id device,commercial name,id manufacturer,manufacturer name,manufacturer country,manufacturer website,ce marking,commercial status,hsc common list,hsc mutual recognition,physical supports,formats,targets,specimens,pathogens,lineages,last updated,id test,assay category,rapid diagnostic,self test,reader required,method,measurement,subclass,detection principle,subcategory,time minutes,LOD,Positive control,Negative control,Performance control,Calibration,Analytical Sensitivity,Analitical Specificity,Crossreactivity,Fp,Fn,Precision,Accuracy,Reproducibility,Robustness,Clinical Sensitivity,Clinical Specificity,Throughput,Type of antigen,
1833,"COVID-VIRO",837,"AAZ-LMB",France,"www.covid19aaz.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-05-17 11:02:12 CET,1512,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,,,16,1.15 AU,,,,Not evaluated,,,Evaluated,0 %,3.4 %,Evaluated,98.74,Not evaluated,Evaluated,96.6 %,100 %,,Nucleoprotein
1232,"Panbio Covid-19 Ag Rapid Test",628,"Abbott Rapid Diagnostics",Switzerland,"",Yes,,Yes,Yes,Cassette; Lateral flow,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,SARS-CoV,,2021-07-23 09:42:00 CET,1015,Immuno-Antigen,Yes,,No,Other,Qualitative,,,,15,0,,,,Evaluated,,,Evaluated,0,Ja,Evaluated,100 %,Not evaluated,Evaluated,98 %,99 %,,Other
1457,"Flowflex SARS-CoV-2 Antigen Rapid Test",565,"Acon Biotech (Hangzhou) Co., Ltd",China,"https://www.aconbio.com/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Lab-based; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,SARS-CoV,A.23.1 (United Kingdom);AT.1 (Russia);B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.427 (USA);B.1.429 (USA);B.1.525 (Nigeria);B.1.526 (USA);B.1.616 (France);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);B.1.621 (Colombia);C.37 (Peru);P.1 (Japan/Brazil);P.2 (Brazil);P.3 (The Philippines);,2021-10-04 08:46:09 CET,1209,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,,,15,160 TCID50/ml,,,,Not evaluated,,,Evaluated,0.45 % (2 out of 435 (Nasal Swab)) 0.56 % (1 out of 176 (Nasopharyngeal Swab)),2.94 % (5 out of 170 (Nasal Swab)) 2.43 % (3 out of 123 (Nasopharyngeal Swab)),Evaluated,98.7 % (Nasopharyngeal Swab) 98.8 % (Nasal Swab),Evaluated,Evaluated,97.1 % (Nasal Swab) 97.6 % (Nasopharyngeal Swab),99.5 % (Nasal Swab) 99.4 % ( Nasopharyngeal Swab),,Nucleocapsid protein
1468,"Flowflex SARS-CoV-2 Antigen rapid test",683,"ACON Laboratories, Inc",United States,"www.aconlabs.com",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 20:07:30 CET,1219,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,160 U/ml,,,,Not Evaluated,,,Evaluated,0.5 %,3.1 %,Evaluated,98.8,Evaluated,Evaluated,96.9,,,Nucleoprotein (nucleoprotein)
2108,"AESKU.RAPID SARS-CoV-2",976,"AESKU.DIAGNOSTICS GmbH & Co. KG",Germany,"www.aesku.com",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab; Throat swab,SARS-CoV,B.1.1.7 (United Kingdom);,2021-06-18 12:48:10 CET,1798,Immuno-Antigen,,,No,Immunoassay,Qualitative,Sandwich, Double,,,15,50 AU,,,,Not evaluated,,,Evaluated,1.8 % (4 false positives out of 222 negative samples),3.66 % (4 false negatives out of 109 positive samples),Evaluated,% ((Antigen)),Evaluated,Evaluated,96 % ( (Antigen)),98 % ( (Antigen)),,Nucleoprotein
2130,"TestNOW® - COVID-19 Antigen Test",987,"Affimedix, Inc.",United States,"www.affimedix.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,Adenovirus; Coronaviruses (HCoV); Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus OC43 (HCoV-OC43); Enterovirus A71 (EV-A71); Influenza A; Influenza A H1N1; Influenza A H3N2; Mycoplasma Pneumoniae; Parainfluenza Virus Type; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Parainfluenza Virus Type 4; Respiratory Syncytial V (RSV) Type A; Respiratory Syncytial V (RSV) Type B; Rhinovirus A,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.427 (USA);B.1.429 (USA);,2021-07-07 17:18:37 CET,1820,Immuno-Antigen,,,No,Immunochromatography,Qualitative,Sandwich,,Extraction kit,15,126 TCID50/ml,,,,Evaluated,,,Evaluated,0.6 %,3.9 %,Evaluated,98.4 %,Evaluated,Evaluated,96.1 %,99.4 %,,Nucleoprotein
