Clinical evaluation of the T-SPOT.TB test for detection of tuberculosis infection in northeastern Guangdong Province, China

Objective We evaluated clinical performance of the T-SPOT.TB test for detecting tuberculosis (TB) infection in Meizhou, China. Methods We enrolled 2,868 patients who underwent T-SPOT.TB, smear, and TB-DNA at the same time. The tests’ sensitivity and specificity were evaluated and compared in different groups, and in pulmonary TB (PTB) and extrapulmonary TB (EPTB) subgroups. Receiver operator characteristic (ROC) curve analysis was used to evaluate T-SPOT.TB’s diagnostic value and determine its cutoff value. Results T-SPOT.TB, TB-DNA, and sputum smear sensitivity was 61.44%, 37.12%, and 14.02%; and specificity was 76.49%, 99.20% and 99.60%, respectively. The T-SPOT.TB positive rate was higher in the PTB and EPTB subgroups than in patients with other pulmonary diseases (61.38% and 61.76% vs. 23.34%). The T-SPOT.TB test had better diagnostic accuracy and sensitivity when the positive cutoff value of marker ESAT-6 was 2.5 [area under ROC curve = 0.701, 95%CI 0.687–0.715] and marker CFP-10 was 6.5 [area under ROC curve = 0.669, 95%CI 0.655–0.683]. Conclusion T-SPOT.TB sensitivity was higher than that of TB-DNA or sputum smear, but the specificity was lower. T-SPOT.TB had moderate sensitivity and specificity for diagnosing TB. T-SPOT.TB’s new positive cutoff value may be clinically valuable according to ROC analysis