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Journal of Clinical Microbiology, August 2002, p. 2903-2907, Vol. 40, No. 8
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.8.2903-2907.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Qualitative Detection of Hepatitis C Virus RNA: Comparison of Analytical Sensitivity, Clinical Performance, and Workflow of the Cobas Amplicor HCV Test Version 2.0 and the HCV RNA Transcription-Mediated Amplification Qualitative Assay

Mel Krajden,1* Rainer Ziermann,2 Asphani Khan,1 Annie Mak,1 Kimmy Leung,3 David Hendricks,2 and Lorraine Comanor4

British Columbia Centers of Disease Control, Vancouver, British Columbia, Canada,1 Bayer Diagnostics, Berkeley,2 Bayer Reference Testing Laboratory, Emeryville,3 Clinical Research Consultant, Palo Alto, California4

Received 26 June 2001/ Returned for modification 15 December 2001/ Accepted 12 May 2002

The qualitative Cobas Amplicor hepatitis C virus (HCV) version 2.0 assay (HCV PCR) and the Bayer Reference Testing Laboratory HCV RNA transcription-mediated amplification assay (HCV TMA) were compared for analytical sensitivity, clinical performance, and workflow. Limits of detection were determined by testing dilutions of the World Health Organization HCV standard in replicates of 15 at concentrations of from 1.0 to 70 IU/ml. The limit of detection of the HCV PCR assay was calculated to be 45 IU/ml on initial testing and 32 IU/ml after resolution of gray zone results. The calculated limit of detection for HCV TMA was 6 IU/ml. To compare clinical performance, 300 specimens, grouped as follows, were evaluated: 112 samples that were indeterminate in an anti-HCV enzyme immunoassay (EIA) and for which HCV RNA was not detected by HCV PCR; 79 samples that were EIA positive and for which HCV RNA was not detected by HCV PCR; and 105 samples that were both EIA and HCV PCR positive. For these groups, interassay concordance ranged from 96.2% to 100%. In addition, three HCV PCR gray zone specimens and one neonatal specimen were also evaluated. A 64-sample run (full run, 91 specimens) required 5 h for testing by HCV TMA, whereas almost 8 h were required to test a full run of 22 specimens by HCV PCR. HCV TMA demonstrated excellent concordance with HCV PCR when clinical samples were tested. However, HCV TMA was more sensitive than HCV PCR, required less time for test result completion, and had a greater throughput.

* Corresponding author. Mailing address: British Columbia Centre for Disease Control, 655 West 12th Avenue, Vancouver, British Columbia. Phone: (604) 660-6044. Fax: (604) 660-6073. E-mail: mel.krajden{at}bccdc.ca.

Journal of Clinical Microbiology, August 2002, p. 2903-2907, Vol. 40, No. 8
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.8.2903-2907.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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