1304,"AMP Rapid Test SARS-CoV-2 Ag",531,"AMEDA Labordiagnostik GmbH",Austria,"www.amp-med.com/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-06-25 12:29:39 CET,1076,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,,,,15,,,,,,,,Evaluated,,,Evaluated,100 %,Evaluated,Evaluated (Evaluated),97.3 %,,,Nucleoprotein (Nucleoprotein)
1822,"Rapid COVID-19 Antigen Test(Colloidal Gold)",307,"Anbio (Xiamen) Biotechnology Co., Ltd",China,"www.anbio.com/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab; Throat swab,,,2021-07-07 17:18:51 CET,1732,Immuno-Antigen,Yes,,,Immunoassay,,,,,,,,,,,,,,,,,,,,,,,
1815,"COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) - Nasal Swab",24,"Anhui Deep Blue Medical Technology Co., Ltd",China,"www.dbluemedical.com/",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Anterior nasal swab; Nasal swab,,,2021-07-07 17:18:58 CET,1493,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,20,320 AU,,,,Evaluated,,,Evaluated,0.2 %,3.6 %,Evaluated,99.03 %,Evaluated,Evaluated,96.4 %,99.8 %,,Nucleoprotein
1736,"COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold)",24,"Anhui Deep Blue Medical Technology Co., Ltd",China,"www.dbluemedical.com/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Other,,,2021-07-07 17:19:10 CET,1415,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,20,320,,,,not evaluated,,,evaluated,2.27 % (5 of 220),0.9 % (2 of 220),evaluated,98,evaluated,not evaluated,95.7,,,nucleoprotein
768,"mariPOC SARS-CoV-2",454,"ArcDia International Ltd",Finland,"www.arcdia.com",Yes,Commercialised,Yes,Yes,Microplate,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-07-07 17:19:16 CET,622,Immuno-Antigen,Yes,,Yes,Immunoassay,Quantitative,Fluorescence,,,20,,,,,,,,"0 with MERS, seasonal coro-naviruses (229E, HKU1, NL63, OC43) or other common respiratory tract pathogens or normal bacterial flora",,,,,,,92 %,100 %,,
2079,"mariPOC Quick Flu+",962,"ArcDia International Oy Ltd",Finland,"https://www.arcdia.com/",Yes,Commercialised,Yes,Yes,Cartridge,Automated; Near POC / POC,Antigen,Nasopharyngeal swab; Wash aspirate,SARS-CoV; Influenza A; Influenza A H1N1; Influenza A H3N2; Influenza A H5N1; Influenza B Victoria; Influenza B Yamagata; Influenza B; Respiratory Syncytial V (RSV); Respiratory Syncytial V (RSV) Type A; Respiratory Syncytial V (RSV) Type B,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.2 (Brazil);,2021-07-13 17:53:23 CET,1761,Immuno-Antigen,,,Yes,Immunoassay,Quantitative,Sandwich,,,20,5.4 AU,,,,Evaluated,,,Evaluated,0 % (No false positives),0 % (No false negatives),Evaluated,100 % ( (Antigen)),Evaluated,Evaluated,100 % ( (Antigen)),100 % ((Antigen)),,Nucleoprotein
2078,"mariPOC Respi+",962,"ArcDia International Oy Ltd",Finland,"https://www.arcdia.com/",Yes,Commercialised,Yes,Yes,Cartridge; Other,Automated; Near POC / POC,Antigen,Nasopharyngeal swab; Wash aspirate,Adenovirus; Adenovirus 3; Adenovirus 7; Adenovirus Subtype B; Adenovirus Subtype C; Beta Coronavirus OC43 (HCoV-OC43); SARS-CoV; Human Metapneumovirus (HMPV); Influenza A; Influenza A H1N1; Influenza A H3N2; Influenza A H5N1; Influenza B; Influenza B Victoria; Influenza B Yamagata; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Respiratory Syncytial V (RSV); Respiratory Syncytial V (RSV) Type A; Respiratory Syncytial V (RSV) Type B,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-07-13 17:52:37 CET,1760,Immuno-Antigen,,,Yes,Immunoassay,Quantitative,Sandwich,,,120,AU (2.7),,,,Evaluated,,,Evaluated,0 % (No false positives),0 % (No false negatives),Evaluated,100 % ((Antigen)),Evaluated,Evaluated,100 % ( (Antigen)),100 % ( (Antigen)),,
1618,"Artron COVID-19 Antigen Test",721,"Artron Laboratories Inc",Canada,"http://www.artronlab.com/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-07-13 17:53:59 CET,1298,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,1000 AU,,,,,,,Evaluated (Evaluated),,,Evaluated (Evaluated),"99.67 % ( (Nasal), ) 98.25 % ((Nasopharyngeal))",Evaluated,Evaluated (Evaluated),96.67 % ( (Nasal)) 91.67 % ( (Nasopharyngeal)),"100 % ((Nasal, Nasopharyngeal))",,nucleoprotein (Nucleoprotein)
