title: Comparative evaluation of three commercial assays for quantitative measurement of hepatitis B virus DNA in serum samples.
abstract: OBJECTIVE
  Quantitative determination of HBV DNA in serum samples is indispensable for predicting disease progression and for monitoring the antiviral treatment in patients with chronic HBV infection.
  
  
  METHODS
  Three commercial assays for quantification of HBV DNA: Digene Hybrid-Capture HBV DNA Assay, Bayer Quantiplex HBV DNA Assay and Roche Amplicor HBV Monitor Test were comparatively evaluated under the routine conditions of diagnostic virology laboratory, using 61 serum samples obtained from 55 Slovenian patients with chronic hepatitis B.
  
  
  RESULTS
  HBV DNA was detected by Amplicor, Quantiplex and Hybrid-Capture in 38 (62.3%), 34 (55.7%) and 27 (44.3%) samples, respectively. The sensitivity of Amplicor and Quantiplex assays did not differ significantly (p = 0.13), while both Amplicor and Quantiplex assays were found to be significantly more sensitive than Hybrid-Capture (p = 0.003 and p = 0.02, respectively). For a given sample, the highest correlation was observed between HBV DNA loads determined by Quantiplex and Hybrid-Capture assays (r = 0.85, p < 0.0001).
  
  
  CONCLUSIONS
  Amplicor HBV Monitor Test seems to be the most sensitive assay for the detection of HBV DNA in serum samples and can be clinically used for monitoring patients with chronic HBV infection.
authors.affiliation: Institute of Microbiology and Immunology, Medical Faculty, Zaloska 4, 1105 Ljubljana, Slovenia.
authors.forename: Irena J
authors.initials: IJ
authors.lastname: Marin
authors.forename: Mario
authors.initials: M
authors.lastname: Poljak
authors.forename: Katja
authors.initials: K
authors.lastname: Seme
authors.forename: Vladimir
authors.initials: V
authors.lastname: Brinovec
authors.forename: Mojca
authors.initials: M
authors.lastname: Maticic
authors.forename: Jelka
authors.initials: J
authors.lastname: Meglic-Volkar
authors.forename: Gorazd
authors.initials: G
authors.lastname: Lesnicar
authors.forename: Primoz
authors.initials: P
authors.lastname: Gradisek
mesh_terms: D004279:DNA, Viral / Q000097:blood* / Q000302:isolation & purification; D006515:Hepatitis B virus / Q000235:genetics*; D006801:Humans; D007118:Immunoassay / Q000379:methods*
chemical_list: D004279:DNA, Viral