Comparison of Versant HBV DNA 3.0 and COBAS AmpliPrep-COBAS TaqMan assays for hepatitis B DNA quantitation: Possible clinical implications

A. R. Garbuglia, C. Angeletti, F. N. Lauria, P. Zaccaro, A. M. Cocca, M. Pisciotta, M. Solmone, M. R. Capobianchi

Research output: Contribution to journalArticlepeer-review

Abstract

We compared two commercial assays for HBV DNA quantitation, Versant HBV 3.0, System 340 (bDNA; Bayer Diagnostics) and COBAS AmpliPrep-COBAS TaqMan HBV Test (TaqMan; Roche Diagnostics). Analytical sensitivity, calculated on WHO International Standard, predicted 95% detection rate at 11.4 and 520.2 IU/ml for TaqMan and bDNA, respectively. Specificity, established on 50 blood donor samples, was 100% and 84% for TaqMan and bDNA, respectively. When using clinical samples, HBV DNA was detected by TaqMan in 21/55 samples negative to bDNA. Mean values of HBV DNA obtained with bDNA were higher than those obtained with TaqMan (4.09 log10 ± 1.90 versus 3.39 log10 ± 2.41, p <0.001), and 24.4% of samples showed differences in viral load values >0.5 log10, without association with HBV genotype. There was a good correlation for HBV DNA concentrations measured by the two assays (r = 0.94; p <0.001) within the overlapping range, and the distribution of results with respect to relevant clinical threshold recently confirmed (20,000 and 2000 IU/ml) was similar. Approximately 50% of samples with low HBV DNA, appreciated by TaqMan but not by bDNA, were successfully sequenced in pol region, where drug resistance mutations are located.

Original languageEnglish
Pages (from-to)274-280
Number of pages7
JournalJournal of Virological Methods
Volume146
Issue number1-2
DOIs
Publication statusPublished - Dec 2007

Keywords

  • Assay performance
  • bDNA
  • Diagnostic accuracy
  • HBV DNA
  • Real time PCR

ASJC Scopus subject areas

  • Virology

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