Xpert MTB/RIF与Hain MTBDRplus检测技术快速诊断肺结核及其耐药性的临床应用价值

摘要

目的 评价利福平耐药实时荧光定量核酸扩增检测技术(Xpert MTB/RIF,Xpert)与Hain MTBDRplus检测技术快速诊断肺结核及其耐药性的临床应用价值.方法 选择2016年1月至2016年5月北京胸科医院261例疑似肺结核的住院患者,同时行痰Xpert检测、痰Hain MTBDRplus检测、痰罗氏培养,培养阳性的结核分枝杆菌行绝对浓度法药敏检测.以临床诊断参考标准为金标准,评价Xpert和Hain MTBDRplus检测痰中结核分枝杆菌的敏感度和特异度.以痰罗氏培养及绝对浓度法为金标准,评价Xpert和Hain MTBDRplus检测痰中结核分枝杆菌耐药性的敏感度.结果 以临床诊断参考标准为金标准,Xpert和Hain MTBDRplus的敏感度分别为83.1%和72.3%,特异度分别为94.7%和100%.以痰罗氏培养为金标准,Xpert诊断肺结核的敏感度为81.7%;Hain MTBDRplus诊断肺结核的敏感度为74.4%.以绝对浓度法药敏结果为金标准,Xpert检测利福平耐药的敏感度为77%,Hain MTBDRplus检测利福平和异烟肼的敏感度分别为78.4%和80.5%.应用NRI比较Xpert和Hain MTBDRplus两种检测技术的诊断能力, NRI=0.055.结论 痰Xpert和Hain MTBDRplu检测结核分枝杆菌的敏感度和特异度高,可用于肺结核的早期诊断及其耐药性检测.%Objective To evaluate the clinical value of Xpert MTB/RIF (Xpert) and Hain MTBDRplus for the rapid diagnosis of pulmonary tuberculosis and drug resistance. Method 261 patients with suspected pulmonary tuberculosis in Beijing Chest Hospital were enrolled from 2016.1-2016.5. Xpert MTB/RIF (Xpert), Hain MTBDRplus, Roche culture were performed for sputum specimens, and drug susceptibility testing (DST) was conducted for all of the isolates obtained. Using the clinical diagnostic reference standard as the gold standard, we evaluated the sensitivity and specificity of Xpert and Hain MTBDRplus in the detection of Mycobacterium tuberculosis in sputum. Using DST (by the absolute concentration method) as the gold standard, we evaluated the sensitivity of Xpert and Hain MTBDRplus in detecting drug resistance. SPSS 22 was used to analyze the data. Result Using clinical diagnosis as the gold standard, the sensitivity of Xpert and Hain MTBDRplus was 83.1% and 72.3% respectively, and the specificity was 94.7% and 100% respectively. Using culture as the gold standard, the sensitivity of Xpert and Hain MTBDRplus to diagnose pulmonary tuberculosis was 81.7% and 74.4% respectively. Using DST as the gold standard, the sensitivity of Xpert to diagnosis rifampicin-resistance was 77%, and the sensitivity of Hain MTBDRplus to diagnosis rifampin-resistance and isoniazid-resistance was 78.4% and 80.5% respectively. Comparing the diagnostic ability of Xpert and Hain MTBDRplus, NRI=0.055. Conclusion With high sensitivities and specificities, Xpert and Hain MTBDR can be used for the rapid diagnosis of pulmonary tuberculosis and drug resistance.