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. 1995 Mar;33(3):620–624. doi: 10.1128/jcm.33.3.620-624.1995

Study on reliability of commercially available hepatitis C virus antibody tests.

H H Feucht 1, B Zöllner 1, S Polywka 1, R Laufs 1
PMCID: PMC228001  PMID: 7751366

Abstract

The serodiagnosis of hepatitis C virus (HCV) infection was analyzed by a recombinant immunoblot assay (RIBA) with recombinant proteins encoded by the viral RNA isolated from our patients in Hamburg, Germany. The HCV RNA was amplified by PCR, and proteins encoded by the viral core and the NS3, NS4, and NS5 regions were expressed subsequently in Escherichia coli. The results obtained with our UKE RIBA were compared with the results of the Abbott HCV second-generation enzyme immunoassay (EIA). Serum samples from 270 patients, which were sent to us on the suspicion of HCV hepatitis and which were negative for hepatitis A virus and hepatitis B virus antibodies, were examined. In 227 cases (84.1%), there were identical positive (204 cases, 75.6%) or negative (23 cases, 8.5%) results in both tests. In 32 cases (11.9%), the reactive Abbott second-generation HCV EIA results could not be confirmed by the UKE RIBA and the HCV PCR. In follow-up studies conducted over 1 year, these results did not change. In three cases (1.1%), the UKE RIBA presented a positive result while the Abbott second-generation HCV EIA was negative. All three cases were positive in the HCV PCR and showed seroconversion in an HCV EIA 4 to 6 weeks later. In addition, 33 patient serum samples were examined by UKE RIBA in parallel with the Ortho RIBA 2.0. In three cases (9.1%), a positive Ortho RIBA 2.0 result could not be confirmed by the UKE RIBA and the HCV PCR. All three patients were free of complaints. The UKE RIBA showed also a smaller number of indeterminate results (3.0%) than the Ortho RIBA 2.0 (24.2%). This comparison study demonstrates that the commercially available HCV antibody tests should be further improved.

