Comparison of two methods for quantification of hepatitis B viral DNA

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Abstract
Background: Quantitation of serum hepatitis B virus (HBV) DNA has proven useful in assisting with patient management and treatment and several commercially available assays have been developed to quantify serum HBV-DNA levels. Methods: The performance of the cross-linking assay and the branched-DNA signal amplification (bDNA) assay for the quantitative measurement of HBV-DNA was studied in 99 hepatitis B surface antigen-positive and viraemic patients. Results: Of these samples, 82 (83%) were positive for HBV-DNA by both assays and four (4%) were below the cut-off for both assays. Of the remaining 13 samples, 10 contained measurable levels of HBV-DNA by the cross-linking assay alone and three other samples contained measurable levels of HBV-DNA by the bDNA assay alone. The sensitivity gain of the cross-linking assay relative to bDNA assay in this study population was 10/92 (11%). In addition, a linear regression analysis showed that the HBV-DNA levels obtained from both assays was significantly correlated (γ = 0.974, P < 0.0001). Conclusions: These findings suggest that the recently developed cross-linking assay is more sensitive than the bDNA assay for the quantitative determination of HBV-DNA.