List of approved COVID-19 Antigen Kits [Updated date: 2078-05-07 / 2021-08-23]

List of WHO-EUL certified COVID-19 antigen kits

SNKit nameManufacturerTechnique applied
1
STANDARD Q COVID-19 Ag Test
(Nasal)
SD Biosensor,zVisual read, ICA
2Panbio COVID-19 Ag Rapid (Nasopharyngeal)Abbott Rapid Diagnostics Jena GmbHVisual read, ICA
3Panbio COVID-19 Ag Rapid (Nasal)Abbott Rapid Diagnostics Jena GmbHVisual read, ICA
4Sure Status COVID-19 Antigen Card TestPremier Medical Corporation Private LimitedVisual read, ICA

List of US-FDA-EUA certified COVID-19 antigen kits

SNKit nameManufacturerTechnique Applied
1CareStart COVID-19 Antigen testAccess Bio, Inc.Visual read, ICA
2Sofia 2 Flu + SARS Antigen FIAQuidel CorporationInstrument read, FIA
3BinaxNOW COVID-19 Ag CardAbbott Diagnostics Scarborough, Inc.Visual read, ICA
4LumiraDx SARS-CoV-2 Ag TestLumiraDx UK Ltd.Instrument read,microfluidic FIA
5BD Veritor System for Rapid
Detection of SARS-CoV-2
Becton, Dickinson and Company (BD)Instrument read, MIA
6Sofia SARS Antigen FIAQuidel CorporationInstrument read, MIA
7Sampinute COVID-19 Antigen MIACelltrion USA, Inc.Instrument read, MIA
8Quidel’s Quickvue SARS Antigen KitsQuidel CorporationVisual read, ICA
9Status COVID-19/FluPrinceton BioMeditech Corp.Visual read, ICA
10Celltrion DiaTrust COVID-19 Ag Rapid TestCelltrion USA, Inc.Visual read, ICA
11Omnia SARS-CoV-2 Antigen TestQorvo Biotechnologies, LLCInstrument read, BAW, Biosensor
12LIAISON SARS-CoV-2 AgDiaSorin, Inc.Instrument read,CLIA
13BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+BBecton, Dickinson and Company (BD)Instrument read, Chromatographic Digital Immunoassay
14VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent PackOrtho Clinical Diagnostics, Inc.Instrument read,CLIA
15Simoa SARS-CoV-2 N Protein Antigen TestQuanterix CorporationInstrument read, Paramagnetic Microbead-based Immunoassay
16Clip COVID Rapid Antigen TestLuminostics, Inc.Instrument read, Lateral flow immunoluminescent assay
17Sienna-Clarity COVID-19 Antigen Rapid TestCassette Salofa Oy Visual read, ICA
18Sienna-Clarity COVID-19 Antigen Rapid Test CassetteSalofa OyVisual read, ICA

List of CE-IVD COVID-19 Antigen Test kits with EU HSC Mutual Recognition

S.N Kit name Manufacturer name
1.         COVID-VIRO AAZ-LMB
2.         Panbio Covid-19 Ag Rapid Test Abbott Rapid Diagnostics
3.         SARS-CoV-2 Antigen Rapid Test Acon Biotech (Hangzhou) Co., Ltd
4.         Flowflex SARS-CoV-2 Antigen rapid test ACON Laboratories, Inc
5.         AESKU.RAPID SARS-CoV-2 AESKU.DIAGNOSTICS GmbH & Co. KG
6.         TestNOW® – COVID-19 Antigen Test Affimedix, Inc.
7.         AMP Rapid Test SARS-CoV-2 Ag AMEDA Labordiagnostik GmbH
8.         Rapid COVID-19 Antigen Test(Colloidal Gold) Anbio (Xiamen) Biotechnology Co., Ltd
9.         COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) – Nasal Swab Anhui Deep Blue Medical Technology Co., Ltd
10.     COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold) Anhui Deep Blue Medical Technology Co., Ltd
11.     mariPOC SARS-CoV-2 ArcDia International Ltd
12.     mariPOC Quick Flu+ ArcDia International Oy Ltd
13.     mariPOC Respi+ ArcDia International Oy Ltd
14.     Artron COVID-19 Antigen Test Artron Laboratories Inc
15.     Asan Easy Test COVID-19 Ag Asan Pharmaceutical CO., LTD
16.     ECOTEST COVID-19 Antigen Rapid Test Device Assure Tech. (Hangzhou) Co., Ltd
17.     ECOTEST COVID-19 Antigen Rapid Test Device Assure Tech. (Hangzhou) Co., Ltd.
18.     NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) Atlas Link Technology Co., Ltd.
19.     Ksmart® SARS-COV2 Antigen Rapid Test AVALUN SAS
20.     COVID-19 Antigen Rapid Test AXIOM Gesellschaft für Diagnostica und Biochemica mbH
21.     COVID-19 Antigen Rapid Test Device Azure Biotech Inc
22.     BD Veritorâ„¢ System for Rapid Detection of SARS CoV 2 Becton Dickinson
23.     Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) Beijing Hotgen Biotech Co., Ltd
24.     Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit Beijing Jinwofu Bioengineering Technology Co.,Ltd.
25.     SARS-CoV-2 Antigen Rapid Test Kit Beijing Lepu Medical Technology Co., Ltd
26.     WANTAI SARS-CoV-2 Ag Rapid Test (Colloidal Gold) Beijing Wantai Biological Pharmacy Enterprise Co., Ltd
27.     Wantai SARS-CoV-2 Ag Rapid Test (FIA) Beijing Wantai Biological Pharmacy Enterprise Co., Ltd
28.     Coronavirus Ag Rapid Test Cassette (Swab) Bio-Rad Laboratories / Zhejiang Orient Gene Biotech
29.     CoviGnost AG Test Device 1×20 BioGnost Ltd
30.     SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) BIOHIT HealthCare (Hefei) Co., Ltd
31.     SARS-CoV-2 Ag Rapid Test BioMaxima SA
32.     Biomerica COVID-19 Antigen Rapid Test (nasopharyngeal swab) Biomerica, Inc.
33.     NowCheck COVID-19 Ag Test Bionote, Inc
34.     BIOSYNEX COVID-19 Ag BSS BIOSYNEX S.A.
35.     BIOSYNEX COVID-19 Ag+ BSS BIOSYNEX S.A.
36.     SARS-CoV-2 Antigen Test Kit (colloidal gold method) BIOTEKE CORPORATION (WUXI) CO., LTD
37.     biotical SARS-CoV-2 Ag Card Biotical Health S.L.U.
38.     AFIAS COVID-19 Ag Boditech Med Inc
39.     Rapid Response COVID-19 Antigen Rapid Test BTNX Inc
40.     CerTest SARS-CoV-2 Card test CerTest Biotec
41.     Coretests COVID-19 Ag Test Core Technology Co., Ltd
42.     OnSite COVID-19 Ag Rapid Test CTK Biotech, Inc
43.     Test Rapid Covid-19 Antigen (tampon nazofaringian) DDS DIAGNOSTIC
44.     DIAQUICK COVID-19 Ag Cassette DIALAB GmbH
45.     COVID-19 Antigen Detection Kit DNA Diagnostic
46.     ActivXpress+ COVID-19 Antigen Complete Testing Kit Edinburgh Genetics Limited
47.     EBS SARS-CoV-2 Ag Rapid Test Eurobio Scientific
48.     ESPLINE SARS-CoV-2 Fujirebio
49.     GA CoV-2 Antigen Rapid Test GA Generic Assays GmbH
50.     Genbody COVID-19 Ag Test GenBody, Inc
51.     SARS-CoV-2 Antigen Test Kit (Colloidal Gold) Genrui Biotech Inc
52.     GenSure COVID-19 Antigen Rapid Kit GenSure Biotech Inc
