The present study investigated the diagnostic value of a recombinant 38-kDa–16-kDa—early secreted antigenic target of 6 kDa (ESAT-6) Mycobacterium tuberculosis (MTB) fusion antigen in 105 patients with tuberculosis (TB), 25 non-TB pulmonary disease patients and 20 healthy individuals. Its diagnostic value was compared with the commercially available enzyme-linked immunosorbent assay kit, the TB-directly observed therapy (DOT) kit. In the controls, the rate of positive antibody response to the TB-DOT kit was significantly higher than that of the recombinant antigen. The area under the receiver operating characteristic curve was 0.751, and the optimum sensitivity and specificity for detecting antibody responses to the recombinant antigen were 65.4% and 84.8%, respectively. The recombinant 38-kDa–16-kDa—ESAT-6 MTB antigen was more effective than the TB-DOT kit in distinguishing between TB patients and controls, and may be an optimal combination of antigens to provide a useful tool for the sensitive and specific diagnosis of patients with TB.
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