流感快检试剂盒在流感监测中的应用分析

Analysis of application of rapid-detection kit for influenza A virus

目的为了应对流感疫情暴发时基层医疗组织流感检测的需要,对甲型流感病毒抗原诊断试剂盒(免疫渗滤法)及新甲型H1N1流感病毒血凝素(hemagglutinin,HA)抗原检测试剂盒(酶联免疫法)的临床应用可行性进行了分析。方法以两种快检试剂盒分别检测100份和120份临床咽拭子样本,同时与实时荧光定量PCR结果进行比较,并通过基因测序进一步确证。结果甲型流感病毒抗原诊断试剂盒检测临床100份咽拭子,其阳性符合率达84.00%、阴性符合率达100.00%,总符合率达92.00%;利用新甲型H1N1流感病毒HA抗原检测试剂盒检测临床120份咽拭子,其阳性符合率达54.12%、阴性符合率达100.00%,总符合率达67.50%。两种试剂盒阳性检出率与样本中病毒载量呈正相关,并且两种快检试剂盒的检测临界值分别为1.0×103以及1.5×103个拷贝数。结论甲型流感病毒抗原诊断试剂盒特异性强、灵敏度高、简便快捷,具有广泛的应用价值,而新甲型H1N1流感病毒HA抗原检测试剂盒的特异性、灵敏度较低一些,在没有PCR仪的现场及基层单位,对于样本的初筛具有一定的实用性,可为流感应急监测方案的制定提供一定的实验室依据。

Objective To meet the need of influenza A virus surveillance in basic medical units in epidemic situation, the evaluation of the application of two rapid-detection kit respectively for influenza A virus and pandemic H1N1 was carried out to provide the laboratory evidence for generating strategies of influenza A virus surveillance. Methods 100 throat swab samples obtained from suspected cases of influenza A virus infection were detected simultaneously with rapiddetection kit for influenza A virus and real-time RT-PCR. All samples were confirmed by sequencing. The same compared method was applied to 120 throat swab samples with rapid-detection kit for pandemic H1N1 virus. Results Compared with real-time RT-PCR, the positive accordance and negative accordance rates of rapid-detection kit for influenza A virus were 84.00 % and 100.00 % respectively, the whole accordance rate was 92.00 %. At the same time, these three accordance rates of the rapid-detection kit for pandemic H1N1 virus were 54.12 % , 100.00 % and 67.50 % respectively. The positive rate of two rapid-detection kits was positively correlated with virus load, and the critical values were 1.0 × 103 copies and 1.5× 103 copies respectively. Conclusions The specificity and sensitivity of the rapid-detection kit for influenza A virus were higher than the rapid-detection kit for pandemic H1N1 virus. Both of these two kits could be applied in the basic medical units which are lack of PCR machines.