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中国生物工程杂志

CHINA BIOTECHNOLOGY
中国生物工程杂志
中国生物工程杂志  2021, Vol. 41 Issue (6): 119-128    DOI: 10.13523/j.cb.2105056
新冠病毒检测与药物研发     
新型冠状病毒抗原快速检测研发现状及展望*
陈晨1,2,胡劲超1,2,曹姗姗1,2,门冬1,2,**()
1 中国科学院武汉病毒研究所 生物安全大科学研究中心 病毒学国家重点实验室 武汉 430071
2 中国科学院大学 北京 100049
The Development of Antigen Testing for SARS-CoV-2
CHEN Chen1,2,HU Jin-chao1,2,CAO Shan-shan1,2,MEN Dong1,2,**()
1 State Key Laboratory of Virology, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan 430071, China
2 University of Chinese Academy of Sciences, Beijing 100049, China
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摘要：

新型冠状病毒肺炎疫情的全球大流行,对全球公共健康、社会和经济运转造成了重大影响。在药物研发迟滞及疫苗有效性未得到充分验证的情况下,对人群进行大规模的快速筛查,寻找潜在的感染者(尤其是轻症和无症状患者),并进行集中隔离,切断传播途径和保护易感人群是首要的任务。因此对于SARS-CoV-2感染,早期诊断尤为重要。总结现有市场上的新冠病毒抗原快速检测产品,对全球抗原快速检测市场进行分析,概述其研发的动向并展望了我国在新冠抗原检测新方法、新技术方面的自主创新能力。
关键词： 新冠病毒;  体外诊断;  新冠抗原快速检测    
Abstract:

The global pandemic of COVID-19 has taken a major impact on global public health, and social and economic operations. In the case of delays in drug development and insufficient verification of vaccine effectiveness, the priority is to take a large-scale rapid screening to filter out potential infections (especially mild and asymptomatic patients), isolate those infected patients centralized to cut off transmission routes and to protect the susceptible people. Therefore, early diagnosis of SARS-CoV-2 infection is particularly important. This paper summarizes the rapid detection products toward SARS-CoV-2 antigens in the current market, analyzes the global market of rapid SARS-CoV-2 antigen detection, outlines its research and development trends, and in the end discusses the prospects for developing the capability of independent innovation in new technologies and methods for SARS-CoV-2 antigen detection in our country.
Key words: SARS-CoV-2    In vitro diagnostic    SARS-CoV-2 antigen point-of-care testing
收稿日期: 2021-05-10 出版日期: 2021-07-06
ZTFLH:  Q819  
基金资助: * 国家重点研发计划(2020YFC0861100)
通讯作者: 门冬     E-mail: d.men@wh.iov.cn
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引用本文:

陈晨,胡劲超,曹姗姗,门冬. 新型冠状病毒抗原快速检测研发现状及展望*[J]. 中国生物工程杂志, 2021, 41(6): 119-128.

CHEN Chen,HU Jin-chao,CAO Shan-shan,MEN Dong. The Development of Antigen Testing for SARS-CoV-2. China Biotechnology, 2021, 41(6): 119-128.

链接本文:

https://manu60.magtech.com.cn/biotech/CN/10.13523/j.cb.2105056    或    https://manu60.magtech.com.cn/biotech/CN/Y2021/V41/I6/119

