MTBDRplus 2.0技术对疑似肺结核和耐多药结核病患者的诊断价值

doi:10.3969/j.issn.1000-6621.2019.12.008

摘要/Abstract

摘要：

目的评价二代线性探针(GenoType MTBDRplus VER 2.0,简称“MTBDRplus 2.0”)技术快速检测疑似肺结核患者痰标本中结核分枝杆菌(MTB)及其对利福平和异烟肼耐药性的诊断价值。方法回顾性分析2018年1—12月就诊于西安市胸科医院的1065例疑似肺结核患者的实验室检测结果,剔除耐药不确定及痰标本污染者96例,最后纳入969例疑似患者作为研究对象。每例患者用同一份痰标本分别进行GeneXpert MTB/RIF(简称“GeneXpert”)检测、 MTBDRplus 2.0检测、BACTEC MGIT 960(简称“MGIT 960”)液体培养,对培养阳性且鉴定为MTB的菌株进行MGIT 960药物敏感性试验(简称“MGIT 960药敏试验”),以MGIT 960液体培养结果为参考标准,评价MTBDRplus 2.0技术检测痰标本中MTB的检测效能;以MGIT 960药敏试验结果为参考标准,评价MTBDRplus 2.0技术检测利福平和异烟肼耐药性的检测效能。结果 969例疑似肺结核患者中,MGIT 960液体培养检测MTB阳性409例,阴性560例。以MGIT 960液体培养检测结果为参考标准,MTBDRplus 2.0和GeneXpert检测疑似肺结核患者痰标本MTB的敏感度、特异度、Kappa值分别为91.0% (372/409)、93.8% (525/560)、0.848和92.9% (380/409)、92.5% (518/560)、0.850。以MGIT 960药敏试验结果为参考标准,MTBDRplus 2.0和GeneXpert检测利福平耐药性的敏感度、特异度、Kappa值分别为89.8% (53/59)、95.8% (295/308)、0.817和91.5% (54/59)、95.8% (295/308)、0.828;MTBDRplus 2.0检测异烟肼耐药性的敏感度、特异度和Kappa值分别为80.4% (82/102)、96.3% (260/270)和0.791。结论 MTBDRplus 2.0技术对检出疑似肺结核患者痰标本中的MTB,以及对利福平和异烟肼的耐药性均具有较好的检测效能。

关键词: 分枝杆菌,结核, 结核,抗多种药物性, 分子探针技术, 实验室技术和方法, 对比研究, 数据说明,统计

Abstract:

Objective To evaluate value of GenoType MTBDRplus VER 2.0 (MTBDRplus 2.0) technology in rapid detection of Mycobacterium tuberculosis (MTB) and its resistance to rifampicin and isoniazid from sputum samples of suspected pulmonary tuberculosis patients.Methods The results of 1065 suspected pulmonary tuberculosis patients from Xi’an Chest Hospital between January and December 2018 were retrospectively analyzed. Of them, 96 cases of drug-resistant uncertainty and contaminated were excluded, the other 969 suspected patients were included as subjects finally. One sputum specimen collected from each patients was tested by GeneXpert MTB/RIF (GeneXpert), MTBDRplus 2.0, BACTEC MGIT 960 (MGIT 960) liquid culture. and MGIT 960 drug sensitivity test. If the result was positive and MTB was detected, MGIT 960 sensitivity test would be performed. The detection performance of MTBDRplus 2.0 for MTB and drug resistance of rifampicin and isoniazid was assessed according to the MGIT 960 liquid culture and MGIT 960 drug sensitivity test resultst.Results Among the 969 cases, MTB was detected positive by MGIT 960 liquid culture in 409 patients, while negative in 560 cases. Based on the results of MGIT 960 liquid culture, the sensitivity, specificity, Kappa value of MTBDRplus 2.0 were and GeneXpert in the detection of MTB was 91.0% (372/409), 93.8% (525/560) and 0.848, and those of GeneXpert were 92.9% (380/409), 92.5% (518/560) and 0.850, respectively. Based on the MGIT 960 drug sensitivity test results, the sensitivity, specificity and Kappa value of MTBDRplus 2.0 in detection of rifampicin resistance were 89.8% (53/59), 95.8% 295/308) and 0.817, and those of GeneXpert were 91.5% (54/59), 95.8% (295/308) and 0.828, respectively; while the sensitivity, specificity and Kappa value of MTBDRplus 2.0 in detection of isoniazid resistance was 80.4% (82/102), 96.3% (260/270) and 0.791.Conclusion MTBDRplus 2.0 technology is of better performance in detecting MTB from sputum samples of suspected tuberculosis patients, as well as the resistance of rifampicin and isoniazid.

Key words: Mycobacterium tuberculosis, Tuberculosis,multidrug-resistant, Molecular probe techniques, Laboratory techniques and procedures, Comparative study, Data interpretation, statistical

刘元,周俊,崔晓利,黄芳,雷佳媛,党丽云. MTBDRplus 2.0技术对疑似肺结核和耐多药结核病患者的诊断价值[J]. 中国防痨杂志, 2019, 41(12): 1277-1282. doi: 10.3969/j.issn.1000-6621.2019.12.008

Yuan LIU,Jun ZHOU,Xiao-li CUI,Fang HUANG,Jia-yuan LEI,Li-yun DANG. Value of GenoType MTBDRplus VER 2.0 in diagnosis of suspected tuberculosis patients and multidrug-resistant patients[J]. Chinese Journal of Antituberculosis, 2019, 41(12): 1277-1282. doi: 10.3969/j.issn.1000-6621.2019.12.008

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检测技术检测结果	MGIT 960液体培养		敏感度 (%)	特异度 (%)	阳性预测值 (%)	阴性预测值 (%)	Kappa值
检测技术检测结果	阳性(例)	阴性(例)	敏感度 (%)	特异度 (%)	阳性预测值 (%)	阴性预测值 (%)	Kappa值
MTBDRplus 2.0
阳性(例)	372	35	91.0	93.8	91.4	93.4	0.848
阴性(例)	37	525
GeneXpert
阳性(例)	380	42	92.9	92.5	90.0	94.7	0.850
阴性(例)	29	518

药敏试验技术检测结果	MGIT 960药敏试验		敏感度 (%)	特异度 (%)	阳性预测值 (%)	阴性预测值 (%)	Kappa值
药敏试验技术检测结果	耐药(例)	敏感(例)	敏感度 (%)	特异度 (%)	阳性预测值 (%)	阴性预测值 (%)	Kappa值
MTBDRplus 2.0
耐药(例)	53	13	89.8	95.8	80.3	98.0	0.817
敏感(例)	6	295
GeneXpert
耐药(例)	54	13	91.5	95.8	80.6	98.3	0.828
敏感(例)	5	295

MTBDRplus 2.0 药敏试验	MGIT 960药敏试验		敏感度 (%)	特异度 (%)	阳性预测值 (%)	阴性预测值 (%)	Kappa值
MTBDRplus 2.0 药敏试验	耐药(例)	敏感(例)	敏感度 (%)	特异度 (%)	阳性预测值 (%)	阴性预测值 (%)	Kappa值
耐药(例)	82	10	80.4	96.3	89.1	92.9	0.791
敏感(例)	20	260