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中国防痨杂志 ›› 2018, Vol. 40 ›› Issue (5): 543-547.doi: 10.3969/j.issn.1000-6621.2018.05.019

所属专题: GeneXpert MTB/RIF检测技术相关研究

• 短篇论著 • 上一篇    下一篇

GeneXpert MTB/RIF在疑似肺结核患者诊断中的应用价值

王蔚,吕青山,郁勤龙,陈恒威,沈伟锋()   

  1. 314000 浙江省嘉兴市第一医院微生物实验室(王蔚、郁勤龙),检验科中心实验室(吕青山、沈伟锋);宁波卫生职业技术学院医学技术学院(陈恒威)
  • 收稿日期:2017-12-13 出版日期:2018-05-10 发布日期:2018-06-12
  • 通信作者: 沈伟锋 E-mail:17658186@qq.com
  • 基金资助:
    嘉兴市科技计划项目(2017AY33022)

Application value of GeneXpert MTB/RIF system in diagnosis of pulmonary tuberculosis

Wei WANG,Qing-shan LYU,Qin-long YU,Heng-wei CHEN,Wei-feng SHEN()   

  1. Clinical Microorganism Laboratory, Jiaxing 1st Hospital, Zhejing Province, Jiaxing 314000, China
  • Received:2017-12-13 Online:2018-05-10 Published:2018-06-12
  • Contact: Wei-feng SHEN E-mail:17658186@qq.com

摘要:

为了解利福平耐药实时荧光定量核酸扩增检测技术(GeneXpert MTB/RIF)在初诊肺结核患者诊断中的应用价值,作者收集了2015年1月至2016年12月浙江省嘉兴市第一医院就诊的初诊疑似肺结核患者361例,留取痰液标本分别进行涂片荧光金胺O染色镜检(简称“涂片镜检”)、结核分枝杆菌MGIT 320液体培养(简称“液体培养”)、GeneXpert MTB/RIF检测(简称“Xpert检测”)和固体比例法药物敏感性试验。最终临床诊断为:肺结核184例(50.97%),肺部感染162例(44.88%),非典型分枝杆菌肺部感染15例(4.15%)。361例疑似肺结核患者中,Xpert 检测的阳性率[32.41%(117/361)]明显高于涂片镜检[22.71%(82/361)](χ 2=8.49,P<0.05),与液体培养[26.32%(95/361)]比较不存在明显差异(χ 2=3.23,P=0.072),涂片镜检法与液体培养法比较差异无统计学意义(χ 2=1.26,P=0.261)。184例肺结核患者中,Xpert 检测的阳性率[63.59%(117/184)]高于涂片镜检[36.41%(67/184)]和液体培养[48.91%(90/184)](χ 2=27.17,P<0.01;χ 2=8.05,P<0.05);117例涂阴肺结核患者的Xpert检测阳性率[42.74%(50/117)]高于液体培养[24.79%(29/117)](χ 2=8.43,P=0.004)。以临床诊断为标准,Xpert检测初诊疑似肺结核患者的敏感度为63.59%(117/184),特异度为100.00%(177/177),正确指数为0.64。以固体比例法药物敏感性试验结果为金标准,Xpert 检测利福平耐药的敏感度为4/5,特异度为97.70%(85/87),正确指数为0.97。说明GeneXpert MTB/RIF在初诊疑似肺结核患者,尤其是涂阴肺结核患者中,检测结核分枝杆菌感染及对利福平耐药具有较高的效能。

关键词: 结核, 肺, 多相筛查, 核酸扩增技术, 实验室技术和方法, 评价研究

Abstract:

To evaluate the application value of GeneXpert MTB/RIF system in the diagnosis of pulmonary tuberculosis (TB) among the TB suspects who sought health care for the first time. A total of 361 TB suspects, who visited Jiaxing 1st Hospital to seek health care for the first time from Jan 2015 to Dec 2016, were consecutively enrolled in the study. The sputum specimens were collected from those patients and smear microscopy, liquid culture, GeneXpert MTB/RIF test and solid drug susceptibility testing (DST) by using proportion method were performed. Finally, 184 cases (50.97%) were confirmed to have pulmonary TB while 162 cases (44.88%) were diagnosed to be pulmonary infections and 15 cases (4.15%) were diagnosed to be pulmonary infections caused by atypical mycobacteria. Among 361 TB suspects, the positive rate of GeneXpert MTB/RIF was 32.41% (117/361), which was significantly higher than the smear-positive rate (22.71%, 82/361) (χ 2=8.49, P<0.05); but the difference of the positive rate between GeneXpert and liquid culture (26.32%, 95/361) was not statistically significant (χ 2=3.23, P=0.072); the smear-positive rate was lower than that of liquid culture (26.32%, 95/361), but the difference was not statistically significant (χ 2=1.26, P=0.261). Among 184 cases with pulmonary TB, the positive rate of GeneXpert MTB/RIF was 63.59% (117/184) which was significantly higher than the smear-positive rate (36.41% (67/184)) and the liquid culture positive rate (48.91% (90/184)) respectively (χ 2=27.17, P<0.01; χ 2=8.05, P<0.05). Among 117 smear-negative pulmonary TB patients, the positive rate of GeneXpert MTB/RIF was 42.74% (50/117), which was significantly higher than that of liquid culture (24.79%, 29/117) (χ 2=8.43, P=0.004). If the clinical diagnosis result was regarded as a standard, the sensitivity of GeneXpert in TB suspects, who sought health care for the first time, was 63.59% (117/184), its specificity was 100.00% (177/177) and its correct indices was 0.64; if the result of solid DST with proportion method was regarded as a standard, the sensitivity of GeneXpert in TB suspects, who sought health care for the first time, was 4/5, its specificity was 97.70% (85/87) and its correct indices was 0.97. GeneXpert MTB/RIF technique has demonstrated a high capacity on detection of tuberculosis and rifampicin resistant TB in TB suspects, especially in smear-negative pulmonary TB patients.

Key words: Tuberculosis, pulmonary, Multiphasic screening, Nucleic acid amplification techniques, Laboratory techniques and procedures, Evaluation research