Evaluation of the performance of the EIAgen HCV test for detection of hepatitis C virus infection

Journal of Virological Methods

Volumn 162, Issue 1-2, 2009, Pages 203-207

  Rao, Hui Ying ^a   Ren, Fu Rong ^b   Guan, Wen Li ^a   Houde, Michel ^c   Du, Shao Cai ^a   Liu, Chang Li ^b   Gong, Xiao Yan ^b   Wei, Lai ^a  

^a PEKING UNIVERSITY PEOPLE S HOSPITAL   (China)

^b BEIJING RED CROSS BLOOD CENTER   (China)

^c Adaltis Development Inc   (Canada)

Author keywords

Anti HCV; Hepatitis C; Performance evaluation; Sensitivity; Specificity

Indexed keywords

ACUTE HEPATITIS; ANTIBODY DETECTION; ARTICLE; AUTOIMMUNE DISEASE; COMPARATIVE STUDY; CONTROLLED STUDY; DIAGNOSTIC TEST; ENZYME IMMUNOASSAY; FEMALE; HEMOLYSIS; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; HYPERLIPIDEMIA; PREGNANT WOMAN; PRIORITY JOURNAL; SCREENING; SENSITIVITY AND SPECIFICITY; SERUM;

FALSE POSITIVE REACTIONS; FEMALE; HEPACIVIRUS; HEPATITIS C; HEPATITIS C ANTIBODIES; HUMANS; IMMUNOENZYME TECHNIQUES; PREDICTIVE VALUE OF TESTS; PREGNANCY; REAGENT KITS, DIAGNOSTIC; SENSITIVITY AND SPECIFICITY;

HEPATITIS C VIRUS;

EID: 70349728777     PISSN: 01660934     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jviromet.2009.08.008     Document Type: Article

References (23)

1. Afdhal N.H. The natural history of hepatitis C. Semin. Liver Dis. 24 (2004) S3-S8
2. Allain J.P. Hepatitis C virus in blood donation. Lancet 365 (2005) 276-278
3. Alter M.J., Kuhnert W.L., and Finelli L. Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. M. M. W. R. 52 (2003) 1-15
4. Bar-Shany S., Green M.S., and Shinar E. False positive tests for anti-hepatitis C antibodies and the problem of notifying blood donors. Int. J. Epidemiol. 25 (1996) 674-678
5. Busch M.P., Tobler L.H., Gerlich W.H., Schaefer S., Giachetti C., and Smith R. Very low level viremia in HCV infectious unit missed by NAT. Transfusion 43 (2003) 1173-1174
6. Centers for Disease Control and Prevention. Public health service inter-agency guidelines for screening donors of blood, plasma, organ, tissues and semen for evidence of hepatitis B and hepatitis C. M. M. W. R. 40 (1991) 1-17
7. Centers for Disease Control and Prevention, 1998. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. M. M. W. R. 47, 1-39.
8. Choo Q.L., Kuo G., Weiner A.J., Overby L.R., Bradley D.W., and Houghton M. Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. Science 244 (1989) 359-362
9. Di Bisceglie A.M. Natural history of hepatitis C: its impact on clinical management. Hepatology 31 (2000) 1014-1018
10. Donahue J.G., Munoz A., Ness P.M., Brown Jr. D.E., Yawn D.H., McAllister Jr. H.A., Reitz B.A., and Nelson K.E. The declining risk of post-transfusion hepatitis C virus infection. N. Engl. J. Med. 327 (1992) 369-373
11. Du S.C., Zhang R., Li J.Q., and Wei L. Utilization of uracil-DNA glycosylase for combining reverse transcription and anti-contamination with polymerase chain reaction in hepatitis C virus. J. Peking Univ. [Health Sci.] 39 (2007) 426-428
12. Hoofnagle J.H. Course and outcome of hepatitis C. Hepatology 36 (2002) S21-S29
13. Hyams K.C., Riddle J., Rubertone M., Trump D., Alter M.J., Cruess D.F., Han X., Nainam O.V., Seeff L.B., Mazzuchi J.F., and Bailey S. Prevalence and incidence of hepatitis C virus infection in the US military: a seroepidemiologic survey of 21,000 troops. Am. J. Epidemiol. 153 (2001) 764-770
14. Janatpour K.A., Kemper M., Aceituno S., and Holland P.V. Incidence of minipool HCV NAT negative, single unit NAT positive units among serological positive blood donations. Transfusion 42 (2002) 80S
15. Kuramoto I.K., Moriya T., Schoening V., and Holland P.V. Fluctuation of serum HCV-RNA levels in untreated blood donors with chronic hepatitis C virus infection. J. Virol. Hepatitis 9 (2002) 36-42
16. Ownby H.E., Korelitz J.J., Busch M.P., Williams A.E., Kleinman S.H., Gilcher R.O., Nourjah P., and Retrovirus Epidemiology Donor Study. Loss of volunteer blood donors because of unconfirmed enzyme immunoassay screening results. Transfusion 37 (1997) 199-205
17. Ren F.R., Lv Q.S., Zhuang H., Li J.J., Gong X.Y., Gao G.J., Liu C.L., Wang J.X., Yao F.Z., Zhen Y.R., Zhu F.M., Tiemuer M.H., Bai X.H., and Shan H. Significance of the signal-to-cutoff ratios of anti-hepatitis C virus enzyme immunoassays in screening of Chinese blood donors. Transfusion 45 (2005) 1816-1822
18. Sakugawa H., Nakasone H., Nakayoshi T., Kinjo F., Saito A., Yakabi S., Zukeran H., Miyagi Y., Taira R., and Koja K. High proportion of false positive reactions among donors with anti-HCV antibodies in a low prevalence area. J. Med. Virol. 46 (1995) 334-338
19. Sharma U.K., Stramer S.L., Wright D.J., Glynn S.A., Hermansen S., Schreiber G.B., Kleinman S.H., Busch M.P., and Retrovirus Epidemiology Donor Study. Impact of changes in viral marker screening assays. Transfusion 43 (2003) 202-214
20. Tobler L.H., Tegtmeier G., Stramer S.L., Quan S., Dockter J., Giachetti C., and Busch M.P. Lookback on donors who are repeatedly reactive on first-generation hepatitis C virus assays: justification and rational implementation. Transfusion 40 (2000) 15-24
21. Tobler L.H., Stramer S.L., Lee S.R., Masecar B.L., Peterson J.E., Davis E.A., Andrews W.E., Brodsky J.P., Kleinman S.H., Phelps B.H., and Busch M.P. Impact of HCV 3.0 EIA relative to HCV 2.0 EIA on blood-donor screening. Transfusion 43 (2003) 1452-1459
22. Vandelli C., Renzo F., Romano L., Tisminetzky S., De Palma M., Stroffolini T., Ventura E., and Zanetti A. Lack of evidence of sexual transmission of hepatitis C among monogamous couples: results of a 10-year prospective follow-up study. Am. J. Gastroenterol. 99 (2004) 855-859
23. Wei L., Wang Q.X., Xu X.Y., Wan H., Gao Y., Tian X.L., Yu M., Sun D.G., Fan C.L., Jin J., Fan W.M., Yin L.M., Zhu W.F., Chen H.S., Zhuang H., and Wang Y. 12-25-year follow-up of hepatitis C virus infection in a rural area of Hebei province. China J. Peking Univ. [Health Sci.] 34 (2002) 574-578