Korean J Blood Transfus.  1996 Jun;7(1):11-22.

Evaluation of Jnnotest HCV 3.0, Genedia HCV 3.0 Enzyme Immunoassay Reagents for Hepatitis C Virus Antibody Detection

• Choi YM
• Hwang YS
• Woo JE
• Lee DH

Abstract

The hepatitis C vims(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 vital carriers from the blood donor population. Recently, a third generation anti-HCV screening(Green Cross Center Innotest HCV 3.0 Genedia HCV 3.0 ) and immunoblot assay, Inno-Lia HCV Ab III (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 Inno-Lia HCV Ab III or presence of HCV-RNA detected by reverse transcriptase-polymerase chain reaction(RT-PCR) were examined samples in which were repeatedly positive or discrepant with Abbott EIA-2, Innotest HCV 3.0 Genedia HCV 3.0 The reaction intensity of Innotest HCV 3.0 Genedia HCV 3.0 was higher than that of Abbott EIA-2. The sensitivity and specificity of Innotest HCV 3.0 and Genedia HCV 3.0 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.

MeSH Terms

Blood Donors
Genome, Viral
Hepacivirus*
Hepatitis C Antibodies
Hepatitis C*
Hepatitis*
Humans
Immunoenzyme Techniques*
Indicators and Reagents*
Mass Screening
Sensitivity and Specificity
Hepatitis C Antibodies
Indicators and Reagents