1. Comparison of Versant HBV DNA 3.0 and COBAS AmpliPrep–COBAS TaqMan assays for hepatitis B DNA quantitation: Possible clinical implications
- Author
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Marina Pisciotta, Maria Rosaria Capobianchi, Anna Rosa Garbuglia, Claudio Angeletti, Mariacarmela Solmone, A.M. Cocca, Paola Zaccaro, and Francesco Nicola Lauria
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Adult ,Male ,Hepatitis B virus ,medicine.disease_cause ,Roche Diagnostics ,Polymerase Chain Reaction ,Sensitivity and Specificity ,law.invention ,law ,Virology ,medicine ,TaqMan ,BDNA test ,Humans ,Polymerase chain reaction ,biology ,Reproducibility of Results ,virus diseases ,Middle Aged ,Viral Load ,Hepatitis B ,medicine.disease ,biology.organism_classification ,Molecular biology ,Real-time polymerase chain reaction ,Hepadnaviridae ,DNA, Viral ,Female - 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 520.2IU/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 (4.09log(10)+/-1.90 versus 3.39log(10)+/-2.41, p0.001), and 24.4% of samples showed differences in viral load values0.5log(10), without association with HBV genotype. There was a good correlation for HBV DNA concentrations measured by the two assays (r=0.94; p0.001) within the overlapping range, and the distribution of results with respect to relevant clinical threshold recently confirmed (20,000 and 2000IU/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.
- Published
- 2007
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