目的:探讨Xpert MTB/RIF(Xpert)技术对结核分枝杆菌(MTB)及其利福平(RIF)耐药性检测的应用价值。方法:对310例抗酸染色阳性的痰标本分别进行Xpert检测、MTB-非结核分枝杆菌(NTM)核酸PCR检测(MTB-NTM-PCR)和罗氏培养,并将MTB阳性菌株作菌种鉴定和比例法药物敏感性试验,分析3种检测方法MTB阳性及阴性的符合情况;以比例法为金标准,计算Xpert检测RIF耐药性的灵敏度、特异度、准确度、阳性预测值和阴性预测值。结果:Xpert和MTB-NTM-PCR检测MTB阳性均为307例,二者符合率为100%;Xpert检测MTB阴性的3例标本,MTB-NTM-PCR检测为NTM;罗氏培养292例阳性,16例阴性,2例污染,Xpert检测MTB阴性的3例标本罗氏培养获得菌株进行对硝基苯甲酸(PNB)试验为阳性;以比例法为金标准,Xpert检测RIF耐药性的灵敏度、特异度、准确度、阳性预测值和阴性预测值分别为95.65%、95.94%、95.85%、91.67%和97.93%(P〉0.05,Kappa〉0.75)。结论:Xpert能快速准确的检测抗酸染色阳性痰标本中MTB及其RIF耐药性,对耐多药结核病(MDR-TB)的快速筛查具有重要价值。
Objective:To evaluate the application of Xpert MTB/RIF( Xpert) test in rapid detection of Mycobacterium tuberculosis( MTB) and its resistance to rifampin( RIF). Methods:Xpert test,Mycobacterium nucleic acid test( MTB-NTM-PCR),and Lowenstein-Jensen culture method were conducted on 310 acid-fast staining positive sputum specimens,and the positive MTB strains isolated on Lowenstein-Jensen media were identified and their drug susceptibility was then determined by ratio sensitivity test. The test result accordance of the 3 methods were analyzed. Using ratio method as golden standard,the sensitivity,specificity,accuracy,positive predictive value and negative predictive value of the strains to RIF determined by Xpert test were calculated. Results:Of the 310 samples,307 cases were MTB positive determined by both Xpert and MTB-NTM-PCR,and the coincidence rate was100%. Three MTB negative samples detected by Xpert test were determined as Nontuberculosis mycobacteria( NTM) by MTB-NTM-PCR test. In isolates by Lowenstein-Jensen media,292 samples were MTB positive,16 negative,and 2 were polluted. Three Xpert MTB negative samples were nitrobenzoic acid test positive determined by Lowenstein-Jensen media culture test. The sensitivity results determined by ratio method,specificity,accuracy,positive predictive value and negative predictive value of Xpert were 95. 65%,95. 94%,95. 85%,91. 67% and 97. 93% respectively. Analyzed with χ^2 and Kappa tests,the p value was higher than 0. 05 and the Kappa value was higher than 0. 75. Conclusions:Xpert can quickly determine MTB and its RIF drug resistance,which shows it has important value in fast screening of multi-drug resistant TB strains.