Jia Ning, Yan Zhong-qiang, Liu Gang, Shen Ding-xia, Suo Ji-jiang, Xing Yu-bin, Gao Yan, Liu Yun-xi
Department of Infection Management and Disease Control, General Hospital of PLA, Beijing 100853, China.
Nan Fang Yi Ke Da Xue Xue Bao. 2010 Oct;30(10):2267-9.
To evaluate the diagnostic efficiency of colloidal gold and dot ELISA rapid tests in clinical screening of influenza A virus.
The pharyngeal swabs were collected from 297 outpatients suspected of influenza between June and October, 2009 for detection with colloid gold and dot ELISA rapid test, with real-time PCR as the golden methods. The discrepant results of colloid gold and dot ELISA methods were confirmed by sequencing, and the diagnostic efficiency of the two methods was evaluated.
Among the 166 samples with influenza A virus infection as confirmed by real-time PCR and sequencing, the diagnostic sensitivity of dot ELISA and colloid gold methods was 54.82% (91/166) and 4.22% (7/166), respectively. The total concordance rate with PCR was 66.67% (Kappa value of 0.35). Among the 133 samples negative for influenza A virus, the specificity of dot ELISA and colloid gold methods was 81.68% (107/131) and 98.47% (129/131), respectively, with a total concordance rate with PCR of 45.79% (Kappa value 0.02). Of the 99 H1N1 influenza samples confirmed by real-time PCR, the detection rate of dot ELISA was 67.3%, whereas that of colloid gold was 5.1%. Out of the 107 dot ELISA-positive but colloid gold-negative samples, 84 were confirmed to be influenza A virus-positive by real-time PCR and sequencing. One sample negative for dot ELISA but positive for colloid gold test was confirmed to be influenza A virus-negative. The detection rate and diagnostic concordance rate for influenza A virus by dot ELISA were significantly higher than those of colloid gold (P<0.05).
Dot ELISA is better than colloid gold in influenza A virus detection and shows great prospect in clinical screening.
评估胶体金和斑点酶联免疫吸附试验（dot ELISA）快速检测法在甲型流感病毒临床筛查中的诊断效率。
收集2009年6月至10月期间297例疑似流感门诊患者的咽拭子，采用胶体金和斑点酶联免疫吸附试验快速检测法进行检测，并以实时荧光定量聚合酶链反应（real-time PCR）作为金标准方法。对胶体金法和斑点酶联免疫吸附试验法结果不一致的样本进行测序确认，评估两种方法的诊断效率。
在经实时荧光定量聚合酶链反应和测序确诊为甲型流感病毒感染的166份样本中，斑点酶联免疫吸附试验法和胶体金法的诊断敏感性分别为54.82%（91/166）和4.22%（7/166）。与PCR的总符合率为66.67%（Kappa值为0.35）。在133份甲型流感病毒阴性样本中，斑点酶联免疫吸附试验法和胶体金法的特异性分别为81.68%（107/131）和98.47%（129/131），与PCR的总符合率为45.79%（Kappa值0.02）。在经实时荧光定量聚合酶链反应确诊的99份H1N1流感样本中，斑点酶联免疫吸附试验法的检出率为67.3%，而胶体金法为5.1%。在107份斑点酶联免疫吸附试验法阳性但胶体金法阴性的样本中，84份经实时荧光定量聚合酶链反应和测序确诊为甲型流感病毒阳性。1份斑点酶联免疫吸附试验法阴性但胶体金试验法阳性的样本经确诊为甲型流感病毒阴性。斑点酶联免疫吸附试验法对甲型流感病毒的检出率和诊断符合率均显著高于胶体金法（P<0.05）。
斑点酶联免疫吸附试验法在甲型流感病毒检测方面优于胶体金法，在临床筛查中具有广阔前景。
