线性探针技术检测结核分枝杆菌耐药性的效果分析

doi:10.3969/j.issn.2095-3755.2018.01.011

摘要/Abstract

摘要：

目的探讨线性探针技术(GenoType^? MTBDRplus)检测结核分枝杆菌耐药性的效能。方法对378例结核分枝杆菌临床分离株采用分子线性探针技术检测利福平(RFP)和异烟肼(INH)的耐药性,并用传统比例法药敏试验(简称“药敏试验”)对该378例菌株进行RFP和INH的耐药性试验,比较两种方法检测耐药性的差别。用SPSS 13.0软件进行统计学分析。率的比较采用χ ²检验,P<0.05为差异有统计学意义;一致性比较采用Kappa检验,Kappa≥0.75表示两者一致性较好。结果线性探针法与比例法检测RFP的耐药率分别为12.2%(46/378)和10.6%(40/378),差异无统计学意义(χ ²=3.60, P>0.05),两种方法检测的总体一致率为97.4%(368/378),具有很高的一致性(Kappa=0.87);检测INH的耐药率分别为14.3%(54/378)和12.2%(46/378),差异无统计学意义(χ ²=3.20,P>0.05),两种方法检测的总体一致率为94.7%(358/378),一致性较好(Kappa=0.77);检测耐多药率分别为7.4%(28/378)和7.9%(30/378),差异无统计学意义(χ ²=0.40,P>0.05),两种方法检测的总体一致率为97.4%(368/378),一致性较好(Kappa=0.81)。以比例法为金标准,线性探针法检测 RFP耐药的敏感度和特异度分别是95.0%(38/40)和97.6%(330/338),检测 INH耐药的敏感度和特异度分别是87.0%(40/46)和95.8%(318/332),检测耐药性的敏感度和特异度分别是80.0%(24/30)和98.9%(344/348)。结论线性探针技术检测结核分枝杆菌临床分离株耐药性是可行的。

关键词: 分子探针技术, 结核, 抗多种药物性, 微生物敏感性试验, 对比研究

Abstract:

Objective To investigate the effectiveness of the line probe assay GenoType^? MTBDRplus in the detection of drug resistance in Mycobacterium tuberculosis.Methods Three hundred and seventy eight Mycobacterium tuberculosis clinical isolates were tested for resistance to rifampicin (RFP) and isoniazid (INH) using the molecular line probe technique, and drug susceptibility testing (“susceptibility testing”) against RFP and INH was performed using conventional proportional assays. Differences in results obtained between the two methods were compared by Chi-square tests using SPSS 13.0 software, P<0.05 being considered statistically significant. The Kappa consistency test was also applied, Kappa≥0.75 indicating better consistency.Results RFP resistance rates obtained by the linear probe and proportional methods, 12.2% (46/378) and 10.6% (40/378), respectively were not significantly different (χ ²=3.60, P>0.05). The overall consistency rate was 97.4% (368/378), the two methods showing good consistency (Kappa=0.87). INH drug resistance rates, 14.3% (54/378) and 12.2% (46/378), respectively, were not significantly different (χ ²=3.20, P> 0.05). Overall consistent rate was 94.7% (358/378), the two methods showing good consistency (Kappa=0.77). Multidrug resistance rates determined by the two methods, 7.4% (28/378) and 7.9% (30/378), respectively, were not significantly difference (χ ²=0.40, P>0.05). The overall consistency rate was 97.4% (368/378), indicating that the two methods show good consistency (Kappa=0.81). The sensitivity and specificity of the linear probe method for detecting RFP resistance was 95.0% (38/40) and 97.6% (330/338), respectively, while that for detection of INH resistance was 87.0% (40/46) and 95.8% (318/332) respectively. The sensitivity and specificity for detecting MDR was 80.0% (24/30) and 98.9% (344/348), respectively.Conclusion Linear probe technology for detecting the drug resistance status of clinical isolates of M.tuberculosis drug resistance is practicable.

Key words: Molecular probe techniques, Tuberculosis, multidrug-resistant, Microbial sensitivity tests, Comparative study

陈丽,秦玉宝,邬剑,唐鹭,林百丰,张学志. 线性探针技术检测结核分枝杆菌耐药性的效果分析[J]. 结核病与肺部健康杂志, 2018, 7(1): 49-53. doi: 10.3969/j.issn.2095-3755.2018.01.011

Li CHEN,Yu-bao QIN,Jian WU,Lu TANG,Bai-feng LIN,Xue-zhi. ZHANG. Evaluation of linear probe technology in the detection of drug resistance in Mycobacterium tuberculosis[J]. Journal of Tuberculosis and Lung Health, 2018, 7(1): 49-53. doi: 10.3969/j.issn.2095-3755.2018.01.011

图/表 3

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线性探针法	比例法药敏试验
线性探针法	耐药(株)	非耐药(株)	合计(株)	敏感度(%)^a	特异度(%)^b
耐药(株)	24	4	28	80.0(24/30)	98.9(344/348)
非耐药(株)	6	344	350
合计	30	348	378	-	-