title: 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.
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 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.
authors.affiliation: Department of Laboratory Medicine, Konkuk University College of Medicine, Seoul, Korea.
authors.forename: Eun Young
authors.initials: EY
authors.lastname: Song
authors.forename: Mina
authors.initials: M
authors.lastname: Hur
authors.forename: Kyu Man
authors.initials: KM
authors.lastname: Lee
authors.forename: Yeomin
authors.initials: Y
authors.lastname: Yun
authors.forename: Chang Hoon
authors.initials: CH
authors.lastname: Lee
authors.forename: Young-Sook
authors.initials: YS
authors.lastname: Choi
authors.forename: Kyung-A
authors.initials: KA
authors.lastname: Lee
authors.forename: Eun Youn
authors.initials: EY
authors.lastname: Roh
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000097:blood; D004279:DNA, Viral / Q000032:analysis* / Q000235:genetics; D003627:Data Interpretation, Statistical; D005260:Female; D006513:Hepatitis B e Antigens / Q000378:metabolism; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification*; D019694:Hepatitis B, Chronic / Q000175:diagnosis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009693:Nucleic Acid Hybridization / Q000379:methods*; D016133:Polymerase Chain Reaction; D012044:Regression Analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000410:Alanine Transaminase