1654,"Asan Easy Test COVID-19 Ag",741,"Asan Pharmaceutical CO., LTD",South Korea,"www.asanpharm.com",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:19:48 CET,1733,Immuno-Antigen,Yes,,,Immunoassay,,,,,,,,,,,,,,,,,,,,,,,
770,"ECOTEST COVID-19 Antigen Rapid Test Device",455,"Assure Tech. (Hangzhou) Co., Ltd",China,"www.diareagent.com",Yes,Commercialised,Yes,Yes,Cassette,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Adenovirus; Bordetella Pertussis; Chlamydia Pneumoniae; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Epstein-Barr Virus (EBV); Human Metapneumovirus (HMPV); Influenza A H1N1; Influenza A H3N2; Influenza A H5N1; Influenza B Victoria; Influenza B Yamagata; Mumps Virus (MuV); Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Respiratory Syncytial V (RSV) Type A; Respiratory Syncytial V (RSV) Type B; Rhinovirus,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.1 (Japan/Brazil);,2021-07-13 17:38:51 CET,623,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,502 AU,,,,Evaluated (Evaluated),,,Evaluated (Evaluated),"0.75 % (A total of 1190 SARS-CoV-2 negative samples were tested, 9 samples were positive by this test.)","7.5 % (A total of 160 SARS-CoV-2 positive samples were tested, 12 samples were negative by this RDT.)",,98.5 %,,,92.5 %,99.2 %,,Nucleoprotein
2350,"ECOTEST COVID-19 Antigen Rapid Test Device",1059,"Assure Tech. (Hangzhou) Co., Ltd.",China,"www.diareagent.com",Yes,Commercialised,Yes,Yes,Lateral flow,Manual; Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,Adenovirus; Chlamydia Pneumoniae; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Epstein-Barr Virus (EBV); Human Metapneumovirus (HMPV); Influenza A; Influenza A H1N1; Influenza A H3N2; Influenza A H5N1; Influenza B Victoria; Influenza B; Influenza B Yamagata; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Respiratory Syncytial V (RSV),B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.1 (Japan/Brazil);,2021-07-22 13:10:53 CET,2051,Immuno-Antigen,Yes,,,Immunoassay,,,,,15,502 AU,,,,Not evaluated,,,Evaluated,"0.86 % (A total of 1036 SARS-CoV-2 negative samples were tested, 9 samples were positive by this test.)","2.3 % (A total of 128 SARS-CoV-2 positive samples were tested, 3 samples were negative by this RDT.)",Evaluated,99 %,Evaluated,Evaluated,97.7 %,99.1 %,,Nucleoprotein
2010,"NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)",924,"Atlas Link Technology Co., Ltd.",China,"http://www.atlas-link.com/english/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow; Strip,Manual; Near POC / POC,Antigen,Nasal swab; Oropharyngeal swab,,,2021-07-07 17:19:54 CET,1688,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,Colloidal gold,Validity test kit,15,50 AU,,,,Not evaluated,,,Evaluated,0.6 %,1.5 %,Not evaluated,99.1 %,Evaluated,Not evaluated,98.5 %,99.4 %,,nucleoprotein
1800,"Ksmart® SARS-COV2 Antigen Rapid Test",820,"AVALUN SAS",France,"avalun.com/",Yes,Commercialised,Yes,Yes,,Semi-automated,Antigen,Nasopharyngeal swab,,,2021-07-07 17:12:25 CET,1479,Immuno-Antigen,,,Yes,Immunochromatography,Qualitative,,Colorimetry,,20,30 U/ml,,,,Not evaluated,,,Evaluated,0.68 % (The specificity was tested using 441 negative specimens.3 False positives results vs the PCR assay),6.81 % (The sensitivity was tested using 176 positive specimens.12 False negatives results vs the PCR assay.),Evaluated,97.57 %,Evaluated,Not evaluated,93.18 %,99.32 %,,
2101,"COVID-19 Antigen Rapid Test",974,"AXIOM Gesellschaft für Diagnostica und Biochemica mbH",,"",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Throat swab,SARS-CoV,A.23.1 (United Kingdom);AT.1 (Russia);B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.427 (USA);B.1.429 (USA);B.1.525 (Nigeria);B.1.526 (USA);B.1.526.1 (USA);B.1.526.2 (USA);B.1.616 (France);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);B.1.621 (Colombia);C.36 (Egypt);C.37 (Peru);P.1 (Japan/Brazil);P.2 (Brazil);P.3 (The Philippines);,2021-07-07 17:20:03 CET,1784,Immuno-Antigen,,,No,Immunoassay,,,,,10,0.05 AU,,,,Evaluated,,,Evaluated,0 %,0 %,Evaluated,99 %,Evaluated,Evaluated,98 %,100 %,,Nucleoprotein
