Multicenter evaluation of the COBAS AMPLICOR HCV assay, an integrated PCR system for rapid detection of hepatitis C virus RNA in the diagnostic laboratory

Journal of Clinical Microbiology

Volumn 36, Issue 4, 1998, Pages 862-865

  Albadalejo, J ^a   Alonso, R ^a   Antinozzi, R ^b   Bogard, M ^c   Bourgault, A M ^d   Colucci, G ^d,e   Fenner, T ^f   Petersen, H ^f   Sala, E ^b   Vincelette, J ^d   Young, C ^g  

^a HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^b SANT ANNA HOSPITAL   (Italy)

^c CENTRE HOSPITALIER DE MEAUX   (France)

^d F HOFFMANN LA ROCHE LTD   (Switzerland)

^e PCR Labor   (Germany)

^f UNIVERSITY OF MONTREAL   (Canada)

^g HOFFMANN LA ROCHE INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; HEPATITIS C ANTIBODY; VIRUS RNA;

ARTICLE; ASSAY; AUTOMATION; CLINICAL TRIAL; DIAGNOSTIC ACCURACY; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; LABORATORY DIAGNOSIS; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PERFORMANCE; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; SEROLOGY;

EID: 0031918127     PISSN: 00951137     EISSN: None     Source Type: Journal    
DOI: 10.1128/jcm.36.4.862-865.1998     Document Type: Article

References (24)

1. Alberti, A., G. Morsica, L. Chemello, D. Cavalletto, F. Noventa, P. Pontisso, and A. Ruol. 1992. Hepatitis C viraemia and liver disease in symptom-free individuals with anti-HCV. Lancet 340:697-698.
2. Alter, H. J. 1995. To C or not to C: these are the questions. Blood 85: 1681-1695.
3. Bonino, F., M. R. Brunetto, F. Negro, M. Baldi, G. Saracco, M. L. Abate, A. Fabiano, G. Verme, et al. 1993. Hepatitis C virus infection and disease. Diagnostic problems. J. Hepatol. 17(Suppl. 3):78-82.
4. College of American Pathologists. 1992. Workload recording method and personnel management manual. College of American Pathologists, Northfield, Ill.
5. Damen, M., H. T. M. Cuypers, H. W. Zaaijer, H. W. Reesink, W. P. Schaasberg, W. H. Gerlich, H. G. M. Niesters, and P. N. Lelie. 1996. International collaborative study on the second EUROHEP HCV-RNA reference panel. J. Virol. Methods 58:175-185.
6. DiDomenico, N., H. Link, R. Knobel, T. Caratsch, W. Weschler, Z. G. Loewy, and M. Rosenstraus. 1996. COBAS AMPLICOR: fully automated RNA and DNA amplification and detection system for routine PCR. Clin. Chem. 42: 1915-1923.
7. Dusheiko, G. M., S. Khakoo, P. Soni, and L. Grellier. 1996. A rational approach to the management of hepatitis C infection. Br. Med. J. 312: 357-364.
8. Gerken, G., P. Pontisso, M. Roggendorf, M. G. Rumi, P. Simmonds, C. Trepo, S. Zeuzem, and G. Colucci. 1996. Clinical evaluation of a single reaction, diagnostic PCR assay for the detection of hepatitis C virus (HCV) RNA. J. Hepatol. 24:33-37.
9. Goergen, B., K. H. Meyer Zum Buschenfelde, and G. Gerken. 1994. Assessment of viral replication for routine diagnosis of HCV infection and for monitoring antiviral treatment using Amplicor HCV detection system. Klin. Lab. 40:1-7.
10. Jungkind, D., S. DiRienzo, K. G. Beavis, and N. S. Silverman. 1996. Evaluation of automated COBAS AMPLICOR PCR system for detection of several infectious agents and its impact on laboratory management. J. Clin. Microbiol. 34:2778-2783.
11. Kwok, S., and R. Higuchi. 1989. Avoiding false positive with PCR. Nature 339:237-238.
12. Longo, M. C., M. S. Berninger, and H. L. Hartley. 1990. Use of uracil DNA glycosylase to control carry-over contamination in polymerase chain reactions. Gene 93:125-128.
13. Marin, M. G., S. Bresciani, M. Puoti, A. Rodella, A. Gussago, A. Ravaggi, G. Pizzocolo, A. Albertini, and E. Cariani. 1996. Clinical significance of serum hepatitis C virus (HCV) RNA as marker of HCV infection. J. Clin. Microbiol. 32:3008-3012.
14. Prati, D., C. Capelli, P. Bosoni, F. Mozzi, A. Zanella, and G. Sirchia. 1994. Determination of hepatitis C virus RNA in the serum by the Amplicor HCV PCR kit. Vox Sang. 67:112-114.
15. Roggendorf, M., M. Lu, H. Meisel, M. Riffelmann, E. Schreier, and S. Viazov. 1996. Rational use of diagnostic tools in hepatitis C. J. Hepatol. 24: 26-34.
16. Rosenstraus, M., Z. Wang, S.-Y. Chang, D. DeBoneville, and J. P. Spadoro. An internal control for routine diagnostic PCR: design, properties, and effect on clinical performance. J. Clin. Microbiol. 36:191-197.
17. Rys, P. N., and D. H. Persing. 1993. Preventing false positives: quantitative evaluation of three protocols for inactivation of polymerase chain reaction amplification products. J. Clin. Microbiol. 31:2356-2360.
18. Tedeschi, V., and L. B. Seeff. 1995. Diagnostic tests for hepatitis C: where are we now? Ann. Intern. Med. 123:383-385.
19. Victor, T., A. Jordaan, R. du Toit, and P. D. Van Helden. 1993. Laboratory experience and guidelines for avoiding false positive polymerase chain reaction results. J. Clin. Chem. Clin. Biochem. 31:531-535.
20. White, T. J., R. Madej, and D. H. Persing. 1992. The polymerase chain reaction: clinical applications. Adv. Clin. Chem. 29:161-196.
21. Wilber, J. C., and A. Polito. 1995. Serological and virological diagnostic tests for hepatitis C virus infection. Semin. Gastrointestinal Dis. 6:13-19.
22. Young, K. K. Y., R. M. Resnick, and T. W. Myers. 1993. Detection of hepatitis C virus RNA by a combined reverse transcription-polymerase chain reaction assay. J. Clin. Microbiol. 31:882-886.
23. Young, K. Y., J. J. Archer, O. Yokosuka, M. Omata, and R. Resnick. 1995. Detection of hepatitis C virus RNA by a combined reverse transcription PCR assay: comparison with nested amplification and antibody testing. J. Clin. Microbiol. 33:654-657.
24. Zaaijer, H. J., H. T. Cuypers, and H. W. Reesink. 1993. Reliability of HCV PCR results. Lancet 341:722-724.