新冠抗原厂家必争之地：欧洲认可度最高的德国PEI评估

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1，PEI简介

PEI全称为保罗埃利希研究所（Paul-Ehrlich-Institut），又名为德国联邦疫苗和生物医学研究所，目前隶属于联邦卫生部，是德国联邦的一个研究机构和医疗监管机构。

它以1908年诺贝尔生理和医学奖获得者Paul Ehrlich先生的名字命名。尽管其隶属于德国卫生部，但具有独立行使生物制品检验、临床试验审批、产品批准上市和批签发等职能。同时还承担对不同组织，特别是对一些欧盟国家、欧盟和国际性的委员会的相关法规起草、修订提供科学的建议，也为德国政府、地方机构以及国会提供专业意见，并提供相关信息给病人和消费者。

2，背景

在新冠流行发展期间，为了抗击疫情，全球各个国家，各个组织都纷纷上市了新冠抗原试剂。在欧盟(EU)，对SARS-CoV-2体外诊断试剂上市之前要完成CE注册。但是根据IVD指令98/79/EC (IVDD)，SARS-CoV-2诊断的认证(ce标志)仅需要自我声明。

在欧洲各国卫生部针对CE门槛较低，容易申报的情况下，各国纷纷在此基础上设置了国家卫生系统“白名单”制度，只有被列入“白名单”的厂家和产品才可以获准在该国市场进行销售。而德国PEI测试是欧洲含金量和认可度最高的测试。

试剂质量的评估包括两部分:

制造商提供符合最低标准的证据和成功的独立实验室评估。

敏感度和特异性的最低标准由德国两家政府机构Paul-Ehrlich-Institut (PEI)和Robert Koch Institut (RKI)共同制定。从BfArM列表中选择试剂，由PEI/RKI进行比较评估。这个比较评估的目的确定代表“先进水平”的诊断试剂的灵敏度，又要筛出没有达到最低灵敏度的试剂。

最后，灵敏度低于“先进水平”的试剂会被从BfArM名单中删除，所有具有成功评价结果的试剂会被公布在PEI网页上。

3，评估结果清单

PEI对不同设计和不同制造商的大量SARS-CoV-2抗原快速检测(POCT)进行了比较评估，并对其敏感性进行了最新技术的概述。下表列出了迄今为止纳入比较评价并在此评估为最先进的POCT。 其他被评估为不符合现有技术的测试已从BfArM列表中删除。 调查将继续进行，表格将相应补充。（下表截至2021.11.05）

