Clinical evaluation of the signal-to-cutoff ratios of hepatitis C virus antibody screening tests used in China

Journal of Medical Virology

Volumn 83, Issue 11, 2011, Pages 1930-1937

  Wu, Shiji ^a   Liu, Yanling ^a   Cheng, Liming ^a   Yin, Botao ^a   Peng, Jing ^a   Sun, Ziyong ^a  

^a HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY   (China)

Author keywords

HCV infection; Immunoassay; RIBA; S CO ratios

Indexed keywords

HEPATITIS C ANTIBODY; VIRUS RNA;

ANTIBODY SCREENING; ARTICLE; CHINA; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; DIAGNOSTIC VALUE; ENZYME IMMUNOASSAY; HEPATITIS C; HUMAN; IMMUNOASSAY; IMMUNOBLOTTING; MAJOR CLINICAL STUDY; MATHEMATICAL PARAMETERS; SCREENING TEST; SIGNAL TO CUTOFF RATIO;

CHINA; CLINICAL LABORATORY TECHNIQUES; HEPACIVIRUS; HEPATITIS C; HEPATITIS C ANTIBODIES; HUMANS; IMMUNOASSAY; MASS SCREENING; PREDICTIVE VALUE OF TESTS;

HEPATITIS C VIRUS;

EID: 80052713725     PISSN: 01466615     EISSN: 10969071     Source Type: Journal    
DOI: 10.1002/jmv.22168     Document Type: Article

References (26)

