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

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.