产品名称	制造商名称
Panbio™COVID-19 Ag Rapid Test Device (NASOPHARYNGEAL)	Abbott Rapid Diagnostics Jena GmbH
RIDA®QUICK SARS-CoV-2 Antigen	R-Biopharm AG
SARS-CoV-2 Rapid Antigen Test	SD BIOSENSOR (Roche Diagnostics GmbH)
NADAL® COVID-19 Ag Schnelltest	nal von minden gmbh
STANDARD™ F COVID-19 Ag FIA	SD BIOSENSOR
STANDARD™ Q COVID-19 Ag Test	SD BIOSENSOR
BIOSYNEX COVID-19 Ag BSS	BIOSYNEX SWISS SA
MEDsan® SARS-CoV-2 Antigen Rapid Test	MEDsan GmbH
TestNOW® - COVID-19 Antigen	Affimedix
NowCheck® COVID-19 Ag Test	BIONOTE
Coronavirus Ag Rapid Test Cassette (Swab)	Zhejiang Orient Gene Biotech Co.,Ltd
Sofia SARS Antigen FIA	Quidel Corporation
COVID-19 Ag Test Kit	Guangdong Wesail Biotech Co., Ltd.
CLINITEST® Rapid COVID-19 Antigen Test	Siemens Healthineers
ESPLINE® SARS-CoV-2	Fujirebio Inc. (Mast Diagnostica GmbH)
BD Veritor™ System for Rapid Detection of SARS-CoV-2	Becton Dickinson
GenBody COVID-19 Ag	IVC Pragen Healthcare
LumiraDx SARS-CoV-2 Ag Test	LumiraDX
Exdia COVID-19-Ag-Test	Precision Biosensor Inc. (Axon Lab AG)
SARS-CoV-2 Ag Rapid Test (FIA)	Wantai (Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.)
SARS-CoV-2 Antigen Schnelltest	Xiamen Boson Biotech Co., Ltd
COVID-19 Antigen Schnelltest (Colloidal Gold)	Joinstar Biomedical Technology Co., Ltd (CIV care impuls Vertrieb)
mö-screen Corona Antigen Test	Mölab GmbH
Rapid SARS-CoV-2 Antigen Test Card	MP Biomedicals Germany GmbH
Lyher Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)	Hangzhou Laihe Biotech Co., Ltd. (Lissner Qi GmbH)
AMP Rapid Test SARS-CoV-2 Ag	Ameda Labordiagnostik GmbH
Clungene COVID-19 Antigen Rapid Test	Hangzhou Clongene Biotech Co., Ltd.
DIA-COVID® COVID-19 Ag Rapid Test Kit	GenSure Biotech Inc.
SARS-CoV-2 Antigen Rapid Test Kit	Beijing Lepu Medical Technology Co., Ltd
Hightop SARS-CoV-2 (Covid-19) Antigen Rapid Test	Qingdao Hightop Biotech Co., Ltd.
Rapid Covid-19 Antigen Test (Colloidal Gold )	Anbio (Xiamen) Biotechnology Co., Ltd
Safecare COVID-19 Ag Rapid Test Kit (Swab)	Safecare Biotech Hangzhou Co., Ltd.
QuickProfile Covid-19 Antigen Test Card	LumiQuick Diagnostics, Inc.
Covid 19 Antigen Schnelltest	BioRepair GmbH
Green Spring SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)	Shenzhen Lvshiyuan Biotechnology Co., Ltd.
CAT Antigen Covid Rapid Test	Oncosem Onkolojik Sistemler San. Ve Tic. A.S.
ScheBo SARS-CoV-2 Quick Antigen	ScheBo Biotech AG
Nova Test SARS-CoV-2 Antigen Rapid Test Kit	Atlas Link Technology Co.,Ltd.
Toda Coronadiag Ag	Toda Pharma
Humasis COVID-19 Ag Test	Humasis Co., Ltd.
Novel Coronavirus 2019-nCoV Antigen Test (Colloidal gold)	Beijing Hotgen Biotech Co., Ltd.
COVID-19 Antigen Rapid Test Kit (Colloidal Gold)	AmonMed (Xiamen) Biotechnology Co., Ltd.
Canea COVID-19 Antigen Schnelltest	Core Technology Co., Ltd.
