Abstract：Objective To evaluate the clinical application value of T cell interferon-gamma release assay (T-SPOT. TB) in the rapid diagnosis of tuberculosis and to try to identify its new cut-off value so as to decline its misdiagnosis rate. Methods Thirty-one patients with Mycobacterium tuberculosis infection and 96 patients with non-TB diseases were enrolled. Antigen A (early secreted antigenic target-6,ESAT-6) and antigen B (culture filtrate protein-10,CFP-10) were used for the stimuli, and then cultured for 16-20 hours. T-SPOT.TB assay was used to detect interferon gamma (IFN-γ) released by the specific T cells, and its sensitivity and specificity were analyzed. The critical value of T-SPOT.TB assay was identified. Results When the cut-off value of 6 SFU recomended by the manufacturer of the reagent was considered as the diagnostic standard, , 28 out of 31 patients with Mycobacterium tuberculosis infection were T-SPOT.TB positive, with the sensitivity of 90.3%, and 88 of 96 patients with non-TB diseases were T-SPOT.TB negative, with the specificity of 91.7%. The receiver operating characteristic curve (ROC curve) based on the tuberculosis infection group showed that when the cut-off value of T-SPOT.TB was defined as 15 SFU, the sensitivity and specificity were 86.9% and 93.1% respectively. Conclusions T-SPOT.TB assay in the detection of Mycobacterium tuberculosis infection has a high sensitivity and specificity. But defining the cut-off value as 6 SFU suggested by the manufacturer of the reagent can easily induce misdiagnosis of suspected patients in the Second Xiangya Hospital of Central South University. Having the cut-off value as 15 SFU, the sensitivity and specificity of T-SPOT.TB assay are 86.9% and 93.1% respectively, which can decline the misdiagnosis of suspected patients.
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2017, Vol. 24 
