甲型H1N1流感病毒核酸国家参考品的研制  

Preparation of National Reference Panel of Influenza A (H1N1)Virus Nucleic Acid

作　　者：范行良[1] 李长贵[1] 王大燕[2] 方捍华[1] 李凤翔[1] 白东亭[1] 王军志[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]中国疾病预防控制中心病毒病预防控制所,北京100052

出　　处：《中国生物制品学杂志》2009年第12期1193-1195,共3页Chinese Journal of Biologicals

基　　金：科技部甲型H1N1流感联防控应急科研项目(2009BAKYJ002)

摘　　要：目的研制甲型H1N1流感病毒核酸国家参考品。方法收集甲型H1N1流感病毒及其他病毒培养物,用实时荧光PCR方法逐一进行验证。参考品通过协同标定,确定最低检出限范围,7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3株病毒经实时荧光PCR验证,特异性良好,经基因芯片进一步验证,均为甲型H1N1流感病毒,且无其他病毒核酸污染,经7家单位检测,符合国家参考品标准要求;反复冻融3次后,稳定性良好。结论建立了第1套甲型H1N1流感病毒核酸国家参考品及相应的质量标准,并已被国家有关部门批准正式使用。Objective To prepare national reference panel of influenza A（H1N1）virus nucleic acid. Methods The cultures of influenza A （H1N1）virus and other influenza viruses were collected and verified individually by real-time fluorescent PCR. The reference panels were collaboratively calibrated to determine the minimum detection limit, then tested for adaptivity by 7 laboratories, and observed for stability by repeat freezing and thawing. Results Three virus strains showed high specificities by real-time fluorescent PCR and was further verified as influenza A （H1N1）virus free from contamination with other viral nucleic acids by gene chip technique. The test results by 7 laboratories proved that the reference met the requirements for national reference panel. The reference showed good stability after 3 cycles of freezing and thawing. Conclusion The first generation of national reference panel of influenza A （H1N1）virus nucleic acid as well as the relevant quality standard were established and approved by the state departments concerned.

关 键 词：甲型H1N1流感病毒 核酸 国家参考品 

分 类 号：R373.13[医药卫生—病原生物学]