fluorecare COVID-19 SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay)	Shenzhen Microprofit Biotech Co., Ltd
Testsealabs®  Rapid Test Kit COVID-19 Antigen Test Cassette	Hangzhou Testsea Biotechnology Co., Ltd
Lysun COVID-19 Antigen Rapid Test Device (Colloidal Gold)	Hangzhou Lysun Biotechnology Co., Ltd.
Wizbiotech SARS-CoV-2 Antigen Rapid Test	Xiamen WIZ Biotech Co., Ltd.
SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay)	PerGrande BioTech Development Co., Ltd.
salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasopharyngeal swab)	Salofa OY
Genrui SARS-CoV-2 Antigen Test Kit (Colloidal Gold)	Genrui Biotech Inc.
Wondfo SARS-CoV-2 Antigen Test (Lateral Flow Method)	Guangzhou Wondfo Biotech Co. Ltd
Aesku Rapid SARS-CoV-2 Rapid Test	Aesku Diagnostics GmbH
Rapid Response COVID-19 Rapid Test Device	BTNX, Inc. (Biotrend Chemikalien Gmbh)
Dia Sure Covid-19 Antigen Rapid Test Device (Nasopharyngeal/Oropharyngeal Swab)	Azure Biotech Inc.
Labnovation SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography)	Labnovation Technologies, Inc.
V-Chek SARS-CoV-2 Rapid Ag Test Kit (Colloidal Gold)	SGA  Mühendislik DAN. EG. Icve DIS.Ltd.STI
SGTi-flex COVID-19 Ag	Sugentech, Inc.
softec SARS COV-2 (Covid-19) Antigen Test Kit	Zet Medikal Tekstil Dis Ticaret Ltd. STI.
Genedia W Covid-19 Ag	Green Cross Medical Science Corp. (Weko Pharma GmbH)
COVID-19 (SARS CoV-2) Antigen Test Kit (Colloidal Gold)	Anhui Deepblue Medical Technology Co. , Ltd.
FRENDTM COVID-19 Ag	NanoEntek Inc
RapidFor SARS-CoV-2 Rapid Antigen Test Colloidal Gold	Vitrosens Biyoteknoloji Ltd. Sti
COVID-19 (SARS-CoV-2) Antigen Test Kit	Wuhan EasyDiagnosis Biomedicine Co., Ltd
PCL COVID19 Ag Gold Saliva	PCL, Inc.
reOpenTest COVID-19 Antigen Rapid Test (Colloidal Gold)	Zhejiang Anji Saianfu Biotech Co.,Ltd.
IMMUNOBIO SARS-CoV-2 Antigen-Schnelltest (COVID-19 Ag)	Hangzhou Immuno Biotech Co.,Ltd.
Zhenrui COVID-19 (SARS-COV-2) Antigen Test Kits	Shenzhen Zhenrui Biotech co.Ltd.
SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold)	Shenzhen Watmind Medical Co.,Ltd.
2019-nCoV Antigen Test Kit(colloidal gold method)	Guangdong Hecin Scientific,Inc.
Asan Easy Test COVID-19 Ag	ASAN PHARM.CO.,LTD.
COVID-19 Antigen Saliva Test Kit (Colloidal Gold)	Nantong Diagnos Biotechnology Co., Ltd.
Axiom Diagnostics COVID-19 Ag Schnelltest	AXIOM Gesellschaft für Diagnostica und Biochemica mbH
Tigsun COVID-19 Saliva Antigen Rapid Test	Beijing Tigsun Diagnostics Co.;Ltd.
PocRoc SARS-CoV-2, Antigen Schnelltest Set (Kolloidales Gold)	Lumigenex (Suzhou) Co., Ltd.
Flowflex SARS-CoV-2-Antigenschnelltest (Nasopharynxtupfer)	ACON Biotech (Hangzhou) Co., Ltd
SARS-CoV-2 Ag Diagnostic Test Kit (Immuno fluorescence)	Shenzhen Watmind Medical Co.,Ltd.
Covid-19-Antigen-Testkit	New Gene (Hangzhou) Bioengineering Co., Ltd.
CoroVisio Covid-19 Ag VersieglungsröhrchenTeststreifen (Kolloidales Gold)	Amazing Biotech (Shanghai) Co., Ltd
