RNA恒温扩增实时荧光检测痰标本结核分枝杆菌对肺结核诊断的应用价值

The application value of RNA simultaneous amplification and testing assay in detection of Mycobacterium tuberculosis in sputum specimens for the diagnosis of tuberculosis

目的探讨结核分枝杆菌RNA恒温扩增实时荧光检测技术(SAT-TB)在肺结核诊断中的应用价值。方法纳入209例临床确诊肺结核患者和211例其他肺部疾病患者作为研究组和对照组,采集患者晨痰,用SAT-TB、涂片抗酸染色镜检(AFS)和BactecMGIT960液体培养(MGIT960)3种方法检测结核分枝杆菌,采用χ^(2)检验比较2组患者SAT-TB、AFS、MGIT960的阳性率和同组3种方法的阳性率差异,绘制ROC曲线比较3种方法的诊断价值。结果研究组3种检测方法阳性率均高于对照组(P<0.05);研究组3种方法检测结果比较差异有统计学意义(P<0.05);SAT-TB、AFS和MGIT960诊断肺结核的AUC分别为0.778(0.732-0.842)、0.620(0.566-0.674)和0.723(0.673-0.772);AFS.MGIT960和SAT-TB的灵敏度分别为28.23%,49.28%和57.42%,特异度分别为95.73%、95.26%和98.10%。结论SAT-TB有较高的灵敏度和特异度,且具有检测耗时短、能鉴别活菌等优点,在肺结核的诊断中有重要的应用价值。

Objective To investigate the application value of simultaneous amplification and testing assay (SAT-TB) for Mycobacterium tuberculosis RNA in the diagnosis of tuberculosis.Methods A total of 209 patients confirmed with pulmonary tuberculosis and 211 patients with other lung diseases are served as study group and control group respectively.Morning sputum specimen were collected from patients to detect mycobacterium by SAT-TB method,AFS method and MGIT960 method.The positive rates between the two groups and between the three methods were compared by χ^(2);test.The diagnostic values of the three methods were compared by ROC curve.Results The positive rates of the three detection methods in the study group were much higher than those in the control group,and the differences were statistically significant (P<0.05),and there was statistical significance on the differences among the three methods in the study group (P<0.05),and the AUC of SAT-TB,AFS and MGIT960 in the diagnosis of pulmonary tuberculosis was 0.778 (0.732-0.842),0.620 (0.566-0.674) and 0.723(0.673-0.772),respectively.The sensitivity of AFS,MGIT960 and SAT-TB was 28.23%,49.28%and 57.42%respectively,and the specificity was 95.73%,95.26%and 98.10%,respectively.Conclusion SAT-TB has high sensitivity and specificity,and has the advantages of short detection time and being able to identify live bacteria,so it has important application value in the diagnosis of pulmonary tuberculosis.