抗C(IgM)血型定型试剂国家参考品的研制  

Development of national reference for anti-C(IgM)blood grouping reagent

作　　者：胡泽斌[1] 孙彬裕[1] 高飞[1] 孙楠[1] 贾峥[1] 张文新 孙晶 黄杰[1] 曲守方[1] HU Ze-bin;SUN Bin-yu;GAO Fei;SUN Nan;JIA Zheng;ZHANG Wen-xin;SUN Jing;HUANG Jie;QU Shou-fang(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院体外诊断试剂检定所,北京100050

出　　处：《中国生物制品学杂志》2020年第10期1139-1142,共4页Chinese Journal of Biologicals

基　　金：国家科技重大专项(2018ZX10732401-003-009)。

摘　　要：目的研制抗C(IgM)血型定型试剂(单克隆抗体)效价测定用国家参考品。方法筛选抗C(IgM)杂交瘤细胞,获得培养上清液,根据效价进行稀释,经冻干为国家参考品。对其进行分装均匀性、冻干后的外观、水分、效价检测,并联合多家实验室进行协作标定,同时进行瓶间精密度及热稳定性检测。结果国家参考品为白色冻干粉末,复溶后外观为无色或淡黄色透明液体,平均水分含量为1.70%,分装瓶间均匀性良好。经协作标定,抗C血型定型试剂(单克隆抗体)对CC红细胞的效价为1∶16,对Cc红细胞的效价为1∶8。瓶间精密度效价检测结果均一致。参考品于37℃放置3、7、14 d后,与-20℃保存的参考品效价一致。结论成功制备了抗C(IgM)血型定型试剂(单克隆抗体)国家参考品,可用于抗C(IgM)血型定型试剂(单克隆抗体)效价检测的质量控制。Objective To develop the national reference for anti-C(IgM)blood grouping reagent(monoclonal antibody).Methods Anti-C(IgM)hybridoma cells were screened,and the obtained culture supernatant was diluted according to the titer and lyophilized as the national reference material.The reference was tested for homogeneity during filling as well as appearance,moisture content and titer after lyophilization,calibrated collaboratively by several laboratories,and evaluated for the precision between containers and thermal stability.Results The national reference was a white freeze-dried powder,which was a colorless or light yellow transparent liquid after reconstitution,at a mean moisture content of 1.70%and with good homogeneity between containers.Collaborative calibration showed that the titer of the reference was 1∶16 for CC red blood cells and 1∶8 for Cc red blood cells.The test results of the precision between containers were in agreement.The titers of the reference after storage at 37℃for 3,7 and 14 d were consistent with that at-20℃.Conclusion The national reference for anti-C(IgM)blood grouping reagent(monoclonal antibody)was successfully developed,which might be used for the quality control of the reagent.

关 键 词：血型定型试剂 冻干 效价 国家参考品 协作标定 

分 类 号：R44[医药卫生—诊断学]