COVID-19 Antigen Schnell Test (Nasopharyngeal / Oropharyngeal Tupfer Kassette)	Chil Tibbi Mal. San. Tic. Ltd. Şti
SARS-CoV-2-Antigen-Testkit (LFIA)	Jiangsu Medomics Medical Technology Co., Ltd
SARS-CoV-2 Antigen Assay Kit (Immunochromatography)	Wuhan Life Origin Biotech Joint Stock Co., Ltd.
COVID-19-Antigen-Schnelltest (Nasopharyngeal-Abstrich)	BIOMERICA Inc.
Covid-19 Antigen Schnelltest	Beijing Beier Bioengineering Co., Ltd.
Ksmart® SARS-COV2 Antigen Rapid Test	Avalun
Rapid Test Ag 2019-nCoV	ProGnosis Biotech
SARS-CoV-2 Antigen Rapid Test Kit	Wuhan UNscience Biotechnology Co., Ltd.
One Step Test for SARS-CoV-2 Antigen (Colloidal Gold)	Getein Biotech, Inc.
SARS-CoV-2 Antigen Rapid Test Kit	Triplex International Biosciences (China) Co., Ltd.
Novel Coronavirus (2019-nCOV) Antigen Testing Kit (Colloidal Gold)	Nanjing Norman Biological Technology Co.,Ltd
SARS-CoV-2 Antigen Rapid Test Cassette	Merlin Biomedical (Xiamen) Co., Ltd.
Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit	Edinburgh Genetics Limited
Covid-19 Antigen Detection Kit	DNA Diagnostic A/S.
COVID-19 Antigen Speicheltest (Immunochromatographie)	ulti med Products (Deutschland) GmbH
EBS SARS-CoV-2 Ag Rapid Test	Eurobio Scientific
COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)	Jiangsu Diagnostics Biotechnology Co., Ltd
novacheck®-Ag SARS-CoV-2 Covid-19 Antigen Rapid Test	Novatech Tibbi Cihaz Ürünlerii San. Ve Tic.A.S.
MSP SARS-CoV-2 Antigen-Schnelltest	MSP bodmann GmbH
fluorecare SARS-CoV-2 Antigen Test Kit	Shenzhen Microprofit Biotech Co., Ltd.
Whole Power One Step 2019-Novel Coronavirus(2019-nCoV) Antigen Test	Co-Innovation Biotech Co. Ltd
ECOTEST COVID-19 Antigen Rapid Test Device	Assure Tech (Hangzhou) Co.,Ltd
COVID-19 Antigen Detection Kit(Colloidal Gold)	Zhuhai Lituo Biotechnology Co. Ltd.
COVID-19 Antigen Rapid Test Kit	Beijing Kewei Clinical Diagnostic Reagent Inc.
Dynamiker SARS-CoV-2 AG Rapid Test	Dynamiker Biotechnology (Tianjin) Co., Ltd.
SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method)	BioTeke Corporation (Wuxi) Co.,Ltd.
COVID-19 Antigentest	Artron Laboratories Inc.
Accu-Tell Rapid In-vitro Diagnostiktest	AccuBioTech Co.,Ltd.
SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method)	Hubei Jinjian Biology Co.,Ltd.
Cora Gentest-19	Abioteq
Jinwofu Novel Coronavirus (SARS-COV-2) Antigen Rapid Test Kit	Beijing Jinwofu Bioengineering Technology Co.,Ltd.
STANDARD i-Q COVID-19 Ag Home Test	SD Biosensor, Inc.
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) SPUCKTEST	JOYSBIO (Tianjin) Biotechnology Co.,Ltd.
SARS-CoV-2 Antigen Test Kit (Colloidal Gold)	Shenzhen Dymind Biotechnology Co. Ltd.
WANTAI SARS-CoV-2 Ag Schnelltest (Kolloidales Gold)	Beijing WANTAI Biological Pharmacy Enterprise Co., Ltd.
