Improved Detection of Antibodies to Hepatitis C Virus Using a Second Generation Elisa
- 69 Downloads
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.
KeywordsVolunteer Blood Donor NANB Hepatitis Generation ELISA ELISA Test System Chronic NANB Hepatitis
Unable to display preview. Download preview PDF.
- Agius, C., Tupper, B., Garcia, G., Botsko, E., Malka, E., Le, A.V., Krauledat, P., DiNello, R., Quan, S., Chien, D., Polito, A., and Nelles, M., 1989, ORTHO HCV Antibody ELISA Test System for the detection of antibodies to hepatitis C (non-A, non-B hepatitis) virus, (Abstr.), 1st International Meeting on Hepatitis C Virus, Rome, Italy.Google Scholar
- Alter, H.J., Purcell, R.H., Shih, J.W., Melpolder, J.C., Houghton, M., Choo, Q.-L., and Kuo, G., 1989, Detection of antibodies to hepatitis C virus in prospectively followed transfusion recipients with acute and chronic non-A, non-B hepatitis, N. Engl. J. Med. 321:1494–1500.CrossRefPubMedGoogle Scholar
- Contreras, M., and Barbara, J.A.J., 1989, Screening for hepatitis C antibody,Lancet ii:796–797.Google Scholar
- Hopf, U., Moller, B., Kuther, D., Stemerowicz, R., Lobeck, H., Ludtke-Handjery, A., Walter, E., Blum, H., Rogegendorf, M., and Deinhardt, F., 1990, Long-term follow-up of post-transfusion and sporadic chronic hepatitis non-A, non-B and frequency of circulating antibodies to hepatitis C virus (HCV), J. Hepatol. 10 (1):69–76.CrossRefPubMedGoogle Scholar
- Kuo, G., Choo, Q.-L., Alter, H.J., Gitnick, G.L., Redeker, A.G., Purcell, R.H., Miyamura, T., Dienstag, J.L., Alter, M.J., Stevens, C.E., Tegtmeier, G.E., Bonino, F., Colombo, M., Lee, W.-S., Kuo, C., Berger, K., Shuter, J.R., Overby, L.R., Bradley, D.W., and Houghton, M., 1989, An assay for circulating antibodies to a major etiologic virus of human non-A, non-B hepatitis, Science 244:362–364.CrossRefPubMedGoogle Scholar