Abstract
BACKGROUND: Previous qualitative studies suggested that the false negative rate of the T cell spot test for tuberculosis infection (T-SPOT.TB) is associated with many risk factors in tuberculosis patients. However, more precise quantitative studies are lacking. The purpose of this study was to investigate the factors affecting quantified spot-forming cells (SFCs) to early secreted antigenic target 6 kDa (ESAT-6) or culture filtrate protein 10 kDa (CFP-10) in patients with active tuberculosis. METHODS: We retrospectively analyzed the data of 360 patients who met the inclusion criteria. Using the SFCs to ESAT-6 or CFP-10 levels as dependent variables, variables with statistical significance in the univariate analysis were subjected to optimal scaling regression analysis. The combination of ESAT-6 and CFP-10 (i.e., T-SPOT.TB) was analyzed by the exact logistic regression model. RESULTS: The results showed that the SFCs to ESAT-6 regression model had statistical significance (P < 0.001) and that previous treatment and CD4+ and platelet counts were its independent risk factors (all P < 0.05). Their importance levels were 0.095, 0.596 and 0.100, respectively, with a total of 0.791. The SFCs to CFP-10 regression model also had statistical significance (P < 0.001); platelet distribution width and alpha-2 globulin were its independent risk factors (all P < 0.05). Their importance levels were 0.287 and 0.247, respectively, with a total of 0.534. The quantification graph showed that quantified SFCs to ESAT-6 or CFP-10 grading had a linear correlation with risk factors. Albumin-globulin ratio, CD4+ and CD8+ were independent risk factors for false negative T-SPOT.TB (all P < 0.05). CONCLUSIONS: In T-SPOT.TB-assisted diagnosis of patients with active tuberculosis, previous treatment, decreased CD4+ and platelet count might lead to the decreased SFCs to ESAT-6, decreased alpha-2 globulin and high platelet distribution width might lead to the decreased SFCs to CFP-10, decreased albumin-globulin ratio, CD4+ and CD8+ might lead to an increase in the false negative rate of the T-SPOT.TB.