免疫层析法用于甲型H1N1流感病毒抗原筛查的初步评价

Primary evaluation of immunochromatographic assay for the screening of influenza A virus H1N1 antigen

目的评估免疫层析法检测甲型H1N1流感病毒抗原的准确性,推广免疫层析法在甲流H1N1抗原检测中的临床应用。方法收集2009年8至12月广东省中医院356例甲型H1N1流感疑似患者的鼻拭子标本,采用免疫层析法进行甲型H1N1流感病毒抗原的快速检测,同时将患者咽拭子送往广州市疾病预防控制中心(CDC)进行甲型H1N1流感病毒核酸检测。结果 356例甲型H1N1流感疑似病例标本中,免疫层析法阳性108例,CDC确诊阳性92例;免疫层析法阴性248例,CDC确诊阴性264例。免疫层析法敏感性为96.7%,特异性为92.8%,假阳性率为17.6%,假阴性率为1.2%。结论免疫层析法操作简便,能对甲型H1N1流感患者进行快速筛查,但存在一定的假阳性和假阴性,因此,不能作为确证方法。

Objective To evaluate the accuracy of the immunochromatographic assay for the detection of influenza A virus H1N1 antigen, and use it into clinical application. Methods 356 nasal mucus samples from patients suspected with influenza A were collected frmn Guangdong Provincial Hospital of Chinese Medicine from August to December 2009. The influenza A virus H1 N1 antigen was detected by the immunochromatographic assay. The patients＇ pharynx samples were send to Guangzhou Center for Disease Control and Prevention （CDC） for the detection of influenza A virus H1N1 gene. Results The results showed that 108 cases were positive of influenza A virus H1N1 antigen by the immunochromatographic assay, and 92 cases were confirmed as positive of influenza A H1 N1 gene in CDC. There were 248 cases with negative influenza A H1N1 antigen, and 264 cases were confirmed by influenza A H1N1 gene. The sensitivity, specificity, false positive rate and false negative rate were 96. 7%, 92. 8%, 17, 6% and 1. 2%, respectively. Conclusions The immunochromatographic assay is rapid and simple for screening influenza A virus H1N1. However, the assay may show some false positive and negative results, and it can＇t be used for confirmatory test.