禽流感病毒H9亚型血凝抑制试验抗原国家参考品的研制

Preparation of National Reference Material for Avian Influenza Virus (H9 subtype) Hemagglutination Inhibition Test Antigen

按照国家一级标准物质要求,研制了一批禽流感病毒H9亚型血凝抑制试验抗原国家参考品,批号为200901。对其物理性状、无菌、效价、特异性、水分、真空度、均一性、稳定性等进行了测定,各项指标均符合要求。经过8家单位对其协作标定,并经统计学分析,该批抗原血凝效价为1∶(460±80),最终定值为1∶400。该禽流感病毒H9亚型血凝抑制试验抗原可以作为国家参考品。

According to requirements, national reference material （batch number： 200901 ） for avian influenza virus （H9 subtype） hemagglutination inhibition test antigen was prepared. Appearance, sterility, specificity, residual moisture, vacuum degree, uniformity and stability were detected. The HA titer of the preparation was studied collaboratively by 8 laboratories and the result was estimated by the statistical methods. The result is 1 ： （460 ± 80）, and the HA titer is defined as 1 ： 400. The preparation can be used as national reference material.