Covid-19 Antigen Rapid Test (Colloidal Gold)	Beijing O&D Biotech Co., Ltd.
OnSite COVID-19 Ag Rapid Test	CTK Biotech, Inc.
COVID 19 Antigen Test Kit (Colloidal Gold Method)	Neo-nostics (Suzhou) Bioengeneering Co., Ltd.
Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold)	Hoyotek Biomedical Co., Ltd.
SARS-CoV-2 Antigen test Kit (Colloidal Gold Method)	Changsha Sinocare Inc.
FUJIFILM COVID-19 Ag Test	FUJIFILM Corporation
GreenLight SARS-CoV-2 Antigen-Test	Senova Gesellschaft für Biowissenschaft und Technik mbH
SARS-CoV-2 Antigen IVD kit SWAB	Shenzhen Reagent Technology Co., Ltd.
Novel Coronavirus (SARS-CoV-2) Ag Rapid Test Kit	Jiangsu Bioperfectus Technologies Co., Ltd.
Rapid SARS-CoV-2 Antigen Test Colloidal Gold (Nasopharyngeal specimen)	InTec Products, Inc.
INNOVA SARS-CoV-2 Selbsttest (Qualitativer Antigen-Schnelltest)	Innova Medical Group,Inc.
Goldsite COVID-19 SARS-CoV-2 Antigen Kit (Colloidal Gold)	Goldsite Diagnostics Inc.
Novel Corona Virus (2019-nCoV) Ag Rapid Test Kit	Glallergen CO., LTD.
KISSH SARS-CoV-2 Antigen Test Kit(GICA)	Shenzhen Kisshealth Biotechnology Co., Ltd.
Longsee 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography)	Guangdong Longsee Biomedical Co.,Inc.
Tell Me Fast Rapid Diagnostic Test	Biocan Diagnostics Inc.
Fosun Covid-19 Ag Card	Shanghai Fosun Long March Medical Science Co., Ltd.
COVID-19 Antigen Rapid Test (Oral Fluid)	CITEST Diagnostics Inc.
INVBIO Antigen Rapid Test Device (Saliva)	Innovation Biotech (Beijing) Co.,Ltd
Saliva SARS-CoV-2(2019-nCoV) Antigen Test Kit (Nanocarbon Assay)	Ningbo Beautiful Life Medical Biotechnology
Vazyme SARS-CoV-2 Antigen Detection Kit (Colloidal Gold-Based)	Nanjing Vazyme Medical Technology Co., LTD.
COVID-19 antigen Schnelltest (Kolloidales Gold) / Novel Coronavirus(SARS-CoV-2) Antigen Rapid Detection Kit	Jiangxi Province JinHuan Medical Instrument Co.,LTD.
Amper COVID-19 Antigen Rapid Testing Kit (Colloidal Gold)	Amper,Inc.
SARS-CoV-2Antigen Test Kit (Colloidal Gold)	Shenzhen Huian Biosci Technology Co.,Ltd
Konsung COVID-19 Antigen Rapid Test Kit	Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd
TBG SARS-CoV-2 Antigen Rapid Test	TBG Biotechnology Xiamen Inc.
Tebsun 2019-nCoV Antigen Test Kit	Gunagzhou Tebsun Bio-Tech Development Co.,Ltd.
ENCODE SARS-COV-2 Antigen Rapid Test Device	Zhuhai Encode Medical Engineering Co., Ltd.
Pro-med COVID-19 Antigen Rapid Detection Kit	Pro-med (Beijing) Technology Co.,Ltd.
Covid-19 Antigen Rapid Test (Oral fluid)	Hangzhou AllTest Biotech Co., Ltd.
Novel Coronavirus (COVID-19) Antigen Rapid Test Kit	Qingdao AIBO Diagnostic CO., LTD.
Rapid SARS-CoV-2 Antigen Test (Colloidal Gold)	InTec Products, Inc.
2019-nCoV Antigen Test Kit	Chongqing M&D Biotechnology Co. Ltd.
Synthgene Neues Coronavirus (SARS-CoV-2) Antigen-Schnellerkennungskit (Collate Gold Methode)	Nanjing Synthgene Medical Technology Co., Ltd.
