PCR) were examined in 180 sera, which were repeatedly positive in Abbott EIA-2, and HCV seroconversion panel sera.
The reaction intensity of HCD 3.0 was higher than that of HCD 2.0. The sensitivity and positive predictive value for viral carrier state of HCD 3.0 were 98.4% and 85.4%, respectively. HCD 3.0 assay enabled the detection of the antibody response 2
weeks
earlier than did other second-generation EIAs. RT-PCR testing of sera with RIBA-2-indeterminate results showed that 33.3% (10/30) had evidence of HCV-RNA. However, all or nine Lucky Confirm-indeterminate cases were negative for HCV-RNA. The
sensitivity
and specificity of Lucky Confirm Test were 99.2% and 76.4%, respectively, and the positive and negative predictive values were 90.5% and 97.7%, respectively.
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