【作者】 陈涛； 周琳； 周杰； 江勇； 周志刚； 彭建明； 文力； 彭东东； 何超文； 钟球；

【Author】 Chen tao~* Zhou lin~* Zhou Jie Jiang yong~* Zhou zhigangPengjianming Wen li PengdongdongZhongqiu~* *Antituberculosis Research Institute of Guangdong Province,Guangzhou 106130,China;* The Fourth People’s Hospital of Foshan City,*Chronic Disease Hospital of Dong Guan City,*Anti-tuberculosis Institute of Huizhou City *Anti-tuberculosis Institute of Jianmen City *Anti-tuberculosis Institute of Shantou City, *Chronic Disease Hospital of Pan Yun District,Guang Zhou City。

【机构】 广东省结核病防治研究所； 佛山市第四人民医院； 东莞市慢性防治院； 惠州市结核病防治所； 江门市结防所； 汕头市结核病防治所； 广州番禺区慢性病防治院；

【摘要】 目的建立环介导等温扩增法(LAMP法)用于结核分枝杆菌临床快速检测方法,评估并验证该方法在结核病临床诊断中的效能。方法选取广东6地市专业结防机构的临床检验科的肺结核疑似病人的痰标本1496份,分别采用直接涂片法,罗氏固体培养法及LAMP法检测痰标本中结核分枝杆菌;另随机广州、汕头两市337例的痰标本浓缩处理后进行qPCR及LAMP两种方法检测。结果 1496例痰标本中,直接涂片法、罗氏固体培养法和LAMP法的阳性检出率分别为18.9%、32.4%和30.4%;同罗氏培养法相比,LAMP法灵敏度、特异性、阳性和阴性预测值分别为93.2%、96.2%、92.4%和96.7%;337例浓缩处理后的痰标本qPCR阳性率为35.1%,LAMP阳性率为35.9%;LAMP法同直接涂片法检测、罗氏固体培养法和qPCR法比较,检测结果一致率分别为86.4%(K=0.644)、91.8%(K=0.819)和91.4%(K=0.812)。结论 LAMP法用于痰标本中结核分枝杆菌检测效能同罗氏培养法及qPCR法相当,同直接涂片法相比,LAMP法能够大幅提高阳性检出率;另外,LAMP法不仅检测周期短,操作简单,而且不需要特殊昂贵仪器,因此,具有很好的应用和推广前景。更多还原

【Abstract】 Objective:loop-mediated isothermal amplification(LAMP) method was established for rapid detection of Mycobacterium tuberculosis and this method was applied in the clinical diagnosis of tuberculosis.Methods:1496sputum samples of suspected TB patients from 6 cities in Guangdong Provinceand 337 enrichment sputum samples randomly selected from Guangzhou and Shantou cities were collected.M. tuberculosis of 1496sputum samples were detected by smear,Roche solid culture and LAMP methods and M tuberculosis of 337 sputum samples were detected by qPCR and LAMP methods,respectively.ResuIts:For 1496 sputum samples,the positive detection rate of smear,cultureand LAMP methods were 18.9%,32.4%and 30.4%,respectively.Compared with the Roche culture method,sensitivity value,specificity value,positive and negative predictive values of the LAMP method were 93.2%,96.2%,92.4%and 96.7%,respectively.For 337 enrichment sputum samples,the positive detection rate of qPCR and LAMP methods were 35.1%and 35.9%, respectively.Compared LAMP with smear,culture and qPCR methods,the consistent rate of the results were 86.4%(K = 0.644),91.8%(K=0.819) and 91.4%(K = 0.812),respectively.Conclusion:The LAMP method was equivalent to culture and qPCR,but superior to smear method in detectingM tuberculosis of sputum specimens.In addition,LAMP method showed the advantages of rapid,simple operation and non-equipment, indicating that good prospects for clinical application and promotionin the diagnosis of tuberculosis.更多还原