title: Comparison of real-time polymerase chain reaction with the COBAS Amplicor test for quantitation of hepatitis B virus DNA in serum samples.
abstract: OBJECTIVE
  To compare the clinical performance of a real-time PCR assay with the COBAS Amplicor Hepatitis B Virus (HBV) Monitor test for quantitation of HBV DNA in serum samples.
  
  
  METHODS
  The reference sera of the Chinese National Institute for the Control of Pharmaceutical and Biological Products and the National Center for Clinical Laboratories of China, and 158 clinical serum samples were used in this study. The linearity, accuracy, reproducibility, assay time, and costs of the real-time PCR were evaluated and compared with those of the Cobas Amplicor test.
  
  
  RESULTS
  The intra-assay and inter-assay variations of the real-time PCR ranged from 0.3% to 3.8% and 1.4% to 8.1%, respectively. The HBV DNA levels measured by the real-time PCR correlated very well with those obtained with the COBAS Amplicor test (r = 0.948). The real-time PCR HBV DNA kit was much cheaper and had a wider dynamic range.
  
  
  CONCLUSIONS
  The real-time PCR assay is an excellent tool for monitoring of HBV DNA levels in patients with chronic hepatitis B.
authors.affiliation: Laboratory Center, No. 6 Hospital of Dalian, 1 Chunhai Street, Dalian 116001, Liaoning Province, China. zhsh6655@sohu.com
authors.forename: Ming
authors.initials: M
authors.lastname: Shi
authors.forename: Yong
authors.initials: Y
authors.lastname: Zhang
authors.forename: Ying-Hua
authors.initials: YH
authors.lastname: Zhu
authors.forename: Jing
authors.initials: J
authors.lastname: Zhang
authors.forename: Wei-Jia
authors.initials: WJ
authors.lastname: Xu
mesh_terms: D004279:DNA, Viral / Q000097:blood*; D006509:Hepatitis B / Q000097:blood / Q000175:diagnosis; D006515:Hepatitis B virus / Q000235:genetics*; D006801:Humans; D016133:Polymerase Chain Reaction / Q000191:economics / Q000379:methods / Q000592:standards; D011933:Reagent Kits, Diagnostic / Q000191:economics / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019562:Viral Load
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic