COMPARISON OF THE CHIRON QUANTIPLEX BRANCHED DNA (BDNA) ASSAY AND THEABBOTT GENOSTICS SOLUTION HYBRIDIZATION ASSAY FOR QUANTIFICATION OF HEPATITIS-B VIRAL-DNA

Several assays for quantification of DNA have been developed and are c urrently used in research and clinical laboratories, However, comparis on of assay results has been difficult owing to the use of different s tandards and units of measurement as well as differences between assay s in dynamic range and quantification limits. Although a few studies h ave compared results generated by different assays, there has been no consensus on conversion factors and thorough analysis has been preclud ed by small sample size and limited dynamic range studied, In this stu dy, 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 facilita te comparison of assay results, Additivity and variance stabilizing (A VAS) regression, a form of non-linear regression analysis, was perform ed on assay results for specimens from HBV clinical trials. Our result s show that there is a strong linear relationship (R(2) = 0.96) betwee n 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 l imit of quantification (LOO) indicated that a significantly (P < 0.01) larger proportion of observations were below the Abbott assay LOO but above the Chiron assay LOO, indicating that the Chiron assay is signi ficantly more sensitive than the Abbott assay, Testing of replicate sp ecimens showed that the Chiron assay consistently yielded lower per ce nt coefficients of variance (% CVs) than the Abbott assay, indicating that the Chiron assay provides superior precision.