Simultaneous detection of hepatitis C virus (HCV) core antigen and anti-HCV antibodies improves the early detection of HCV infection

Journal of Clinical Microbiology

Volumn 43, Issue 8, 2005, Pages 3877-3883

  Laperche, Syria ^a   Le Marrec, Nadine ^a   Girault, Annie ^a   Bouchardeau, Françoise ^a   Servant Delmas, Annabelle ^a   Maniez Montreuil, Michèle ^b   Gallian, Pierre ^b   Levayer, Thierry ^b   Morel, Pascal ^b   Simon, Nicole ^c  

^a INSTITUT NATIONAL DE LA TRANSFUSION SANGUINE   (France)

^b ETABLISSEMENT FRANÇAIS DU SANG   (France)

^c Unité d'Hémodialyse Association Pour l'Utilisation du Rein Artificiel   (France)

Author keywords

[No Author keywords available]

Indexed keywords

HEPATITIS C ANTIBODY; HEPATITIS C ANTIGEN; VIRUS RNA;

ARTICLE; BLOOD DONOR; BLOOD SAMPLING; COHORT ANALYSIS; EARLY DIAGNOSIS; ENZYME IMMUNOASSAY; EVALUATION; FOLLOW UP; HEMODIALYSIS; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; NONHUMAN; NUCLEIC ACID ANALYSIS; PRIORITY JOURNAL; QUANTITATIVE ASSAY; SCREENING TEST; SENSITIVITY AND SPECIFICITY; SEROCONVERSION;

BLOOD DONORS; HEPACIVIRUS; HEPATITIS C; HEPATITIS C ANTIBODIES; HUMANS; RENAL DIALYSIS; RNA, VIRAL; VIRAL CORE PROTEINS;

HEPATITIS C VIRUS;

EID: 23744473330     PISSN: 00951137     EISSN: None     Source Type: Journal    
DOI: 10.1128/JCM.43.8.3877-3883.2005     Document Type: Article

References (48)

