title: Multicenter evaluation of the VERSANT hepatitis B virus DNA 3.0 assay.
abstract: The VERSANT hepatitis B virus (HBV) 3.0 Assay (branched DNA [bDNA]) (referred to herein as VERSANT 3.0) was evaluated at four external sites for analytical sensitivity, specificity, reproducibility, linearity of quantification, and limits of detection. In addition, each of the test evaluation sites provided HBV DNA-positive clinical samples that were previously analyzed by one of three commercially available HBV DNA quantitative tests: Digene Hybrid Capture II HBV DNA Test (Digene); VERSANT HBV DNA 1.0 Assay (bDNA) (VERSANT 1.0); and COBAS AMPLICOR HBV Monitor Test (COBAS AMPLICOR). These samples were reexamined using VERSANT 3.0. The results from these studies showed that VERSANT 3.0 has high specificity (99.3%), excellent reproducibility (between-run coefficient of variation [CV] = 1.6 to 9.4%; within-run CV = 6.5 to 20.7%), and a broad linear range of quantification (2.0 x 10(3) to 1.0 x 10(8) HBV DNA copies/ml) that facilitate the monitoring of HBV DNA levels at diagnosis and throughout the course of treatment. In general, correlation was very good between results obtained from clinical samples analyzed by VERSANT 3.0 and the comparative HBV DNA quantitative assays (VERSANT 1.0, R(2) = 0.900; Digene, R(2) = 0.985; COBAS AMPLICOR, R(2) = 0.771). The greatest differences in comparative quantitation occurred at HBV DNA levels approaching the limits of the dynamic ranges for the comparative assays. The performance characteristics of the new VERSANT 3.0 assay demonstrated that it provides a reliable and robust method for routinely monitoring serum HBV DNA levels in assessing disease activity and determining response to antiviral treatment.
authors.affiliation: Division of Clinical Microbiology, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Joseph D C
authors.initials: JD
authors.lastname: Yao
authors.forename: Marcel G H M
authors.initials: MG
authors.lastname: Beld
authors.forename: Lynette Lin Ean
authors.initials: LL
authors.lastname: Oon
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Sherlock
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Germer
authors.forename: Sandra
authors.initials: S
authors.lastname: Menting
authors.forename: Su Yun
authors.initials: SY
authors.lastname: Se Thoe
authors.forename: Linda
authors.initials: L
authors.lastname: Merrick
authors.forename: Rainer
authors.initials: R
authors.lastname: Ziermann
authors.forename: Johan
authors.initials: J
authors.lastname: Surtihadi
authors.forename: H James
authors.initials: HJ
authors.lastname: Hnatyszyn
mesh_terms: D004279:DNA, Viral / Q000097:blood* / Q000235:genetics; D005821:Genetic Techniques; D006509:Hepatitis B / Q000175:diagnosis; D006515:Hepatitis B virus / Q000235:genetics*; D006801:Humans; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D004279:DNA, Viral