恒温微流控系统检测及鉴定结核分枝杆菌复合群与非结核分枝杆菌的应用价值  

Application value of thermostatic microfluidic system in detection and identification of Mycobacterium tuberculosis complex and nontuberculous mycobacteria

作　　者：王泉 马瑞瑛 杨婷[1] 张亚丽 许苗 撒玉玲 陈清波 WANG Quan;MA Rui-ying;YANG Ting;ZHANG Ya-li;XU Miao;SA Yu-ling;CHEN Qing-bo(Department of Laboratory Medicine,the Eighth Affiliated Hospital of Xinjiang Medical University,Urumqi 830049,China)

机构地区：[1]新疆医科大学第八附属医院检验科,乌鲁木齐830049

出　　处：《中国防痨杂志》2021年第8期817-820,共4页Chinese Journal of Antituberculosis

摘　　要：目的评价恒温微流控系统检测分枝杆菌并鉴定结核分枝杆菌复合群(Mycobacterium tuberculosis complex,MTBC)与非结核分枝杆菌(nontuberculous mycobacteria,NTM)的应用价值。方法收集新疆医科大学第八附属医院2018年9月至2019年12月间经抗酸染色镜检阳性的痰液标本,共624份。分别应用罗氏固体培养,对硝基苯甲酸(PNB)和噻吩-2-羧酸肼(TCH)生长试验,以及恒温微流控系统进行分枝杆菌检测和菌种鉴定;以罗氏固体培养和PNB/TCH生长试验菌种鉴定结果为参照,评价恒温微流控系统检测分枝杆菌和鉴定菌种的效能。结果624份痰标本中,经罗氏固体培养法检测阳性612份(98.1%),恒温微流控系统检测阳性607份(97.3%),差异无统计学意义(χ^(2)=0.021,P=0.950)。以罗氏固体培养法检测结果作为参照标准,恒温微流控系统检测抗酸染色镜检阳性的痰液标本中分枝杆菌的敏感度和特异度分别为99.2%(607/612)和100.0%(12/12),Kappa值为0.82。以PNB/TCH生长试验结果作为参照标准,恒温微流控系统检测痰液标本中MTBC的敏感度和特异度分别为99.6%(513/515)和100.0%(97/97),Kappa值为0.99;恒温微流控系统检测痰液标本中NTM的敏感度和特异度分别为96.9%(94/97)和100.0%(515/515),Kappa值为0.98。结论恒温微流控系统在以抗酸染色镜检阳性为诊断基础时,鉴定痰液标本中MTBC与NTM具有较好的性能。Objective To evaluate the application value of thermostatic microfluidic system in detection and identification of Mycobacterium tuberculosis complex(MTBC)and nontuberculous mycobacteria(NTM).Methods A total of 624 sputum specimens positive in acid-fast staining were collected from the Eighth Affiliated Hospital of Xinjiang Medical University from September 2018 to December 2019.Roche solid culture,p-nitrobenzoic acid(PNB)and thiophene-2-carboxylic acid hydrazine(TCH)growth test,and constant temperature microfluidic system were used for mycobacterial detection and strain identification;bacterial species identification results of Roche solid culture and PNB/TCH growth test were used as reference to evaluate the efficiency of the thermostatic microfluidic system in detecting mycobacteria and identifying bacterial species.Results Among 624 sputum samples,612(98.1%)were positive using Roche solid culture,and 607(97.3%)were positive by thermostatic microfluidic system.The difference was not statistically significant(χ^(2)=0.021,P=0.950).Using the results of Roche solid culture method as the standard,the sensitivity and specificity of the thermostatic microfluidic system for detecting mycobacteria in sputum samples with positive acid-fast staining were 99.2%(607/612)and 100.0%(12/12),respectively,the Kappa value was 0.82.Using the results of the PNB/TCH growth test as the standard,the sensitivity and specificity of the thermostatic microfluidic system for detecting MTBC in sputum samples were 99.6%(513/515)and 100.0%(97/97),respectively,and the Kappa value was 0.99;the sensitivity and specificity of the thermostatic microfluidic system for detecting NTM in sputum samples were 96.9%(94/97)and 100.0%(515/515),respectively,and the Kappa value was 0.98.Conclusion The thermostatic microfluidic system has good performance in identifying MTBC and NTM in sputum specimens when based on acid-fast staining.

关 键 词：分枝杆菌 结核 分枝杆菌 非典型性 核酸扩增技术 诊断 鉴别 评价研究 

分 类 号：R446.5[医药卫生—诊断学]