1. Alvarez, M., D. Planelles, E. Vila, J. Montoro, and E. Franco. 2004. Prolonged hepatitis C virus seroconversion in a blood donor, detected by HCV antigen test in parallel with HCV RNA. Vox Sang. 86:266-267.
2. Assal, A., J. Coste, V. Barlet, S. Laperche, C. Cornillot, W. Smilovici, J. Pillonel, and G. Andreu. 2003. Application of molecular biology to blood transfusion safety: the nucleic acid testing. Transfus. Clin. Biol. 10:217-226.
3. Barrera, J. M., B. Francis, G. Ercilla, M. Nelles, D. Achord, J. Darner, and S. R. Lee. 1995. Improved detection of anti-HCV in post-transfusion hepatitis by a third-generation ELISA. Vox Sang. 68:15-18.
4. Bouvier-Alias, M., K. Patel, H. Dahari, S. Beaucourt, P. Larderie, L. Blatt, C. Hezode, G. Picchio, D. Dhumeaux, A. U. Neumann, J. G. McHutchison, and J. M. Pawlotsky. 2002. Clinical utility of total HCV core antigen quantification: a new indirect marker of HCV replication. Hepatology 36:211-218.
5. Busch, M. 2001. Closing the windows on viral transmission by blood transfusion, p. 33-54. In S. L. Stramer (ed.), Blood safety in the new millenium. American Association of Blood Banks, Bethesda, Md.
6. Busch, M. P., L. H. Tobler, W. H. Gerlich, S. Schaefer, C. Giachetti, and R. Smith. 2003. Very low level viremia in HCV infectious unit missed by NAT. Transfusion 43:1173-1174.
7. Buti, M., C. Mendez, M. Schaper, S. Sauleda, A. Valdes, F. Rodriguez-Frias, R. Jardi, and R. Esteban. 2004. Hepatitis C virus core antigen as a predictor of non-response in genotype 1 chronic hepatitis C patients treated with peginterferon alpha-2b plus ribavirin. J. Hepatol. 40:527-532.
8. Cano, H., M. J. Candela, M. L. Lozano, and V. Vicente. 2003. Application of a new enzyme-linked immunosorbent assay for detection of total hepatitis C virus core antigen in blood donors. Transfus. Med. 13:259-266.
9. Challine, D., B. Pellegrin, M. Bouvier-Alias, P. Rigot, L. Laperche, and J. M. Pawlotsky. 2004. HIV and hepatitis C virus RNA in seronegative organ and tissue donors. Lancet 364:1611-1612.
10. Coste, J., T. Levayer, J. Izopet, S. Laperche, P. Parneix, H. Rech, J. L. Payen, and J. F. Schved. 2003. Acute HCV infection detected in a blood donor by NAT. Transfusion 43:116-118.
11. Courouce, A. M., N. Le Marrec, F. Bouchardeau, A. Razer, M. Maniez, S. Laperche, and N. Simon. 2000. Efficacy of HCV core antigen detection during the preseroconversion period. Transfusion 40:1198-1202.
12. Courouce, A. M., J. Pillonel, et al. 1996. Transfusion-transmitted viral infections. N. Engl. J. Med. 335:1609-1610.
13. Durand, F., A. Beauplet, and P. Marcellin. 2000. Evidence of hepatitis C virus viremia without detectable antibody to hepatitis C virus in a blood donor. Ann. Intern. Med. 133:74-75.
14. Eiras, A., S. Sauleda, D. Planelles, M. Sedeno, A. Ibarra, M. A. Vesga, E. Franco, J. A. Montoro, J. M. Hernandez, and R. G. Villaescusa. 2003. HCV screening in blood donations using RT-PCR in mini-pool: the experience in Spain after routine use for 2 years. Transfusion 43:713-720.
15. Fang, C. T., S. P. Field, M. P. Busch, and P. Heyns Adu. 2003. Human immunodeficiency virus-1 and hepatitis C virus RNA among South African blood donors: estimation of residual transfusion risk and yield of nucleic acid testing. Vox Sang. 85:9-19.
16. Glynn, S. A., S. H. Kleinman, D. J. Wright, and M. P. Busch. 2002. International application of the incidence rate/window period model. Transfusion 42:966-972.
17. Jackson, B. R., M. P. Busch, S. L. Stramer, and J. P. AuBuchon. 2003. The cost-effectiveness of NAT for HIV, HCV, and HBV in whole-blood donations. Transfusion 43:721-729.
