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Abstract
Background
Some differences exist among various Hepatitis B virus (HBV) DNA quantification assays due to lack of standardization and besides clinical usefulness has not been firmly elucidated in Korean HBV patients.
Methods
We compared Bayer VERSANT HBV DNA 3.0 Assay (VERSANT 3.0) with Digene Hybrid Capture II HBV DNA Test (HC-II) according to HBeAg status and ALT levels in 232 HBV-infected Korean patients. One hundred and seventeen sera with undetectable DNA levels by HC-II were further analyzed by Real-Q HBV quantification assay (BioSewoom).
Results
Although VERSANT 3.0 and HC-II showed an excellent correlation (r=0.9739), the results (copies/mL) by VERSANT 3.0 were 0.45 log10 higher than those by HC-II. HBV DNA levels were higher in HBeAg-positive group than in HBeAg-negative group (P=0.002), and in abnormal ALT group than in normal ALT group (P<0.0001). The detection rate of HBV DNA by VERSANT 3.0 was lower in HBeAg-negative and normal ALT group (n=68) than in HBeAg-positive or abnormal ALT group (n=164) (35.3% vs 89.6%, P<0.0001). Fifty two sera out of 61 sera with undetectable DNA by VERSANT 3.0 were measurable by Real-Q with mean value of 3.26 log10 copies/mL.
Conclusions
VERSANT 3.0 and HC-II showed an excellent correlation, but a little difference (0.45 log10) existed. VERSANT 3.0 effectively measured clinically relevant HBV DNA levels in most HBV-infected patients in Korea. However, more sensitive assays are needed for patients with negative HBeAg and normal ALT to see the low copies of HBV DNA levels.
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Fig. 1.
(A) Correlation of log10 quantitative HBV DNA levels between VERSANT 3.0 and HC-II. (B) Differences in log 10 quantitative HBV DNA levels between VERSANT 3.0 and HC-II in relation to average log10 quantification (n=54).
Fig. 2.
Detection rates of HBV DNA by VERSANT 3.0 and HC-II in relation to clinical status of HBV.
Abbreviations: HBeAg, hepatitis B virus e antigen; abnl, abnormal; nl, normal.
Fig. 3.
HBV DNA levels by VERSANT 3.0 in relation to clinical status of HBV. The plots display the median values (lines inside boxes), 25th and 75th percentiles (lower and upper limits of boxes), and the minimum and 99th percentiles.
Abbreviations: nl, normal; abnl, abnormal.
Fig. 4.
Scatter plot shows HBV DNA levels measured by Real-Q (log10 copies/mL) in sera with undetectable DNA by both of VERSANT 3.0 (V3.0) and HC-II (n=52) (left) and in sera with detectable DNA by VERSANT 3.0 (V3.0) but undetectable by HC-II (n=55) (right). Horizontal bars represent the means and±2SD. The difference between two groups was tested by Student's t test. ∗P<0.0001.
Fig. 5.
(A) Correlation of log10 quantitative HBV DNA levels between VERSANT 3.0 and Real-Q (n=55). (B) Differences in log10 quantitative HBV DNA levels between VERSANT 3.0 and Real-Q in relation to average log10 quantification (n=55).
Table 1.
Distribution of HBV DNA levels measured by VERSANT 3.0 and HC-II
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