重组人粒细胞集落刺激因子生物学活性标准品的免疫学活性测定

The determining of immunological activity for the biological standards of rhG CSF

目的测定重组人粒细胞集落刺激因子 (rhG CSF)生物学活性标准品的免疫学活性。方法用深圳晶美公司及美国R&D公司的G CSFELISA试剂盒分别对WHOrhG CSF生物学活性国际标准品、惠尔血针剂 75 (GRAN 75 )及用WHOrhG CSF生物学活性国际标准品标定过生物学活性的工作标准品T1、T2、T3进行免疫学活性测定。结果不同公司的rhG CSFELISA试剂盒对所测定样品的测定结果不同 ,且用不同稀释液稀释样品测定结果亦不同。结论用免疫学方法定量测定rhG CSF的含量是有条件的 ,且免疫反应能识别聚体但不能识别蛋白分子的降解。

PurposeThe aim is to determine the immunological activity of the biological standards for rhG CSF.MethodsThe immunological activity of WHO INTERNATIONAL STANDARD FOR G CSF,corresponding sample(GRAN 75),the biological working standard of T1,T2,T3 were measured respectively by G CSF ELISA kit of JINGMEI and R&D SYSTEMS. Results The results are variant between two G CSF ELISA kits and different dilution. ConclusionThere are some conditions which must be satistied by using the quantitatve immunoassay of the rhG CSF. The immunoassay could recognize the dipolymer but not the disaggregation.