TY - JOUR
T1 - Comparison of Versant HBV DNA 3.0 and COBAS AmpliPrep-COBAS TaqMan assays for hepatitis B DNA quantitation
T2 - Possible clinical implications
AU - Garbuglia, A. R.
AU - Angeletti, C.
AU - Lauria, F. N.
AU - Zaccaro, P.
AU - Cocca, A. M.
AU - Pisciotta, M.
AU - Solmone, M.
AU - Capobianchi, M. R.
PY - 2007/12
Y1 - 2007/12
N2 - 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.
AB - 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.
KW - Assay performance
KW - bDNA
KW - Diagnostic accuracy
KW - HBV DNA
KW - Real time PCR
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U2 - 10.1016/j.jviromet.2007.07.005
DO - 10.1016/j.jviromet.2007.07.005
M3 - Article
C2 - 17707918
AN - SCOPUS:35648971593
VL - 146
SP - 274
EP - 280
JO - Journal of Virological Methods
JF - Journal of Virological Methods
SN - 0166-0934
IS - 1-2
ER -