Hepatitis C virus quantitation: Optimization of strategies for detecting low-level viremia

Journal of Clinical Microbiology

Volumn 38, Issue 2, 2000, Pages 888-891

  Hofgärtner, Wolfgang T ^a,c   Kant, Jeffrey A ^c   Weck, Karen E ^b,c  

^a Becton Dickinson UK Ltd   (United Kingdom)

^b UNIVERSITY OF PITTSBURGH   (United States)

^c UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

VIRUS RNA;

ARTICLE; CLINICAL LABORATORY; COST EFFECTIVENESS ANALYSIS; DNA DETERMINATION; HEALTH ECONOMICS; HEPATITIS C VIRUS; NONHUMAN; PRIORITY JOURNAL; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; VIREMIA; VIRUS DETECTION; VIRUS GENOME; VIRUS LOAD; VIRUS TITRATION;

HEPATITIS C VIRUS; RNA VIRUSES;

EID: 0342632830     PISSN: 00951137     EISSN: None     Source Type: Journal    
DOI: 10.1128/jcm.38.2.888-891.2000     Document Type: Article

References (34)

1. Albadalejo, J., R. Alonso, R. Antinozzi, M. Bogard, A. M. Bourgault, G. Colucci, T. Fenner, H. Petersen, E. Sala, J. Vincelette, and C. Young. 1998. Multicenter evaluation of the COBAS AMPLICOR HCV assay, an integrated PCR system for rapid detection of hepatitis C virus RNA in the diagnostic laboratory. J. Clin. Microbiol. 36:862-865.
2. Alter, H. J., R. Sanchez-Pescador, M. S. Urdea, J. C. Wilber, R. J. Lagier, A. M. Di Bisceglie, J. W. Shih, and P. D. Neuwald. 1995. Evaluation of branched DNA signal amplification for the detection of hepatitis C virus RNA. J. Viral Hepat. 2:121-132.
3. Alter, M. J. 1997. Epidemiology of hepatitis C. Hepatology 26:62S-65S.
4. Chen, Y., D. L. Cooper, and G. D. Ehrlich. 1996. Comparative analysis of three nucleic acid-based detection systems for hepatitis C virus RNA in plasma from liver transplant recipients. Mol. Cell. Probes. 10:331-336.
5. Davis, G. L., R. Esteban-Mur, V. Rustgi, J. Hoefs, S. C. Gordon, C. Trepo, M. L. Shiffman, S. Zeuzem, A. Craxi, M. H. Ling, and J. Albrecht. 1998. Interferon alfa-2b alone or in combination with ribavirin for the treatment of relapse of chronic hepatitis C. International Hepatitis Interventional Therapy Group. N. Engl. J. Med. 339:1493-1499.
6. Detmer, J., R. Lagier, J. Flynn, C. Zayati, J. Kolberg, M. Collins, M. Urdea, and R. Sanchez-Pescador. 1996. Accurate quantification of hepatitis C virus (HCV) RNA from all HCV genotypes by using branched-DNA technology. J. Clin. Microbiol. 34:901-907.
7. Diodati, G., P. Bonetti, F. Noventa, C. Casarin, M. Rugge, S. Scaccabarozzi, A. Tagger, L. Pollice, F. Tremolada, C. Davite, et al. 1994. Treatment of chronic hepatitis C with recombinant human interferon-alpha 2a: results of a randomized controlled clinical trial. Hepatology 19:1-5.
8. European Association for the Study of the Liver. 1999. EASL International Consensus Conference on Hepatitis C. Consensus Statement. J. Hepatol. 30:956-961.
9. Federal Register. 1997. Medical devices; classification/reclassification; restricted devices; analyte specific reagents - FDA. Final rule. Fed. Regist. 62:62243-62260.
10. Gretch, D. R. 1997. Diagnostic tests for hepatitis C. Hepatology 26:43S-47S.
11. Gretch, D. R., C. dela Rosa, R. L. Carithers, Jr., R. A. Willson, B. Williams, and L. Corey. 1995. Assessment of hepatitis C viremia using molecular amplification technologies: correlations and clinical implications. Ann. Intern. Med. 123:321-329.
12. Hawkins, A., F. Davidson, and P. Simmonds. 1997. Comparison of plasma virus loads among individuals infected with hepatitis C virus (HCV) genotypes 1, 2, and 3 by quantiplex HCV RNA assay versions 1 and 2, Roche Monitor assay, and an in-house limiting dilution method. J. Clin. Microbiol. 35:187-192.
13. Hayashi, J., M. Ohmiya, Y. Kishihara, Y. Tani, N. Kinukawa, H. Ikematsu, and S. Kashiwagi. 1994. A statistical analysis of predictive factors of response to human lymphoblastoid interferon in patients with chronic hepatitis C. Am. J. Gastroenterol. 89:2151-2156.
14. Hayashi, J., E. Yoshimura, Y. Kishihara, K. Yamaji, Y. Etoh, H. Ikematsu, and S. Kashiwagi. 1996. Hepatitis C virus RNA levels determined by branched DNA probe assay correlated with levels assessed using competitive PCR. Am. J. Gastroenterol. 91:314-318.
