Division of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Clinical Epidemiology Unit, International Epidemiology Network, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Sci Rep. 2017 Aug 10;7(1):7764. doi: 10.1038/s41598-017-07785-6.
T-SPOT.TB didn't perform a perfect diagnosis for active tuberculosis (ATB), and some factors may influence the results. We did this study to evaluate possible factors associated with the sensitivity and specificity of T-SPOT.TB, and the diagnostic parameters under varied conditions. Patients with suspected ATB were enrolled prospectively. Influencing factors of the sensitivity and specificity of T-SPOT.TB were evaluated using logistic regression models. Sensitivity, specificity, predictive values (PV), and likelihood ratios (LR) were calculated with consideration of relevant factors. Of the 865 participants, 205 (23.7%) had ATB, including 58 (28.3%) microbiologically confirmed TB and 147 (71.7%) clinically diagnosed TB. 615 (71.7%) were non-TB. 45 (5.2%) cases were clinically indeterminate and excluded from the final analysis. In multivariate analysis, serous effusion was the only independent risk factor related to lower sensitivity (OR = 0.39, 95% CI: 0.18-0.81) among patients with ATB. Among non-TB patients, age, TB history, immunosuppressive agents/glucocorticoid treatment and lymphocyte count were the independent risk factors related to specificity of T-SPOT.TB. Sensitivity, specificity, PV+, PV-, LR+ and LR- of T-SPOT.TB for diagnosis of ATB were 78.5%, 74.1%, 50.3%, 91.2%, 3.0 and 0.3, respectively. This study suggests that influencing factors of sensitivity and specificity of T-SPOT.TB should be considered for interpretation of T-SPOT.TB results.
T-SPOT.TB 并未对活动性结核病（ATB）进行完美诊断，一些因素可能会影响结果。我们进行这项研究是为了评估 T-SPOT.TB 的敏感性和特异性相关的可能因素，以及在不同条件下的诊断参数。前瞻性纳入疑似 ATB 的患者。使用逻辑回归模型评估 T-SPOT.TB 的敏感性和特异性的影响因素。考虑相关因素后，计算敏感性、特异性、预测值（PV）和似然比（LR）。在 865 名参与者中，205 名（23.7%）患有 ATB，包括 58 名（28.3%）经微生物学证实的结核病和 147 名（71.7%）临床诊断的结核病。615 名（71.7%）为非结核病。45 例（5.2%）为临床不确定，被排除在最终分析之外。在多变量分析中，胸腔积液是 ATB 患者中与敏感性降低相关的唯一独立危险因素（OR=0.39，95%CI：0.18-0.81）。在非结核病患者中，年龄、结核病史、免疫抑制剂/糖皮质激素治疗和淋巴细胞计数是与 T-SPOT.TB 特异性相关的独立危险因素。T-SPOT.TB 诊断 ATB 的敏感性、特异性、PV+、PV-、LR+和 LR-分别为 78.5%、74.1%、50.3%、91.2%、3.0 和 0.3。本研究表明，在解释 T-SPOT.TB 结果时，应考虑 T-SPOT.TB 的敏感性和特异性的影响因素。
