Comparison of the AdvanSure HBV real-time PCR test with three other HBV DNA quantification assays.

BACKGROUND We compared the AdvanSure hepatitis B virus real-time polymerase chain reaction (AdvanSure HBV) kit with three other HBV DNA quantification assays and evaluated its performance. METHODS The AdvanSure HBV real-time PCR assay was compared with the Abbott RealTime HBV Quantification Kit, the COBAS TaqMan HBV Test, and the VERSANT HBV branched DNA 3.0 assay. The precision, linearity, accuracy, limit of detection (LOD), cross reactivity, and genotype inclusivity of the assays were compared, and any influence of the sampling tube type was evaluated. RESULTS The AdvanSure HBV PCR showed good correlations with the three other HBV DNA assays. The R(2) coefficients were 0.944, 0.939, and 0.921 with the Abbott RealTime HBV Quantification Kit, the COBAS TaqMan HBV Test, and the VERSANT bDNA 3.0 assay, respectively. Linearity was good in the tested range of 1.15-8.45 log10 IU/ml. The lower LOD result was consistent with the 18 IU/ml claimed by the manufacturer. HBV genotypes A-F were all correctly amplified, and no cross reactivity was found in samples with high HCV RNA levels or high protein concentrations. The results were not influenced by the sample preparation tube (i.e. plain tube, SST, and EDTA containing tubes). CONCLUSION The AdvanSure HBV real-time PCR assay is a reliable method for quantifying HBV DNA levels in routine laboratory testing.