Clinical utility of transcription mediated amplification-hybridization protection method(TMA-HPA) for the detection of HBV DNA: a comparison with the branched DNA probe assay

The clinical utility of the TMA-HPA method for the detection of HBV DNA was evaluated by comparing results with the branched DNA probe(b-DNA) assay. Sera from 135 biopsy-confirmed HBV carriers were included in the study. Dilution tests with two representative sera revealed the sensitivity of the TMA-HPA method to be 100-fold higher than that of the b-DNA assay. Among the 135 test sera, HBV DNA measurements obtained by the two assays showed a high degree of correlation(r = 0.861, p < 0.0001). Of the 72 sera which tested positive for HBe antigen, 71 and 67 were positive for HBV DNA when tested by TMA-HPA and b-DNA assay, respectively. In contrast, of the 63 which tested negative for HBe antigen, 42 were positive for HBV DNA when tested by TMA-HPA, and only 19 were positive when tested by b-DNA assay(p < 0.05). Among HBe antigen-positive HBV carriers, HBV DNA levels as determined both TMA-HPA and b-DNA assay showed an inverse relationship with pathological stage, but among HBe antigen-negative HBV carriers, no such tendency was observed. Based on these results, it is felt that the detection of HBV DNA by TMA-HPA is useful for the evaluating anti-viral therapeutic effect in HBV carriers, and in estimating a prognosis.