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Journal of Clinical Microbiology, February 2003, p. 651-656, Vol. 41, No. 2
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.2.651-656.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Multicenter Evaluation of the VERSANT HCV RNA Qualitative Assay for Detection of Hepatitis C Virus RNA

David A. Hendricks,1 Michel Friesenhahn,1 Lorine Tanimoto,1 Bernd Goergen,1,{dagger} Deborah Dodge,1 and Lorraine Comanor2*

Bayer Corp., Berkeley,1 Bayer Corp., Palo Alto, California2

Received 3 September 2002/ Returned for modification 9 October 2002/ Accepted 2 November 2002

We report the results of a multicenter evaluation of a new assay for the detection of hepatitis C virus (HCV) RNA in human serum or plasma based on transcription-mediated amplification (HCV TMA). Analysis of combined data obtained from 15 independent sites, including 4 sites in the United States and 11 in Europe, by using preproduction kits showed a limit of detection of 9.8 IU/ml and an overall mean specificity of 97.9%. In addition, assay runs and samples were valid consistently (97.8% of assay runs and 98.0% of specimen results). Of the 15 sites that participated in the multicenter evaluation, 2 subsequently carried out additional performance studies with production kits in support of the assay's registration in France. Comparison of the findings from these two sites during the multicenter evaluation and during the registration studies showed an overall improvement in assay performance. A statistically significant (P < 0.001) improvement was achieved for both specificity and specimen validity in the registration studies, which were 99.4 and 98.1%, respectively. Combined data from the two sites showed a lower limit of detection of approximately 2.4 IU/ml and an improved assay validity of 100%, although the sample size was too small to show statistical significance at the 0.05 level. In summary, the performance characteristics of HCV TMA indicate that this assay is a reliable tool for the detection of HCV RNA in serum or plasma. Improvement in assay performance has been demonstrated with refinement of assay reagents, instrumentation, and operator experience.

* Corresponding author. Mailing address: 1801 Waverley St., Palo Alto, CA 94301. Phone: (650) 321-8871. Fax: (650) 321-8872. E-mail: lorraine.comanor.b{at}bayer.com.

{dagger} Press address: D G Bank, Frankfurt, Germany

Journal of Clinical Microbiology, February 2003, p. 651-656, Vol. 41, No. 2
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.2.651-656.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



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