人巨细胞病毒特异性免疫球蛋白原料血浆的筛选

用北京贝尔公司的人巨细胞病毒(HCMV)IgG检测试剂盒检测5~6月入库的武汉生物制品研究所(WIBP)下属四个浆站共7433份普通血浆,HCMV-IgG阳性率为36%~55%。建立内部参考品Pc1、Pc2、Pc3、Pc4,用德国赛润公司的HCMV-IgG定量检测试剂盒对内部参考品进行标定,效价分别为648、962、1757、2940PEI-U/ml。以A450值>Pc1为标准确定HCMV-IgG阳性的献血员名单,按照检疫期的要求,利用浆站管理系统软件查找献血员前3个月的血浆编号,统计建档。逐批检测符合检疫期的建档血浆,以A450值>Pc2为标准收集阳性血浆,以A450值>Pc3为标准投料,进行人巨细胞免疫球蛋白(HCMV-IG)的低温乙醇纯化。通过成品的中和试验结果决定收浆方案是否可行。

The sieving protocols of HCMV-IgG positive plasma for HCMV-IG production

7433 plasma samples from 4 plasma stations of WIBP were detected with Beijing Bayer ELISA kits in order to understand the ratio of positive HCMV-IgG plasma.The results showed that the positive rates of HCMV-IgG are between 36% to 55%.The inner references Pc1,Pc2,Pc3 and Pc4 were established and their potencies were standardised by German Serion HCMV-IgG quantitative ELISA kit,the titer is 648,962,1757 and 2940 PEI-U/ml respectively.The statistical form of positive HCMV-IgG donor was made in accordance with the standard of A450>Pc1.According to quarantining period demand,the serial number of plasma donor 3 months ago was looked for using the plasma station management system software with the aim of estabolishing archives.Each batch of HCMV-IgG plasma was detected and the positive plasma was collected in the light of the standard of A450>Pc2.The purification of HCMV-IgG was performed by low temperature ethanol technology.The feasibility of collecting plasma protocol was evaluated on the basis of the neutralization test result of final product.