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KMID : 0387719960070010011
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Korean Journal of Blood Transfusion
1996 Volume.7 No. 1 p.11 ~ p.22
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Evaluation of Innotest HCV 3.0, Genedia HCV 3.0 Enzyme Immunoassay Reagents for Hepatitis C Virus Antibody Detection
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Abstract
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The hepatitis C virus(HCV) is now known to be the chief cause of transfusion-associated non-A, non-B hepatitis. The ultimate goal of blood donor screening for anti-HCV antibodies is the specific exclusion of viral carriers from the blood donor
population. Recently, a third generation anti-HCV screening (Green Cross Center Innotest HCV 3.0(r), Genedia HCV 3.0(r)) and immunoblot assay, Inno-Lia HCV Ab Ⅲ(r)(Innogenetics) using antigens derived from the core and different nonstructural
regions
(NS3, NS4 and NS5) of the HCV viral genome were developed. To evaluate the usefulness of these assays, anti-HCV reaction patterns of the InnoLia HCV Ab Ⅲ(r) or presence of HCV-RNA detected by reverse transcriptase-polymerase chain reaction
(RTPCR)
were
examined samples in which were repeatedly positive or discrepant with Abbott EIA-2, Innotest HCV 3.0(r), Genedia HCV 3.0(r). The reaction intensity of Innotest HCV 3.0(r) , Genedia HCV 3.0(r) was higher than that of Abbott EIA-2. The sensitivity
and
specificity of Innotest HCV 3.0(r), Genedia HCV 3.0(r). The reaction intensity of Innotest HCV 3.0(r) and Gendia HCV 3.0(r) were 92.9% and 86.8%, respectively, and the positive and negative predictive values were 72.2% and 97.1%, both. The
sensitivity
and specificity of Abbott EIA-2 were 100% and 78.9%, respectively, and the positive and negative predictive values were 63.6% and 100%, respectively. We concluded that the new third generation HCV EIA reagents can decrease a false positivity of
second
generation EIA reagents and correlate well with detection of HCV-RNA by RT-PCR.
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KEYWORD
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