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.
Song
Eun Young
EY
Department of Laboratory Medicine, Konkuk University College of Medicine, Seoul, Korea.
Hur
Mina
M
Lee
Kyu Man
KM
Yun
Yeomin
Y
Lee
Chang Hoon
CH
Choi
Young-Sook
YS
Lee
Kyung-A
KA
Roh
Eun Youn
EY
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
D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000410:Alanine Transaminase