Comparison of performance characteristics of three real-time reverse transcription-PCR test systems for detection and quantification of hepatitis C virus

Journal of Clinical Microbiology

Volumn 45, Issue 8, 2007, Pages 2529-2536

  Sábato, M Fernanda ^a   Shiffman, Mitchell L ^b   Langley, Michael R ^c   Wilkinson, David S ^a   Ferreira Gonzalez, Andrea ^a  

^a VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^b VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DIAGNOSTIC ACCURACY; GENOTYPE; HEPATITIS C VIRUS; HUMAN; HUMAN TISSUE; INTERMETHOD COMPARISON; PLASMA; PRIORITY JOURNAL; REPRODUCIBILITY; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY; STATISTICAL ANALYSIS; VIRUS DETECTION; VIRUS TITRATION;

HEPACIVIRUS; HEPATITIS C; HUMANS; REAGENT KITS, DIAGNOSTIC; REPRODUCIBILITY OF RESULTS; REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION; RNA, VIRAL; SENSITIVITY AND SPECIFICITY; VIRAL LOAD;

HEPATITIS C VIRUS;

EID: 34548105194     PISSN: 00951137     EISSN: None     Source Type: Journal    
DOI: 10.1128/JCM.00058-07     Document Type: Article

References (27)

1. Barbeau, J. M., J. Goforth, A. M. Caliendo, and F. S. Nolte. 2004. Performance characteristics of a quantitative TaqMan hepatitis C virus RNA analyte-specific reagent. J. Clin. Microbiol. 42:3739-3746.
2. Bland, J. M., and D. G. Altman. 1986. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1:307-310.
3. Caliendo, A. M., A. Valsamakis, Y. Zhou, B. Yen-Lieberman, J. Andersen, S. Young, A. Ferreira-Gonzalez, G. J. Tsongalis, R. Pyles, J. W. Bremer, and N. S. Lurain. 2006. Multilaboratory comparison of hepatitis C virus viral load assays. J. Clin. Microbiol. 44:1726-1732.
4. Ferreira-Gonzalez, A., and M. L. Shiffman. 2004. Use of diagnostic testing for managing hepatitis C virus infection. Semin. Liver Dis. 24(Suppl. 2):9-18.
5. Ferreira-Gonzalez, A., M. L. Shiffman, D. H. Lofland, M. R. Langley, D. W. Gainey, and C. T. Garrett. 1996. Assessing clinical utility of hepatitis C virus quantitative RT-PCR data: implications for identification of responders among alpha-interferon-treated patients. Mol. Diagn. 1:109-120.
6. Forman, M. S., and A. Valsamakis. 2004. Verification of an assay for quantification of hepatitis C virus RNA by use of an analyte-specific reagent and two different extraction methods. J. Clin. Microbiol. 42:3581-3588.
7. Gelderblom, H. C., S. Menting, and M. G. Beld. 2006. Clinical performance of the new Roche COBAS TaqMan HCV Test and High Pure System for extraction, detection and quantitation of HCV RNA in plasma and serum. Antivir. Ther. 11:95-103.
8. Germer, J. J., W. S. Harmsen, J. N. Mandrekar, P. S. Mitchell, and J. D. C. Yao. 2005. Evaluation of the COBAS TaqMan HCV Test with automated sample processing using the MagNA Pure LC instrument. J. Clin. Microbiol. 43:293-298.
9. Germer, J. J., N. N. Zein, M. A. Metwally, T. L. Hoskin, H. W. Scott, T. F. Smith, and R. Patel. 2003. Comparison of the VERSANT HCV RNA qualitative assay (transcription-mediated amplification) and the COBAS AMPLICOR hepatitis C virus test, version 2.0, in patients undergoing interferon-ribavirin therapy. Diagn. Microbiol. Infect. Dis. 47:615-618.
10. Hendricks, D. A., M. Friesenhahn, L. Tanimoto, B. Goergen, D. Dodge, and L. Comanor, 2003. Multicenter evaluation of the VERSANT HCV RNA qualitative assay for detection of hepatitis C virus RNA. J. Clin. Microbiol. 41:651-656.
11. Kim, W. R. 2002. The burden of hepatitis C in the United States. Hepatology 36:S30-S34.
12. Kleiber, J., T. Walter, G. Haberhausen, S. Tsang, R. Babiel, and M. Rosenstraus. 2000. Performance characteristics of a quantitative, homogeneous TaqMan RT-PCR test for HCV RNA. J. Mol. Diagn. 2:158-166.
