结核病与肺部健康杂志 ›› 2018, Vol. 7 ›› Issue (4): 284-287.doi: 10.3969/j.issn.2095-3755.2018.04.012

• 论著 • 上一篇    下一篇

交叉引物扩增技术在结核病诊断中的应用

林百丰(),苏欣,张学志   

  1. 150030 哈尔滨,黑龙江省结核病预防控制中心参比实验室(林百丰、张学志); 黑龙江省五常市结核病防治所参比实验室(苏欣)
  • 收稿日期:2018-08-13 出版日期:2018-12-30 发布日期:2019-01-08
  • 通信作者: 林百丰 E-mail:linbaifeng2@163.com

Evaluation of cross primer amplification technique application in diagnosis of tuberculosis

Bai-feng LIN(),Xin SU,Xue-zhi ZHANG   

  1. Reference Laboratory, Heilongjiang Tuberculosis Control and Prevention Center, Harbin 150030, China(LIN Bai-feng)
  • Received:2018-08-13 Online:2018-12-30 Published:2019-01-08
  • Contact: Bai-feng LIN E-mail:linbaifeng2@163.com

摘要:

目的 探讨交叉引物扩增技术(crossing priming amplification,CPA)在结核病防治中的应用。方法 采集2017年5月至2018年3月五常市结核病防治所门诊初诊的疑似肺结核患者的痰标本,按照《WS 288—2008肺结核诊断标准》进行诊断,最终纳入267例肺结核患者,64例非结核性肺疾病患者。分别进行痰涂片、痰培养和CPA检测,分析CPA的检测效能。结果 331例患者中痰涂片检测阳性66例,阴性265例;痰培养阳性136例,阴性195例;CPA检测阳性137例,阴性194例。以痰培养检查结果为标准,CPA检测的敏感度和特异度分别为98.94%(186/188)、92.31%(132/143)。以临床诊断为标准,痰涂片检查的敏感度和特异度分别为23.97%(64/267)、96.88% (62/64),痰培养检查的敏感度和特异度分别为48.69% (130/267)、90.63% (58/64),CPA检查的敏感度和特异度分别为 51.31%(137/267)、96.88%(62/64)。结论 CPA是一种新型的结核恒温检测技术,具有操作简单、快速、稳定,检测结核分枝杆菌具有较高的敏感度和特异度,可以明显提高结核病病原学的阳性检出率,适合在县(区)级结核病实验室应用。

关键词: 结核,肺, 交叉引物扩增技术, 评价研究

Abstract:

Objective To explore amplification of cross primer amplification (CPA) technique in tuberculosis (TB) prevention and control.Methods Sputum specimens were collected from the TB suspects who visited TB clinic of Wuchang TB Dispensary for seeking health care during May 2017 to March 2018. Diagnosis to those TB suspects were performed following the WS 288-2008 Diagnostic Criteria for Tuberculosis. Finally 331 cases were confirmed as TB including 267 cases were pulmonary TB while 64 cases were extra-pulmonary TB. Sputum smear, sputum culture and CPA were performed for TB diagnosis and the effectiveness of CPA was evaluated.Results Among 331 confirmed TB cases, 66 cases were sputum smear positive while 265 cases were smear negative; 136 cases were sputum culture positive while 195 cases were culture negative; 137 cases were CPA positive while 194 cases were CPA negative. When culture was as the standard, the sensitivity and specificity of CPA were 98.94% (186/188) and 92.31% (132/143) respectively; when clinical diagnosis was as the standard, the sensitivity and specificity of sputum smear were 23.97% (64/267) and 96.88% (62/64), the sensitivity and specificity of sputum culture were 48.69% (130/267) and 90.63% (58/64), the sensitivity and specificity of CPA were 51.31% (137/267) and 96.88%(62/64).Conclusion CPA is a new thermostatically diagnostic technology for tuberculosis, which is simple, fast and stable. It has higher sensitivity and specificity on Mycobacterium tuberculosis detection, can significantly improve the positive detection rate of TB. It is suitable for application in tuberculosis laboratories at county/district level.

Key words: Tuberculosis, pulmonary, Crossing priming amplification, Evaluation research