Abstract
After observing a high incidence of low positive hepatitis C virus (HCV) antibody screens by the Ortho‐Clinical Vitros ECi test (Orthoclinical Diagnostics, Raritan, NJ), we compared results against those obtained using another chemiluminescent analyzer, as well as two U.S. Food and Drug Administration (FDA)‐approved confirmatory methodologies. To ascertain the true anti‐HCV status of samples deemed low‐positive by the Ortho‐Clinical Vitros ECi test, we tested samples using the ADVIA Centaur HCV screen test (Siemens Medical Solutions Diagnostics), the Chiron recombinant immunoblot assay (RIBA) test (Chiron Corp., Emeryville, CA), and the Roche COBAS Amplicor HCV qualitative test (Roche Diagnostics, Indianapolis, IN) in a series of studies. Of 94 specimens positive by Vitros ECi, 19% were observed to be negative by Centaur. A separate study of 91 samples with signal‐to‐cutoff (s/co) values less than 8.0 showed that all but one was negative for HCV ribonucleic acid (RNA). In comparison with RIBA, 100% (77) samples positive by the Vitros ECi test with s/co values less than 12.0 were negative or indeterminate by RIBA. A final study comparing all four methods side‐by‐side showed 63% disagreement by Centaur for Vitros ECi low‐positive samples, 75% disagreement by RIBA, and 97% disagreement by polymerase chain reaction (PCR). In conclusion, the Ortho‐Clinical Vitros ECi Anti‐HCV test yields a high rate of false‐positive results in the low s/co range in our patient population. J. Clin. Lab. Anal. 21:162–166, 2007. © 2007 Wiley‐Liss, Inc.
Keywords: hepatitis C virus, HCV, Vitros ECi, ADVIA Centaur, RIBA
REFERENCES
- 1. Centers for Disease Control and Prevention . February 15, 2005. Hepatitis C Fact Sheet. Available at: http://www.cdc.gov/ncidod/diseases/hepatitis/c/fact.htm. Accessed 12 March 2007.
- 2. Centers for Disease Control and Prevention . Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV‐related chronic disease. MMWR Morb Mortal Wkly Rep 1998;47(RR19):1–39.9450721 [Google Scholar]
- 3. Centers for Disease Control and Prevention . Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. MMWR Morb Mortal Wkly Rep 2003;52(RR03):1–16. [PubMed] [Google Scholar]
- 4. Ismail N, Fish GE, Smith MB. Laboratory evaluation of a fully automated chemiluminescence immunoassay for rapid detection of HBsAg, antibodies to HBsAg, and antibodies to hepatitis C virus. J Clin Microbiol 2004;42:610–617. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5. Oethinger M, Mayo DR, Falcone JA, Barua PK, Griffith BP. 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 2005;43:2477–2480. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6. Taylor P, Pickard G, Gammie A, Atkins M. Comparison of the ADVIA Centaur and Abbott AxSYM immunoassay systems for a routine diagnostic virology laboratory. J Clin Virol 2004;30(Suppl 1):S11–S15. [DOI] [PubMed] [Google Scholar]
- 7. Zachary P, Ullmann M, Djeddi S, et al. Evaluation of three commercially available hepatitis C virus antibody detection assays under the conditions of a clinical virology laboratory. J Clin Virol 2005;34:207–210. [DOI] [PubMed] [Google Scholar]
- 8. Pierson T, Learmonth S, Blunt D, Perez J, McNabb K. A study of soldiers returning from deployment contradicts the Centers for Disease Control's 2003 hepatitis C confirmatory testing guidance. Society of Armed Forces Medical Laboratory Scientists. Society Scope 2005;8:1–5. [Google Scholar]
- 9. Kalamvoki M, Miriagou V, Hadzivannis A, et al. 2002. Expression of immunoreactive forms of the hepatitis C NS5A protein in E. coli and their use for diagnostic assays. Arch Virol 2002;147:1733–1745. [DOI] [PubMed] [Google Scholar]