Comparative evaluation of three commercial assays for quantitative measurement of hepatitis B virus DNA in serum samples

Hepatogastroenterology. Sep-Oct 2002;49(47):1390-4.


Background/aims: Quantitative determination of HBV DNA in serum samples is indispensable for predicting disease progression and for monitoring the antiviral treatment in patients with chronic HBV infection.

Methodology: Three commercial assays for quantification of HBV DNA: Digene Hybrid-Capture HBV DNA Assay, Bayer Quantiplex HBV DNA Assay and Roche Amplicor HBV Monitor Test were comparatively evaluated under the routine conditions of diagnostic virology laboratory, using 61 serum samples obtained from 55 Slovenian patients with chronic hepatitis B.

Results: HBV DNA was detected by Amplicor, Quantiplex and Hybrid-Capture in 38 (62.3%), 34 (55.7%) and 27 (44.3%) samples, respectively. The sensitivity of Amplicor and Quantiplex assays did not differ significantly (p = 0.13), while both Amplicor and Quantiplex assays were found to be significantly more sensitive than Hybrid-Capture (p = 0.003 and p = 0.02, respectively). For a given sample, the highest correlation was observed between HBV DNA loads determined by Quantiplex and Hybrid-Capture assays (r = 0.85, p < 0.0001).

Conclusions: Amplicor HBV Monitor Test seems to be the most sensitive assay for the detection of HBV DNA in serum samples and can be clinically used for monitoring patients with chronic HBV infection.

Publication types

  • Comparative Study

MeSH terms

  • DNA, Viral / blood*
  • DNA, Viral / isolation & purification
  • Hepatitis B virus / genetics*
  • Humans
  • Immunoassay / methods*


  • DNA, Viral