禽流感病毒(H5N1亚型,Re-5株)血凝抑制抗原国家参考品的制备

Preparation of national reference material for the hemagglutination inhibition antigen of the Re-5 strain from the H5N1 subtype avian influenza virus

为了研制用于禽流感病毒(AIV)H5N1亚型Re-5株重组疫苗检测的血凝抑制(HI)抗原参考品,试验采用国家现行的AIV H5亚型HI抗原制备方法,研制出AIV(H5N1亚型,Re-5株)血凝抑制抗原参考品,批号为200901。结果表明:经过8家单位对AIV(H5N1亚型,Re-5株)血凝抑制抗原协作标定,确定该批禽流感抗原的血凝效价为1∶(320±80);所研制的禽流感抗原均一稳定,无菌检验、剩余水分测定、真空度测定等各项指标均符合要求。说明该AIV(H5N1亚型,Re-5株)血凝抑制抗原可以作为国家参考品。

To develop the reference material of hemagglutination inhibition（HI） antigen for the detection of the recombinant vaccine of Re -5 strain from the HSN1 subtype avian influenza virus （ AIV）, the existing national method for the preparation of hemagglutination inhibition（HI） antigen of the H5 subtype AIV was used to develop the reference material of the HI antigen of the Re - 5 strain from the H5N1 subtype A[V （ batch number 200901 ）. The results showed that the HA titer of the batch of the preparation was determined as 320 ：t： 80 using cooperative calibration by 8 laboratories and statistical analysis. In addition, this preparation was qualified in uniform and stability, and the indicators from sterile test, the determination of residual moisture and the degree of vacuum measurement etc. were detected, which could meet the require- ments. The results indicate that this preparation can be used as the national reference material.