QuantiFERON-TB Gold Plus检测活动性肺结核的效能分析  

The value of QuantiFERON-TB Gold Plus in the clinical diagnosis of active pulmonary tuberculosis

作　　者：陈静 秦娅莉 王明栋 杨儒斌 王倩 彭燕清 邱继瑶 张晓 周昕艾 Chen Jing;Qin Yali;Wang Mingdong;Yang Rubin;Wang Qian;Peng Yanqing;Qiu Jiyao;Zhang Xiao;Zhou Xinai(Department of Tuberculosis,Guiyang Public Health Clinical Center,Guiyang 550003,China;Department of Medical Education,the Third People Hospital of Liupanshui,Liupanshui 553000,China;Department of Laboratory,Guiyang Public Health Clinical Center,Guiyang 550003,China)

机构地区：[1]贵阳市公共卫生救治中心结核科,贵阳550003 [2]贵州省六盘水市第三人民医院医教科,六盘水553000 [3]贵阳市公共卫生救治中心检验科,贵阳550003

出　　处：《结核与肺部疾病杂志》2025年第1期61-67,共7页Journal of Tuberculosis and Lung Disease

基　　金：“十三五”国家重大新药创制项目(2017ZX09304009);贵阳市科技计划项目(筑科合同[2018]1-47号)。

摘　　要：目的:评估QuantiFERON-TB Gold Plus(QFT-Plus)检测活动性肺结核的效能。方法:回顾性收集2023年1月至2024年1月贵阳市公共卫生救治中心住院并进行QFT-Plus检测的患者,共纳入研究对象1360例,剔除不确定36例患者后,结核病组985例、非结核病组339例。收集患者的基本信息、临床表现、实验室检测结果和影像学检查等资料。将结核病组痰涂片抗酸杆菌、痰培养、GeneXpert MTB/RIF检测载菌量分级,并分析与QFT-Plus检测结果的关系;痰涂片抗酸杆菌、痰培养结果分为阳性组与阴性组,根据肺结核严重程度分级标准分为轻、中、重度肺结核3级,对传统抗原肽段(QFT-Plus tube 1,TB1)、添加了诱导CD8^(+)T细胞免疫应答的新抗原肽段(QFT-Plus tube 2,TB2)、TB2-TB1抗原管内γ-干扰素(IFN-γ)水平进行对比分析。结果:1324例患者中,结核病组985例,非结核病组339例,QFT-Plus检测活动性结核病的敏感度为94.11%(927/985)、特异度为51.62%(175/339)、阳性预测值为84.97%(927/1091)、阴性预测值为75.11%(175/233)、符合率为83.23%(1102/1324)。结核病组TB1管、TB2管和TB2-TB1的IFN-γ水平分别为5.11(2.00,9.90)IU/ml,6.24(2.54,10.00)IU/ml,(0.66±1.58)IU/ml,高于非结核病组[0.38(0.07,3.37)IU/ml,0.41(0.08,4.12)IU/ml,(0.27±1.16)IU/ml],差异均有统计学意义(Z=-14.970,P<0.001;Z=15.230,P<0.001;t=-4.910,P<0.001)。痰涂片抗酸杆菌阳性组TB2、TB2-TB1的IFN-γ水平分别为6.81(3.27,10.00)IU/ml、(0.85±1.80)IU/ml,高于阴性组[5.61(2.21,10.00)IU/ml、(0.53±1.41)IU/ml],差异均有统计学意义(Z=-3.060,P<0.001;t=-2.920,P<0.001)。痰培养的阳性组TB1、TB2的IFN-γ水平分别为5.37(2.46,10.00)IU/ml、7.08(3.86,10.00)IU/ml,高于阴性组[4.44(1.56,9.41)IU/ml、5.04(1.90,10.00)IU/ml],差异有统计学意义(Z=-3.450、-4.920,P<0.001)。不同严重程度结核抗原管的IFN-γ水平比较,轻度肺结核TB1、TB2、TB2-TB1的IFN-γ水平分别为5.12(2.57,10.00)IU/ml、6.04(3.20,10.00)IU/ml、(0.49±1.16)IObjective:To evaluate the efficacy of QuantiFERON-TB Gold Plus(QFT-Plus)for the detection of active tuberculosis.Methods:A total of 1360 patients who were hospitalized and underwent QFT-Plus test in Guiyang Public Health Clinical Centre from January 2023 to January 2024 were retrospectively collected.After excluding 36 uncertain patients,985 patients were in the tuberculosis group and 339 patients were in the non-tuberculosis group.The basic information,clinical manifestations,laboratory test results and imaging examination data of the patients were collected.Sputum smear antacid bacilli,sputum culture,GeneXpert MTB/RIF test for carrier bacilli were graded in the TB group and analyzed in relation to the QFT-Plus test results;sputum smear antacid bacilli and sputum culture results were divided into a positive group and a negative group,and classified into 3 grades of mild,moderate,and severe tuberculosis according to the grading criteria of the degree of severity,and the IFN-γin the tube of the antigens of TB1,TB2,TB2-TB1 was analysed in comparison.Results:Out of 1324 patients,985 were in the tuberculosis group and 339 were in the non-tuberculosis group,the sensitivity of QFT-Plus for detecting active tuberculosis was 94.11%(927/985),specificity was 51.62%(175/339),positive predictive value was 84.97%(927/1091)and negative predictive value was 75.11%(175/233),the coincidence rate was 83.23%(1102/1324).The IFN-γlevels in TB1 tube,TB2 tube and TB2-TB1 in the tuberculosis group were 5.11(2.00,9.90)IU/ml,6.24(2.54,10.00)IU/ml,and(0.66±1.58)IU/ml,which were higher than those in the non-tuberculosis group(0.38(0.07,3.37)IU/ml,0.41(0.084.12)IU/ml,(0.27±1.16)IU/ml),and the differences were statistically significant(Z=-14.970,P<0.001;Z=15.230,P<0.001;t=-4.910,P<0.001).The IFN-γlevels of TB2 and TB2-TB1 in the sputum smear antacids-positive group were 6.81(3.27,10.00)IU/ml and(0.85±1.80)IU/ml,which were higher than those in the negative group(5.61(2.21,10.00)IU/ml and(0.53±1.41)IU/ml),and the difference was statistic

关 键 词：结核 肺 干扰素调节因子类 诊断 

分 类 号：R521[医药卫生—内科学] R446[医药卫生—临床医学]