COMPARISON OF METHODS FOR DETECTION OF HEPATITIS-B VIRUS-DNA

We compared the performance of four assays for detection of hepatitis B virus (HBV) DNA: the PCR; the branched DNA hybridization assay (Chir on); and two hybridization assays that use liquid hybridization (Abbot t) or direct membrane hybridization (MH). Testing 109 random hepatitis B surface antigen-positive patient samples, the percentages found to be HBV DNA positive among 30 hepatitis B e antigen (HBeAg)-positive sa mples and 79 HBeAg-negative samples were as follows: PCR, 100 and 90%; Chiron, 73 and 25%; Abbott, 67 and 13%; and MH, 40 and 8%. In six hep atitis B surface antigen-positive, HBeAg-negative samples, all three h ybridization assays detected HBV DNA. Testing dilutions prepared from the Eurohep HBV DNA standards, the detection limits of the assays appe ared to be the following: PCR, 2.5 x 10(2) HBV genomes per ml; Chiron, 2.5 x 10(6) genomes per ml; and Abbott and MH, 2.5 x 10(7) genomes pe r ml. HBV DNA levels in the dilution series, as reported by the Chiron and MH assays, were, on average, 2 times higher than calculated; the Abbott results were, on average, 19 times lower than calculated. We co ncluded that high levels of HBV DNA and the presence of HBeAg do not n ecessarily coincide, that the application of hybridization assays is l imited to the monitoring of relatively high levels of HBV DNA, and tha t further standardization of quantitative HBV DNA assays is necessary to facilitate comparison of HBV DNA levels.