Comparison of VERSANT Hepatitis B virus DNA 3.0 Assay with Digene Hybrid Capture II Hepatitis B virus DNA test in relation to clinical status of Hepatitis B virus.

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 log(10) 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 log(10) 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.