基于基因芯片技术对耐利福平或异烟肼结核分枝杆菌基因突变位点的检测分析  

Detection Analysis of Gene Mutation Sites of Rifampin-or Isoniazid-resistant Mycobacterium Tuberculosis Based on Gene Chip Technology

作　　者：孙青 宋华峰[1] 黄帆 SUN Qing;SONG Hua-feng;HUANG Fan(Department of Laboratory Medicine,The Fifth People's Hospital of Suzhou(The Affiliated Infectious Disease Hospital of Soochow University),Suzhou Jiangsu 215000,China)

机构地区：[1]苏州市第五人民医院(苏州大学附属传染病医院)检验中心,江苏苏州215000

出　　处：《抗感染药学》2023年第10期1108-1112,共5页Anti-infection Pharmacy

基　　金：苏州市基础研究计划(医学应用基础研究)项目(编号:SKY2023220);苏州市卫生青年骨干人才(编号:Qngg2021028);苏州市生物医药产业创新医工结合协同创新研究项目(编号:SLJ2022022);苏州市科教兴卫青年科技项目(编号:KJXW2022045)。

摘　　要：目的:分析基因芯片技术对耐利福平或异烟肼结核分枝杆菌(Mycobacterium tuberculosis,MTB)基因突变位点的检测情况,为耐多药结核的临床诊断提供依据。方法:收集2020年—2023年在苏州市第五人民医院就诊的395例结核患者的痰液标本,采用基因芯片技术对利福平耐药基因ropB(511、513、516、526、531、533)和异烟肼耐药基因KatG(315)、inhA(-15)突变位点进行检测,以罗氏固体培养绝对浓度法作为金标准,分析基因芯片技术对MTB耐利福平或异烟肼的准确性。结果:基因芯片技术对利福平耐药诊断的Kappa值为0.80,符合率为92.15%,灵敏度为87.74%,特异度为93.77%,阳性预测值为83.78%,阴性预测值为95.42%,而对异烟肼耐药诊断的Kappa值为0.87,符合率为93.42%,灵敏度为98.82%,特异度为89.38%,阳性预测值为87.43%,阴性预测值为99.02%。结论:基因芯片技术可以快速、高效地检测MTB耐利福平和耐异烟肼基因突变,与罗氏固体培养绝对浓度法高度一致,可为临床诊疗提供依据。Objective:To analyze the detection on genemutation sites of rifampin-or isoniazid-resistantMycobacterium tuberculosis(MTB)with the gene chip technology,so as to provide a basis for the clinical diagnosis of multidrug-resistant tuberculosis.Methods:Sputum specimens from 395 tuberculosis patients treated in the Fifth People's Hospital of Suzhou from 2020 to 2023 were collected,and the gene chip technology was utilized to detect the mutation sites of rifampin resistance gene ropB(511,513,516,526,531,533)and isoniazid resistance genes KatG(315)and inhA(-15).By using the Roche solid culture absolute concentration method as the gold standard,the accuracy of the gene chip technology on MTB resistance to rifampin or isoniazid was analyzed.Results:The Kappa value of the gene chip technology for the diagnosis of rifampin resistance was 0.80,the coincidence rate was 92.15%,the sensitivity was 87.74%,the specificity was 93.77%,the positive predictive value was 83.78%,and the negative predictive value was 95.42%.The Kappa value of the gene chip technology for the diagnosis of isoniazid resistance was 0.87,the coincidence rate was 93.42%,the sensitivity was 98.82%,the specificity was 89.38%,the positive predictive value was 87.43%,and the negative predictive value was 99.02%.Conclusion:The gene chip technology can detect the gene mutations of MTB resistance to rifampin and isoniazid in a rapid and efficient manner,which is highly consistent with the Roche solid culture absolute concentration method and can provide a basis for the clinical diagnosis and treatment.

关 键 词：结核分枝杆菌 基因芯片技术 利福平 异烟肼 耐药基因 

分 类 号：R52[医药卫生—内科学] R181.32[医药卫生—临床医学]