新型冠状病毒标准物质研究进展  

Research progress of novel coronavirus reference materials

作　　者：高颖 杨怡 欧阳艳艳 米薇[1] 董莲华[1] 戴新华[1] Gao Ying;Yang Yi;Ouyang Yanyan;Mi Wei;Dong Lianhua;Dai Xinhua(Center for Advanced Measurement Science,National Institute of Metrology,Beijing 100029,China)

机构地区：[1]中国计量科学研究院,北京100029

出　　处：《中华实验和临床病毒学杂志》2021年第5期590-595,共6页Chinese Journal of Experimental and Clinical Virology

基　　金：国家市场监督管理总局科技计划(2020MK147);国家市场监督管理总局技术保障(2020YJ039,2020YJ054);中国计量科学研究院基本业务费项目(AKYYJ2009)。

摘　　要：新型冠状病毒(简称新冠病毒,2019n-CoV)标准物质是具有确定的新冠病毒序列和量值信息的一类足够均匀稳定的物质。国内外新冠病毒相关标准物质主要包括体外转录和基因组RNA标准物质、假病毒和灭活病毒标准物质,以及蛋白质类标准物质。它相当于一把"标尺",可用于新冠病毒检测试剂盒的量值溯源和方法验证、试剂盒性能评价和实验室能力验证,还可作为质控物质保证检测结果的准确性。此外,在确保全球新冠病毒测量的国际等效和国际互认中,新冠病毒标准物质也发挥了重要作用。The reference material(RM)of novel coronavirus(2019n-CoV)is a kind of sufficiently homogeneous and stable material including determined 2019n-CoV sequence and quantity information.The international and domestic RM includes in vitro transcribed and genomic RNA RM,pseudovirus and inactivated virus RM,and protein RM.It can be used as a"ruler"for traceability and method validation of testing agent,performance evaluation of 2019n-CoV testing kits,and laboratory proficiency testing.It also can be used as quality control material to ensure accuracy of tests.Furthermore,RMs of 2019n-CoV plays an important role in the international equivalence and international mutual recognition about 2019n-CoV testing.

关 键 词：新型冠状病毒 标准物质 体外转录RNA 灭活病毒 假病毒 单克隆抗体 核酸检测 免疫检测 

分 类 号：R373[医药卫生—病原生物学]