Comparison of the nucleic acid-based crosslinking hybridization assay and the branched DNA signal amplification assay in the quantitative measurement of serum hepatitis B virus DNA.

Abstract

Quantitative measurement of hepatitis B virus (HBV) DNA has become important in the clinical diagnosis of patients with chronic hepatitis B, especially in patients with hepatitis B e antigen (HBeAg)-negative precore mutant and in patients who received treatment with interferon or antiviral agents. Two different hybridization assays for quantitative measurement of HBV DNA: Naxcor crosslinking assays and Chiron branched DNA signal amplification (bDNA) assay, were applied to 158 serum samples which were positive for HBV DNA by polymerase chain reaction. Among 158 serum samples, 135 samples (85.4%) were positive by the crosslinking assay and 129 samples (81.6%) were positive by the bDNA assay in the quantification of serum HBV DNA (P > 0.05). Serum HBV DNA levels obtained from both assays showed a good linear correlation (r = 0.91, P < 0.001). The sensitivity of both assays in HBeAg-positive samples was 90.5%, significantly higher than in HBeAg-negative samples (69.6% for the crosslinking assay and 56.5% for the bDNA assay, P < 0.05). In HBeAg-negative patients with elevated serum alanine transaminase levels, the so-called precore HBV mutant, the detection sensitivity for HBV DNA was better in the crosslinking assay (83%) than in the bDNA assay (61%). The crosslinking assay was less time consuming than the bDNA assay in performing the measurement of serum HBV DNA (6 hours vs. 20 hours). In conclusion, Naxcor crosslinking hybridization assay was equally as sensitive as Chiron bDNA assay in the quantitative measurement of serum HBV DNA. Less time-consuming procedures and better sensitivity in the detection of HBeAg-negative samples with elevated serum alanine transaminase levels may favor the clinical use of the crosslinking assay.