基因芯片技术在检测痰涂阳肺结核患者结核分枝杆菌耐药性的应用效果

Evaluation of genechip in rapid detection of patients with multidrug-resistant tuberculosis

目的探讨基因芯片技术在结核病耐多药快速检测中的应用效果。方法收集重庆市五个区县1 030例涂阳肺结核患者的痰标本,同时进行罗氏培养和基因芯片检测异烟肼、利福平耐药性,培养后的菌株用比例法药敏试验检测异烟肼、利福平的耐药性。以比例法药敏试验为判断标准,对基因芯片的检测效果进行分析。结果对同时有两种耐药性检测结果的958例患者进行了统计学分析,基因芯片对异烟肼检测结果和比例法药敏试验比较差异无统计学意义(P>0.05),符合率94.1%,灵敏度80.2%,特异度95.9%,阳性预测值71.8%,阴性预测值97.4%,Kappa值为0.724。基因芯片对利福平检测结果和比例法药敏试验比较差异无统计学意义(P>0.05),符合率96.3%,灵敏度86.4%,特异度97.5%,阳性预测值80.9%,阴性预测值98.3%,Kappa值为0.815。此外,基因芯片对异烟肼和利福平耐药结核病检测结果和比例法药敏试验比较差异无统计学意义(P>0.05),符合率96.9%,灵敏度78.3%,特异度98.3%,阳性预测值78.3%,阴性预测值98.3%,Kappa值为0.766。结论基因芯片技术可用于耐多药结核病早期快速筛查和诊断,以弥补传统药敏试验的不足,但该方法对检测环境要求较高,需对操作人员严格培训。

Objective To analyze the performance of genechip in rapid detecting multidrug-resistant tuberculosis （MDR-TB）.Methods The sputum samples collected from 1 030 smear positive TB patients detected in five districts of Chongqing were analyzed by genechip for detecting INH-and RFP-resistance.Simultaneously,the sputum samples were cultured with Lwenstein-Jensen culture medium followed by conventional drug susceptibility testing （DST） for detecting INH-and RFP-resistance.The conventional DST results by proportion method were served as the gold standard to evaluate the detection capability of genechip.Results Finally 958 patients with the results of genechip and DST were analyzed.The coincidence rate,sensitivity,specificity,positive predictive value and negative predictive value of genechip for INH drug resistance were 94.1%,80.2%,95.9%,71.8% and 97.4%,respectively.Compared with conventional DST,the difference had no statistical significance （P〉0.05）.And Kappa value was 0.724.The coincidence rate,sensitivity,specificity,positive predictive value and negative predictive value of genechip for INH drug resistance were 96.3%,86.4%,97.5%,80.9% and 98.3%,respectively.Compared with conventional DST,the difference had no statistical significance（P〉0.05）.And Kappa value was 0.815.Additionally,coincidence rate,sensitivity,specificity,positive predictive value and negative predictive value of NH-and RFP-resistance were 96.9%,78.3%,98.3%,78.3% and 98.3%,and Kappa value was 0.766.Compared with conventional DST,the difference had no statistical significance（P〉0.05）.Conclusion Genechip can be used for early and rapid screening and diagnosis for MDR-TB,which could cover the shortage of conventional DST,but genechip is strict with testing environment and needs strict training for the operators.