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结核病与肺部健康杂志 ›› 2019, Vol. 8 ›› Issue (3): 160-162.doi: 10.3969/j.issn.2095-3755.2019.03.002

• 论著 • 上一篇    下一篇

GeneXpert MTB/RIF检测MTB及利福平耐药的应用价值

郁大伟1,宋华峰1,2,邱文娜1,薛婧1,郦芳华1,胥萍1,2()   

  1. 1. 2150072 苏州大学附属传染病医院 苏州市第五人民医院检验中心
    2. 苏州市结核病防治重点实验室
  • 收稿日期:2019-09-07 出版日期:2019-09-30 发布日期:2019-10-15
  • 通信作者: 胥萍 E-mail:573311485@qq.com
  • 基金资助:
    江苏省科学技术厅基础研究计划自然科学基金(BK20161230);苏州市“科教兴卫”青年科技项目基金(KJXW2016041);苏州市临床重点病种诊疗技术专项(LCZX201614)

Application value of GeneXpert MTB/RIF in the detection of MTB rifampicin resistance

YU Da-wei1,SONG Hua-feng1,2,QIU Wen-na1,XUE Jing1,LI Fang-hua1,XU Ping1,2()   

  1. 1. Inspection Center of Infectious Disease Hospital Affiliated to Soochow University, The Fifth People’s Hospital of Suzhou, Suzhou 215007, China;
  • Received:2019-09-07 Online:2019-09-30 Published:2019-10-15
  • Contact: Ping XU E-mail:573311485@qq.com

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摘要：

目的 评估 GeneXpert MTB/RIF(简称“GeneXpert”)检测技术在MTB及利福平耐药检测中的应用价值。方法 收集2018年1—12月苏州市第五人民医院收治的疑似肺结核患者的痰标本414份,同时进行痰涂片抗酸染色、BACTEC MGIT 960液体培养(简称“MGIT 960”)及GeneXpert检测,比较不同方法的阳性检出率。以MGIT 960液体培养及改良罗氏药物敏感性试验(简称“药敏试验”)结果为参照,分析GeneXpert检测MTB及利福平耐药的效能。结果 痰涂片阳性检出率为18.6%(77/414),MGIT 960的阳性检出率为31.4%(130/414),GeneXpert检测的阳性检出率为35.3%(146/414)。GeneXpert和MGIT 960的阳性检出率明显高于痰涂片(χ 2=29.22,P<0.001;χ 2=18.09,P<0.001),而GeneXpert的阳性检出率与MGIT 960培养相比,差异无统计学意义(χ 2=1.39,P=0.238)。GeneXpert检出的146份阳性标本中利福平耐药检出率为9.6%(14/146),MGIT 960培养阳性的130份痰标本中利福平耐药检出率为9.2%(12/130),两者之间差异无统计学意义(χ 2=0.01,P=0.919)。以MGIT 960药敏试验结果为参照,GeneXpert检测MTB利福平耐药的敏感度为81.8%(9/11)、特异度为98.9%(87/88)、符合率为97.0%(96/99)、Kappa值为0.84。 结论 与MGIT 960液体培养法及药敏试验相比,GeneXpert检测MTB及利福平耐药具有较好的诊断效能。

关键词: 分枝杆菌, 结核, 微生物敏感性试验, 利福平, 核酸扩增技术, 评价研究

Abstract:

Objective To evaluate the application value of GeneXpert MTB/RIF (GeneXpert) technology in the detection of MTB rifampicin resistance.Methods A total of 414 sputum specimens from patients with suspected pulmonary tuberculosis admitted to the Fifth People’s Hospital of Suzhou from January to December 2018 were collected. Meanwhile, acid fast staining of sputum smear, BACTEC MGIT 960 (MGIT 960) liquid culture and GeneXpert test were conducted to compare the positive detection rates of different methods. Based on the results of MGIT 960 liquid culture and improved roche drug sensitivity test (referred to as “drug sensitivity test”) as references, the efficacy of GeneXpert in the detection of MTB rifampicin resistance was analyzed.Results The positive detection rate of sputum smear was 18.6% (77/414), the positive detection rate of MGIT 960 culture was 31.4% (130/414), and the positive detection rate of GeneXpert test was 35.3% (146/414). The positive detection rate of GeneXpert or MGIT 960 culture was significantly higher than that of sputum smear (χ 2=29.22, P<0.001; χ 2=18.09, P<0.001). No statistically significant difference was observed between the positive detection rates of GeneXpert and MGIT 960 culture (χ 2=1.39, P=0.238). Among the 146 positive samples detected by GeneXpert, the detection rate of rifampicin resistance was 9.6% (14/146), and the detection rate of rifampicin resistance among the 130 positive samples detected by MGIT 960 culture was 9.2% (12/130), without statistical significant difference (χ 2=0.01, P=0.919). Based on the results of MGIT 960 culture and drug sensitivity test as references, the sensitivity, specificity, coincidence rate, and the Kappa value of GeneXpert test were 81.8% (9/11), 98.9% (87/88), 96.9% (96/99) and 0.84, respectively. Conclusion Compared with MGIT 960 liquid culture method and drug sensitivity test, GeneXpert technology has better detection efficiency for MTB rifampicin resistance.

Key words: Mycobacterium tuberculosis, Microbial sensitivity tests, Rifampin, Nucleic acid amplification techniques, Evaluation studies

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