环介导等温扩增法对痰标本中结核分枝杆菌检测效果的评估  

Evaluation of the loop-mediated isothermal amplification method for detecting M. tuberculosis in sputum specimens

作　　者：丁卫忠[1] 陈巍[2] 石莲[2] 梁秋[2] 李玲[2] 孙德斌[2] 王悦[1] 张申富 孙娇[1] 谭珂[1] 孙炳奇[1] 冈田耕辅 野口典久 安中敏光 吴邦杰 

机构地区：[1]沈阳市胸科医院结核病实验室,110044 [2]沈阳市胸科医院结核科,110044 [3]日本结核预防会国际部 [4]日本荣研化学株式会社企划部

出　　处：《中国防痨杂志》2016年第10期818-822,共5页Chinese Journal of Antituberculosis

摘　　要：目的评价环介导等温扩增法（loop-mediated isothermal amplification，Lamp）对结核分枝杆菌快速检测效果的临床验证与应用，评估该方法在结核病临床诊断中的效能。方法选取本院临床诊断结核病患者的痰标本483份，分别采用直接涂片法、固体培养法、液体培养法及Lamp法检测痰标本，并应用χ^2检验对不同方法的检测结果进行统计分析，P〈0.05为差异有统计学意义。结果在483例结核病患者痰标本中，以传统检测方法（涂片＋培养）为标准进行比较，Lamp检测的敏感度为84．67％[232／（232＋42）]，特异度为87．08％[182／（27＋182）]，阳性预测值为89．58％[232／（232＋27）]，阴性预测值为81．25％[182／（42＋182）]，一致性为85．71％[（232＋182）／483]。在干酪样痰标本中，Lamp和传统检测方法的阳性检出率分别为77．96％（145／186）和77．42％（144／186），均高于黏液痰的阳性率[38．46％（110／286）和42．66％（122／286）]（χ^2=70．78和χ^2=53．05，P值均〈0．01）。结论与传统检测方法比较，Lamp对结核分枝杆菌的检出，具有良好的敏感度、特异度和一致性。Lamp对于酪样痰标本的检出阳性率高于传统检测方法，而对于同一性状的标本检测，两种方法之间并无显著差异。Objective To evaluate the diagnostic value of loop-mediated isothermal amplification （Lamp） method for rapid detection of Mycobacteriurn tuberculosis. Methods Four hundred and eighty-three sputum samples were collected from clinically diagnosed TB patients in our hospital, and samples were examined by smear, liquid culture, solid culture and Lamp methods to detect Mycobacterium tuberculosis. Results from different testing methods were compared using the χ^2 test. Results For the 483 specimens tested, the sensitivity of Lamp was 84.67% （232/（232＋42））, and the specificity was 87.08% （182/（27＋ 182））. The positive predictive value was 89.58% （232/（232＋27））, the negative predictive value was 81.25% （182/（42＋182））, and the consistency was 85.71% （（232＋182）/483）. For caseous sputum samples, the positive detection rate was 77.96M （145/186） and 77. 420//00 （144/186） by Lamp and bacteriological testing methods, respectively, and was higher than that for mucus sputum, which was 38.46% （110/286） and 42.66% （122/286）, respectively （χ^2 =70.78, P〈0.01 and χ^2 =53.05, P〈0.01）. Conclusion The Lamp method had a comparably high positive detection rate for Mycobacterium tuberculosis as smear and liquid culture methods, and showed good sensitivity, specificity and consistency. For caseous sputum samples, the positive detection rate of Lamp was higher than that for bacteriological testing, and test results for Lamp-TB and bacteriological methods on the same sputum samples was not significantly different.

关 键 词：核酸扩增技术 分枝杆菌 结核 结核 肺 细菌学技术 评价研究 

分 类 号：R378.911[医药卫生—病原生物学]