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.
10.3343/kjlm.2007.27.6.451
- Author:
Eun Young SONG
1
;
Mina HUR
;
Kyu Man LEE
;
Yeomin YUN
;
Chang Hoon LEE
;
Young Sook CHOI
;
Kyung A LEE
;
Eun Youn ROH
Author Information
1. Department of Laboratory Medicine, Konkuk University College of Medicine, Seoul, Korea.
- Publication Type:Original Article ; Comparative Study ; Evaluation Studies
- Keywords:
Hepatitis B virus;
DNA;
Quantification;
HBe antigen;
Alanine aminotransferase
- MeSH:
Adolescent;
Adult;
Aged;
Aged, 80 and over;
Alanine Transaminase/blood;
DNA, Viral/*analysis/genetics;
Data Interpretation, Statistical;
Female;
Hepatitis B e Antigens/metabolism;
Hepatitis B virus/genetics/*isolation & purification;
Hepatitis B, Chronic/*diagnosis;
Humans;
Male;
Middle Aged;
Nucleic Acid Hybridization/*methods;
Polymerase Chain Reaction;
Regression Analysis;
Reproducibility of Results;
Sensitivity and Specificity
- From:The Korean Journal of Laboratory Medicine
2007;27(6):451-457
- CountryRepublic of Korea
- Language:English
-
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.
