2020年国家级疫苗检测能力验证的结果与分析  

Results and Discussion on National Vaccine Proficiency Testing Schemes in 2020

作　　者：刘雅丹[1] 项新华[1] 黄维金[1] 王斌[1] 胡忠玉[1] 于欣[1] LIU Ya-dan;XIANG Xin-hua;HUANG Wei-jin;WANG Bin;HU Zhong-yu;YU Xin(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药学杂志》2021年第13期1099-1103,共5页Chinese Pharmaceutical Journal

摘　　要：目的通过2020年我国疫苗检测能力验证计划的开展,分析和评估疫苗生产企业及检验机构的质量控制水平。方法中国食品药品检定研究院(中检院)针对疫苗的安全性、稳定性等考察指标以及新冠疫苗的辅助研发方法策划完成3项能力验证计划,在全国范围内组织实施能力验证活动,并对参加机构的检测能力进行全面的考察和评价。结果全年累计89家单位参与这3项计划,满意率分别为96.9%,96.4%和76.0%。结论我国疫苗生产企业及检验机构的检测能力和质控水平良好,参加者对疫苗无菌检查及疫苗铝佐剂中铝含量测定的检测水平有保障,仅有部分生产企业对假病毒中和抗体检测方法的掌握程度有待提高。OBJECTIVE To acquire the knowledge of quality control performance through carrying out proficiency Testing Schemes(PTS)nationwide.METHODS National Institutes for Food and Drug Control(NIFDC)schemed three PTS to evaluate the testing competence of participants from the aspects of safety and stability of vaccine products and pseudotyped virus-based neutralization assay,pseudotyped virus based neutralization assay(PBNA),which takes as a hand of COVID-19 vaccine development.RESULTS Eighty-nine participants took part in the three PTS and the satisfaction rate stated as 96.9%,96.4%and 76.0%.CONCLUSION The testing ability and quality control performance of Official Medical Control Laboratories(OMCL),manufacturers and research institutes are acceptable.The testing results of sterile testing and aluminum assay of aluminum adjuvanted vaccine can be assured well,while the ability of PBNA needs to be improved by some manufacturers.

关 键 词：能力验证 项目策划 疫苗 质控水平 

分 类 号：R917[医药卫生—药物分析学]