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中国防痨杂志 ›› 2021, Vol. 43 ›› Issue (10): 1102-1106.doi: 10.3969/j.issn.1000-6621.2021.10.022

• 短篇论著 • 上一篇    

GeneXpert MTB/RIF联合线性探针检测技术在耐药结核病诊断中的应用研究

李静, 郁晨蕾, 张阳奕, 王莉莉, 沈旭辉, 陈炜, 江渊()   

  1. 200336 上海市疾病预防控制中心结核病检测实验室
  • 收稿日期:2021-04-29 出版日期:2021-10-10 发布日期:2021-10-11
  • 通信作者: 江渊 E-mail:jiangyuan@scdc.sh.cn
  • 基金资助:
    上海市公共卫生体系建设三年行动计划(2020—2022年)重点学科建设(GWV-10.1-XK03);上海市卫生健康委员会科研课题(20194Y0169)

Application of GeneXpert MTB/RIF combined with linear probe detection technology in the diagnosis of drug-resistant tuberculosis

LI Jing, YU Chen-lei, ZHANG Yang-yi, WANG Li-li, SHEN Xu-hui, CHEN Wei, JIANG Yuan()   

  1. Tuberculosis Reference Laboratory, Shanghai Municipal Center for Disease Control and Prevention, Shanghai 200336, China
  • Received:2021-04-29 Online:2021-10-10 Published:2021-10-11
  • Contact: JIANG Yuan E-mail:jiangyuan@scdc.sh.cn

摘要:

选择上海市19家结核病定点医院作为研究现场,对2017年12月至2018年12月初诊为可疑肺结核患者的痰样本(3903份)同时进行痰涂片、BACTEC MGIT 960液体培养(简称“液体培养”)和GeneXpert MTB/RIF(简称GeneXpert)检测,研究GeneXpert检测结核分枝杆菌的效能;对同期收集到的707例临床诊断肺结核患者的分离菌株采用线性探针检测技术(line probe assay,LPA)进行利福平耐药性检测,将检测结果与GeneXpert检测结果不一致的痰样本,用培养阳性菌株采用最低抑菌浓度(minimun inhibitory concentration,MIC)法和GeneXpert方法复测,比较同一例患者从痰样本中采用GeneXpert检测利福平耐药情况与其培养阳性菌株采用LPA检测利福平耐药情况的一致性。结果显示,3903例痰标本同时进行痰涂片、液体培养和GeneXpert检测,阳性检出率分别为19.63%(766/3903)、25.93%(1012/3903)、25.16%(982/3903)。GeneXpert阳性检出率高于痰涂片,差异有统计学意义(χ2=34.390,P<0.001);略低于液体培养,但差异无统计学意义(χ2=0.610,P=0.436)。以液体培养(培养阳性鉴定为结核分枝杆菌)为标准,GeneXpert检测的敏感度和特异度分别为81.23%(822/1012)和94.47%(2731/2891),痰涂片检测的敏感度和特异度分别为64.92%(657/1012)和96.23%(2782/2891)。对同一例患者的痰样本采用GeneXpert检测利福平耐药性,与对其培养阳性菌株采用LPA检测利福平耐药性进行比较,两种分子检测技术符合率达98.30%(695/707)。GeneXpert和LPA两种方法检测利福平耐药性符合率很高,但也可能存在漏检或过诊情况。对于检测结果不一致的情况,还需要引入其他检测方法,为精准诊断提供实验室依据。

关键词: 结核, 抗药性, 分子诊断技术, 分子探针技术, 利福平

Abstract:

Between December 2017 and December 2018, a total of 3903 sputum samples from suspected primary tuberculosis patients from 19 designated tuberculosis hospitals in Shanghai were simultaneously tested by sputum smear, BACTEC MGIT 960 liquid culture (liquid culture) and GeneXpert MTB/RIF (GeneXpert) assay, to compare the efficacy of GeneXpert in detecting Mycobacterium tuberculosis. Of the clinical strain from tuberculosis patients diagnosed in the same period, 707 were tested for rifampicin resistance using linear probe assays (LPA). If the results were inconsistent with those of GeneXpert, the sputum samples were then re-tested with the minimum inhibitory concentration (MIC) for culture-positive strains and GeneXpert. The consistency between the rifampicin resistance detected by GeneXpert in sputum samples of the same patient and the rifampicin resistance detected by LPA in culture positive strains were compared. The positive detection rates of sputum smear, liquid culture and GeneXpert were 19.63% (766/3903), 25.93% (1012/3903) and 25.16% (982/3903), respectively. The positive detection rate of GeneXpert was significantly higher than that of sputum smear (χ2=34.390, P<0.001), but lower than that of liquid culture (χ2=0.610, P=0.436). Take liquid culture results (MTB positive) as the standard, the sensitivity and specificity were 81.23% (822/1012) and 94.47% (2731/2891) of the GeneXpert assay, and 64.92% (657/1012) and 96.23% (2782/2891) of sputum smear. GeneXpert was used to detect rifampicin resistance in sputum samples, and LPA was used to detect rifampicin resistance in cultured positive strains of the same patient. The coincidence rate of the two molecular detection techniques was 98.30% (695/707). The coincidence rate of GeneXpert and LPA in detecting rifampicin resistance was high, however, there still might be missed detection or over diagnosis. If the results were inconsistent, other test methods should be used to provide laboratory basis for accurate diagnosis.

Key words: Tuberculosis, Drug resistance, Molecular diagnostic techniques, Molecular probe techniques, Rifampin