This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrowReprints and Permissions
Right arrow Copyright Information
Right arrow Books from ASM Press
Right arrow MicrobeWorld
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Yu, M.-L.
Right arrow Articles by Chang, W.-Y.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Yu, M.-L.
Right arrow Articles by Chang, W.-Y.

 Previous Article  |  Next Article 

Journal of Clinical Microbiology, August 2000, p. 2933-2939, Vol. 38, No. 8
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Clinical Evaluation of the Automated COBAS AMPLICOR HCV MONITOR Test Version 2.0 for Quantifying Serum Hepatitis C Virus RNA and Comparison to the Quantiplex HCV Version 2.0 Test

Ming-Lung Yu,1,2 Wan-Long Chuang,1 Chia-Yen Dai,1,2 Shinn-Cherng Chen,1 Zu-Yau Lin,1 Ming-Yuh Hsieh,1 Liang-Yen Wang,1 and Wen-Yu Chang1,*

Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University,1 and Department of Internal Medicine, Municipal Hsiao Kang Hospital,2 Kaohsiung, Taiwan

Received 7 December 1999/Returned for modification 21 February 2000/Accepted 19 May 2000

A second-generation hepatitis C virus (HCV) quantitative assay (COBAS AMPLICOR HCV MONITOR Test, version 2.0; COBAS HCM-2) has been developed, with the intention of achieving equivalent quantification of all HCV genotypes and improving assay performance. To evaluate the clinical performance of COBAS HCM-2 and its utility in predicting the response to alpha interferon treatment, sera from 215 chronic hepatitis C patients were analyzed and the results were compared with those obtained by the Quantiplex bDNA HCV RNA, version 2.0, assay (bDNA-2). The COBAS HCM-2 had significantly greater sensitivity than bDNA-2 (94.9 versus 88.4%; P < 0.001) when performed with sera from chronic hepatitis C patients who were viremic by a qualitative PCR test. The standard deviations for the within-run and between-run reproducibilities of COBAS HCM-2 were <0.1 and <0.2, respectively, and it showed an improved linear range between genotypes with the threefold serial dilutions tested (r2 = 0.986 to 0.995). The COBAS HCM-2 results were positively correlated with the bDNA-2 results, but the values for COBAS HCM-2 were on average 0.96 log lower than the values for bDNA-2. The mean difference in quantification values between these two assays did not differ among samples with different genotypes (0.70 to 1.00 log). No genotype-dependent difference in viral load was observed. The pretreatment viral load was significantly lower in complete responders. By using multivariate analysis, the viral load 2 weeks after the initiation of alpha interferon treatment was the strongest predictor of a complete response. In conclusion, COBAS HCM-2 demonstrated good sensitivity, linearity, and reproducibility and efficiency equal to that of bDNA-2 for the quantification of HCV genotypes 1 and 2. Hence, this assay provides a rapid and reliable method for the quantification of HCV RNA in serum and is useful for the planning of interferon treatment.

* Corresponding author. Mailing address: Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Rd, Kaohsiung 807, Taiwan. Phone: 886-7-3121101, ext. 6014. Fax: 886-7-3123955. E-mail: fishya{at}ms14.hinet.net.

Journal of Clinical Microbiology, August 2000, p. 2933-2939, Vol. 38, No. 8
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


This article has been cited by other articles:

  • Desombere, I., Van Vlierberghe, H., Couvent, S., Clinckspoor, F., Leroux-Roels, G. (2005). Comparison of Qualitative (COBAS AMPLICOR HCV 2.0 versus VERSANT HCV RNA) and Quantitative (COBAS AMPLICOR HCV Monitor 2.0 versus VERSANT HCV RNA 3.0) Assays for Hepatitis C Virus (HCV) RNA Detection and Quantification: Impact on Diagnosis and Treatment of HCV Infections. J. Clin. Microbiol. 43: 2590-2597 [Abstract] [Full Text]  
  • Miyachi, H., Masukawa, A., Asai, S., Miura, T., Tamatsukuri, S., Hirose, T., Ando, Y. (2003). Quantitative Assay of Hepatitis C Virus RNA Using an Automated Extraction System for Specific Capture with Probes and Paramagnetic Particle Separation. J. Clin. Microbiol. 41: 572-575 [Abstract] [Full Text]  
  • Schirm, J., van Loon, A. M., Valentine-Thon, E., Klapper, P. E., Reid, J., Cleator, G. M. (2002). External Quality Assessment Program for Qualitative and Quantitative Detection of Hepatitis C Virus RNA in Diagnostic Virology. J. Clin. Microbiol. 40: 2973-2980 [Abstract] [Full Text]  
  • Giachetti, C., Linnen, J. M., Kolk, D. P., Dockter, J., Gillotte-Taylor, K., Park, M., Ho-Sing-Loy, M., McCormick, M. K., Mimms, L. T., McDonough, S. H. (2002). Highly Sensitive Multiplex Assay for Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNA. J. Clin. Microbiol. 40: 2408-2419 [Abstract] [Full Text]  
  • Germer, J. J., Heimgartner, P. J., Ilstrup, D. M., Harmsen, W. S., Jenkins, G. D., Patel, R. (2002). Comparative Evaluation of the VERSANT HCV RNA 3.0, QUANTIPLEX HCV RNA 2.0, and COBAS AMPLICOR HCV MONITOR Version 2.0 Assays for Quantification of Hepatitis C Virus RNA in Serum. J. Clin. Microbiol. 40: 495-500 [Abstract] [Full Text]  


Copyright © 2009 by the American Society for Microbiology.   For an alternate route to Journals.ASM.org, visit: http://intl-journals.asm.org | More Info»