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Journal of Clinical Microbiology, March 2002, p. 788-793, Vol. 40, No. 3
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.3.788-793.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Performance of the New Bayer VERSANT HCV RNA 3.0 Assay for Quantitation of Hepatitis C Virus RNA in Plasma and Serum: Conversion to International Units and Comparison with the Roche COBAS Amplicor HCV Monitor, Version 2.0, Assay

Marcel Beld,1* Roel Sentjens,2 Sjoerd Rebers,1 Christine Weegink,2 Jan Weel,1 Cees Sol,1 and René Boom1

Section of Clinical Virology, Department of Medical Microbiology,1 Section of Hepatology, Department of Gastro-Enterology, Academic Medical Center, 1105 AZ Amsterdam, The Netherlands2

Received 5 July 2001/ Returned for modification 11 September 2001/ Accepted 15 December 2001

We have evaluated the VERSANT HCV RNA 3.0. Assay (HCV 3.0 bDNA assay) (Bayer Diagnostics, Berkeley, Calif.), which is an improved signal amplification procedure for the HCV 2.0 bDNA assay for the quantitation of hepatitis C virus (HCV) RNA in serum or plasma of HCV-infected individuals. The HCV 3.0 bDNA assay has a linear dynamic range of 2.5 x 103 to 4.0 x 107 HCV RNA copies per ml (c/ml). The performance of the HCV 3.0 bDNA assay was evaluated using three different test panels. An overall specificity of 96.8% relative to the detection limit of the HCV 3.0 bDNA assay was found. The intra- and interrun reproducibilities for both the dilution panel and the NAP (AcroMetrix, Benicia, Calif.) panel were consistent with coefficients of variation of less than 9%. Quantitation with the HCV 3.0 bDNA assay was linear over the entire range of both panels (ranges of 4.4 x 103 to 3.5 x 106 c/ml and 5 x 103 to 2 x 106 IU/ml, respectively), with correlation coefficients of 0.999, slopes close to one, and intercepts close to zero. The regression equation indicated that 1 IU corresponded to about 4.8 copies of HCV RNA. A correlation coefficient of 0.941 was found for HCV RNA values (in international units per milliliter) obtained from the HCV 3.0 bDNA assay and the HCV Monitor version 2.0 assay (HCV Monitor 2.0 assay) (Roche Diagnostic Systems, Branchburg, N.J.). Quantitative results obtained close to the lower limit of the HCV 3.0 bDNA assay might imply that its lower limit should be reconsidered and raised, if necessary. It appeared that quantitation values obtained from the HCV Monitor 2.0 assay of between 5 x 102 and 105 IU/ml were in general higher than those obtained from the HCV 3.0 bDNA assay, whereas values obtained from the HCV Monitor 2.0 assay were underestimated for samples with HCV RNA levels above 105 IU/ml.

* Corresponding author. Mailing address: Academic Medical Center, Department of Medical Microbiology, Section of Clinical Virology, University of Amsterdam, Meibergdreef 15, 1105 AZ, Amsterdam, The Netherlands. Phone: 31-20-5665472. Fax: 31-20-6914005. E-mail: m.beld{at}amc.uva.nl.

Journal of Clinical Microbiology, March 2002, p. 788-793, Vol. 40, No. 3
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.3.788-793.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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