title: [The clinical significance of quantitation of HBV DNA in serum-comparison of the branched-DNA assay with the second-generation digene hybrid capture assay and long-term observation].
abstract: OBJECTIVE
  Serum levels of hepatitis B virus (HBV) DNA are direct measures of viral replication in hepatocytes. We compared branched-DNA assay (Quantiplex(TM), bDNA) and Hybridization Capture II (HCII), and evaluated the clinical significance of HBV DNA quantitation in the natural course of HBV infection.
  
  
  METHODS
  We analyzed results of bDNA in 324 serum samples from 83 untreated male patients with chronic hepatitis B. Mean follow up period was 11.8 years. HCII was also performed in 157 arbitrarily selected samples.
  
  
  RESULTS
  HBV DNA levels measured with two assays were very similar (r(2)=0.893, p<0.0001). HBV DNA detection rate of HCII was 6.4% higher than that of bDNA in HBeAg positive samples. HBV DNA detection rate was higher in cases with higher ALT. Among 73 patients with initial diagnosis of chronic hepatitis, 38 patients (52.1%) experienced progression to cirrhosis, and hepatocellular carcinoma (HCC) was developed in 9 (12.3%). HCC was developed in 5 (50.0%) of 10 patients with initial diagnosis of cirrhosis. While HBeAg positive rates during chronic hepatitis, cirrhosis and HCC were 57.8%, 55.0% and 14.3%, respectively (p=0.006), HBV DNA detection rates were 70.6%, 64.0% and 42.9%, respectively (p=0.08). Especially in HCC, the discrepancy between HBeAg positive rate and HBV DNA detection rate may suggest the appearance of variants which cannot produce HBeAg.
  
  
  CONCLUSIONS
  Both HCII and bDNA were similar HBV DNA quantitation assays for clinical use. HBV DNA level correlated with the severity of liver disease. Screening tests for HCC should be recommended in patients whose HBeAg is negative and have detectable HBV DNA.
authors.affiliation: Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea. jkkim@cmc.cuk.ac.kr
authors.forename: Eun Jung
authors.initials: EJ
authors.lastname: Jun
authors.forename: Joon Yeol
authors.initials: JY
authors.lastname: Han
authors.forename: Hwang
authors.initials: H
authors.lastname: Choi
authors.forename: U Im
authors.initials: UI
authors.lastname: Chang
authors.forename: Tae Kyu
authors.initials: TK
authors.lastname: Lee
authors.forename: Young Hwan
authors.initials: YH
authors.lastname: Kim
authors.forename: Jin Il
authors.initials: JI
authors.lastname: Kim
authors.forename: Soo Heon
authors.initials: SH
authors.lastname: Park
authors.forename: Jae Kwang
authors.initials: JK
authors.lastname: Kim
authors.forename: Kyu Won
authors.initials: KW
authors.lastname: Chung
authors.forename: Hee Sik
authors.initials: HS
authors.lastname: Sun
mesh_terms: D021121:Branched DNA Signal Amplification Assay; D006528:Carcinoma, Hepatocellular / Q000821:virology; D004279:DNA, Viral / Q000032:analysis*; D005500:Follow-Up Studies; D006515:Hepatitis B virus / Q000235:genetics*; D019694:Hepatitis B, Chronic / Q000150:complications / Q000821:virology*; D006801:Humans; D008103:Liver Cirrhosis / Q000821:virology; D008113:Liver Neoplasms / Q000821:virology; D008297:Male; D009693:Nucleic Acid Hybridization; D011379:Prognosis
chemical_list: D004279:DNA, Viral