QUANTITATIVE DETECTION OF HEPATITIS-B VIRUS-DNA IN SERUM USING CHEMILUMINESCENCE - COMPARISON WITH RADIOACTIVE SOLUTION HYBRIDIZATION ASSAY

A quantitative, non-radioactive hybrid capture HBV DNA assay (Digene D iagnostics), which uses an efficient solution hybridization procedure coupled to a sensitive chemiluminescent signal amplification system, w as compared with the quantitative, radioactive solution hybridization assay (Genostics, Abbott Laboratories), in hepatitis B virus carriers, particularly in those undergoing antiviral therapy. The qualitative r eproducibility of the chemiluminescent method, tested on 30 sera, was acceptable, with a reproducibility rate of 93.3%. A comparison of this hybrid capture HBV DNA assay with the radioactive test on 113 sera ob tained from 48 patients (39 HBsAg-positive patients) gave a sensitivit y of 87.2%, a specificity of 100% and an agreement between the two tes ts of 89.4% (101 sera including 82 HBV DNA positive and 19 negative sa mples). Changes in HBV DNA levels measured by the two assays showed a good correlation with each other during interferon therapy. However, t he hybrid capture values were higher than the radioactive assay values , with the ratio of the two values being variable in the same patient during the course of treatment. The Genostics assay therefore seems to be a more accurate procedure for evaluating changes in viral replicat ion, particularly at high HBV DNA levels. However, the hybrid capture method is faster and has the advantage of being a non-radioactive proc edure. This chemiluminescent assay is easy to perform as a routine dia gnostic procedure and may be a useful alternative to the radioactive s olution hybridization method.