鸡新城疫血凝抑制试验用阳性血清国家标准品的研制

Preparation and characterization of the national standard for Newcastle disease Hemagglutination Inhibition Test positive serum, chicken

关键词:  鸡新城疫  阳性血清  国家标准品  HI效价测定

Key words:  Newcastle disease  anti-serum  the national standard  HI potency standardization

摘要:

为制备标定HI试验用的鸡新城疫阳性血清国家标准品,以鸡新城疫La Sota株病毒和灭活疫苗免疫SPF鸡制备鸡新城疫高免血清。将检验合格的鸡新城疫阳性血清以鸡阴性血清稀释为HI效价与NIBSC国际标准血清完全一致后,用于标准品制备。对该标准品进行了物理性状、无菌检验、真空度测定、剩余水分检验、均匀性检测和稳定性试验,检测结果均符合要求。以国际标准品为参比,测定了该标准品的HI效价为1:60“－”,与协作标定结果基本一致。该标准品以国际标准品溯源的国际单位含量为320 IU/mL。为鸡新城疫的研究提供了物质基础。

Abstract:

In order to prepare the national standard for anti- Newcastle disease serum used for calibrate the HI test, the hyper immunized serum on chicken Newcastle disease were prepared using NDV La sota strain virus and inactivated vaccine against NDV as antigen to immune twelve SPF chickens. The selected positive serum was diluted by the negative serum to the HI titer samed to the NIBSC international standard. The character, sterility, vaccum degree residual moisture, uniformity and stability of this standard material had been tested and proved to meet the requirement. Referring to the international standard, HI titer of this standard material was measured to be 1:60 “-”, which are identical with the collaborative assay results. International unit of the standard material is 320 IU/ mL.