追溯合格献浆员滚动采集较高效价水痘-带状疱疹病毒IgG血浆的可行性分析  

Feasibility analysis of rolling collection for plasma with higher potency of varicella-zoster virus IgG by tracing qualified plasma donors

作　　者：周志军 陈丽梅 岳胜兰 宋池忠 张胜平 汪菲菲 李娟 李策生 胡勇 张金 ZHOU Zhijun;CHEN Limei;YUE Shenglan;SONG Chizhong;ZHANG Shengping;WANG Feifei;LI Juan;LI Cesheng;HU Yong;ZHANG Jin(Scientific Research and Development,Sinopharm Wuhan Biopharmaceuticals Co.,Ltd.,Wuhan 430207,Hubei Province,China)

机构地区：[1]国药集团武汉生物制药有限公司科研开发部,湖北武汉430207

出　　处：《微生物学免疫学进展》2024年第4期34-41,共8页Progress In Microbiology and Immunology

基　　金：湖北省中国科学院科技合作专项。

摘　　要：目的通过筛选合格献浆员、确定较高效价水痘-带状疱疹病毒(varicella-zoster virus,VZV)-IgG的维持时间并追溯合格献浆员的在库血浆,建立快速、高效的合格原料血浆采集方案,用于静脉注射水痘带状疱疹人免疫球蛋白[human varicella zoster immune globulin for intravenous administration,VZIG(IV)]的制备。方法随机抽取本公司辖属5个浆站的血浆留样,每个浆站随机抽取100份,用已经建立并验证的VZV-IgG定量ELISA检测VZV-IgG,筛选出VZV-IgG效价≥3.0000 IU/mL的合格血浆,并建立合格血浆对应的献浆员名单(编号202201);按照名单202201与2020年筛选的合格(以VZV-IgG效价≥1.5000 IU/mL为合格血浆标准)献浆员名单(编号2020),在本公司2022年12月尚未出库的血浆中找到名单中献浆员对应的所有未出库血浆,取小样检测VZV-IgG效价,2轮检测结果汇总,确定VZV-IgG效价稳定保持的时间,按照更新合格献浆员名单的同时滚动收集其对应的未出库血浆的流程建立合格血浆采集方案。按照该方案在本公司辖属另外8个浆站中筛选出更多合格献浆员(名单编号202202)和合格血浆。随机截取100份合格血浆留样进行混合,检测其VZV-IgG效价,确定原料血浆筛选标准是否合理;汇总1300份血浆的VZV-IgG效价检测结果,计算较高效价VZV-IgG在健康人群中的比例,进行部分成本核算。结果按照202201和2020合格献浆员名单共追溯到121份未出库的合格献浆员血浆,其中202001名单(48人)中仅有15名合格献浆员,在2022年未出库血浆中找到79份血浆,大部分献浆员超过2年后血浆中的抗体效价明显下降,仅有1名献浆员的血浆在2022年仍然合格;202201名单的8名合格献浆员中有7人对应的32份血浆保持较高效价VZV-IgG(最低效价>2.5000 IU/mL),保持时间最长为8个月;以同样的收浆标准检测其余8个浆站800份血浆获得15名合格献浆员(名单编号202202)。按照追溯合格献浆员滚动收集�Objective To quickly and efficiently screen qualified plasma for the development of Human varicella zoster immune globulin for intravenous administration[VZIG(IV)]by screening qualified plasma donors,determing the maintenance time of higher potency of VZV-IgG and tracing the plasma of qualified plasma donors in the plasma bank.Methods The VZV-IgG potency of plasma samples in the station under the jurisdiction of the company was detected by the established and verified VZV-IgG quantitative ELISA.Five plasma stations were randomly selected,and 100 plasma samples per plasma station were randomly selected for VZV-IgG detection.Qualified plasma with VZV-IgG potency≥3.0000 IU/mL was screened and the corresponding list of plasma donors(No.202201)was established.According to the list No.202201 and the list of qualified plasma donors screened in 2020(with VZV-IgG potency≥1.5000 IU/mL as the qualified plasma standard)(No.2020),all the plasma of the corresponding plasma donors in the company's plasma bank that had not been delivered before December 2022 was found and the VZV-IgG potency of plasma sample were detected.The results of two rounds of detection were summarized to judge the stable maintenance time of VZV-IgG.According to the process of updating the list of qualified plasma donors and rolling collection of their corresponding undelivered plasma,a qualified plasma collection scheme was established.According to this scheme,more qualified plasma donors(No.202202)and qualified plasma were screened out from another 8 plasma stations under the jurisdiction of the company.100 qualified plasma samples were randomly intercepted and mixed,and its VZV-IgG potency was detected to determine whether the screening standard of material plasma was reasonable.Summarize the results of 1300 plasma's VZV-IgG potency,calculate the proportion of higher potency VZV-IgG in healthy people,and make partial cost accounting.Results The list No.202201 and No.2020 were traced back to 121 plasma samples of qualified plasma donors who had not

关 键 词：水痘-带状疱疹病毒 IGG 效价 献浆员 原料血浆 ELISA 

分 类 号：R392-33[医药卫生—免疫学]