18. Kolk, D. P., J. Dockter, J. Linnen, M. Ho-Sing-Loy, K. Gillotte-Taylor, S. H. McDonough, L. Mimms, and C. Giachetti. 2002. Significant closure of the human immunodeficiency virus type 1 and hepatitis C virus preseroconversion detection windows with a transcription-mediated-amplification-driven assay. J. Clin. Microbiol. 40:1761-1766.
19. Krajden, M., R. Shivji, K. Gunadasa, A. Mak, G. McNabb, M. Friesenhahn, D. Hendricks, and L. Comanor. 2004. Evaluation of the core antigen assay as a second-line supplemental test for diagnosis of active hepatitis C virus infection. J. Clin. Microbiol. 42:4054-4059.
20. Kuo, G., Q. L. Choo, H. J. Alter, G. L. Gitnick, A. G. Redeker, R. H. Purcell, T. Miyamura, J. L. Dienstag, M. J. Alter, C. E. Stevens, et al. 1989. An assay for circulating antibodies to a major etiologic virus of human non-A, non-B hepatitis. Science 244:362-364.
21. Laperche, S. 2005. Blood safety and nucleic acid testing in Europe. Euro Surveill. 10:3-4.
22. Laperche, S., F. Bouchardeau, M. Maniez, M. Beolet, M. H. Elghouzzi, and J. J. Lefrere. 2004. Nucleic acid testing in blood donations reactive to hepatitis C virus antibody, but with an extremely low viral load. Vox Sang. 86:198.
23. Laperche, S., N. Le Marrec, N. Simon, F. Bouchardeau, C. Defer, M. Maniez-Montreuil, T. Levayer, J. P. Zappitelli, and J. J. Lefrere. 2003. A new HCV core antigen assay based on disassociation of immune complexes: an alternative to molecular biology in the diagnosis of early HCV infection. Transfusion 43:958-962.
24. Lefrere, J. 1998. Sécurité virale et transplantation d'organes. Virologie 2:227-232.
25. Letowska, M., E. Brojer, M. Mikulska, A. Gronowska, and A. Rosiek. 2004. Hepatitis C core antigen in Polish blood donors. Transfusion 44:1067-1071.
26. Ly, T. D., S. Laperche, C. Brennan, A. Vallari, A. Ebel, J. Hunt, L. Martin, D. Daghfal, G. Schochetman, and S. Devare. 2004. Evaluation of the sensitivity and specificity of six HIV combined p24 antigen and antibody assays. J. Virol. Methods 122:185-194.
27. Maniez-Montreuil, M., and F. Dubois. 2000. Interpretation of hepatitis C virus serology: immunoblot and genome amplification. Transfus. Clin. Biol. 7(Suppl. 1):25s-30s.
28. Marshall, D. A., S. H. Kleinman, J. B. Wong, J. P. AuBuchon, D. T. Grima, N. A. Kulin, and M. C. Weinstein. 2004. Cost-effectiveness of nucleic acid test screening of volunteer blood donations for hepatitis B, hepatitis C and human immunodeficiency virus in the United States. Vox Sang. 86:28-40.
29. Maynard, M., P. Pradat, P. Berthillon, G. Picchio, N. Voirin, M. Martinot, P. Marcellin, and C. Trepo. 2003. Clinical relevance of total HCV core antigen testing for hepatitis C monitoring and for predicting patients' response to therapy. J. Viral Hepat. 10:318-323.
30. Mine, H., H. Emura, M. Miyamoto, T. Tomono, K. Minegishi, H. Murokawa, R. Yamanaka, A. Yoshikawa, and K. Nishioka. 2003. High throughput screening of 16 million serologically negative blood donors for hepatitis B virus, hepatitis C virus and human immunodeficiency virus type-1 by nucleic acid amplification testing with specific and sensitive multiplex reagent in Japan. J. Virol. Methods 112:145-151.
31. Netski, D. M., X. H. Wang, S. H. Mehta, K. Nelson, D. Celentano, S. Thongsawat, N. Maneekarn, V. Suriyanon, J. Jittiwutikorn, D. L. Thomas, and J. R. Ticehurst. 2004. Hepatitis C virus (HCV) core antigen assay to detect ongoing HCV infection in Thai injection drug users. J. Clin. Microbiol. 42:1631-1636.
32. Nubling, C. M., G. Unger, M. Chudy, S. Raia, and J. Lower. 2002. Sensitivity of HCV core antigen and HCV RNA detection in the early infection phase. Transfusion 42:1037-1045.
