三种分子诊断技术在常见肺外结核脓液样本中的结核分枝杆菌检测效果比较  

Comparison of three molecular diagnostic techniques in the detection of Mycobacterium tuberculosis in extrapulmonary tuberculosis pus samples

作　　者：王卓 邹远妩 姜亚萍 李静 李春梅 王晓琳 Wang Zhuo;Zou Yuanwu;Jiang Yaping;Li Jing;Li Chunmei;Wang Xiaolin(Department of Laboratory Medicine,Shaanxi Provincial Tuberculosis Prevention and Control Hospital,Xi′an 710100,China;Department of Clinical Laboratory,the Third Hospital of Xi′an,Xi′an 710016,China;Department of Respiratory Medicine,the Third Affiliated Hospital of Xi′an Medical College,Xi′an 710072,China)

机构地区：[1]陕西省结核病防治院检验科,西安710100 [2]西安市第三医院检验科,西安710016 [3]西安医学院第三附属医院呼吸内科,西安710072

出　　处：《中华检验医学杂志》2025年第2期270-275,共6页Chinese Journal of Laboratory Medicine

基　　金：陕西省重点研发计划(2022SF-346)。

摘　　要：目的评价GeneXpert MTB/RIF(简称"Xpert")、DNA恒温扩增荧光检测法(简称"DNA恒温扩增")、RNA恒温扩增实时荧光检测(简称"SAT-TB")3种分子检测技术在浅表淋巴结结核和骨结核两类常见肺外结核的脓液样本中结核分枝杆菌检测效果。方法横断面研究。收集2022年1月至2023年12月陕西省结核病防治院收治的疑似浅表淋巴结结核和骨结核患者,并在病灶取脓液标本送检的242例患者,其中实验室确诊或临床诊断为结核病患者210例,浅表淋巴结结核患者108例、骨结核患者102例;非结核病患者32例;所有患者脓液标本均行结核培养、Xpert、DNA恒温扩增、SAT-TB检测,检测结果采用SPSS26.0和MedCalc软件进行统计分析,比较几种不同检测方法在脓液标本中的结核分枝杆菌检出效果,以P<0.05为差异有统计学意义。结果脓液样本结核培养、Xpert、DNA恒温扩增、SAT-TB在结核病患者中的检测敏感度分别为25.2%(53/210)、88.6%(186/210)、81.9%(172/210)、61.0%(128/210),4种检测方法在结核病诊断中的AUC值分别为0.626、0.943、0.910、0.805,结核培养在结核病诊断中的AUC值低于3种分子诊断技术的AUC值(P<0.05),除此之外,DNA恒温扩增的AUC值高于SAT-TB检测方法(P<0.05);以结核培养阳性为参考标准,Xpert、DNA恒温扩增、SAT-TB的敏感度分别为96.2%(51/53)、90.6%(48/53)、86.8%(46/53),3种分子诊断技术的敏感度差异无统计学意义(P>0.05);Xpert MTB阳性患者中,DNA恒温扩增的阳性检出率为90.3%(168/186),DNA恒温扩增与Xpert MTB检出结果一致性较好(Kappa=0.765,P<0.001);Xpert检测利福平耐药27例,耐药率为12.9%(27/210)。结论GeneXpert、DNA恒温扩增在肺外结核脓液样本中具有较高的敏感度和特异度,DNA恒温扩增与GeneXpert MTB/RIF检测效果一致性高,在结核病筛查中可应用DNA恒温扩增荧光检测法用于初筛,减少检测成本。ObjectiveThe performance of GeneXpert MTB/RIF(Xpert),DNA isothermal amplification fluorescence assay(DNA isothermal amplification)and RNA simultaneous amplification and testing(SAT-TB)were evaluated by detecting Mycobacterium tuberculosis in the pus samples of superficial tuberculous lymphadenitis and skeletal tuberculosis,two common extrapulmonary tuberculosis.MethodsCross-sectional study.A total of 242 patients with suspected superficial tuberculous lymphadenitis and skeletal tuberculosis admitted to Shaanxi Provincial Tuberculosis Prevention and Control Hospital were collected from January 2022 to December 2023 and pus samples were taken from the lesions for examination.Among them,210 patients were laboratory confirmed or clinically diagnosed with tuberculosis,108 patients with superficial tuberculous lymphadenitis and 102 patients with skeletal tuberculosis.32 patients without tuberculosis.Mycobacterium Tuberculosis culture,Xpert,DNA isothermal amplification,and SAT-TB detection were performed on the pus samples of all patients.The detection results were statistically analyzed using SPSS26.0 and MedCalc software.The detection effectiveness of several different detection methods for Mycobacterium tuberculosis in pus samples was compared,and P<0.05 was considered statistically significan.ResultsThe sensitivity of Mycobacterium Tuberculosis culture,Xpert,DNA isothermal amplification and SAT-TB in TB patients were 25.2%(53/210),88.6%(186/210),81.9%(172/210)and 61.0%(128/210),respectively.The area under curve(AUC)values of the four detection methods in the diagnosis of tuberculosis were 0.626,0.943,0.910 and 0.805,respectively.The AUC value of tuberculosis culture in the diagnosis of tuberculosis was significantly lower than that of the three molecular diagnostic techniques(P<0.05).The AUC value of DNA isothermal amplification was significantly higher than that of SAT-TB detection method(P<0.05).The positive tuberculosis culture was used as a reference standard where the sensitivity of Xpert,DNA isothermal amplifi

关 键 词：结核 诊断 分子诊断技术 骨结核 浅表淋巴结结核 脓液 

分 类 号：R52[医药卫生—内科学]