新型冠状病毒灭活疫苗抗原含量检测能力验证  

Laboratory Proficiency Testing for Antigen Content of Inactived COVID-19 Vaccines

作　　者：徐康维[1] 郭君贞 高晓明 鲁旭[1] 权娅茹[1] 项新华[1] 李长贵[1] XU Kangwei;GUO Junzhen;GAO Xiaoming;LU Xu;QUAN Yaru;XIANG Xinhua;LI Changgui(National Institutes for Food and Drug Control,Beijing 102629,China;Shandong Institute for Food and Drug Control,Jinan 250101,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]山东省食品药品检验研究院,济南250101

出　　处：《中国药学杂志》2024年第6期555-558,共4页Chinese Pharmaceutical Journal

基　　金：国家科技重大专项资助(2018ZX09738-005,2018ZX09737-003);北京市自然科学基金项目资助(L192009)。

摘　　要：目的 开展新型冠状病毒灭活疫苗抗原含量检测能力验证,对参加实验室检测能力进行评价。方法 对能力验证用新型冠状病毒灭活疫苗样品进行均匀性和稳定性检验,采用冷链运输方式将新型冠状病毒灭活疫苗样品、参考品及检测试剂盒分发至各参加实验室。考察鉴别试验、抗原含量检测和实验室内变异3项指标。结果 能力验证样品的均匀性和稳定性符合要求,共有14家实验室参加本次能力验证并按要求报告结果,各实验室3项指标考核结果均为满意。结论 参加本次能力验证的我国省级药检机构及灭活疫苗生产企业具有较好的新型冠状病毒灭活疫苗检测能力和质控水平。OBJECTIVE To evaluate the capacity of laboratories which participate in the proficiency testing of antigen content inactived COVID-19 vaccines.METHODS Samples of inactived COVID-19 vaccines for proficiency testing were tested for uniformity and stability,and was distributed together with reference and test kits to participating laboratories by cold chain transportation.Three indexes were evaluated:differential test,antigen content detection and laboratory variation.RESULTS The uniformity and stability of the proficiency test samples met the requirements.A total of 14 laboratories participated in this proficiency test and reported the results as required,and the assessment results of three indicators by each laboratory all satisfactory.CONCLUSION China's provincial drug testing institutions and inactivated vaccine manufacturers participating in this proficiency test have good detection capabilities and quality control levels for inactived COVID-19 vaccines.

关 键 词：新型冠状病毒灭活疫苗 酶联免疫吸附试验 能力验证 

分 类 号：R917[医药卫生—药物分析学]