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Journal of Clinical Microbiology, February 2004, p. 800-806, Vol. 42, No. 2
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.2.800-806.2004
Copyright © 2004, American Society of Microbiology. All Rights Reserved.

Multicenter Evaluation of the VERSANT Hepatitis B Virus DNA 3.0 Assay

Joseph D. C. Yao,1 Marcel G. H. M. Beld,2 Lynette Lin Ean Oon,3 Christopher H. Sherlock,4 Jeffrey Germer,1 Sandra Menting,2 Su Yun Se Thoe,3 Linda Merrick,4 Rainer Ziermann,5 Johan Surtihadi,5 and H. James Hnatyszyn5*

Division of Clinical Microbiology, Mayo Clinic, Rochester, Minnesota,1 Department of Clinical Virology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands,2 Department of Pathology, Singapore General Hospital, Singapore, Singapore,3 Diagnostic Virology and Reference Laboratory, St. Paul's Hospital, Vancouver, British Columbia, Canada,4 Bayer HealthCare-Diagnostics, Berkeley, California5

Received 31 July 2003/ Returned for modification 12 October 2003/ Accepted 11 November 2003

The VERSANT hepatitis B virus (HBV) 3.0 Assay (branched DNA [bDNA]) (referred to herein as VERSANT 3.0) was evaluated at four external sites for analytical sensitivity, specificity, reproducibility, linearity of quantification, and limits of detection. In addition, each of the test evaluation sites provided HBV DNA-positive clinical samples that were previously analyzed by one of three commercially available HBV DNA quantitative tests: Digene Hybrid Capture II HBV DNA Test (Digene); VERSANT HBV DNA 1.0 Assay (bDNA) (VERSANT 1.0); and COBAS AMPLICOR HBV Monitor Test (COBAS AMPLICOR). These samples were reexamined using VERSANT 3.0. The results from these studies showed that VERSANT 3.0 has high specificity (99.3%), excellent reproducibility (between-run coefficient of variation [CV] = 1.6 to 9.4%; within-run CV = 6.5 to 20.7%), and a broad linear range of quantification (2.0 x 103 to 1.0 x 108 HBV DNA copies/ml) that facilitate the monitoring of HBV DNA levels at diagnosis and throughout the course of treatment. In general, correlation was very good between results obtained from clinical samples analyzed by VERSANT 3.0 and the comparative HBV DNA quantitative assays (VERSANT 1.0, R2 = 0.900; Digene, R2 = 0.985; COBAS AMPLICOR, R2 = 0.771). The greatest differences in comparative quantitation occurred at HBV DNA levels approaching the limits of the dynamic ranges for the comparative assays. The performance characteristics of the new VERSANT 3.0 assay demonstrated that it provides a reliable and robust method for routinely monitoring serum HBV DNA levels in assessing disease activity and determining response to antiviral treatment.

* Corresponding author. Mailing address: Bayer HealthCare Diagnostics, P.O. Box 2466, Berkeley, CA 94702. Phone: (510) 705-5845. Fax: (510) 705-5718. E-mail: james.hnatyszyn.b{at}bayer.com.

Journal of Clinical Microbiology, February 2004, p. 800-806, Vol. 42, No. 2
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.2.800-806.2004
Copyright © 2004, American Society of Microbiology. All Rights Reserved.



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