SAT技术在肺结核早期筛查中的应用价值

The value of SAT technology application in the early screening of pulmonary tuberculosis

目的:探讨RNA恒温扩增实时荧光检测技术(SAT)在肺结核辅助诊断中的临床应用价值。方法:选取2016年1月至2019年3月在德阳市人民医院初诊患者的痰液标本1 080例,其中以临床确诊的肺结核患者痰标本762例作为试验组,肺部非结核性疾病患者318例作为对照组,分别采用SAT、实时荧光聚合酶链式反应法(RT-PCR)与抗酸染色法进行检测,以临床诊断为金标准,比较3种方法的敏感度、特异性、阳性预测值、阴性预测值以及联合诊断效能。结果:试验组SAT、RT-PCR、抗酸染色法的阳性检出率分别为48.43%、41.47%、21.52%,SAT法阳性检出率高于RT-PCR法及抗酸染色法(P<0.01)。SAT法的敏感度、特异性、阳性预测值、阴性预测值与RT-PCR法有较好的一致性(P>0.05),与抗酸染色法结果一致性较差(P<0.05)。3种方法联合检测的敏感度为49.34%(376/762),特异度为98.74%(314/318),绘制3种检测方法及其联合诊断肺结核的受试者工作特征曲线(ROC曲线),SAT、RT-PCR、抗酸染色、抗酸染色+SAT、抗酸染色+PCR、SAT+PCR、抗酸染色+SAT+PCR对应的曲线下面积(AUC)分别为0.741、0.704、0.607、0.741、0.706、0.742、0.742。结论:采用SAT技术检测结核分枝杆菌,其敏感度和特异度均优于其它两种方法,SAT操作简便、快捷,经济,值得在临床推广。

Objective:To explore the clinical value of simultaneous amplification and testing(SAT) in the auxiliary diagnosis ofpulmonary tuberculosis. Methods:A total of 1,080 sputum specimens from newly diagnosed patients in Deyang People’s Hospital from January 2016 to March 2019 were selected, among which 762 sputum specimens from patients with tuberculosis were selected as the experimental group, and 318 patients with pulmonary non-tuberculous diseases were selected as the control group.SAT, real-time fluorescent PCR(RT-PCR) and acid-fast staining were used for detection. Taking clinical diagnosis as the gold standard, the sensitivity, specificity, positive predictive value, negative predictive value and combined diagnostic efficacy of the three methods were compared.Results: The positive rates of SAT, RT-PCR and acid-fast staining in experimental groupwere48.43%, 41.47% and 21.52%, respectively. The positive detection rate of SAT method was higher than that of RTPCR and acid-fast staining(P<0.01).The sensitivity, specificity, positive predictive value and negative predictive value of SAT were in agreement with those of RT-PCR(P>0.05), while the results of acid-fast staining were not consistent with those of acid fast staining(P<0.05).The sensitivity and specificity of the combined detection of the three methods were 49.34%(376/762) and 98.74%(314/318), respectively. The area under the ROC curve of SAT, RT-PCR, acid-fast staining, acid-fast staining+SAT, acid-fast staining+PCR, SAT+PCR, and acid-fast staining+SAT+PCR were 0.741, 0.704, 0.607, 0.741, 0.706, 0.742, and 0.742, respectively.Conclusion: The sensitivity and specificity of SAT for the detection of Mycobacterium tuberculosis are superior to other two methods. SAT is a simple, fast and economical method that is worthy of clinical promotion.