Abstract
A screening assay for the detection of antibodies to hepatitis C virus (HCV); ORTHOTM HCV ELISA Test System, Second Generation, was compared with the currently licensed c100-3 based test (ORTHOTM HCV ELISA Test System). The second generation ELISA differs from the c100-3 based assay in that it detects circulating antibodies to both structural (nucleocapsid) and non-structural (NS3/NS4) HCV proteins. Specimens tested consisted of a cohort of 35 patients diagnosed with non-A, non-B hepatitis (NANBH) and 3971 presumably healthy volunteer blood donors. Second generation ELISA demonstrated significantly greater clinical sensitivity in patients with acute phase NANBH (80% vs. 60%) as well as chronic disease (88% vs. 72%). Additional specimens reactive only in second generation ELISA, demonstrated reactivity to HCV antigens c33c and/or c22-3 in supplemental testing by the Chiron HCV RIBA tm Assay System. The second generation ELISA also detected additional RIBA reactive volunteer blood donors (0.18% of the population tested) that were nonreactive in first generation ELISA. This data indicated that second generation ELISA would detect approximately 2 additional antiHCV reactive donors per 1,000 screened. Specificities obtained with this low risk population were 99.6% for first generation and 99.7% for second generation ELISA.
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© 1992 Springer Science+Business Media New York
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Lee, S. et al. (1992). Improved Detection of Antibodies to Hepatitis C Virus Using a Second Generation Elisa. In: Block, T.M., Jungkind, D., Crowell, R.L., Denison, M., Walsh, L.R. (eds) Innovations in Antiviral Development and the Detection of Virus Infections. Advances in Experimental Medicine and Biology, vol 312. Springer, Boston, MA. https://doi.org/10.1007/978-1-4615-3462-4_19
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DOI: https://doi.org/10.1007/978-1-4615-3462-4_19
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