| 摘要: |
| 按照国家一级标准物质要求和禽流感病毒H5亚型血凝抑制试验抗原制造及检验规程规定的抗原制备方法，研制了一批禽流感病毒H5亚型血凝抑制抗原国家参考品，该参考品用于检测AIV (H5亚型)制品生物效价和血凝抑制操作过程中的校验。该批抗原经过8家单位对其协作标定后对结果进行统计学分析，确定该批禽流感抗原的血凝效价为1: 80。另对所研制的禽流感抗原均一性、稳定性、无菌检验、剩余水分测定、真空度测定等各项指标进行检测，结果均符合禽流感病毒H5亚型血凝抑制试验抗原制造及检验规程和国家一级标准物质要求，说明该AIV (H5亚型)血凝抑制抗原可以作为国家参考品。 |
| 关键词: 禽流感病毒 H5亚型 抗原 参考品 |
| DOI： |
| 投稿时间：2013-11-27修订日期：2014-01-26 |
| 基金项目:“十一五”国家科技支撑计划项目(2006BAD06A10) |
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| Preparation of National Reference Material for Avian Influenza Virus(H5 subtype) Hemagglutination Inhibition Test Antigen |
| 胡井雷 |
| (Harbin Weike Biotechnology Development Co) |
| Abstract: |
| According to the related national standards and the rules of the avian influenza virus (H5 subtype) hemagglutination inhibition test antigen, national reference material for AIV (H5 subtype) HI test antigen was prepared. The reference product is used for detecting AIV (H5 subtype) products biological titer and calibration in the process of HI test. The HA titer of the reference product was studied collaboratively by 8 laboratories and the result was estimated by the statistical methods. The HA titer of this preparation was confirmed as 1:80. Appearance, sterility, specificity, residual moisture, vacuum degree, uniformity and stability were detected, and the results conformed to the rules. The reference product can be used as national reference material. |
| Key words: Avian influenza virus H5 subtype antigen Standard product |
