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MULTI-CENTER EVALUATION OF THE VERSANT HBV DNA 3.0 ASSAY: ASSESSMENT OF ANALYTICAL AND CLINICAL PERFORMANCE
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Reported by Jules Levin
Joseph D C Yao, Mayo Clinic, Rochester, MN and colleagues and Bayer HealthCare, Berkeley, CA reported on this study at the 54th Annual AASLD Liver meeting in Boston, (October 2003) evaluating the Bayer HBV DNA 3.0 Assay.
Viral load assays for quantitative detection of HBV DNA in serum and/or EDTA-plasma of subjects with chronic HBV infection are increasingly used for monitoring anti-viral strategies and disease progression. The Versant HBV 3.0 Assay (bDNA) [Bayer HealthCare - Diagnostics, Tarrytown, New York] (HBV 3.0) was evaluated at four 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 Corp., Gaithersburg, Maryland] (Digene), N = 247; Versant HBV DNA 1.0 Assay (bDNA) [Bayer HealthCare - Diagnostics] (HBV 1.0), N = 185; and Cobas Amplicor HBV Monitor Test [Roche Diagnostics, Branchburg, New Jersey] (Amplicor), N = 79.
These samples were re-examined using HBV 3.0. The results from these studies showed that HBV 3.0 has high specificity (99.3%), excellent reproducibility (between-run CV = 1.6% to 9.4%; within-run CV = 6.5% to 20.7%), and a broad linear range of quantification (2,000 to 100,000,000 HBV DNA copies/ml) that will 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 HBV 3.0 and the comparative HBV DNA quantitative assays (HBV 1.0, R2= 0.9001; Digene, R2= 0.9849; Amplicor, R2= 0.7711; all these products are for research use only). The greatest differences in comparative quantitation occurred at HBV DNA levels approaching or exceeding the limits of the dynamic ranges for the comparative assays. The performance characteristics of the new Versant HBV DNA 3.0 Assay (bDNA) will provide a reliable and robust method for routinely monitoring serum HBV DNA levels in assessing disease activity and determining response to anti-viral treatment.
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