Comparison of two methods for quantification of hepatitis B viral DNA.
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 (gamma=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.
Kao
J H
JH
Department of Internal Medicine, Graduate Institute of Clinical Medicine, Hepatitis Research Center, National Taiwan University College of Medicine, National Taiwan University Hospital, Taipei.
Wood
M
M
Chen
P J
PJ
Lai
M Y
MY
Chen
D S
DS
D004279:DNA, Viral / Q000097:blood*; D006515:Hepatitis B virus / Q000302:isolation & purification*; D006801:Humans; D018189:Immunomagnetic Separation; D016014:Linear Models; D008163:Luminescent Measurements; D009693:Nucleic Acid Hybridization; D012680:Sensitivity and Specificity; D014466:Ultraviolet Rays
D004279:DNA, Viral