Improved COBAS TaqMan hepatitis C virus test (Version 2.0) for use with the high pure system: Enhanced genotype inclusivity and performance characteristics in a multisite study

Journal of Clinical Microbiology

Volumn 45, Issue 11, 2007, Pages 3595-3600

  Colucci, G ^a   Ferguson, J ^b   Harkleroad, C ^b   Lee, S ^b   Romo, D ^b   Soviero, S ^b   Thompson, J ^b   Velez, M ^b   Wang, A ^b   Miyahara, Y ^c   Young, S ^d   Sarrazin, C ^e  

^a Roche Molecular Systems   (Switzerland)

^b ROCHE MOLECULAR SYSTEMS   (United States)

^c Roche Diagnostics KK   (Japan)

^d TRICORE REFERENCE LABORATORIES   (United States)

^e SAARLAND UNIVERSITY   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BUFFER;

ACCURACY; ARTICLE; AUTOMATION; CONTROLLED STUDY; DEVICE; FLAVIVIRUS; GENOTYPE; HEPATITIS C VIRUS; HUMAN; MONITORING; NONHUMAN; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REAL TIME POLYMERASE CHAIN REACTION; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY; VIRUS LOAD;

GENOTYPE; HEPACIVIRUS; HUMANS; POLYMERASE CHAIN REACTION; RNA, VIRAL; SENSITIVITY AND SPECIFICITY; VIRAL LOAD;

FLAVIVIRIDAE; HEPATITIS C VIRUS;

EID: 36348989741     PISSN: 00951137     EISSN: None     Source Type: Journal    
DOI: 10.1128/JCM.01320-07     Document Type: Article

References (25)

1. Chevaliez, S., and J. M. Pawlotsky. 2006. Hepatitis C virus serologic and virologie test and clinical diagnosis of HCV related liver disease. Int. J. Med. Sci. 3:35-40.
2. Davis, G. L., J. B. Wong, J. G. McHutchinson, M. P. Manns, J. Harvey, and J. Albrecht. 2003. 2003. Early virologie response to treatment with peginterferon alpha 2b plus ribavirin in patients with chronic hepatitis C. Hepatology 38:646-652.
3. Davis, G. 2006. Tailoring in anti-viral therapy in hepatitis C. Hepatology 43:909-911.
4. Gleaves, C. A., J. Welle, M. Campbell, et al. 2002. Multicenter evaluation of the Bayer VERSANT HIV-1 RNA 3.0 assay: analytical and clinical performance. J. Clin. Virol. 25:205-216.
5. Halfen, P., M. Bourliere, G. Penaranda, H. Khiri, and D. N. Ouzan. 2006. Real-time PCR for hepatitis C virus RNA quantification are adequate for clinical management of patients with chronic HCV infection. J. Clin. Microbiol. 44:2507-2511.
6. Holland, P. M., R. D. Abramson, R. Watson, and D. H. Gelfand. 1991. Detection of specific polymerase chain reaction product by utilizing the 5′-3′ exonuclease activity of Thermus aquaticus DNA polymerase. Proc. Natl. Acad. Sci. USA 88:7276-7280.
7. Jensen, D. M., T. R. Morgan, P. Marcellin, P. J. Pockrus, K. R. Reddy, and S. Hadzyiannis. 2006. Early identification of HCV genotype 1 patients responding to 24 weeks peginterferon alpha 2a/ribavirin therapy. Hepatology 43:954-960.
8. Jungkind, D. 2001. Molecular testing for infectious disease. Science 294: 1553-1555.
9. Lauer, G. M., and B. D. Walker. 2001. Hepatitis C virus infection. N. Engl. J. Med. 35:41-52.
10. Lee, S., A. Anthony, N. Lee, et al. 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.
11. Lee, S. S., E. J. Heathcote, K. R. Reddy, et al. 2002. Prognostic factor and early predictability of sustained viral response with peginterferon alfa-2a (40KD). J. Hepatol. 37:500-506.
12. Liu, L. W., J. Tomlinson, T. Mazzulli, A. Murray, and J. Heathcote. 2003. Early predictors of non responders to treatment with interferon alpha 2b and ribavirin in patients with chronic hepatitis C. Can. J. Gastroenterol. 17:483-487.
13. Mangia, A., R. Santoro, N. Minerva, G. L. Ricci, V. Carretta, M. Persico, et al. 2005. Peginterferon alpha 2a and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N. Engl. J. Med. 352:2609-2617.
14. Neumann, A. U., N. P. Lam, H. Dahari, D. R. Gretch, T. E. Wiley, T. J. Layden, and A. S. Perelson. 1998. Hepatitis C viral dynamics in vivo and the antiviral efficacy of interferon-alpha therapy. Science 282:103-107.
15. Niesters, H. G. M. 2004. Molecular and diagnostic clinical virology in real time. Clin. Microbiol. Infect. 10:5-11.
16. Pawlotsky, J. M. 2002. Use and interpretation of virological tests for hepatitis C. Hepatology 36:S65-S73.
17. Raimondo, G., M. Brunette, P. Pontisso, A. Smedile, A. M. Maina, C. Saitta, et al. 2006. Longitudinal evaluation reveals a complex spectrum of virological profiles in hepatitis B/hepatitis C virus co-infected patients. Hepatology 43:100-107.
18. Saldanha, J., N. Lelie, and A. Heath. 1999. Establishment of the first international standard for nucleic acid amplification technology (NAT) assays for HCV RNA. Vox Sang. 76:149-158.
19. Saldanha, J., A. Heath, C. Aberham, J. Albrech, G. Gentili, M. Gessner, and G. Pisani. 2005. World Heath Organization collaborative study to establish a replacement WHO international standard for hepatitis C virus RNA nucleic acid amplification technology assays. Vox Sang. 88:202-204.
20. Sarrazin, C., B. C. Gärtner, 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.
21. Stelzl, E., A. Kormann-Klement, J. Haas, J., E. Draghofer, B. I. Santner, E. Marth, and H. H. Kessler. 2002. Evaluation of an automated sample preparation protocol for quantitative detection of hepatitis C virus RNA. J. Clin. Microbiol. 40:1447-1450.
22. Tholen, D. W., M. Kroll, J. R. Astles, A. L. Caffo, T. M. Happe, J. Krouwer, and F. Lasky. 2003. Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline, CLSIEP6-A. Clinical and Laboratory Standards Institute, Wayne, PA.
23. WalkerPeach, C. R., M. Winkler, D. B. Dubois, and B. L. Pasloske. 1999. Ribonuclease-resistant RNA controls (Armored RNA) for reverse transcription-PCR, branched DNA, and genotyping assays for hepatitis C virus. Clin. Chem. 45:2079-2085.
24. Zeuzem, S. 1999. Clinical implications of hepatitis C viral kinetics. J. Hepatol. 31(Suppl. 1):61-64.
25. Zeuzem, S., E. Herrmann, J.-H. Lee, J. Fricke, A. Neumann, M. Modi, G. Colucci, and W. K. Roth. 2001. Viral kinetics in patients with chronic hepatitis C treated with standard or peginterferon alpha 2a. Gastroenterology 120:1438-1447.