53.     SARS-CoV-2 Antigen (Colloidal Gold) Getein Biotech, Inc
54.     One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) Getein Biotech, Inc.
55.     SARS-CoV-2 Antigen Kit (Colloidal Gold) Goldsite Diagnostics Inc
56.     GENEDIA W COVID-19 Ag Green Cross Medical Science Corp.
57.     2019-nCoV Antigen Test Kit (colloidal gold method) Guangdong Hecin Scientific, Inc.
58.     COVID-19 Ag Rapid Test Kit (Immuno-Chromatography) Guangdong Longsee Biomedical Co., Ltd
59.     COVID-19 Ag Test Kit Guangdong Wesail Biotech Co., Ltd
60.     V-CHEK, 2019-nCoV Ag Rapid Test Kit (Immunochromatography) Guangzhou Decheng Biotechnology Co., LTD
61.     Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) Guangzhou Wondfo Biotech Co., Ltd
62.     COVID-19 Antigen Rapid Test Hangzhou AllTest Biotech Co., Ltd
63.     COVID-19 Antigen Rapid Test Cassette Hangzhou Clongene Biotech Co., Ltd
64.     Covid-19 Antigen Rapid Test Kit Hangzhou Clongene Biotech Co., Ltd
65.     COVID-19/Influenza A+B Antigen Combo Rapid Test Hangzhou Clongene Biotech Co., Ltd
66.     Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive) Hangzhou Immuno Biotech Co.,Ltd
67.     SARS-CoV-2 Antigen Rapid Test Hangzhou Immuno Biotech Co.,Ltd
68.     LYHER Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) Hangzhou Laihe Biotech Co., Ltd
69.     COVID-19 Antigen Rapid Test Device(Colloidal Gold) HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD.
70.     COVID-19 Antigen Test Cassette Hangzhou Testsea Biotechnology Co., Ltd
71.     Coronavirus Ag Rapid Test Cassette Healgen Scientific
72.     SARS-CoV-2 Antigen Test Kit Hubei Jinjian Biology Co., Ltd
73.     Humasis COVID-19 Ag Test Humasis
74.     Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit Jiangsu Bioperfectus Technologies Co., Ltd.
75.     COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) Jiangsu Diagnostics Biotechnology Co.,Ltd.
76.     SARS-CoV-2 antigen Test Kit (LFIA) Jiangsu Medomics medical technology Co.,Ltd.
77.     COVID-19 Rapid Antigen Test (Colloidal Gold) Joinstar Biomedical Technology Co., Ltd
78.     SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) JOYSBIO (Tianjin) Biotechnology Co., Ltd
79.     SARS-CoV-2 Antigen Rapid Test Kit Labnovation Technologies Inc
80.     PocRoc®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) Lumigenex (Suzhou) Co., Ltd
81.     QuickProfile COVID-19 Antigen Test LumiQuick Diagnostics Inc
82.     LumiraDx SARS-CoV-2 Ag Test LumiraDX
83.     MEDsan SARS-CoV-2 Antigen Rapid Test MEDsan GmbH
84.     SARS-CoV-2 Antigen Rapid Test Cassette Merlin Biomedical (Xiamen) Co., Ltd.
85.     MEXACARE COVID-19 Antigen Rapid Test MEXACARE GmbH
86.     mö-screen Corona Antigen Test möLab
87.     Rapid SARS-CoV-2 Antigen Test Card MP Biomedicals
88.     NADAL COVID -19 Ag +Influenza A/B Test Nal von minden GmbH
89.     NADAL COVID-19 Ag Test Nal von minden GmbH
90.     FREND COVID-19 Ag NanoEntek
91.     NanoRepro SARS-CoV-2 Antigen Rapid Test NanoRepro AG
92.     MARESKIT NESAPOR EUROPA SL
93.     COVID-19 Antigen Detection Kit New Gene (Hangzhou) Bioengineering Co., Ltd
94.     SARS CoV-2 Antigen Rapid Test Novatech
95.     CAT Oncosem Onkolojik Sistemler San. ve Tic. A.S.
96.     PCL COVID19 Ag Rapid FIA PCL Inc
97.     PCL COVID19 Ag Gold PCL Inc.
98.     SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay) PerGrande BioTech Development Co., Ltd.
99.     Exdia COVID-19 Ag Precision Biosensor, Inc
100.                         Rapid Test Ag 2019-nCov Prognosis Biotech
101.                         SARS-CoV-2 Antigen Rapid Test (Immunochromatography) Qingdao Hightop Biotech Co., Ltd
102.                         Sofia SARS Antigen FIA Quidel Corporation
