title: Quantitation of HBV DNA in human serum using a branched DNA (bDNA) signal amplification assay.
abstract: The aim of this study was to establish the performance characteristics of a nonradioisotopic branched DNA (bDNA) signal amplification assay for quantitation of hepatitis B virus (HBV) DNA in human serum. Quantitation was determined from a standard curve and expressed as HBV DNA equivalents/mL (Eq/mL; 285,000 Eq = 1 pg of double stranded HBV DNA). The bDNA assay exhibited a nearly four log dynamic range of quantitation and an analytical detection limit of approximately 100,000 Eq/mL. To ensure a specificity of 99.7%, the quantitation limit was set at 700,000 Eq/mL. The interassay percent coefficient of variance for quantification values ranged from 10% to 15% when performed by novice users with different sets of reagents. Using the bDNA assay, HBV DNA was detected in 94% to 100% of hepatitis B e antigen-positive specimens and 27% to 31% of hepatitis B e antigen-negative specimens from chronic HBV-infected patients. The bDNA assay may be useful as a prognostic and therapy monitoring tool for the management of HBV-infected patients undergoing antiviral treatment.
authors.affiliation: Chiron Corporation, Emeryville, CA 94608-2916, USA.
authors.forename: D A
authors.initials: DA
authors.lastname: Hendricks
authors.forename: B J
authors.initials: BJ
authors.lastname: Stowe
authors.forename: B S
authors.initials: BS
authors.lastname: Hoo
authors.forename: J
authors.initials: J
authors.lastname: Kolberg
authors.forename: B D
authors.initials: BD
authors.lastname: Irvine
authors.forename: P D
authors.initials: PD
authors.lastname: Neuwald
authors.forename: M S
authors.initials: MS
authors.lastname: Urdea
authors.forename: R P
authors.initials: RP
authors.lastname: Perrillo
mesh_terms: D015342:DNA Probes; D004279:DNA, Viral / Q000032:analysis*; D005069:Evaluation Studies as Topic; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D021141:Nucleic Acid Amplification Techniques; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D014766:Viremia / Q000175:diagnosis* / Q000188:drug therapy / Q000276:immunology / Q000821:virology
chemical_list: D015342:DNA Probes; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha