title: Comparison of the Chiron Quantiplex branched DNA (bDNA) assay and the Abbott Genostics solution hybridization assay for quantification of hepatitis B viral DNA.
abstract: Several assays for quantification of DNA have been developed and are currently used in research and clinical laboratories. However, comparison of assay results has been difficult owing to the use of different standards and units of measurements as well as differences between assays in dynamic range and quantification limits. Although a few studies have compared results generated by different assays, there has been no consensus on conversion factors and thorough analysis has been precluded by small sample size and limited dynamic range studied. In this study, we have compared the Chiron branched DNA (bDNA) and Abbott liquid hybridization assays for quantification of hepatitis B virus (HBV) DNA in clinical specimens and have derived conversion factors to facilitate comparison of assay results. Additivity and variance stabilizing (AVAS) regression, a form of non-linear regression analysis, was performed on assay results for specimens from HBV clinical trials. Our results show that there is a strong linear relationship (R2 = 0.96) between log Chiron and log Abbott assay results. Conversion factors derived from regression analyses were found to be non-constant and ranged from 6-40. Analysis of paired assay results below and above each assay's limit of quantification (LOQ) indicated that a significantly (P < 0.01) larger proportion of observations were below the Abbott assay LOQ but above the Chiron assay LOQ, indicating that the Chiron assay is significantly more sensitive than the Abbott assay. Testing of replicate specimens showed that the Chiron assay consistently yielded lower per cent coefficients of variance (% CVs) than the Abbott assay, indicating that the Chiron assay provides superior precision.
authors.affiliation: Corning Scicor Inc., Indianapolis, IN 46214-2985, USA.
authors.forename: G E
authors.initials: GE
authors.lastname: Kapke
authors.forename: G
authors.initials: G
authors.lastname: Watson
authors.forename: S
authors.initials: S
authors.lastname: Sheffler
authors.forename: D
authors.initials: D
authors.lastname: Hunt
authors.forename: C
authors.initials: C
authors.lastname: Frederick
mesh_terms: D004279:DNA, Viral / Q000032:analysis*; D005069:Evaluation Studies as Topic; D006515:Hepatitis B virus / Q000235:genetics*; D006801:Humans; D009693:Nucleic Acid Hybridization / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic