摘要
目的评估快速核酸提取环介导等温扩增检测（PURE-LAMP）技术在肺结核临床诊断中的应用价值。方法选取2012年4月至2013年1月在河南省新乡市结核病防治所和获嘉县疾病预防控制中心就诊的初诊肺结核可疑症状者作为研究对象，共1378例。每例患者留取3份痰标本，分别进行痰涂片镜检、固体培养和PURE-LAMP检测。以临床诊断结果为标准，比较痰涂片镜检、固体培养和PUREI．AMP法检测MTB的效能；以固体培养试验结果为标准，评估PURKLAMP检测MTB的效能。结果以临床诊断结果为标准，痰涂片镜检、固体培养和PURE-LAMP检测MTB的敏感度分别为23．40％（168／718）、58．91％（423／718）和49．44％（355／718）。PURE-LAMP检测敏感度高于痰涂片镜检（X2=185．02，P=0．000），但低于固体培养试验（X2=46．24，P=0．000）。以固体培养试验结果为标准。PURE-I。AMP检测MTB的敏感度和特异度分别为90．24％（333／369）和96．86％（924／954），涂阴患者中检测敏感度和特异度分别为82．52％（170／206）和97．06％（924／952）。结论PUREIrAMP检测操作简单，敏感度和特异度较高，在我国县（区）级结核病防治机构具有一定的应用前景。
Objective To evaluate the rapid nucleic acid extraction loop-mediated isothermal amplification technology （PURE-LAMP） in the diagnosis of pulmonary tuberculosis （TB）. Methods A total of 1378 TB sus- pects were continuously recruited in Xinxiang tuberculosis dispensary and Huojia CIX; from April 2102 to January 2013, three sputum specimens collecting from each patient were examined by smear, solid culture and PURE-LAMP. Then, compare sensitivities of smear, solid culture and PURE-LAMP based on the diagnosis and evaluate the sensi tivity of PURE LAMP according to solid culture result. Results Based on the diagnosis, the sensitivities of smear microscopy, solid culture and PURE-LAMP were 23.40% （168/718）, 58. 91G （423/718） and 49.44% （355/718）, respectively. The sensitivity of PURE LAMP was higher than that of smear （X2 = 185.02, P= 0. 000）, but lower than that of solid culture （X2 =46.24, P=0. 000）. Based on solid culture result, the sensitivity and specificity of PURE-LAMP were 90.24% （333/369） and 96.86% （924/954）, respectively; while the sensitivity and specificity in smear negative patients were 82. 52%o （170/206） and 97.06G （924/952）, respectively. Conclusion PURE-LAMP is easily operated, its sensitivity and specificity is relatively higher. It should be widely used in tuberculosis dispensary at county （district） level.
出处
《中国防痨杂志》
CAS
2016年第5期393-397,共5页
Chinese Journal of Antituberculosis
基金
中国卫计委与比尔及梅琳达·盖茨基金会结核病防治项目（200904-01）
关键词
分枝杆菌
结核
核酸扩增技术
诊断
Mycobacterium tuberculosis
Nucleic acid amplification technique
Diagnosis
