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目的采用ROC曲线分析法评估交叉引物扩增技术(CPA)直接检测临床痰样本结核分枝杆菌的检测效能,为临床应用提供参考依据。方法选取肺结核患者225例和非肺结核患者82例,采用CPA进行检测,并同时使用涂片抗酸染色、罗氏培养法、荧光定量PCR技术(FQ-PCR)三种最常用的实验室诊断方法作为对照。根据每种方法对样本检测结果的灵敏度和特异度,以受试者工作曲线(ROC)进行分析比较。结果去除非结核分枝杆菌的26个样本,以临床诊断为金标准,涂片抗酸染色、罗氏培养法、FQPCR技术和CPA的灵敏度分别为46.73%(93/199),63.32%(126/199),69.85%(139/199),70.35%(140/199),假阳性率分别为0%(0/82),0%(0/82),1.22%(1/82),1.22%(1/82)。ROC曲线下的面积分别为0.729、0.817、0.841、0.843,均P<0.01。结论 ROC曲线分析结果显示,交叉引物扩增技术诊断结核病具有较好的准确性,该方法可作为结核病的实验室诊断方法。
Objective To evaluate the detection efficiency of direct detection of Mycobacterium tuberculosis in clinical sputa by cross-primer amplification (RIA) using ROC curve analysis, and provide a reference for clinical application. Methods Totally 225 patients with pulmonary tuberculosis and 82 patients with non-tuberculosis were enrolled in the study. CPA was used for the detection. The three most commonly used laboratory diagnostic methods of smear anti-acid staining, Roche culture and quantitative PCR (FQ-PCR) Control. Based on the sensitivity and specificity of the test results for each method, the receiver operating curve (ROC) was used for analysis and comparison. Results The sensitivity of smear anti-acid staining, Roche culture, FQPCR and CPA were 46.73% (93/199) and 63.32% (126 / The false positive rates were 0% (0/82), 0% (0/82), 1.22% (1/82), 1.22% (1/82). The area under the ROC curve was 0.729,0.817,0.841,0.843, all P <0.01. Conclusion The results of ROC curve analysis show that the cross-primer amplification technique has a good accuracy in diagnosis of tuberculosis. This method can be used as a laboratory diagnostic method for tuberculosis.