Liu Shengsheng, Wu Meiying, A Ertai, Wu Shucai, Geng Shujun, Li Zhihui, Li Mingwu, Li Liang, Pang Yu, Kang Wanli, Tang Shenjie
Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing.
Souzhou 5th People's Hospital, Souzhou.
Medicine (Baltimore). 2021 Feb 26;100(8):e24615. doi: 10.1097/MD.0000000000024615.
The T-SPOT.TB assay detects cellular immune responses to 2 core Mycobacterium tuberculosis antigens, early secreted antigenic target of 6-kDa protein (ESAT-6) and culture filtrate protein-10 (CFP-10). T-SPOT.TB has been recently used for auxiliary diagnosis of active pulmonary tuberculosis (PTB). However, testing can produce inconsistent results due to differential PTB patient immune responses to these antigens, prompting us to identify factors underlying inconsistent results.Data were retrospectively analyzed from 1225 confirmed PTB patients who underwent T-SPOT.TB testing at 5 specialized tuberculosis hospitals in China between December 2012 and November 2015. Numbers of spot-forming cells (SFCs) reflecting T cell responses to ESAT-6 and CFP-10 antigens were recorded then analyzed via multivariable logistic regression to reveal factors underlying discordant T cell responses to these antigens.The agreement rate of 84.98% (82.85%-86.94%) between PTB patient ESAT-6 and CFP-10 responses demonstrated high concordance. Additionally, positivity rates were higher for ESAT-6 than for CFP-10 (84.8% vs 80.7%, P < .001), with ESAT-6 and CFP-10 microwell SFC numbers for each single positive group not differing significantly (P > .99), while spot numbers of the single positive group were lower than numbers for the double positive group (P < .001). Elderly patients (aged ≥66 years) and patients receiving retreatment were most likely to have discordance results.ESAT-6 promoted significantly more positive T-SPOT.TB results than did CFP-10 in PTB patients. Advanced age and retreatment status were correlated with discordant ESAT-6 and CFP-10 results. Assessment of factors underlying discordance may lead to improved PTB diagnosis using T-SPOT.TB.
结核感染T细胞检测（T-SPOT.TB）试验可检测机体对两种结核分枝杆菌核心抗原，即早期分泌性抗原靶6 kDa蛋白（ESAT-6）和培养滤液蛋白10（CFP-10）的细胞免疫反应。T-SPOT.TB最近已用于活动性肺结核（PTB）的辅助诊断。然而，由于PTB患者对这些抗原的免疫反应存在差异，该检测可能会产生不一致的结果，这促使我们确定结果不一致的潜在因素。
对2012年12月至2015年11月期间在中国5家专业结核病医院接受T-SPOT.TB检测的1225例确诊PTB患者的数据进行回顾性分析。记录反映T细胞对ESAT-6和CFP-10抗原反应的斑点形成细胞（SFC）数量，然后通过多变量逻辑回归分析，以揭示T细胞对这些抗原反应不一致的潜在因素。
PTB患者ESAT-6和CFP-10反应之间的一致率为84.98%（82.85%-86.94%），显示出高度一致性。此外，ESAT-6的阳性率高于CFP-10（84.8%对80.7%，P<0.001），每个单阳性组的ESAT-6和CFP-10微孔SFC数量差异无统计学意义（P>0.99），而单阳性组的斑点数低于双阳性组（P<0.001）。老年患者（年龄≥66岁）和接受再次治疗的患者最有可能出现不一致的结果。
在PTB患者中，ESAT-6比CFP-10更能显著促进T-SPOT.TB检测结果呈阳性。高龄和再次治疗状态与ESAT-6和CFP-10结果不一致相关。评估不一致的潜在因素可能会改善使用T-SPOT.TB对PTB的诊断。