Joysbio SARS-CoV-2 Antigen rapid test kit -PRO (Colloidal Gold)	JOYSBIO (Tianjin) Biotechnology Co.,Ltd.
SureScreen COVID-19 Antigen Rapid	SureScreen Diagnostics Ltd.
2019-nCoV Ag Test (Latex ChromatographyAssay)	Innovita (Tangshan) Biological Technology Co.;LTD.
SARS-CoV-2 Antigen Test Kit (Lateral Flow Assay)	Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay)	Shenzhen Microprofit Biotech Co., Ltd
Zijian SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit (Lateral Flow Method)	Shen Zhen Zi Jian Biotechnology Co., Ltd.
New Coronavirus (COVID-19) Antigen Rapid Test	Anhui Formaster Biosci Co., Ltd
Sienna COVID-19 Antigen-Schnelltestkassette (Nasenabstrich)	Hangzhou Biotest Biotech Co., Ltd
SARS-CoV-2 Antigen Rapid Detection Kit (LFA)	Acro Diagnostics Co., Ltd
SARS-CoV-2 Antigen Test Cassette	Jiangsu Mole Bioscience Co., Ltd
SARS-CoV-2-Antigen-Schnelltestgerät	Hangzhou Funworld Biotech. Co., Ltd
COVID-19 Antigen Test Kit	Beijing Homa Biological Engineering Co., Ltd.
InstantSure Covid-19 Ag CARD	Suzhou Soochow University SAIER IMMUNO BIOTECH Co., Ltd.
KaiBiLi COVID-19 AntigenPro	Hangzhou Genesis Biodetection & Biocontrol Co.,Ltd.
SARS-Cov-2-Antigen-Schnelltest-Karte	BioDetect (Xiamen) Biotechnology Co., Ltd
Neuartiges Coronavirus (2019-nCoV) Antigendetektionsreagenz (immunochromatographischer Assay)	Zhongxiu Science and Technology Co., Ltd
Virusee® SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) (Saliva/Swab)	Genobio Pharmaceutical Co., Ltd.
SARS-CoV-2 Ag Rapid Test	BioMaxima S.A.
SARS-Cov-2 Nucleocapsid(N) Antigen Rapid Test Cassette	Hangzhou Zheda Dixun Biological Gene Engineering CO. Ltd.
SARS-CoV-2 Antigen Rapid Test	Nantong Egens Biotechnology
Convergys® COVID-19 Rapid Antigen Test	Convergent Technologies
INVBIO One Step Diagnostic Rapid Test Cassette	Innovation Biotech (Beijing) Co.,Ltd
SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography)	Shenzhen Huaree Technology Co.,Ltd
Dräger Antigen Test SARS-CoV-2	Dräger Safety AG & Co. KGaA
LionRun™ SARS-CoV-2 Antigen Rapid Test Kit (Lateral Flow Immunoassay)	Shanghai Liangrun Biomedicine Technology Co.,Ltd.
SARS-CoV-2 Antigen Saliva Rapid Test Kit	Shenzhen Huaree Technology Co.,Ltd
SARS-CoV-2 Antigen Assay Kit by Latex Immunochromatography method	Sichuan Xincheng Biological Co., LTD
COVID-19 Schnelltestgerät	Jiangsu Well Biotech Co., Ltd.
SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method)	Jinan Babio Biotechnology Co., Ltd.
GLINE-2019-nCoV Ag	Shenzhen YHLO Biotech Co. Ltd.
SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method)	Sansure Biotech Inc.
SARS-CoV-2 Antigen Schnelltestkassette	Hangzhou Sejoy Electronics & Instruments Co.,Ltd.
SARS-CoV-2-Antigen-Schnelltest	Hangzhou Careomedic Tech Co., Ltd.
