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Comparative evaluation of supplemental hepatitis C virus antibody test systems
Author(s) -
Evans C.S.,
Tobler L.,
Polito A.,
Stewart J.,
Chien D.,
Wilber J.,
Quan S.,
Delaney S.,
Kuo G.,
Busch M.P.
Publication year - 1992
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1046/j.1537-2995.1992.32592327712.x
Subject(s) - neutralization , virology , immunoassay , radioimmunoassay , medicine , antibody , concordance , hepatitis c virus , recombinant dna , virus , biology , immunology , gene , biochemistry
Implementation of routine blood donor screening using anti‐hepatitis C virus (HCV) enzyme immunoassay (EIA) has resulted in an urgent need for well‐characterized supplemental assays to confirm the presence of HCV antibodies. A comparative study of four commercially available supplemental assays is reported here: first‐ and second‐generation versions of a strip recombinant immunoblot assay (RIBA‐1 and RIBA‐2), an HCV neutralization EIA, and HCV neutralization plus synthetic peptide EIA. Three hundred sixty‐seven blood donor specimens that were repeatedly reactive on HCV EIA were studied. Most specimens (93%) were also evaluated by radioimmunoassay (RIA) with a six‐antigen panel, and 60 selected specimens were tested for HCV RNA by the polymerase chain reaction (PCR). RIBA‐1 and RIBA‐2 gave concordant results with 86 percent of specimens, while an additional 13 percent were correctly classified by RIBA‐2 but not RIBA‐1. Neutralization EIA alone correctly identified 94 percent of the study group, while the remaining 6 percent required the peptide EIA or the combined neutralization‐peptide assay system for correct classification. The RIBA‐2 and neutralization‐peptide assay systems yielded identical results for 86 percent of specimens, and these results were supported by RIA and selected PCR testing. Only 2 specimens (0.5%) were frankly discrepant, while 51 specimens were indeterminate on either (47) or both (4) assays. When either the RIBA‐2 or neutralization‐peptide assay yielded an indeterminate interpretation, the other system correctly classified the specimen (based on concordance with RIA and PCR data) in a high proportion (92%) of cases. The overall high degree of concordance between RIBA‐2 and neutralization‐peptide assays, as well as the correlating RIA and PCR results, supports the validity and utility of these supplemental anti‐HCV test systems.