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 HBVinfected 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.
Subject(s)
Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Alanine Transaminase/blood , DNA, Viral/analysis , Data Interpretation, Statistical , Hepatitis B e Antigens/metabolism , Hepatitis B virus/genetics , Hepatitis B, Chronic/diagnosis , Nucleic Acid Hybridization/methods , Polymerase Chain Reaction , Regression Analysis , Reproducibility of Results , Sensitivity and SpecificityABSTRACT
insufficiency of both the spleen and the kidney (type E). The serum levels of ALT and AST in type B were significantly more higher than the other syndromes (P0.05). Conclusion The distribution of TCM types of syndrome of the patients with HBeAg-negative chronic hepatitis B has its characteristic. There are some relationships between TCM types of syndrome and the levels of transaminases, HBVDNA, the abnormal rates of four hepatic fibrosis markers.