AS-check COVID-19 Antigen Schnelltest	Asterion Otel Insaat Bilisim Medikal Maden Tic.Ltd.Sti.
Kanzone COVID-19 Antigen Rapid Test	Weihai Kangzhou Biotechnology Engineering Co., Ltd.
COVID-19 Antigen Test Kit	Surge Medical Inc.
GENEDIAN COVID-19 Antigen Test Cassette	Hangzhou DIAN Biotechnology Co., Ltd.
Novel Coronavirus(COVID-19) Antigen Test Kit (Colloidal Gold)	Changzhou Biowin Pharmaceutical Co.,Ltd.
SARS-CoV-2 Antigen Rapid Test (Lateral Flow Assay)	Shenzhen Kang Sheng Bao Bio- Technology Co.,Ltd.
Rapidan Tester COVID-19 Ag Test	Türklab Tibbi Malzemeler San. ve Tic. A.S.
ISIA SARS-CoV-2 Antigen Rapid Test Kit	Chongqing ISIA BIO-Technology Co.,Ltd
Check Up SARS-CoV-2 Nasal Antigen Rapid Test	Cesna Biyoteknoloji Arastirma Gelistirme Laboratuvar Sist. Ins.Müh.Dan.San.Tic-Ltd.Sti (Istanbul, Turkey)
SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method)	Biohit Healthcare (Hefei) Co., Ltd. (Hefei, China)
Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography)	Zhejiang Gene Science Co., Ltd. (Hangzhou Bay, China)
SARS-CoV-2 Antigen Rapid Test Cassette	Merlin Biomedical (Xiamen) Co., Ltd. (Xiamen,China)
SARS-CoV-2 Antigen Test Kit (Colloidal Gold)	Shenzhen Dymind Biotechnology Co. Ltd.(Shenzhen, China)
Novel Coronavirus(2019-nCoV) Antigen Rapid Test	Bioscience (Tianjin) Diagnostic Technology Co.,Ltd (Tianjin, China)
StrongStep® SARS-COV2 Antigen Rapid Test	Nanjing Liming Bio-Products Co., Ltd. (Nanjing,China)
COVID-19 Rapid Test Cassette Antigen Test Kit	Lifecosm Biotech Limited (Shenzhen, China)
COVID-19 Antigen Detection Kit (Quantum Dots-Based Immunofluorescence Chromatography)	Shenzhen Kingfocus Biomedical Engineering Co., Ltd.
SARS-Cov-2 Antigen Rapid Detection Kit	Shenzhen CAS-Envision Medical Technology Co., Ltd. (Shenzhen, China)
SARS-CoV-2 Ag Schnelltestkit	Hangzhou Jucheng Medical Products Co., Ltd
ZandCell COVID-19 Saliva Antigen-Test	ZandCell AB
SARS-CoV-2 Antigen Test Kit (Colloidal Gold)	Wuhan HealthCare Biotechnology Co., Ltd.
AllTest SARS-CoV-2 Antigen Rapid Test (Nasal Swab)	Hangzhou AllTest Biotech Co.,Ltd.
Saliva SARS-CoV-2 (2019-nCoV) Antigen Test Kit (Nanocarbon Assay)	Jiaxing Wisetest Bio-Tech Co., Ltd.
Bisdeal SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Test Cassette	Hangzhou Zheda Dixun Biological Gene Engineering CO. Ltd.

4，情况分析

在上述多家制造商中，有些厂商在PEI取得了两个或以上产品的认证。新型冠状病毒抗原检测法适合于大规模新冠病毒感染疑似病例的快速排查，对疫情集中暴发的快速排查非常有效。鉴于全球更为严峻与复杂的疫情形势，国际多个组织，如世界卫生组织（WHO）、全球创新诊断基金会（FIND）也在大力推进更快更便捷的检测手段。

Science杂志在5月7号发表了一遍关于英国和斯洛伐克两个国家利用抗原试剂进行全面普检来控制疫情传播的文章，这篇文章来自于英国Liverpool大学研究人员Marta García-Fiñana和Iain E. Buchan，他们在文章中量化分析了这两个国家在2020年11月份进行的抗原全民检测对控制疫情传播的作用。根据Pavelka 的统计模型，这次全国性的抗原检测让斯洛伐克的疫情传播降低了70%。

新冠抗原试剂通过PEI性能验证，是对产品质量的再一次肯定。目前，全球疫情防控共工作已初见成效，但后疫情时代，中国IVD企业仍不断向世界展现出自主研发、创新发展的品牌实力，不断优化新冠疫情解决方案，为构筑全球抗疫防火墙贡献力量！

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