结核分枝杆菌RNA恒温扩增实时检测法诊断活动性肺结核分析

The application of isothermal RNA amplification assay in thedetection of Mycobacterium Tuberculosis in active pulmonary tuberculosis

目的分析结核分枝杆菌RNA恒温扩增实时检测法诊断活动性肺结核。方法随机选取2016年8月至2018年8月在河北省胸科医院就诊的活动性肺结核患者642例作为研究组,另随机选取同期在河北省胸科医院就诊的肺部其他疾病患者98例为对照组,运用涂片镜检法、SAT-TB法、BACTEC 960培养法检测两组患者的痰液样本。结果研究组642例患者中,180例涂片镜检法阳性,546例BACTEC 960培养法检测结核分枝杆菌阳性,480例SAT-TB法检测阳性,敏感度分别为28.04%、85.05%、74.77%。BACTEC 960培养法、SAT-TB法敏感度均高于涂片镜检法(P<0.05),而BACTEC 960培养法敏感度又高于SAT-TB法(P<0.05)。对照组98例患者中,4例BACTEC 960培养法检出阳性,特异度为95.90%,最终鉴定为非结核分枝杆菌。BACTEC 960培养法阳性患者546例中,涂片镜检法、SAT-TB法的敏感度分别为32.23%、84.25%。SAT-TB法检测550例确诊肺结核患者的敏感度、阳性预测值、阴性预测值分别为84.36%、100.00%、53.26%。结论结核分枝杆菌RNA恒温扩增实时检测法诊断活动性肺结核价值高,值得在临床推广应用。

Objective To evaluate the clinical value of isothermal RNA amplification assay(SAT)in the detection of Mycobacterium tuberculosis to diagnose active pulmonary tuberculosis.Methods Sputum samples were collected from 642 patients with confirmed active pulmonary tuberculosis in our hospital from August 2016 to August 2018 and 98 cases with other pulmonary diseases during the same period as controls.Samples were detected using sear microscopy,SAT-TB method and BACTEC 960 culture method.Results Among total 642 cases,180546 and 480 were positive for smear microscopy,BACTEC 960 culture and SAT-TB method with the the sensitivity rates of 28.04%,85.05%and 74.77%,respectively.The sensitivity of BACTEC 960 culture method and SAT-TB method were significantly higher than smear microscopy method(P<0.05),while the sensitivity of BACTEC 960 culture method was significantly higher than SAT-TB method(P<0.05).In the control group,98 cases were negative by smear microscopy and SAT-TB,4 cases were positive for BACTEC 960 culture which were identified as non-tuberculosis mycobacterium.The sensitivities of smear microscopy and SAT-TB were 32.23%and 84.25%in 546 patients with BACTEC 960 culture positive.The sensitivity of SAT-TB was significantly higher than smear microscopy(P<0.05).The sensitivity,positive predictive value and negative predictive value of SAT-TB were 84.36%,100.00%,53.26%in 550 patients with confirmed tuberculosis.Conclusions SAT,as a new technology in laboratory diagnosis of TB has high sensitivity and specificity which can be a promising candidate in the diagnosis of active pulmonary TB.