3种常规结核分枝杆菌及耐药突变检测方法的对比研究  

A comparative study of three different detection methods for Mycobacterium tuberculosis and drug-resistant mutations

作　　者：薛建昌 邸红芹[2] 吴海峰[1] 郑浩[3] 郑立恒[1] 梁冰锋[4] XUE Jian-chang;DI Hong-qin;WU Hai-feng;ZHENG Hao;ZHENG Li-heng;LIANG Bing-feng(Department of Laboratory, Hebei Chest Hospital, Shijiazhuang 050041, China;Molecular Biology Laboratory, Hebei Chest Hospital, Shijiazhuang 050041, China;Department of Ultrasound, Hebei Chest Hospital, Shijiazhuang 050041,China;Department of Nursing, Hebei Women′s Vocational College, Shijiazhuang 050091, China)

机构地区：[1]河北省胸科医院检验科,河北石家庄050041 [2]河北省胸科医院分子生物室,河北石家庄050041 [3]河北省胸科医院超声室,河北石家庄050041 [4]河北女子职业技术学院护理系,河北石家庄050091

出　　处：《河北医科大学学报》2020年第6期715-719,共5页Journal of Hebei Medical University

基　　金：河北省医学科学重点课题(20170424)。

摘　　要：目的评价3种实验室常规检测方法用于诊断肺结核患者结核分枝杆菌(Mycobacterium tuberculosis,MTB)及耐药突变情况的应用价值。方法回顾性分析经临床确诊的肺结核患者246例,应用Gene Xpert MTB/RIF技术(Xpert法)、BD960液体快速培养法(BD960法)联合快速药物敏感试验(药敏试验)、MTB核酸检测联合MTB耐药基因(DNA芯片法)检测诊断MTB及耐药突变检出情况。结果BD960法对MTB的阳性检出率低于MTB核酸检测和Xpert法,差异有统计学意义(P<0.05)。药敏试验、MTB耐药基因检测和Xpert法利福平耐药检出率差异无统计学意义(P>0.05)。与药敏试验利福平耐药结果相比,MTB耐药基因检测和Xpert法的敏感度、特异度、阳性预测值、阴性预测值、准确度和约登指数分别为91.30%、95.32%、84.00%、97.60%、94.47%、86.63%和95.65%、93.57%、80.00%、98.77%、94.01%、89.22%,X-pert法和MTB耐药基因检测利福平耐药结果高度一致(Kappa值=0.833,0.840)。药物敏感试验和MTB耐药基因检测异烟肼耐药检出率差异无统计学意义(P>0.05)。结论BD960法、Xpert法和MTB核酸检测均能准确检测样本中的MTB,药敏试验、MTB耐药基因检测和Xpert法能分析MTB利福平(异烟肼)耐药情况,MTB耐药基因检测和Xpert法且具有较高的敏感度和特异度,可结合实际需求在耐多药结核病防治中应用。Objective To evaluate the application value of three routine detection methods in the laboratory for the diagnosis of Mycobacterium tuberculosis(MTB)and drug-resistant mutations in patients with tuberculosis.Methods A retrospective study of 246 patients with tuberculosis who were positive for MTB was made.Gene Xpert MTB/RIF(Xpert method),BD960 liquid rapid culture method(BD960 method)combined with rapid drug sensitivity test(drug sensitivity test),and mycobacterial nucleic acid test(TB-DNA method)combined with MTB drug resistance gene test(DNA chip method)tests were performed to assess the detection of three MTB and drug-resistant mutations.Results The positive detection rate of MTB by BD960 method was lower than that of TB-DNA method and Xpert method,the difference was statistically significant(P<0.05).There was no significant difference in drug sensitivity test,MTB resistance gene detection and Xpert rifampicin resistance detection rate(P>0.05).Compared with the rifampicin resistance test results,the sensitivity,specificity,positive predictive value,negative predictive value,accuracy,and Youden index of the DNA chip method and Xpert method were 91.30%,95.32%,84.00%,97.60%,94.47%,86.63%and 95.65%,93.57%,80.00%,98.77%,94.01%,89.22%,The results of rifampin resistance detected by X-Pert and MTB are highly consistent(Kappa value=0.833,0.840).There was no significant difference in the detection rate of isoniazid resistance between drug sensitivity test and MTB resistance gene detection(P>0.05).Conclusion The BD960 method,Xpert method and TB-DNA method can accurately detect MTB in samples.Drug susceptibility test,DNA chip method and Xpert method can analyze the resistance of MTB rifampicin(isoniazid).MTB resistance gene detection and Xpert method have high sensitivity and specificity,which can be applied in MDR-TB control according to the actual needs.

关 键 词：结核分枝杆菌 耐药 临床实验室技术 

分 类 号：R446[医药卫生—诊断学] R378.911[医药卫生—临床医学]