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Clinical Chemistry 38: 1352-1355, 1992;
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Clinical Chemistry, Vol 38, 1352-1355, Copyright © 1992 by American Association for Clinical Chemistry

Detection of hepatitis B virus DNA in serum by a nonisotopic hybridization technique

A Akar, B Bournique and R Scholler
Fondation de Recherche en Hormonologie, Fresnes, France.

We developed a nonisotopic technique, Hepagene, for measuring hepatitis B virus (HBV) DNA in human serum by using a sulfonated probe that is detected by a sandwich immunoenzymatic reaction. The detection limit, determined by serum dilution tests, was 2.5 ng/L. The precision of the Hepagene test was demonstrated by the accurate reproducibility observed for low (3 ng/L) and medium (38 ng/L) concentrations of HBV DNA assayed in 24 different series. Specificity was established by assaying HBV DNA in sera from 98 patients by the Hepagene technique or by a solution hybridization assay with an 125I-labeled probe. Results by both techniques agreed for 94 sera (96%), with 68 being concordant for HBV DNA negativity and 26 for positivity. HBV DNA titers assayed by both methods also agreed. Hepagene represents the first nonisotopic HBV DNA assay involving a sulfonated probe and with performance characteristics equivalent to those of classical radioactive hybridization techniques.




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Copyright © 1992 by the American Association for Clinical Chemistry.