13. Konnick, E. Q., M. Erali, E. R. Ashwood, and D. R. Hillyard. 2002. Performance characteristics of the COBAS Amplicor Hepatitis C Virus (HCV) Monitor, version 2.0, international unit assay and the National Genetics Institute HCV Superquant assay. J. Clin. Microbiol. 40:768-773.
14. Lee, S. C., A. Antony, N. Lee, J. Leibow, J. Q. Yang, S. Soviero, K. Gutekunst, and M. Rosenstraus. 2000. Improved version 2.0 qualitative and quantitative AMPLICOR reverse transcription-PCR tests for hepatitis C virus RNA: calibration to international units, enhanced genotype reactivity, and performance characteristics. J. Clin. Microbiol. 38:4171-4179.
15. Majid, A. M., and D. R. Gretch. 2002. Current and future hepatitis C virus diagnostic testing: problems and advancements. Microbes Infect. 4:1227-1236.
16. Martell, M., J. Gómez, J. I. Esteban, S. Sauleda, J. Quer, B. Cabot, R. Esteban, and J. Guardia. 1999. High-throughput real-time reverse transcription-PCR quantitation of hepatitis C virus RNA. J. Clin. Microbiol. 37:327-332.
17. Morishima, C., M. Chung, K. W. Ng, D. J. Brambilla, and D. R. Gretch. 2004. Strengths and limitations of commercial tests for hepatitis C virus RNA quantification. J. Clin. Microbiol. 42:421-425.
18. National Institutes of Health. 2006. National Institutes of Health Consensus Development Conference statement. Management of hepatitis C: 2002-2004. National Institutes of Health, Bethesda, MD. http://consensus.nih. gov.
19. Nolte, F. S., M. W. Fried, M. L. Shiffman, A. Ferreira-Gonzalez, C. T. Garrett, E. R. Schiff, S. J. Polyak, and D. R. Gretch. 2001. Prospective multicenter clinical evaluation of AMPLICOR and COBAS AMPLICOR hepatitis C virus tests. J. Clin. Microbiol. 39:4005-4012.
20. Pawlotsky, J. M. 2002. Molecular diagnosis of viral hepatitis. Gastroenterology 122:1554-1568.
21. Pawlotsky, J. M., M. Martinot-Peignoux, J. D. Poveda, A. Bastie, V. Le Breton, F. Darthuy, J. Remire, S. Erlinger, D. Dhumeaux, and P. Marcellin. 1999. Quantification of hepatitis C virus RNA in serum by branched DNA-based signal amplification assays. J. Virol. Methods 79:227-235.
22. Pisani, G., K. Cristiano, M. Wirz, G. M. Bisso, and G. Gentili. 2002. Over-estimation of the hepatitis C virus RNA content of reference preparations by the AMPLICOR HCV monitor test, version 2.0. J. Clin. Microbiol. 40:47654767.
23. Sarrazin, C., B. C. Gartner, D. Sizmann, R. Babiel, U. Mihm, W. P. Hofmann, M. von Wagner, and S. Zeuzem. 2006. Comparison of conventional PCR with real-time PCR and branched DNA-based assays for hepatitis C virus RNA quantification and clinical significance for genotypes 1 to 5. J. Clin. Microbiol. 44:729-737.
24. Sarrazin, C., D. A. Hendricks, F. Sedarati, and S. Zeuzem. 2001. Assessment, by transcription-mediated amplification, of virologic response in patients with chronic hepatitis C virus treated with peginterferon α-2a. J. Clin. Microbiol. 39:2850-2855.
25. Schirm, J., A. M. van Loon, E. Valentine-Thon, P. E. Klapper, J. Reid, and G. M. Cleator. 2002. External quality assessment program for qualitative and quantitative detection of hepatitis C virus RNA in diagnostic virology. J. Clin. Microbiol. 40:2973-2980.
26. Yang, J. H., J. P. Lai, S. D. Douglas, D. Metzger, X. H. Zhu, and W. Z. Ho. 2002. Real-time RT-PCR for quantitation of hepatitis C virus RNA. J. Virol. Methods 102:119-128.
27. Zaaijer, H. L., H. T. Cuypers, H. W. Reesink, I. N. Winkel, G. Gerken, and P. N. Lelie. 1993. Reliability of polymerase chain reaction for detection of hepatitis C virus. Lancet 341:722-724.