1. Alter HJ, Seeff LB. 2000. Recovery, persistence, sequelae in hepatitis C virus infection: A perspective on longterm outcome. Semin Liver Dis 20: 17-35.
2. Alter HJ, Jett BW, Polito AJ, Farci P, Melpolder JC. 1991. Analysis of the role of hepatitis C virus in transfusion associated hepatitis. In: Hollinger FB, Lemon SM, Margolis HS, editors. Viral hepatitis and liver disease. Baltimore, MD: Williams and Wilkins, pp 396-402.
3. Alter MJ, Margolis HS, Krawczynski K, Judson FN, Mares A, Alexander WJ, Hu PY, Miller JK, Gerber MA, Sampliner RE. 1992. Natural history of community acquired hepatitis C in the United States. N Engl J Med 327: 1899-1905.
4. Alter MJ, Kuhnert WL, Finelli L. 2003. Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. Centers for Disease Control and Prevention. MMWR Recomm Rep 52: 12-15.
5. Contreras AM, Tornero-Romo CM, Toribio JG, Celis A, Orozco-Hernández A, Rivera PK, Méndez C, Hernández-Lugo MI, Olivares L, Alvarado MA. 2008. Very low hepatitis C antibody levels predict false-positive results and avoid supplemental testing. Transfusion 48: 2540-2548.
6. Busch MP, Kleinman SH, Jackson B, Stramer SL, Hewlett I, Preston S. 2000. Committee report. Nucleic acid amplification testing of blood donors for transfusion transmitted infectious diseases: Report of the interorganiza-tional Task Force on Nucleic Acid Amplification of Blood Donors. Transfusion 40: 143-159.
7. Centers for Disease Control and Prevention. 1998. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR Recomm Rep 47: 1-39.
8. Centers for Disease Control and Prevention. 2001. Recommendations for preventing transmission of infections among chronic hemodialysis patients. MMWR 50: 1-43.
9. Centers for Disease Control and Prevention. 2007. CDC letter ARCHITECT-HCV exclusion. May 24, 2007.
10. Dufour DR, Talastas M, Fernandez MDA, Harris B, Strader DB, Seeff LB. 2003. Low-positive anti-hepatitis C virus enzyme immunoassay results: An important predictor of low likelihood of hepatitis C infection. Clin Chem 49: 479-486.
11. 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, Zheng Y-R, Zhu F-M, Tiemuer M-H-L, Bai X-H, Shan H. 2005. Significance of the signal-to-cutoff ratios of anti-hepatitis C virus enzyme immunoassays in screening of Chinese blood donors. Transfusion 45: 1816-1822.
12. Zhang H, Su XL, Liu. XL. 2007. Value of RIBA in HCV infection diagnosis. J Shaanxi Med 36: 314-315.
13. Watterson JM, Stallcup P, Escamilla D, Chernay P, Reyes A, Trevino SC. 2007. Evaluation of the ortho-clinical diagnostics vitros ECi anti-HCV test: Comparison with three other methods. J Clin Lab Anal 21: 162-166.
14. Gu JL, Qi ZB, Wang ZW, Hua-yuan Z, Yang Y, Zhen Y. 2005. Reliability of commercial anti-HCV diagnostic kits in China's market. Chin J Lab Med 28: 580-583.
15. Larghi A, Zuin M, Crosignani A, Ribero ML, Pipia C, Battezzati PM, Binelli G. 2002. Outcome of an outbreak of acute hepatitis C among healthy volunteers participating in pharmacokinetics studies. Hepatology 36: 993-1000.
16. Oethinger M, Mayo DR, Falcone JA, Barua PK, Griffith BP. 2005. Efficiency of the ortho VITROS assay for detection of hepatitis c virus-specific antibodies increased by elimination of supplemental testing of samples with very low sample-to-cutoff ratios. J Clin Microbiol 43: 2477-2480.
17. Busch MP, Glynn SA, Stramer SL, Orland J, Murphy EL, Wright DJ, Kleinman S. 2006. Correlates of hepatitis C virus (HCV) RNA negativity among HCV-seropositive blood donors. Transfusion 46: 469-475.
18. Mifumi K, Matsuo D, Masanori K, Nori Y, Eiji K, Mikio W, Seishi A, Kiyoharu Y, Yoshinori I. 2009. Clinical utility and characteristics of nine anti-HCV antibody screening reagents used in Japan. Clin Lab 55: 9-22.
19. Qi ZB, Zhou C, Gu JL, Zheng Y, Shumin Z, Shixin L, Heqiu Z, Guohua W, Xiaoguo S, Kun C, Hemin L. 1998. Evaluating Chinese anti-HCV EIA kit and foreign third-generation anti-HCV EIA kit. Chin J Lab Med 21: 348-351.
20. Sakugawa H, Nakasone H, Nakayoshi T, Kinjo F, Saito A, Yakabi S, Zukeran H, Miyagi Y, Taira R, Koja K. 1995. High proportion of false positive reactions among donors with anti-HCV antibodies in a low prevalence area. J Med Virol 46: 334-338.
21. Kim S, Kim J-H, Yoon S, Park Y-H, Kim H-S. 2008. Clinical performance evaluation of four automated chemiluminescence immunoassays for hepatitis C virus antibody detection. J Clin Microbiol 46: 3919-3923.
22. Cavazza S, Lagging M. 2005. Indeterminate third-generation hepatitis C recombinant immunoblot assay and HCV RNA analysis: Isolated reactivity against NS5 associated with HCV viraemia in clinical patients but not blood donors. Scand J Infect Dis 37: 488-492.
23. Thomas DL, Astemborski J, Rai RM, Anania FA, Schaeffer M, Galai N. 2000. Natural history of hepatitis C virus infection: Host, viral, and environmental factors. J Am Med Assoc 284: 450-456.
24. Williams IT, Gretch D, Fleenor M. 2002. Hepatitis C virus RNA concentration and chronic hepatitis in a cohort of patients followed after developing acute hepatitis C. In: Margolis HS, Alter MJ, Liang TJ, Dienstag JL, editors. Viral hepatitis and liver disease. Atlanta, GA: International Medical Press, p 341.
25. Huang X, Wang ZX, Fu M. 2003. Verification of anti-HCV screening repeat positive and the reagent analysis. Chin J Blood Transfus 16: 21-22.
26. Yu Y, Qi ZB, Zhou C, Gu JL, Yang Z, Shumin Z, Huayuan Z, Hemin L. 2001. Quality analysis of domestic anti- HCV EIA kits. Chin J Prev Med 2: 168-170.