恒温扩增荧光检测法检测结核分枝杆菌复合群的应用价值  

Application of isothermal amplification fluorescence method for rapid detection of Mycobacterium tuberculosis complex

作　　者：李静[1] 吴哲渊[1] 杨景卉[2] 杨丽媛 王莉莉[1] 袁锋 沈鑫[1] 江渊[1] Li Jing;Wu Zheyuan;Yang Jinghui;Yang Liyuan;Wang Lili;Yuan Feng;Shen Xin;Jiang Yuan(Division of Tuberculosis and HIV/AIDS Control and Prevention,Shanghai Municipal Center for Disease Control and Prevention,Shanghai 200336,China;Department of Clinical Laboratory,Shanghai Pulmonary Hospital,Shanghai 200433,China;Department of Clinical Laboratory,Central Hospital of Songjiang District,Shanghai,Shanghai 201600,China;Department of Clinical Laboratory,Central Hospital of Minhang District,Shanghai,Shanghai 201199,China)

机构地区：[1]上海市疾病预防控制中心结核病和艾滋病防治所,上海200336 [2]上海市肺科医院检验科,上海200433 [3]上海市松江区中心医院检验科,上海201600 [4]上海市闵行区中心医院检验科,上海201199

出　　处：《中国防痨杂志》2022年第11期1167-1173,共7页Chinese Journal of Antituberculosis

基　　金：上海市静安区科学技术委员会课题(公共卫生2020GW01);上海市公共卫生体系建设三年行动计划(2020—2022年)重点学科建设(GWV-10.1-XK03)。

摘　　要：目的:评价恒温扩增荧光检测法检测痰样本中结核分枝杆菌复合群(Mycobacterium tuberculosis complex,MTBC)的临床应用价值。方法:选择上海市6家结核病定点医院作为研究现场,收集2020年1月至2020年11月各家医院肺科门诊初诊的1848例疑似肺结核患者痰样本,分别进行恒温扩增荧光检测法与传统的痰涂片、BACTEC MGIT 960液体培养(液体培养)及GeneXpert MTB/RIF(简称“GeneXpert”)检测。以液体培养为参照标准,分析比较恒温扩增荧光检测法、痰涂片及GeneXpert的检测效能。结果:在1848例患者痰样本中,恒温扩增荧光检测法、痰涂片、液体培养和GeneXpert检测MTBC的检出率分别为16.7%(309/1848)、14.4%(266/1848)、25.4%(470/1848)和28.7%(530/1848)。以液体培养为参照标准,恒温扩增荧光检测法、痰涂片和GeneXpert检测的敏感度分别为58.94%(277/470)、52.77%(248/470)、80.43%(378/470);特异度分别为97.68%(1346/1378)、98.69%(1360/1378)、88.97%(1226/1378);一致率分别为87.82%(1623/1848)、87.01%(1608/1848)、86.80%(1604/1848),Kappa值分别为0.638、0.600、0.666。4种不同性状痰样本(黏液样痰、唾液样痰、干酪样痰和血样痰)中,除在唾液样痰中液体培养检出率最高[38.8%(59/152)]外,其余3种性状痰样(黏液样痰、干酪样痰和血样痰)均为GeneXpert检出率最高,分别为51.5%(308/598)、66.7%(28/42)和64.0%(16/25)。结论:恒温扩增荧光检测法检测痰样本中MTBC具有良好的检测特异度,该方法和痰涂片及GeneXpert与液体培养检测结果一致性均一般,临床可以根据实验室硬件条件及患者情况选择开展多种方法联合检测,以提高肺结核的病原学诊断率。Objective:To evaluate the clinical application value of isothermal amplification fluorescence method for detection of Mycobacterium tuberculosis complex(MTBC)in sputum samples.Methods:Between January and November 2020,a total of 1848 sputum samples from suspected pulmonary tuberculosis patients in Shanghai 6 designated tuberculosis hospitals were respectively tests by isothermal amplification fluorescence,sputum smear,BACTEC MGIT 960 liquid culture and GeneXpert MTB/RIF(GeneXpert).Test effectiveness of isothermal amplification fluorescence,sputum smear and GeneXpert were compared according to liquid culture method.Results:Of all the 1848 sputum samples,the positive detection rates of isothermal amplification fluorescence,sputum smear,liquid culture and GeneXpert were 16.7%(309/1848),14.4%(266/1848),25.4%(470/1848)and 28.7%(530/1848),respectively.Based on liquid culture,the sensitivity of isothermal amplification fluorescence,sputum smear and GeneXpert were 58.94%(277/470),52.77%(248/470)and 80.43%(378/470),respectively.The specificity of isothermal amplification fluorescence,sputum smear and GeneXpert were 97.68%(1346/1378),98.69%(1360/1378)and 88.97%(1226/1378),respectively.The concordance rate of the isothermal amplification fluorescence,sputum smear and GeneXpert were 87.82%(1623/1848),87.01%(1608/1848)and 86.80%(1604/1848),respectively.The Kappa value were 0.638,0.600 and 0.666,respectively.Among the four sputum samples with different characteristics(mucoid sputum,salivary sputum,caseous sputum and blood sputum),the highest detection rate was by GeneXpert with 51.5%(308/598),66.7%(28/42)and 64.0%(16/25)respectively,and the highest detection rate in salivary sputum was liquid culture with 38.8%(59/152).Conclusion:The isothermal amplification fluorescence detection method showed good specificity for detecting MTBC in sputum samples,and the result was general consistent with the liquid culture for detecting MTBC.Multiple detection methods should be considered according to laboratory and patient’s condition to

关 键 词：分枝杆菌 结核 痰 核酸扩增技术 诊断 鉴别 

分 类 号：R521[医药卫生—内科学] R446.5[医药卫生—临床医学]