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Comparison of two methods for quantification of hepatitis B viral DNA

Authors

  • Jia-Horng Kao,

    1. Department of Internal Medicine, Graduate Institute of Clinical Medicine, Hepatitis Research Center, National Taiwan University College of Medicine, National Taiwan University Hospital, Taipei, Taiwan and, NAXCOR, Menlo Park, California, USA
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  • Michael Wood,

    1. Department of Internal Medicine, Graduate Institute of Clinical Medicine, Hepatitis Research Center, National Taiwan University College of Medicine, National Taiwan University Hospital, Taipei, Taiwan and, NAXCOR, Menlo Park, California, USA
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  • Pei-Jer Chen,

    1. Department of Internal Medicine, Graduate Institute of Clinical Medicine, Hepatitis Research Center, National Taiwan University College of Medicine, National Taiwan University Hospital, Taipei, Taiwan and, NAXCOR, Menlo Park, California, USA
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  • Ming-Yang Lai,

    1. Department of Internal Medicine, Graduate Institute of Clinical Medicine, Hepatitis Research Center, National Taiwan University College of Medicine, National Taiwan University Hospital, Taipei, Taiwan and, NAXCOR, Menlo Park, California, USA
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  • Ding-Shinn Chen

    1. Department of Internal Medicine, Graduate Institute of Clinical Medicine, Hepatitis Research Center, National Taiwan University College of Medicine, National Taiwan University Hospital, Taipei, Taiwan and, NAXCOR, Menlo Park, California, USA
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DS Chen Hepatitis Research Center, National Taiwan University Hospital, 1 Chang-Te St., Taipei 100, Taiwan. Email: <dschen@ha.mc.ntu.edu.tw>

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.

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