33. Operskalski, E. A., J. W. Mosley, L. H. Tobler, E. W. Fiebig, M. J. Nowicki, L. T. Mimms, J. Gallarda, B. H. Phelps, and M. P. Busch. 2003. HCV viral load in anti-HCV-reactive donors and infectivity for their recipients. Transfusion 43:1433-1441.
34. Pawlotsky, J. M. 2002. Use and interpretation of virological tests for hepatitis C. Hepatology 36:S65-S73.
35. Peterson, J., G. Green, K. Iida, B. Caldwell, P. Kerrison, S. Bernich, K. Aoyagi, and S. R. Lee. 2000. Detection of hepatitis C core antigen in the antibody negative 'window' phase of hepatitis C infection. Vox Sang. 78:80-85.
36. Pillonel, J., and S. Laperche. 2005. Trends in risk of transfusion-transmitted viral infections (HIV, HCV, HBV) in France between 1992 and 2003 and impact of nucleic acid testing (NAT). Euro Surveill. 10:5-8.
37. Pillonel, J., S. Laperche, C. Saura, J. C. Desenclos, and A. M. Courouce. 2002. Trends in residual risk of transfusion-transmitted viral infections in France between 1992 and 2000. Transfusion 42:980-988.
38. Raker, C. A., E. Tabor, A. Okayama, M. Y. Yu, M. Kohara, N. E. Mueller, H. Tsubouchi, and S. O. Stuver. 2004. HCV core antigen as an alternative to NAT to detect HCV viremia. Transfusion 44:307-308.
39. Roth, W. K., M. Weber, S. Buhr, C. Drosten, W. Weichert, W. Sireis, D. Hedges, and E. Seifried. 2002. Yield of HCV and HIV-1 NAT after screening of 3.6 million blood donations in central Europe. Transfusion 42:862-868.
40. Sanz, C., D. Tassies, J. Costa, C. Freire, and A. Pereira. 2002. The first case of HCV infection detected before seroconversion in blood donors tested by HCV core antigen ELISA. Transfusion 42:505-506.
41. Seed, C. R., A. Cheng, S. L. Ismay, W. V. Bolton, P. Kiely, T. J. Cobain, and A. J. Keller. 2002. Assessing the accuracy of three viral risk models in predicting the outcome of implementing HIV and HCV NAT donor screening in Australia and the implications for future HBV NAT. Transfusion 42:1365-1372.
42. Shah, D. O., C. D. Chang, L. X. Jiang, K. Y. Cheng, A. S. Muerhoff, R. A. Gutierrez, T. P. Leary, S. M. Desai, I. V. Batac-Herman, V. A. Salbilla, A. S. Haller, J. L. Stewart, and G. J. Dawson. 2003. Combination HCV core antigen and antibody assay on a fully automated chemiluminescence analyzer. Transfusion 43:1067-1074.
43. Simmonds, P., J. Kurtz, and R. Tedder. 2002. The UK blood transfusion service: over a (patent) barrel. Lancet 359:1713-1714.
44. Stramer, S. L., S. A. Glynn, S. H. Kleinman, D. M. Strong, C. Sally, D. J. Wright, R. Y. Dodd, and M. P. Busch. 2004. Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid-amplification testing. N. Engl. J. Med. 351:760-768.
45. Tanaka, E., C. Ohue, K. Aoyagi, K. Yamaguchi, S. Yagi, K. Kiyosawa, and H. J. Alter. 2000. Evaluation of a new enzyme immunoassay for hepatitis C virus (HCV) core antigen with clinical sensitivity approximating that of genomic amplification of HCV RNA. Hepatology 32:388-393.
46. Tobler, L. H., S. L. Stramer, S. R. Lee, B. L. Masecar, J. E. Peterson, E. A. Davis, W. E. Andrews, J. P. Brodsky, S. H. Kleinman, B. H. Phelps, and M. P. Busch. 2003. Impact of HCV 3.0 EIA relative to HCV 2.0 EIA on blood-donor screening. Transfusion 43:1452-1459.
47. Toyoda, H., H. Sakamoto, T. Mizuno, Y. Horiguchi, and H. Nakano. 2000. Eradication of hepatitis C virus 1b by interferon in a health care worker with acute hepatitis following needlestick transmission from a patient with chronic hepatitis C unresponsive to interferon. Scand. J. Gastroenterol. 35:1117-1120.
48. Velati, C., L. Romano, L. Baruffi, M. Pappalettera, V. Carreri, and A. R. Zanetti. 2002. Residual risk of transfusion-transmitted HCV and HIV infections by antibody-screened blood in Italy. Transfusion 42:989-993.