Korean J Blood Transfus.  1994 Nov;5(2):115-126.

Evaluation of the Third-generation Enzyme Immunoassay and Confirmatory Test for Anti-HCV

Abstract

The ultimate goal of blood donor screening for anti-hepatitis C virus(HCV) antibodies is the specific exclusion of vital carriers from the blood donor population. Recently, a third-generation anti-HCV screening (Lucky HCD 3.0) and immunoblot assay (Lucky Confirm) using antigens derived from the core and different nonstructural regioris (NS3, NS4 and NS5) of the HCV vital genome were developed. To evaluate 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 vital 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-indetermihate results showed that 33.3%(10/30) had evidence of HCV-RNA. However, all of 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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