摘要
H5N1病毒高度变异,为确保本中心研制的H5N1禽流感病毒抗原快速诊断试剂对不同变异分支的H5N1病毒,特别是实时流行株的高度检测准确性,本研究根据抗原活性变异情况对中心开发的第一代H5抗原快速诊断试剂进行了改进。改进后的第二代H5抗原快速诊断试剂(H5-Dot-2nd)对25株代表亚洲地区流行的不同进化分支的H5N1禽流感病毒检测均为阳性,其中12株检测下限达到0.01HA;而对20株32HA滴度的非H5亚型流感病毒株检测均为阴性;不同机构的评价结果显示,H5-Dot-2nd的灵敏度比国外同类试剂高出10～1000倍,对非H5现场标本特异性达到99.0%(399/403)。上述结果提示,H5-Dot-2nd对历年来特别是当前流行株均具有很好的检测灵敏度,能更好地满足流感疫情监控的需要。
The HA of influenza virus mutants quickly.To make sure the H5-HA(Ag) Dot-ELISA can effectively detect representative H5N1 virus strains,we improve the H5-Dot-1st by analyzing HA antigen variation.H5-Dot-2nd can detect all of the 25 representative H5N1 virus strains in the allantoic fluid from different genetic groups(clades or subclades),the detect limit of 12 virus strains is 0.01HA.It also showed the nice specificity for 20 non-H5 virus.Evaluation results of different organization showed that the sensitivity of the H5-Dot-2nd was 10～1000 times higher than the similar kits,and its specificity for non-H5 virus in field samples was 99%(399/403).These results suggest that H5-Dot-2nd is an acceptable detection test for early detection of H5N1 infection,has great significance to monitor the influenza epidemic situation.
基金
福建省科技计划重点项目(2008Y0059)
厦门市科技计划社会发展项目(3502Z20073001)
