Wang X Y, Su B Y, Chen Z Y, Kuang H B, Guan P, Cao Z Z, Tan Y J
Graduate School, Guangzhou Medical University, Guangzhou 511436, China.
Department of Pathogenic Laboratory, Guangzhou Chest Hospital, Guangzhou 510095, China.
Zhonghua Jie He He Hu Xi Za Zhi. 2022 May 12;45(5):445-452. doi: 10.3760/cma.j.cn112147-20220206-00095.
To compare the screening value of QuantiFERON-TB Gold Plus (QFT-Plus) and QuantiFERON®-TB Gold in tube (QFT-GIT) in the auxiliary diagnosis of pulmonary tuberculosis (TB). A screening test was performed. Patients who were hospitalized in Guangzhou Chest Hospital and underwent QFT-GIT testing from October to December 2020 were prospectively included as research subjects, QFT-Plus testing was added. And the basic information, clinical manifestations, laboratory test results, imaging examinations and other data of these patients were collected. A total of 207 patients were included and divided into tuberculosis group and non-tuberculosis group according to these data. There were 124 cases in the tuberculosis group (94 confirmed patients and 30 clinically diagnosed patients), including 90 males and 34 females, aged 18-93 years, with a median age of 57 (38, 67) years. The non-tuberculosis group included 83 patients (16 patients with non-tuberculous and 67 patients with other lung diseases), including 49 males and 34 females, with a median age of 60 (51, 68) years. The confirmed patients were subdivided into three grades of low, medium and high (MTB) bacterial load, and three grades of mild, moderate and severe pulmonary tuberculosis. The results of QFT-Plus and QFT-GIT were compared, and the levels of IFN-γ in different antigen tubes were compared. Differences between different groups were compared using Mann-Whitney test and Kruskal-Wallis test. The QFT-Plus showed a high degree of agreement with the QFT-GIT (=0.786, 95%: 0.740-0.832), while the main discordant result was QFT-GIT negative/QFT-Plus positive, accounting for 15/17. The sensitivity of QFT-GIT was 80.7%(95%: 0.706-0.880), the specificity was 76.3%(95%: 0.649-0.850), the positive predictive value was 79.8%(95%: 0.697-0.873), and the negative predictive value was 77.3%(95%: 0.659-0.859), repectively. QFT-Plus showed a sensitivity of 84.3%(95%: 0.743-0.910), a specificity of 78.8% (95%: 0.679-0.868), and a positive predictive value of 80.5%(95%: 0.703-0.879), the negative predictive value being 82.9%(95%: 0.721-0.902), slightly improved to that of the QFT-GIT. Also, this study found that there were significant differences in IFN-γ values between different MTB load or disease severity (<0.05). There is a good consistency between the QFT-Plus test and the QFT-GIT test, both of which show good application value in the auxiliary diagnosis of pulmonary tuberculosis. Moreover, because of the addition of tuberculosis-specific CD8 cell antigen, the QFT-Plus test has higher sensitivity, lower uncertainty and more application value. This study also found that the bacterial load and disease severity of patients with pulmonary tuberculosis may have a certain correlation with the measured value of IFN-γ.
比较全血γ-干扰素释放试验增强版（QFT-Plus）和全血γ-干扰素释放试验（QFT-GIT）在肺结核辅助诊断中的筛查价值。进行了一项筛查试验。前瞻性纳入2020年10月至12月在广州市胸科医院住院并接受QFT-GIT检测的患者作为研究对象，增加QFT-Plus检测。收集这些患者的基本信息、临床表现、实验室检查结果、影像学检查等数据。共纳入207例患者，根据这些数据分为结核组和非结核组。结核组124例（确诊患者94例，临床诊断患者30例），其中男性90例，女性34例，年龄18 - 93岁，中位年龄57（38，67）岁。非结核组包括83例患者（非结核患者16例，其他肺部疾病患者67例），其中男性49例，女性34例，中位年龄60（51，68）岁。确诊患者细分为低、中、高三个等级的结核分枝杆菌（MTB）菌量以及轻、中、重三个等级的肺结核。比较QFT-Plus和QFT-GIT的结果，并比较不同抗原管中IFN-γ水平。采用Mann-Whitney检验和Kruskal-Wallis检验比较不同组间差异。QFT-Plus与QFT-GIT显示出高度一致性（κ=0.786，95%CI：0.740 - 0.832），而主要不一致结果为QFT-GIT阴性/QFT-Plus阳性，占15/17。QFT-GIT的敏感性为80.7%（95%CI：0.706 - 0.880），特异性为76.3%（95%CI：0.649 - 0.850），阳性预测值为79.8%（95%CI：0.697 - 0.873），阴性预测值为77.3%（95%CI：0.659 - 0.859）。QFT-Plus的敏感性为84.3%（95%CI：0.743 - 0.910），特异性为78.8%（95%CI：0.679 - 0.868），阳性预测值为80.5%（95%CI：0.703 - 0.879），阴性预测值为82.9%（95%CI：0.721 - 0.902），较QFT-GIT略有提高。此外，本研究发现不同MTB菌量或疾病严重程度之间的IFN-γ值存在显著差异（P<0.05）。QFT-Plus检测与QFT-GIT检测具有良好的一致性，两者在肺结核辅助诊断中均显示出良好的应用价值。而且，由于添加了结核特异性CD8细胞抗原，QFT-Plus检测具有更高的敏感性、更低的不确定性和更大的应用价值。本研究还发现肺结核患者的菌量和疾病严重程度可能与IFN-γ测量值存在一定相关性。
