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

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合格血浆的采集方案,本次1300份血浆初筛共获得合格献浆员23人,占比1.76%,获得对应的未出库的合格血浆152袋,其中15名为1年内连续献浆5次以上的献浆员,最长连续献浆时间达8个月。随机截取100份合格血浆的小样制备的合并血浆的VZV-IgG效价为5.5275 IU/mL,达到VZIG(IV)的投料标准(≥4.5000 IU/mL);用该方案采集合格的原料血浆预计减少血浆检测量约7336份,可以大幅缩小检测人群的范围,极大降低检测成本。结论采用追溯合格献浆员滚动采集较高效价VZV-IgG血浆的方案可用于小规模VZIG制备所需原料血浆的快速、高效采集。

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 been delivered out of the plasma bank.According to the list of No.2020(48 donors),only 79 plasma samples that had not been delivered out of the bank in 2022 corresponding to 15 qualified plasma donors were found,most of which showed a significant decrease in antibody potency after more than 2 years,and only one plasma donor's plasma was still qualified in 2022.According to the list of No.202201,42 plasma samples that had not been delivered out of the bank in 2022 corresponding to 8 qualified plasma donors,7 of them corresponding to 32 qualified plasma samples had stable high potency of VZV-IgG(the lowest potency>2.5000 IU/mL)and the longest retention time is 8 months.With the same plasma collection standard,15 qualified plasma donors were obtained in another 8 plasma stations(List 202202).According to the collection scheme of rolling collection of qualified plasma by tracing qualified plasma donors,in this preliminary screening of 1300 plasma samples,23 plasma donors with potency≥3.0000 IU/mL were obtained,accounting for 1.76%,and 152 bags of corresponding qualified plasma which were not delivered out of the bank were obtained,of which 15 were plasma donors who donated plasma more than 5 times continuously within a year,and the longest plasma continuous donation time was 8 months.The VZV-IgG potency of pool plasma was 5.5275 IU/mL,which reached the feeding standard of VZIG(IV)(≥4.5000 IU/mL).Using this scheme to collect qualified material plasma was expected to reduce the amount of plasma detection by about 7336 test,which can greatly reduce the scope of detection population and greatly reduce the detection cost.Conclusion The scheme of rolling collection for plasma with high potency of VZV-IgG by tracing qualified plasma donors can be used for rapid and efficient collection of material plasma needed for small-scale VZIG preparation.