摘要
目的探讨血液单采浆技术在新型冠状病毒肺炎(Coronavirus Disease 2019,COVID-19)康复者恢复期血浆采集工作中的应用及安全性,并分析COVID-19康复者恢复期血浆的质量特征。方法捐献者知情后,登记捐献血浆者性别、年龄、出院或解除医学隔离日期等基本情况,体检后使用血液分离机单采浆技术采集COVID-19康复者恢复期血浆,进行亚甲蓝病毒灭活,并进行重症急性呼吸综合征冠状病毒2(severe acute respiratory symptom coronavirus 2,SARS-CoV-2)核酸及抗体(RBD-IgG)等检测。结果采集过程顺利,过程中和采集后随访,均未报道血浆采集相关严重不良事件。捐献者平均年龄为38岁(n=933),收集到的COVID-19康复者恢复期血浆Rh阳性血型分布中A、B、AB、O型比例分别为33.4%、29.2%、10%和27.2%。捐献血浆日期距离出院日期平均为18 d。COVID-19康复者血浆SARS-CoV-2核酸检测均为阴性,SARS-CoV-2抗体滴度大于1∶160的比例为92.60%。结论单采血浆技术安全可靠。COVID-19康复者恢复期血浆含有高滴度抗体,大规模采集制备抗SARS-CoV-2病毒灭活血浆可对COVID-19救治发挥重要作用。
Objective To explore the application and safety of apheresis technology in collection of Coronavirus Disease 2019(COVID-19)convalescent plasma(CP),and to analyze the quality characteristics of the plasma.Methods The general data of COVID-19 convalescent plasma(CP)donors,including gender,age,date of discharge or release from medical isolation,were collected based on informed consent.After physical examination,the CP was collected by apheresis technology with plasma separator,inactivated with methylene blue,and determined for severe acute respiratory symptom coronavirus 2(SARS-CoV-2)nucleic acid and specific antibody(RBD-IgG)against SARS-CoV-2.Results The collection process went well,and no serious adverse events related to plasma collection were reported during or after the collection.The average age of COVID-19 CP donors was 38 years(n=933).The distributions of blood groups A,B,AB and O in RhD(+)COVID-19 CP were 33.4%,29.2%,10%and 27.2%respectively.The plasma donation date was 18 d from the discharge date in average.All the test results of SARS-CoV-2 nucleic acid in CP were negative,while the proportion of plasma samples at SARS-CoV-2 antibody titer of more than 1∶160 was 92.60%.Conclusion Apheresis technology was safe and reliable.The COVID-19 CP contained high titer antibody.Large-scale collection and preparation of inactivated plasma against SARS-CoV-2 played an important role in the treatment of COVID-19.
作者
李策生
谢勇
杨汇川
余鼎
侯继锋
袁明超
周东波
杜涛
吴晓
王丹
胡勇
喻剑虹
邓琨
王月
龚钦
周志军
彭焱
林连珍
韩韧
邢延涛
梁小龙
毛敏
梅宇
李陶敬
张勇
梁洪
董德梅
何彦林
付道兴
杨晓明
LI Ce-sheng;XIE Yong;YANG Hui-chuan;YU Ding;HOU Ji-feng;YUAN Ming-chao;ZHOU Dong-bo;DU Tao;WU Xiao;WANG Dan;HU Yong;YU Jian-hong;DENG Kun;WANG Yue;GONG Qin;ZHOU Zhi-jun;PENG Yan;LIN Lian-zhen;HAN Ren;XING Yan-tao;LIANG Xiao-long;MAO Min;MEI Yu;LI Tao-jing;ZHANG Yong;LIANG Hong;DONG De-mei;HE Yan-lin;FU Dao-xing;YANG Xiao-ming(Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd.,Wuhan 430207,Hubei Province,China)
出处
《中国生物制品学杂志》
CAS
CSCD
北大核心
2021年第6期699-703,708,共6页
Chinese Journal of Biologicals
基金
国家科技部重点专项(2020YFC0841800)。
关键词
新型冠状病毒肺炎
康复者恢复期血浆
质量控制
重症急性呼吸综合征冠状病毒2
亚甲蓝
病毒灭活
单采浆技术
Coronavirus Disease 2019(COVID-19)
Convalescent plasma
Quality control
Severe acute respiratory symptom coronavirus 2(SARS-CoV-2)
Methylene blue
Virus inactivation
Apheresis technology
