摘要
目的研制甲型流感病毒抗原检测试剂盒质控参考品。方法收集甲型流感病毒阳性样本、乙型流感病毒阳性样本和非流感病毒样本,采用流感病毒抗原检测试剂盒方法对样本进行验证。通过协同标定参考品,确定最低检出限范围,3家单位进行适用性检测。反复冻融观察其稳定性。结果所用的16株病毒经3家单位联合检测,特异性良好,均为甲型流感病毒,检测结果符合率为100%;反复冻融5次后,稳定性良好。结论建立了第1套甲型流感病毒抗原检测试剂盒质控参考品及相应的质量标准。
Objective To prepare the reference panel for influenza A H1N1 virus antigen. Methods The specimens of influenza A and B viruses as well as other viruses were collected and verified individually by hemagglutination assay. The reference panels were collaboratively calibrated to determine the minimum detection limit, then tested for adaptability by three laboratories, and observed for stability by repeat freezing and thawing. Results Sixteen influenza virus strains calibrated collaboratively by three laboratories showed high specificities, all of which were influenza A virus. The coincidence rate of detection results by three laboratories was 100%. The reference showed high stability after 5 cycles of freezing and thawing. Conclusion The first generation of reference panel for influenza A virus antigen as well as the relevant quality requirement were established.
出处
《中国生物制品学杂志》
CAS
CSCD
2014年第8期1039-1041,1047,共4页
Chinese Journal of Biologicals
基金
流感诊断产品的国家质控参考品和质控标准研究(2010AA022805)
