Clinical Laboratory, Guangzhou Chest Hospital, Guangzhou/State Key Laboratory of Respiratory Diseases, Guangzhou, China.
Clinical Laboratory, Hunan Chest Hospital, Changsha, China.
J Transl Med. 2021 Jul 3;19(1):289. doi: 10.1186/s12967-021-02970-8.
We performed a prospective multicentre diagnostic study to evaluate the combined interferon-γ (IFN-γ) and interleukin-2 (IL-2) release assay for detect active pulmonary tuberculosis (TB) in China.
Adult patients presenting symptoms suggestive of pulmonary TB were consecutively enrolled in three TB-specialized hospitals. Sputum specimens and blood sample and were collected from each participant at enrolment. The levels of Mycobacterium tuberculosis (MTB)-specific antigen-stimulated IFN-γ and IL-2 were determined using enzyme-linked immunosorbent assay (ELISA).
Between July 2017 and December 2018, a total of 3245 patients with symptoms suggestive of pulmonary TB were included in final analysis. Of 3245 patients, 2536 were diagnosed as active TB, consisting of 1092 definite TB and 1444 clinically diagnosed TB. The overall sensitivity and specificity of IFN-γ were 83.8% and 81.5%, respectively. In addition, compared with IFN-γ, the specificity of IL-2 increased to 94.3%, while the sensitivity decreased to 72.6%. In addition, the highest sensitivity was achieved with parallel combination of IFN-γ/IL-2, with a sensitivity of 87.9%, and its overall specificity was 79.8%. The sensitivity of series combination test was 68.5%. Notably, the sensitivity of series combination test in definite TB (72.1%) was significantly higher than that in clinically diagnosed TB (65.8%).
In conclusion, we develop a new immunological method that can differentiate between active TB and other pulmonary diseases. Our data demonstrates that the various IFN-γ/IL-2 combinations provides promising alternatives for diagnosing active TB cases in different settings. Additionally, the diagnostic accuracy of series combination correlates with severity of disease in our cohort.
我们进行了一项前瞻性多中心诊断研究，以评估干扰素-γ（IFN-γ）和白细胞介素-2（IL-2）释放试验联合用于检测中国活动性肺结核（TB）。
连续纳入三家结核病专科医院有疑似肺结核症状的成年患者。每位参与者在入组时采集痰标本和血样。采用酶联免疫吸附试验（ELISA）测定结核分枝杆菌（MTB）特异性抗原刺激的 IFN-γ和 IL-2水平。
2017 年 7 月至 2018 年 12 月，共有 3245 例疑似肺结核症状的患者纳入最终分析。3245 例患者中，2536 例诊断为活动性 TB，其中 1092 例为确诊 TB，1444 例为临床诊断 TB。IFN-γ的总灵敏度和特异性分别为 83.8%和 81.5%。此外，与 IFN-γ相比，IL-2 的特异性增加至 94.3%，而灵敏度降低至 72.6%。此外，IFN-γ/IL-2 平行联合的灵敏度最高，为 87.9%，其总特异性为 79.8%。串联联合检测的灵敏度为 68.5%。值得注意的是，串联联合检测在确诊 TB（72.1%）中的灵敏度明显高于临床诊断 TB（65.8%）。
总之，我们开发了一种新的免疫学方法，可以区分活动性 TB 和其他肺部疾病。我们的数据表明，不同的 IFN-γ/IL-2 组合为在不同环境中诊断活动性 TB 病例提供了有前途的选择。此外，我们队列中串联组合的诊断准确性与疾病严重程度相关。
