结核病与肺部健康杂志 ›› 2019, Vol. 8 ›› Issue (3): 172-177.doi: 10.3969/j.issn.2095-3755.2019.03.005

• 论著 • 上一篇    下一篇

GeneXpert MTB/RIF技术诊断肺结核及利福平耐药性的价值

吴海燕,叶志坚,王霞芳,虞忻,吴妹英()   

  1. 215000 苏州大学附属传染病医院 苏州市第五人民医院
  • 收稿日期:2019-09-06 出版日期:2019-09-30 发布日期:2019-10-15
  • 通信作者: 吴妹英 E-mail:wu_my@126.com
  • 基金资助:
    苏州市科技局民生科技项目(SS201656;SYS201778;SS201880;SYS2018096);苏州市“科教兴卫”青年科技项目(KJXW2017047);江苏省青年医学人才项目(QNRC2016226)

Evaluation of clinical value of GeneXpert MTB/RIF in diagnosis and drug resistance detection of pulmonary tuberculosis

WU Hai-yan,YE Zhi-jian,WANG Xia-fang,YU Xin,WU Mei-ying.()   

  1. Infectious Diseases Hospital Affiliated to Soochow University, the Fifth People’s Hospital of Suzhou,Suzhou 215000,China
  • Received:2019-09-06 Online:2019-09-30 Published:2019-10-15
  • Contact: Mei-ying. WU E-mail:wu_my@126.com

摘要:

目的 探讨GeneXpert MTB/RIF检测在诊断肺结核及其耐药性方面的临床价值。方法 搜集苏州大学附属传染病医院(苏州市第五人民医院)结核病科2017年8月至2018年11月间收治住院的981例患者为研究对象,最终临床确诊肺结核患者862例,非结核患者119例。分析患者痰及肺泡灌洗液(bronchoalveolar lavage fluid,BALF)标本涂片抗酸染色镜检(简称“涂片法”)、GeneXpert MTB/RIF(简称“GeneXpert法”)、BACTEC MGIT 960培养(简称“MGIT 960法”)及固体药敏比例法(简称“药敏试验”)的检测结果,评价3种检测方法的诊断效能。结果 以临床诊断为参考标准,涂片、GeneXpert法、MGIT 960法检测肺结核患者痰标本的敏感度分别为32.02%(276/862)、53.02%(457/862)、53.25%(459/862);检测肺结核患者BALF标本的敏感度分别为31.32%(270/862)、72.97%(629/862)、69.37%(598/862)。在 MGIT 960和GeneXpert法检测均阳性的527例肺结核患者中,固体比例法药敏试验检测对利福平耐药的28例患者中,GeneXpert法检测也为耐药者26例,其余2例提示敏感。药敏试验检测结果对利福平敏感者共有499例,而GeneXpert 法检测为敏感者497例,其余2例提示为对利福平耐药;对两种方法的检测结果进行Kappa检验,Kappa=0.612,P<0.001;说明两种方法检测结果具有较好的一致性。以罗氏固体比例法药敏试验为金标准,GeneXpert 法检测对利福平耐药的敏感度为92.86%(26/28),特异度为99.60%(497/499)。结论 GeneXpert 法诊断肺结核的敏感度高、特异度强,同时可检测是否耐利福平,在肺结核早期诊断及耐药性检测方面具有较好的应用前景。GeneXpert法检测患者BALF的敏感度显著高于痰标本,故应早期积极行电子气管镜检查。

关键词: 结核, 肺, 诊断技术和方法, 微生物敏感性试验, 利福平, 核酸扩增技术, 评价研究

Abstract:

Objective To explore the clinical value of GeneXpert MTB/RIF detection in the diagnosis of pulmonary tuberculosis and its drug resistance.Methods A total of 981 patients admitted to the Department of Tuberculosis of Suzhou Fifth People’s Hospital from August 2017 to November 2018 were selected. The results of acid fast staining microscopic examination(Abbreviated as “smear method”),GeneXpert MTB/RIF(Abbreviated as “GeneXpert”), BACTEC MGIT 960 tuberculosis culture(Abbreviated as“MGIT 960”) and proportional drug sensitivity test of sputum(Abbreviated as“drug sensitive test”)and alveolar lavage fluid (Bronchoalveolar lavage fluid, BALF) were analyzed to evaluate the diagnostic efficacy of the three methods.Results According to the standard of clinical diagnosis, the sensitivity of sputum smear, GeneXpert and BACTEC MGIT 960 in the diagnosis of pulmonary tuberculosis was 32.02% (276/862),53.02% (457/862) and 53.25% (459/862),respectively.The sensitivity of the three methods was 31.32% (270/862), 72.97% (629/862) and 69.37% (598/862). Among the 527 patients with pulmonary tuberculosis who were both positive for BACTEC MGIT 960 and GeneXpert, 28 cases were RFP resistant by proportional drug sensitivity test,26 cases were drug resistant by GeneXpert, and the other 2 cases were sensitive. The results of proportional assay showed that rifampicin was sensitive in 499 cases, GeneXpert was sensitive in 497 cases, and the remaining 2 cases suggested drug resistance. The Kappa showed that those has good consistency (K=0.612, P<0.001). Take the solid proportional drug sensitivity test as standard, the sensitivity and specificity of GeneXpert in detecting RFP resistance were 92.86% (26/28) and 99.60% (497/499).Conclusion GeneXpert has high sensitivity and specificity. At the same time, the detection of RFP, resistance has a good application prospect in the early diagnosis and drug resistance detection of pulmonary tuberculosis. It is also found that the spiritual sensitivity of BALF GeneXpert is significantly higher than that of sputum samples, so electronic tracheoscopy should be performed in the early stage.

Key words: Tuberculosis, pulmonary, Diagnostic techniques and procedures, Microbial sensitivity tests, Rifampin, Nucleic acid amplification techniques, Evaluation studies