GeneXpert MTB/RIF在新发活动性肺结核诊断及对利福平耐药快速检测中的应用价值

doi:10.3969/j.issn.2095-3755.2018.01.007

摘要/Abstract

摘要：

目的探讨GeneXpert MTB/RIF(简称“Xpert”)法在新发活动性肺结核诊断及对利福平是否耐药的快速检测中的应用价值。方法选取2015年6月—11月大连市结核病医院临床确诊肺结核268例、排除肺结核诊断患者102例。对其痰标本分别进行涂片、固体培养和Xpert法检测,并对3种方法的检测结果进行比较。另外,以临床诊断为标准,对固体培养与Xpert法的敏感度、特异度进行比较;将Xpert与比例法进行药物敏感性试验(简称“药敏试验”)检测对利福平是否耐药的结果比较。采用SPSS 21.0软件进行数据的统计学处理,计数资料采用χ ²检验,以P<0.05为差异有统计学意义。结果痰涂片、固体培养及Xpert法的阳性检出率分别为29.5%(79/268)、43.7%(117/268)、55.6%(149/268),三种方法比较差异有统计学意义(χ ²=37.42,P=0.000)。189例涂阴肺结核患者中,涂阴培阳率为20.1%(38/189);涂阴肺结核患者Xpert 检测的阳性率为37.0%(70/189),二者比较差异有统计学意义(χ ²=13.27,P=0.000)。以临床诊断为标准,固体培养检测结核病的敏感度为43.7%(117/268)、特异度为99.0%(101/102);Xpert 检测结核病的敏感度为55.6%(149/268)、特异度为98.0%(100/102)。固体培养与Xpert法的敏感度比较,差异有统计学意义(χ ²=7.64,P=0.006);特异度比较,差异无统计学意义(χ ²=0.00,P=1.000)。在固体培养和Xpert 检测均阳性的113例肺结核患者中,其中比例法检测结果为耐药的11例中,Xpert检测结果为耐药的有10例、敏感的有1例;比例法检测结果为敏感的102例中,Xpert检测结果为敏感的有101例、耐药的有1例。Xpert与比例法药敏试验对利福平耐药检测结果一致性比较,Kappa值为0.899。结论 Xpert法简便、快速、安全,能够快速诊断新发活动性肺结核及检测对利福平是否耐药,特别是对快速诊断涂阴肺结核有较大价值。

关键词: 结核, 肺, 抗药性, 细菌, 利福平, 核酸扩增技术, 临床实验室技术, 对比研究

Abstract:

Objective To investigate the application value of GenXpert MTB/RIF (Xpert) in diagnosis of newly active pulmonary tuberculosis (PTB) and rapid detection of rifampin-resistant.Methods The data of 268 clinical diagnosed PTB patients and 102 cases excluded from PTB from June to November 2015 in Dalian Tuberculosis Hospital were collected. Sputum smear, solid culture and Xpert were used to detect sputum samples, and results were compared. Based on clinical diagnosis, the sensitivity and specificity of solid culture and Xpert for PTB detection were compared, as were the results of drug sensitivity test of proportion method and Xpert for rifampin-resis-tant detection. SPSS 21.0 was used for data analysis and χ ² test was used for enumeration data, statistical significance was set at two-tailed P<0.05.Results The positive rates of the three tests were 29.5% (79/268), 43.7% (117/268) and 55.6% (149/268), respectively, the difference was statistically significant (χ ²=37.42, P=0.000). Of the 189 cases of PTB smear negative, the difference of positive rates of culture and Xpert MTB were statistically significant (20.1% (38/189) vs. 37.0% (70/189);χ ²=13.27, P=0.000). Based on clinical diagnosis, the sensitivities of culture and Xpert were 43.7% (117/268) and 55.6% (149/268), and the specificities of them were 99.0% (101/102) and 98.0% (100/102), respectively. There was statistically significant difference between the sensitivity of solid culture and that of Xpert (χ ²=7.64, P=0.006), but no difference was found in specificity (χ ²=0.00, P=1.000). Of the 113 cases of PTB with solid culture +/Xpert +, there were 11 drug-resistant cases confirmed by proportion method but one was sensitive by Xpert, and there was only one drug-resistant case in the left 102 cases confirmed by proportion. There was fine consistence between Xpert and proportion methods to detect rifampin resistant (Kappa=0.899).Conclusion Xpert is convenient, rapid, and of high sensitivity in diagnosis of newly active PTB and is valuable for rapid detect of rifampin-resistant.

Key words: Tuberculosis, pulmonary, Drug resistance, bacterial, Rifampin, Nucleic acid amplification techniques, Clinical laboratory techniques, Comparative study

高阳,宋其生,周洁,张冬,王心愿,安东成. GeneXpert MTB/RIF在新发活动性肺结核诊断及对利福平耐药快速检测中的应用价值[J]. 结核病与肺部健康杂志, 2018, 7(1): 29-32. doi: 10.3969/j.issn.2095-3755.2018.01.007

Yang GAO,Qi-sheng SONG,Jie ZHOU,Dong ZHANG,Xin-yuan WANG,Dong-cheng. AN. Application value of GeneXpert MTB/RIF in diagnosis of newly active pulmonary tuberculosis and rapid detection of rifampin-resistant[J]. Journal of Tuberculosis and Lung Health, 2018, 7(1): 29-32. doi: 10.3969/j.issn.2095-3755.2018.01.007

