纳米孔测序技术对涂阴肺结核患者诊断价值的多中心临床研究  

A multicenter clinical study on the diagnostic value of nanopore sequencing technology in patients with smear-negative tuberculosis

作　　者：闫晓婧 王宇津 王隽[1] 荆玮[1] 李雪莲[1] 程洁 杨国立[3] 王玉清 初乃惠[1] 聂文娟[1] 矫晓克 Yan Xiaojing;Wang Yujin;Wang Jun;Jing Wei;Li Xuelian;Cheng Jie;Yang Guoli;Wang Yuqing;Chu Naihui;Nie Wenjuan;Jiao Xiaoke(DepartmentⅠof Tuberculosis,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China;Department of Tuberculosis,Anhui Provincial Chest Hospital,Hefei 230022,China;Department of Tuberculosis,Tuberculosis Hospital of Jilin Province,Changchun 130500,China;Department of Respiratory,The Fourth People’s Hospital of Qinghai Province,Xining 810000,China)

机构地区：[1]首都医科大学附属北京胸科医院结核一科,北京101149 [2]安徽省胸科医院结核科,合肥230022 [3]吉林省结核病医院结核科,长春130500 [4]青海省第四人民医院呼吸科,西宁810000

出　　处：《中国防痨杂志》2025年第2期169-174,共6页Chinese Journal of Antituberculosis

基　　金：高层次公共卫生技术人才建设项目;首都医科大学临床专科开放课题(CCMU2022ZKYXZ003);临床医学发展专项“扬帆3.0”计划项目(ZLRK202331)。

摘　　要：目的:分析纳米孔测序技术用于涂阴肺结核患者的诊断价值。方法:本研究采集了来自北京、安徽、青海和吉林4个不同省份传染病专科医院2021年9月至2022年4月收治的107例疑似涂片阴性肺结核患者的支气管肺泡灌洗液(BALF)作为研究样本,对其进行BACTEC MGIT 960液体培养(简称“MGIT 960培养”)和GeneXpert MTB/RIF(简称“Xpert”)检测和纳米孔测序。以临床最终诊断结果为参照标准,比较3种方法对肺结核的检测效能。结果:107例疑似肺结核患者中,最终诊断为肺结核70例(65.42%),非结核分枝杆菌病15例(14.02%),非结核病22例(20.56%)。以临床最终诊断结果为参照标准,纳米孔测序技术、MGIT 960培养和Xpert检测的敏感度分别为84.29%(59/70)、37.14%(26/70)和41.43%(29/70),特异度分别为86.49%(32/37)、75.68%(28/37)和97.30%(36/37),约登指数分别为0.71、0.13和0.39。纳米孔测序的曲线下面积(AUC值)为0.854(95%CI:0.773~0.935),Xpert检测的AUC值为0.694(95%CI:0.596~0.792),MGIT 960培养的AUC值为0.564(95%CI:0.451~0.677)。结论:纳米孔测序技术在检测涂阴肺结核方面具有较Xpert和MGIT 960培养更好的诊断效能。Objective:To analyze the diagnostic value of nanopore sequencing technology in patients with smear-negative pulmonary tuberculosis(PTB).Methods:In this study,107 smear-negative patients with suspected PTB admitted to infectious disease hospitals from Beijing,Anhui,Qinghai and Jilin Provinces from September 2021 to April 2022 were enrolled as research subjects.Samples of these cases were subjected to BACTEC MGIT 960 liquid culture(MGIT 960 culture),GeneXpert MTB/RIF(Xpert)assay and nanopore sequencing.The final clinical diagnosis was used as reference standard to evaluate diagnostic accuracy of the three methods for detecting PTB.Results:Among the 107 patients with suspected PTB,70 cases(65.42%)were finally diagnosed as PTB,15 cases(14.02%)were nontuberculous mycobacteria and 22 cases(20.56%)were non-TB.The sensitivities of nanopore sequencing technology,MGIT 960 culture and Xpert detection were 84.29%(59/70),37.14%(26/70)and 41.43%(29/70),respectively,and their specificities were 86.49%(32/37),75.68%(28/37)and 97.30%(36/37),respectively.Their Youden index were 0.71,0.13,and 0.39,respectively.Their AUC values were 0.854(95%CI:0.773-0.935),0.694(95%CI:0.596-0.792)and 0.564(95%CI:0.451-0.677),respectively.Conclusion:Nanopore sequencing technology has better diagnostic performance than Xpert and MGIT 960 culture in the detection of smear-negative PTB.

关 键 词：结核 肺 支气管肺泡灌洗液 纳米技术 多中心研究 

分 类 号：R521[医药卫生—内科学] R446[医药卫生—临床医学]