103.                         LIAISON® Quick Detect Covid Ag Assay Rapid Pathogen Screening, Inc.
104.                         SARS-CoV-2 Rapid Antigen Test Roche (SD BIOSENSOR)
105.                         SARS-CoV-2 Rapid Antigen Test Nasal Roche (SD BIOSENSOR)
106.                         COVID-19 Antigen Rapid Test Kit (Swab) Safecare Biotech (Hangzhou) Co. Ltd
107.                         Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19) Safecare Biotech (Hangzhou) Co. Ltd
108.                         ScheBo SARS CoV-2 Quick Antigen ScheBo Biotech AG
109.                         STANDARD F COVID-19 Ag FIA SD BIOSENSOR Inc
110.                    nbsp;     STANDARD Q COVID-19 Ag Test SD BIOSENSOR Inc
111.                         STANDARD Q COVID-19 Ag Test Nasal SD BIOSENSOR Inc
112.                         V-Chek SARS-CoV-2 Ag Rapid Test Kit (Colloidal Gold) SGA Medikal
113.                         V-Chek SARS-CoV-2 Rapid Ag Test (colloidal gold) SGA Medikal
114.                         Green Spring SARS-CoV-2 Antigen-Rapid test-Set Shenzhen Lvshiyuan Biotechnology Co., Ltd.
115.                         SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay) Shenzhen Microprofit Biotech Co., Ltd
116.                         SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay) Shenzhen Microprofit Biotech Co., Ltd
117.                         SARS-CoV-2 Antigen Test Kit Shenzhen Ultra-Diagnostics Biotec.Co.,Ltd
118.                         SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) Shenzhen Watmind Medical Co., Ltd
119.                         SARS-CoV-2 Ag Diagnostic Test Kit (Immuno-fluorescence) Shenzhen Watmind Medical Co., Ltd
120.                         Zhenrui ®COVID-19 Antigen Test Cassette Shenzhen Zhenrui Biotechnology Co., Ltd
121.                         CLINITEST Rapid Covid-19 Antigen Test Siemens Healthineers
122.                         SGTi-flex COVID-19 Ag Sugentech, Inc
123.                         TODA CORONADIAG Ag TODA PHARMA
124.                         SARS-CoV-2 Antigen Rapid Test Kit Triplex International Biosciences (China) Co., LTD.
125.                         SARS-CoV-2 Antigen Rapid Test Kit Triplex International Biosciences Co., Ltd
126.                         RapidFor SARS-CoV-2 Rapid Ag Test Vitrosens Biotechnology Co., Ltd
127.                         VivaDiag Pro SARS-CoV-2 Ag Rapid Test VivaChek Biotech (Hangzhou) Co., Ltd
128.                         COVID-19 (SARS-CoV-2) Antigen Test Kit Wuhan EasyDiagnosis Biomedicine Co., Ltd.
129.                         The SARS-CoV-2 Antigen Assay Kit (Immunochromatography) Wuhan Life Origin Biotech Joint Stock Co., Ltd.
130.                         SARS-CoV-2 Antigen Rapid Test Kit Wuhan UNscience Biotechnology Co., Ltd.
131.                         COVID-19 Antigen Rapid Test Kit (Colloidal Gold) Xiamen AmonMed Biotechnology Co., Ltd
132.                         Rapid SARS-CoV-2 Antigen Test Card Xiamen Boson Biotech Co. Ltd
133.                         SARS-CoV-2 Antigen Rapid Test Xiamen Wiz Biotech Co., Ltd
134.                         SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) Xiamen Wiz Biotech Co., Ltd
135.                         AndLucky COVID-19 Antigen Rapid Test Zhejiang Anji Saianfu Biotech Co., Ltd
136.                         reOpenTest COVID-19 Antigen Rapid Test Zhejiang Anji Saianfu Biotech Co., Ltd
137.                         Coronavirus Ag Rapid Test Cassette (Swab) Zhezhiang Orient Gene Biotech Co., Ltd
138.                         COVID-19 Antigen Detection Kit (Colloidal Gold) Zhuhai Lituo Biotechnology Co., Ltd

Notes :

  • Subject to change. Revision will be updated in NPHL website.
  • This list is subject to change as per reporting and adverse events in post marketing surveillance.