痰标本基因芯片法检测耐多药肺结核的临床价值

doi:10.3969/j.issn.2096-8493.2020.02.004

摘要/Abstract

摘要：

目的评估基因芯片法检测耐多药肺结核(MDR-TB)的效能,探讨痰标本基因芯片法诊断耐多药结核病的临床价值。方法连续纳入2019年6月1日至12月31日内蒙古自治区第四医院就诊的痰涂片阳性的295例患者痰标本进行基因芯片法结核分枝杆菌耐多药检测,排除传统培养为阴性或污染、鉴定为非结核分枝杆菌等原因造成无法进行药物敏感性试验(简称“药敏试验”),以及基因芯片法未检测到结核分枝杆菌、非结核分枝杆菌等原因,共计排除60例患者的痰标本。以罗氏比例法药敏试验结果作为参考标准,对235例患者痰标本基因芯片法耐药检测结果中的利福平耐药、异烟肼耐药和MDR-TB检测的敏感度、特异度、阳性预测值、阴性预测值和一致率进行分析。结果以罗氏比例法表型药敏试验结果作为参考标准,基因芯片对利福平耐药检测的敏感度、特异度、阳性预测值、阴性预测值和一致率分别为95.7%(22/23)、98.6%(209/212)、88.0%(22/25)、99.5%(209/212)和98.3%(231/235);对异烟肼的敏感度、特异度、阳性预测值、阴性预测值和一致率分别为80.0%(16/20)、98.6%(212/215)、84.2%(16/19)、98.1%(212/216)和97.0%(228/235);对于同时耐利福平和异烟肼的敏感度、特异度、阳性预测值、阴性预测值和一致率别为76.2%(16/21)、97.2%(208/214)、72.7%(16/22)、97.7%(208/213)和95.3%(224/235)。结论痰标本基因芯片法对利福平、异烟肼耐药和同时对利福平和异烟肼耐药的检测均具有较高的真实性和可靠性,具有较高的临床应用价值。

关键词: 结核,肺, 结核,抗多种药物性, 微生物敏感性试验, 芯片分析技术, 利福平, 异烟肼, 对比研究

Abstract:

Objective To evaluate the efficacy of Genechip technology in detection of multidrug-resistant tuberculosis (MDR-TB) bacilli, and to explore its clinical value in diagnosis of MDR-TB. Methods From June 1st 2019 to December 31st 2019, smear positive sputum samples of 295 patients in the Fourth Hospital of Inner Mongolia Autonomous Region were continuously enrolled and tested by Genechip. 60 cases for which traditional culture results were failure/contamination/non-tuberculous Mycobacteria, or gene chip couldn’t detect Mycobacterium tuberculosis bacteria or only detected non-tuberculous Mycobacteria were excluded. The susceptibility, specificity, positive predictive value (PPV) and negative predictive value (NPV) of detecting Rifampicin-resistant, Isoniazid-resistant and MDR TB were analyzed by using L-J solid proportion method as standard reference. Results The result indicated that susceptibility, specificity, PPV and NPV of detecting Rifampicin-resistance in 235 patients were 95.7% (22/23), 98.6% (209/212), 88.0% (22/25), 99.5% (209/210), respectively. The susceptibility, specificity, PPV and NPV for detecting Isoniazid-resistance were 80.0% (16/20),98.6% (212/215),84.2% (16/19) and 98.1% (212/216),respectively. The susceptibility, specificity, PPV and NPV for Multi-drug resistance were 76.2% (16/21), 97.2% (208/214), 72.7% (16/22), 97.7% (208/213) and 95.3% (224/235), respectively. Conclusion Using Genechip to detect drug resistantt TB in sputum samplesis of high value,high authenticity and high reliability in the diagnosis of Rifampicin, Isoniazid and Multidrug-resistant tuberculosis.

Key words: Tuberculosis,pulmonary, Tuberculosis,multidrug-resistant, Microbial sensitivity tests, Microchip analytical procedures, Rifampin, Isoniazid, Comparative study

马岩, 杨晓军, 任振娟, 苏云开. 痰标本基因芯片法检测耐多药肺结核的临床价值[J]. 结核与肺部疾病杂志, 2020, 1(2): 112-116. doi: 10.3969/j.issn.2096-8493.2020.02.004

MA Yan, YANG Xiao-jun, REN Zhen-juan, SU Yun-kai. Clinical value of Genechip in detecting multidrug-resistant Mycobacterium tuberculosis bacteria in sputum samples[J]. Journal of Tuberculosis and Lung Disease, 2020, 1(2): 112-116. doi: 10.3969/j.issn.2096-8493.2020.02.004

图/表 2

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标本阳性级别	无结果			有结果	合计
标本阳性级别	无法判读	无分枝杆菌	合计	有结果	合计
实际条数	1(6.7)	2(13.3)	3(20.0)	12(80.0)	15(100.0)
+	1(1.3)	6(7.9)	7(9.2)	69(90.8)	76(100.0)
++	1(1.3)	4(5.0)	5(6.3)	75(93.7)	80(100.0)
+++	1(1.7)	1(1.7)	2(3.4)	57(96.6)	59(100.0)
++++	1(1.5)	0(0.0)	1(1.5)	64(98.5)	65(100.0)
合计	5(1.7)	13(4.4)	18(6.1)	277(93.9)	295(100.0)