图1  新冠病毒感染和人体免疫系统响应示意图
样本种类 病毒核酸 病毒抗原 病毒抗体
检测方法 RT-PCR等恒温扩增 侧流免疫分析化学发光 测流免疫分析(胶体金)ELISA、化学发光
检测标本 鼻咽拭子、痰液、灌洗液 鼻咽拭子、痰液、灌洗液、尿液 血浆、血清
最早可检出
的病程时段 		感染后,发病前 感染后,发病前 发病1周后
检测耗时 60~180 min 约15 min 15~180 min
阳性结果临床意义 SARS-CoV-2感染状态 SARS-CoV-2感染状态 SARS-CoV-2当前感染或近期曾经感染
特点 对实验室、仪器设备和人员要求高;检测灵敏度高、特异性好,有一定漏检率 对实验室要求低,可用于筛查,适合级层医院大规模筛查,检测速度快,有一定漏检率 对实验室要求低,取样误差小,最快15 min内出结果,既往感染诊断
特异性 约100% 95%~100% 95%~100%
灵敏度 高 高
技术难度 高 低 低
NMPA国内注册 27家 3家 15家
表1  新冠病毒三种检测方法的对比
图2  免疫测流层析法原理示意图
国家 名称 厂家 注册时间
美国 BinaxNOW COVID-19 Ag Card Abbott Diagnostics Scarborough, Inc. 12/16/2020
Ellume COVID-19 Home Test Ellume Limited 12/16/2020
BinaxNOW COVID-19 Ag Card Home Test Abbott Diagnostics Scarborough, Inc. 12/16/2020
Clip COVID Rapid Antigen Test Luminostics, Inc. 12/07/2020
Sampinute COVID-19 Antigen MIA Celltrion USA, Inc. 10/23/2020
CareStart COVID-19 Antigen test Access Bio, Inc. 10/13/2020
Sofia 2 Flu + SARS Antigen FIA Quidel Corporation 10/02/2020
LumiraDx SARS-CoV-2 Ag Test LumiraDx UK Ltd. 08/18/2020
BD Veritor System for Rapid Detection of SARS-CoV-2 Becton, Dickinson and Company (BD) 07/23/2020
Sofia SARS Antigen FIA Quidel Corporation 07/17/2020
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack Qrtho Clinical Diagnostics, Inc. 01/11/2021
Status COVID-19/Flu Princeton BioMeditech Corp. 02/04/2021
Simoa SARS-CoV-2 N Protein Antigen Test Quanterix Corporation 01/05/2021
QuickVue SARS Antigen Test Quidel Corporation 12/08/2020
日本 イムノエースSARS-CoV-2 株式会社タウンズ -
エスプラインSARS-CoV-2(SARS-CoV-2抗原検出用试薬) 富士レビオ株式会社 -
クイックナビ-COVID19 Ag(10回用) デンカ株式会社 -
韩国 GenBody COVID-19 Ag GenBody Inc 07/13/2020
BIOCREDIT COVID-19 Ag RapiGEN, INC 04/21/2020
PCL COVID19 Ag Rapid FIA PCL, Inc. 03/30/2020
STANDARTMF COVID-19 Ag FIA SD Biosensor, Inc. 03/25/2020
新加坡 V-CODE ENCODE SARS-COV-2 Antigen Rapid Test Device HealthGroup Medical Pte Ltd 12/10/2020
SARS-CoV-2 Rapid Antigen Test Roche Diagnostics Asia Pacific Pte Ltd 10/19/2020
Camtech COVID-19 Antigen Rapid Test Camtech Diagnostics Pte Ltd 08/28/2020
COVID-19 Antigen Rapid Test Kit Jian Yuan Holdings Pte Ltd 08/28/2020
Sofia SARS Antigen FIA Quantum Technologies Global Pte Ltd 08/05/2020
SAVANTTMNew Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography) Hi-Beau Group 07/13/2020
FaStep COVID-19 Antigen Rapid Test Device
(Nasopharyngeal/Oropharyngeal Swab) 		Alcotech Pte Ltd 07/07/2020
中国 新型冠状病毒(2019-nCoV)抗原检测试剂盒(胶体金法) 广州万孚生物技术股份有限公司 12/04/2020
新型冠状病毒(2019-nCoV)抗原检测试剂盒(乳胶法) 北京金沃夫生物工程科技有限公司 11/03/2020
新型冠状病毒(2019-nCoV)抗原检测试剂盒(荧光免疫层析法) 深圳华大因源医药科技有限公司 11/03/2020
表2  新冠病毒抗原检测产品信息
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