15. Ichyo, T., A. Matsumoto, M. Kobayashi, K. Furihata, and E. Tanaka. 1997. Quantitative measurement of HCV RNA in the serum: a comparison of three assays based on different principles. J. Gastroenterol. Hepatol. 12:500-506.
16. Jacob, S., D. Baudy, E. Jones, L. Xu, A. Mason, F. Regenstein, and R. P. Perrillo. 1997. Comparison of quantitative HCV RNA assays in chronic hepatitis C. Am. J. Clin. Pathol. 107:362-367.
17. Lau, J. Y., G. L. Davis, J. Kniffen, K. P. Qian, M. S. Urdea, C. S. Chan, M. Mizokami, P. D. Neuwald, and J. C. Wilber. 1993. Significance of serum hepatitis C virus RNA levels in chronic hepatitis C. Lancet 341:1501-1504.
18. Lindsay, K. L. 1997. Therapy of hepatitis C: overview. Hepatology 26:71S-77S.
19. Lu, R. H., S. J. Hwang, C. Y. Chan, F. Y. Chang, and S. D. Lee. 1998. Quantitative measurement of serum HCV RNA in patients with chronic hepatitis C: comparison between Amplicor HCV monitor system and branched DNA signal amplification assay. J. Clin. Lab. Anal. 12:121-125.
20. Lunel, F., P. Cresta, D. Vitour, C. Payan, B. Dumont, L. Frangeul, D. Reboul, C. Brault, J. C. Piette, and J. M. Huraux. 1999. Comparative evaluation of hepatitis C virus RNA quantitation by branched DNA, NASBA, and monitor assays. Hepatology 29:528-535.
21. Matsumoto, A., E. Tanaka, T. Suzuki, H. Ogata, and K. Kiyosawa. 1994. Viral and host factors that contribute to efficacy of interferon-alpha 2a therapy in patients with chronic hepatitis C. Dig. Dis. Sci. 39:1273-1280.
22. Mayerat, C., P. Burgisser, D. Lavanchy, A. Mantegani, and P. C. Frei. 1996. Comparison of a competitive combined reverse transcription-PCR assay with a branched-DNA assay for hepatitis C virus RNA quantitation. J. Clin. Microbiol. 34:2702-2706.
23. McHutchison, J. G., S. C. Gordon, E. R. Schiff, M. L. Shiffman, W. M. Lee, V. K. Rustgi, Z. D. Goodman, M. H. Ling, S. Cort, and J. K. Albrecht. 1998. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group. N. Engl. J. Med. 339:1485-1492.
24. Mita, E., N. Hayashi, H. Hagiwara, K. Ueda, Y. Kanazawa, A. Kasahara, H. Fusamoto, and T. Kamada. 1994. Predicting interferon therapy efficacy from hepatitis C virus genotype and RNA titer. Dig. Dis. Sci. 39:977-982.
25. Nolte, F. S., C. Thurmond, and M. W. Fried. 1995. Preclinical evaluation of AMPLICOR hepatitis C virus test for detection of hepatitis C virus RNA. J. Clin. Microbiol. 33:1775-1778.
26. Poljak, M., K. Seme, and S. Koren. 1997. Evaluation of the automated COBAS AMPLICOR hepatitis C virus PCR system. J. Clin. Microbiol. 35:2983-2984.
27. Reichard, O., G. Norkrans, A. Fryden, J. H. Braconier, A. Sonnerborg, and O. Weiland. 1998. Comparison of 3 quantitative HCV RNA assays - accuracy of baseline viral load to predict treatment outcome in chronic hepatitis C. Scand. J. Infect. Dis. 30:441-446.
28. Roth, W. K., J. H. Lee, B. Ruster, and S. Zeuzem. 1998. Quantification of hepatitis C virus RNA by RT-PCR in comparison to the branched DNA method. Z. Gastroenterol. 36:5-11.
29. Shiratori, Y., N. Kato, O. Yokosuka, E. Hashimoto, N. Hayashi, A. Nakamura, M. Asada, H. Kuroda, H. Ohkubo, Y. Arakawa, A. Iwama, and M. Omata. 1997. Quantitative assays for hepatitis C virus in serum as predictors of the long-term response to interferon. J. Hepatol. 27:437-444.
30. Tong, M. J., L. M. Blatt, J. G. McHutchison, R. L. Co, and A. Conrad. 1907. Prediction of response during interferon alfa 2b therapy in chronic hepatitis C patients using viral and biochemical characteristics: a comparison. Hepatology 26:1640-1645.
31. Walsh, K. M., T. Good, S. Cameron, D. Thorburn, E. A. McCruden, P. R. Mills, and A. J. Morris. 1998. Viral kinetics can predict early response to alpha-interferon in chronic hepatitis C. Liver 18:191-195.
32. Wiley, T. E., L. Briedi, N. Lam, and T. J. Layden. 1998. Early HCV RNA values after interferon predict response. Dig. Dis. Sci. 43:2169-2172.
33. Yamada, G., M. Takatani, F. Kishi, M. Takahashi, T. Doi, T. Tsuji, S. Shin, M. Tanno, M. S. Urdea, and J. A. Kolberg. 1995. Efficacy of interferon alfa therapy in chronic hepatitis C patients depends primarily on hepatitis C virus RNA level. Hepatology 22:1351-1354.
34. 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.