人巨细胞病毒特异性免疫球蛋白原料血浆的筛选  

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

作　　者：彭良俊[1] 林连珍[1] 高菲[1] 方亮[1] 李策生[1] 周志军[1] 

机构地区：[1]武汉生物制品研究所,武汉430060

出　　处：《微生物学免疫学进展》2009年第4期14-18,共5页Progress In Microbiology and Immunology

摘　　要：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。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 Pe1 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 〉 Pcl. 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 eoBeeted 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.

关 键 词：人巨细胞病毒IgG 内部参考品 效价 浆站管理系统软件 检疫期 

分 类 号：R392[医药卫生—免疫学]