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Selected References

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  1. Bradley D. W., Beach M. J., Purdy M. A. Molecular characterization of hepatitis C and E viruses. Arch Virol Suppl. 1993;7:1–14. doi: 10.1007/978-3-7091-9300-6_1. [DOI] [PubMed] [Google Scholar]
  2. Bresters D., Zaaijer H. L., Cuypers H. T., Reesink H. W., Winkel I. N., van Exel-Oehlers P. J., van Drimmelen A. A., Jansen P. L., van der Poel C. L., Lelie P. N. Recombinant immunoblot assay reaction patterns and hepatitis C virus RNA in blood donors and non-A, non-B hepatitis patients. Transfusion. 1993 Aug;33(8):634–638. doi: 10.1046/j.1537-2995.1993.33893342743.x. [DOI] [PubMed] [Google Scholar]
  3. Chicheportiche C., Cantaloube J. F., Biagini P., Aumont P., Donnadieu F., Escher J., Larabi F., Zepitelli J. P. Analysis of ELISA hepatitis C virus-positive blood donors population by polymerase chain reaction and recombinant immunoblot assay (RIBA). Comparison of second and third generation RIBA. Acta Virol. 1993 Apr-Jun;37(2-3):123–131. [PubMed] [Google Scholar]
  4. Chomczynski P., Sacchi N. Single-step method of RNA isolation by acid guanidinium thiocyanate-phenol-chloroform extraction. Anal Biochem. 1987 Apr;162(1):156–159. doi: 10.1006/abio.1987.9999. [DOI] [PubMed] [Google Scholar]
  5. Choo Q. L., Kuo G., Weiner A. J., Overby L. R., Bradley D. W., Houghton M. Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. Science. 1989 Apr 21;244(4902):359–362. doi: 10.1126/science.2523562. [DOI] [PubMed] [Google Scholar]
  6. Choo Q. L., Richman K. H., Han J. H., Berger K., Lee C., Dong C., Gallegos C., Coit D., Medina-Selby R., Barr P. J. Genetic organization and diversity of the hepatitis C virus. Proc Natl Acad Sci U S A. 1991 Mar 15;88(6):2451–2455. doi: 10.1073/pnas.88.6.2451. [DOI] [PMC free article] [PubMed] [Google Scholar]
  7. Dow B. C., Coote I., Munro H., McOmish F., Yap P. L., Simmonds P., Follett E. A. Confirmation of hepatitis C virus antibody in blood donors. J Med Virol. 1993 Nov;41(3):215–220. doi: 10.1002/jmv.1890410309. [DOI] [PubMed] [Google Scholar]
  8. Gretch D., Lee W., Corey L. Use of aminotransferase, hepatitis C antibody, and hepatitis C polymerase chain reaction RNA assays to establish the diagnosis of hepatitis C virus infection in a diagnostic virology laboratory. J Clin Microbiol. 1992 Aug;30(8):2145–2149. doi: 10.1128/jcm.30.8.2145-2149.1992. [DOI] [PMC free article] [PubMed] [Google Scholar]
  9. Houghton M., Weiner A., Han J., Kuo G., Choo Q. L. Molecular biology of the hepatitis C viruses: implications for diagnosis, development and control of viral disease. Hepatology. 1991 Aug;14(2):381–388. [PubMed] [Google Scholar]
  10. Hsu H. H., Gonzalez M., Foung S. K., Feinstone S. M., Greenberg H. B. Antibodies to hepatitis C virus in low-risk blood donors: implications for counseling positive donors. Gastroenterology. 1991 Dec;101(6):1724–1727. doi: 10.1016/0016-5085(91)90413-f. [DOI] [PubMed] [Google Scholar]
  11. 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. An assay for circulating antibodies to a major etiologic virus of human non-A, non-B hepatitis. Science. 1989 Apr 21;244(4902):362–364. doi: 10.1126/science.2496467. [DOI] [PubMed] [Google Scholar]
  12. Lelie P. N., Cuypers H. T., Reesink H. W., van der Poel C. L., Winkel I., Bakker E., van Exel-Oehlers P. J., Vallari D., Allain J. P., Mimms L. Patterns of serological markers in transfusion-transmitted hepatitis C virus infection using second-generation HCV assays. J Med Virol. 1992 Jul;37(3):203–209. doi: 10.1002/jmv.1890370310. [DOI] [PubMed] [Google Scholar]
  13. McHutchison J. G., Person J. L., Govindarajan S., Valinluck B., Gore T., Lee S. R., Nelles M., Polito A., Chien D., DiNello R. Improved detection of hepatitis C virus antibodies in high-risk populations. Hepatology. 1992 Jan;15(1):19–25. doi: 10.1002/hep.1840150105. [DOI] [PubMed] [Google Scholar]
  14. Miller R. H., Purcell R. H. Hepatitis C virus shares amino acid sequence similarity with pestiviruses and flaviviruses as well as members of two plant virus supergroups. Proc Natl Acad Sci U S A. 1990 Mar;87(6):2057–2061. doi: 10.1073/pnas.87.6.2057. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Reuter D., Polywka S., Iske L., Feucht H. H., Laufs R. Close correlation between hepatitis C virus serology and polymerase chain reaction in chronically infected patients. Infection. 1992 Nov-Dec;20(6):320–323. doi: 10.1007/BF01710675. [DOI] [PubMed] [Google Scholar]
  16. Sanger F., Nicklen S., Coulson A. R. DNA sequencing with chain-terminating inhibitors. Proc Natl Acad Sci U S A. 1977 Dec;74(12):5463–5467. doi: 10.1073/pnas.74.12.5463. [DOI] [PMC free article] [PubMed] [Google Scholar]
  17. Simmonds P., Holmes E. C., Cha T. A., Chan S. W., McOmish F., Irvine B., Beall E., Yap P. L., Kolberg J., Urdea M. S. Classification of hepatitis C virus into six major genotypes and a series of subtypes by phylogenetic analysis of the NS-5 region. J Gen Virol. 1993 Nov;74(Pt 11):2391–2399. doi: 10.1099/0022-1317-74-11-2391. [DOI] [PubMed] [Google Scholar]
  18. Van der Poel C. L., Cuypers H. T., Reesink H. W., Weiner A. J., Quan S., Di Nello R., Van Boven J. J., Winkel I., Mulder-Folkerts D., Exel-Oehlers P. J. Confirmation of hepatitis C virus infection by new four-antigen recombinant immunoblot assay. Lancet. 1991 Feb 9;337(8737):317–319. doi: 10.1016/0140-6736(91)90942-i. [DOI] [PubMed] [Google Scholar]
  19. Weiner A. J., Truett M. A., Rosenblatt J., Han J., Quan S., Polito A. J., Kuo G., Choo Q. L., Houghton M., Agius C. HCV testing in low-risk population. Lancet. 1990 Sep 15;336(8716):695–695. doi: 10.1016/0140-6736(90)92194-m. [DOI] [PubMed] [Google Scholar]

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