【摘要】 目的 评估交叉引物扩增法(cross priming amplication,CPA)对初诊疑似肺结核患者的检测效能及推广价值。方法 选取2015年2-12月于首都医科大学附属北京胸科医院、北京市昌平区结核病防治所、天津市海河医院等21家医疗机构门诊就诊的初诊疑似肺结核患者作为研究对象,共1020例。收集研究对象3份痰标本,由实验室人员按要求对痰标本进行痰涂片和痰培养[17家单位使用罗氏固体培养检测819例患者,4家单位只使用BACTEC MGIT 960培养(检测151例)或其他液体培养(检测50例)]和CPA检测,评估CPA检测效能,并于试验结束后对实验室操作人员进行CPA检测技术可接受度问卷调查。结果 现场共纳入肺结核可疑症状的初诊患者1020例,涂阳患者334例,涂阴患者685例,1例无涂片结果。痰培养阳性率为45.3%(462/1020),CPA检测阳性率为47.6%(485/1019)。以培养法作为参照,CPA检测结核分枝杆菌的敏感度为89.8%(415/462),特异度为87.4%(487/557);在涂阳患者中,CPA检测结核分枝杆菌的敏感度为93.8%(289/308),特异度为34.6%(9/26);在涂阴患者中,CPA检测结核分枝杆菌的敏感度为81.8%(126/154),特异度为90.0%(478/531)。CPA检测法与固体(液体)培养法一致性较好(Kappa=0.769)。通过可接受度问卷调查,81.8%(18/22)的操作人员认为CPA检测操作比较容易和便捷;相比培养法,所有操作人员均认为CPA检测对实验室人员的感染风险较小。结论 CPA检测方法具有较高的敏感度和特异度,并且与培养法一致性较好,有助于早期、快速发现结核病患者,在我国结核病诊断发现中具有推广应用的前景。更多还原

【Abstract】 Objective To evaluate the efficiency and reliability of the cross priming amplication(CPA)test for pulmonary tuberculosis(PTB) in China. Methods A total of 1020 patients with suspected PTB from Feb. to Dec. 2015 were continuously enrolled from the outpatient departments of 21 medical institutions, such as Beijing Chest Hospital affiliated to Capital Medical University, Changping Tuberculosis Dispensary and Tianjin Haihe Hospital. Three sputum samples were collected from each recruited patient. Detection of Mycobacterium tuberculosis(MTB) by CPA was compared to a reference standard(roche solid culture method in 17 institutions for 819 patients; in the other 4 institutions, BACTEC MGIT 960 culture system for 151 cases and liquid culture system for 50 cases). Satisfaction survey of CPA Test was conducted after CPA test. Results Among the recruited 1020 PTB suspects, 334 were smear positive, whereas 685 were smear negative. Culture positive rate was 45.3%(462/1020), while CPA positive rate was 47. 6%(485/1019). The results showed that the sensitivity and specificity of the CPA test based on spot sputum for MTB detection were 89.8%(415/462) and 87.4%(487/557). The sensitivity and specificity of the CPA test in smear positive patients were 93. 8%(289/308) and 34. 6%(9/26), while those in smear negative patients were 81. 8%(126/154) and 90. 0%(478/531), respectively. The CPA test showed high consistency with solid(liquid) culture method(Kappa=0.769). According to the results of acceptability questionnaire survey, 81. 8%(18/22) of the manipulators believed that CPA test was easier and more convenient to operate and had lower infection risk for laboratory staff,compared with culture method. Conclusion CPA test had high sensitivity and specificity and also had a good consistency with culture. It’ll contribute to find out TB patients early and fast. CPA test has a good prospect for application in China.更多还原