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参考文献 24

[1]	World Health Organization . Global tuberculosis report 2017. Geneva: World Health Organization, 2017.
[2]	全国第五次结核病流行病学抽样调查技术指导组,全国第五次结核病流行病学抽样调查办公室. 2010年全国第五次结核病流行病学抽样调查报告. 中国防痨杂志, 2012,34(8):485-508.
[3]	赵雁林, 欧喜超, 李强 , 等. 结核病实验室诊断技术培训教程.北京: 人民卫生出版社, 2014: 174-177.
[4]	路丽苹, 陆斌, 刘梅 , 等. GeneXpert MTB/RIF技术在结核病早诊断中的应用. 中国防痨杂志, 2017,39(1):71-75. doi: 10.3969/j.issn.1000-6621.2017.01.016 URL
[5]	中华人民共和国卫生部. 肺结核诊断标准(WS 288-2008).北京: 人民卫生出版社, 2008.
[6]	牛广明, 苏秉亮 . 临床比较影像学. 北京: 科学出版社, 2007: 304-411.
[7]	赵雁林, 姜广路 . 痰涂片镜检标准化操作及质量保证手册.北京: 中国协和医科大学出版社, 2009: 5-13.
[8]	赵雁林, 王黎霞, 成诗明 , 等. 分枝杆菌分离培养标准化操作程序及质量保证手册.北京: 人民卫生出版社, 2013: 26-30.
[9]	赵雁林, 王黎霞, 成诗明 , 等. 结核分枝杆菌药物敏感性试验标准化操作程序及质量保证手册.北京: 人民卫生出版社, 2013: 15-26.
[10]	李强, 陆其斌 . 影响痰涂片抗酸杆菌检出率的因素分析. 检验医学与临床, 2011,8(1):64-65. doi: 10.3969/j.issn.1672-9455.2011.01.031 URL
[11]	于霞, 梁倩, 马异峰 , 等. 环介导等温扩增技术快速检测痰标本中结核分枝杆菌的初步评价. 中国实验诊断学, 2013,17(5):846-849. doi: 10.3969/j.issn.1007-4287.2013.05.017 URL
[12]	丁卫忠, 陈巍, 石莲 , 等. 环介导等温扩增法对痰标本中结核分枝杆菌检测效果的评估. 中国防痨杂志, 2016,38(10):818-822. doi: 10.3969/j.issn.1000-6621.2016.10.007 URL
[13]	张国钦, 钟达, 陈盛玉 , 等. GenoType线性探针技术检测结核分枝杆菌及其药物敏感性的价值. 结核病与肺部健康杂志, 2016,5(4):267-270. doi: 10.3969/j.issn.2095-3755.2016.04.005 URL
[14]	Helb D, Jones M, Story E , et al. Rapid detection of Mycobacterium tuberculosis and rifampin resistance by use of on-demand,near-patient technology. J Clin Microbiol, 2010,48(1):229-237. doi: 10.1128/JCM.01463-09 URL
[15]	李辉, 谭耀驹, 李洪敏 , 等. 利福平耐药实时荧光定量核酸检测技术的诊断效果对比研究. 中国防痨杂志, 2014,36(6):472-476. doi: 10.3969/j.issn.1000-6621.2014.06.013 URL
[16]	陈子芳, 孙本海, 魏海冬 , 等. GeneXpert MTB/RIF技术对菌阴肺结核患者辅助诊断的价值. 中国防痨杂志, 2016,38(10):827-831. doi: 10.3969/j.issn.1000-6621.2016.10.009 URL
[17]	张志学, 苍爱泽, 孙静 . 应用GeneXpert MTB/RIF技术检测肺泡灌洗液对菌阴肺结核的临床诊断价值. 结核病与肺部健康杂志, 2017,6(2):128-130. doi: 10.3969/j.issn.2095-3755.2017.02.011 URL
[18]	Boehme CC, Nabeta P, Hillemann D , et al. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med, 2010,363(11):1005-1015. doi: 10.1056/NEJMoa0907847 URL
[19]	张治国, 欧喜超, 孙倩 , 等. 利福平耐药实时荧光定量核酸扩增技术检测痰标本中结核分枝杆菌及其耐药性的研究. 中国防痨杂志, 2013,35(1):13-16.
[20]	李妍, 张天华, 鲜小萍 , 等. Xpert Mtb/RIF检测技术诊断肺结核和肺外结核的价值. 中国防痨杂志, 2015,37(6):586-589. doi: 10.3969/j.issn.1000-6621.2015.06.003 URL
[21]	牛海军, 王歌, 李明虎 . GeneXpert MTB/RIF 检测在肺结核诊断中的价值评估. 中国防痨杂志, 2017,39(8):829-832. doi: 10.3969/j.issn.1000-6621.2017.08.008 URL
[22]	尹青琴, 申阿东 . Xpert MTB/RIF试验在结核病诊断中的研究现状. 中华结核和呼吸杂志, 2012,35(5):363-365. doi: 10.3760/cma.j.issn.1001-0939.2012.05.013 URL
[23]	World Health Organization . Rapid implementation of the Xpert Mtb/RIF diagnostic test: technical and operational‘How to’; practical considerations. Geneva: World Health Organization, 2011.
[24]	胡忠义 . 结核病耐药性检测技术进展及存在的问题和对策. 中国防痨杂志, 2013,35(11):865-867.