1906,"COVID-19 Antigen Rapid Test Device",871,"Azure Biotech Inc",United States,"www.azure.bio",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,,,2021-07-07 17:20:10 CET,1672,Immuno-Antigen,Yes,,,Immunoassay,,,,,,,,,,,,,,,,,98.9 %,,,94.3 %,,,
1906,"COVID-19 Antigen Rapid Test Device",871,"Azure Biotech Inc",United States,"www.azure.bio",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,,,2021-07-07 17:20:10 CET,1682,Immuno-Antigen,Yes,,No,Immunoassay,,,,,15,,,,,Evaluated,,,Evaluated,,,Evaluated,98.7 %,Evaluated,Evaluated,95 %,99.2 %,,Other
1065,"BD Veritor™ System for Rapid Detection of SARS CoV 2",42,"Becton Dickinson",United States,"https://www.bd.com/en-us",Yes,Commercialised,Yes,Yes,Cartridge; Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:13:00 CET,49,Immuno-Antigen,Yes,,Yes,Immunochromatography,Qualitative,,Magnetic Electrochemical,,15,140 TCID50/ml,,,,,,,Evaluated,,,Evaluated,98.1 %,Evaluated,Evaluated,91.1 %,99.6 %,,Nucleoprotein (Nucleoprotein)
1870,"Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)",328,"Beijing Hotgen Biotech Co., Ltd",China,"www.hotgen.com.cn/",Yes,Commercialised,Yes,Yes,Lateral flow; Strip,Near POC / POC,Antigen,Saliva,,,2021-05-10 20:07:30 CET,1547,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,,,15,250 AU,,,,Not evaluated,,,Evaluated,0 %,0 %,Evaluated,98.87 %,Not evaluated,Evaluated,97.1 %,99.76 %,,Nucleoprotein
2072,"Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit",958,"Beijing Jinwofu Bioengineering Technology Co.,Ltd.",China,"jwfbio.com",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Anterior nasal swab; Nasal swab; Nasopharyngeal swab; Oropharyngeal swab; Saliva,Adenovirus; Adenovirus 3; Adenovirus 7; Adenovirus Subtype B; Adenovirus Subtype C; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Enterovirus A71 (EV-A71); Cytomegalovirus (CMV); Epstein-Barr Virus (EBV); Influenza A; Influenza A H1N1; Influenza A H3N2; Influenza A H5N1; Influenza B Victoria; Influenza B Yamagata; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Parainfluenza Virus Type 4; Respiratory Syncytial V (RSV); Respiratory Syncytial V (RSV) Type A; Respiratory Syncytial V (RSV) Type B; Rhinovirus A; Rhinovirus B,A.23.1 (United Kingdom);AT.1 (Russia);B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.616 (France);B.1.621 (Colombia);C.36 (Egypt);C.37 (Peru);P.1 (Japan/Brazil);P.2 (Brazil);,2021-07-13 17:54:34 CET,1754,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,,Validity test kit,30,100 AU,,,,Evaluated,,,Evaluated,0 %,3.125 %,Evaluated,98.82 %,Evaluated,Evaluated,% (96.88%),100 %,,Nucleoprotein
1331,"SARS-CoV-2 Antigen Rapid Test Kit",319,"Beijing Lepu Medical Technology Co., Ltd",China,"en.lepumedical.com/",Yes,Commercialised,Yes,Yes,Card,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-07-27 11:43:24 CET,1100,Immuno-Antigen,Yes,,No,Immunochromatography,Quantitative,,Colloidal gold,,15,,,,,,,,,,,,,,,95.06 %,99.62 %,,
1485,"WANTAI SARS-CoV-2 Ag Rapid Test (Colloidal Gold)",49,"Beijing Wantai Biological Pharmacy Enterprise Co., Ltd",China,"www.ystwt.cn",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Anterior nasal swab; Nasal swab; Nasopharyngeal swab; Oropharyngeal swab; Saliva,,,2021-07-23 09:30:21 CET,1237,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,,,20,20 AU,,,,evaluated,,,evaluated,0.9 % (99.1% (1036/1045) (CI: 98.37%~99.55%)),3.9 % (96.1% (173/180) (CI: 92.19%~98.10%)),evaluated,,evaluated,evaluated,96.1 %,,,nucleoprotein
1484,"Wantai SARS-CoV-2 Ag Rapid Test (FIA)",49,"Beijing Wantai Biological Pharmacy Enterprise Co., Ltd",China,"www.ystwt.cn",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Nasal swab; Other,,,2021-07-07 17:20:18 CET,1236,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,Fluorescence,,,20,5 U/ml,,,,Evaluated,,,Evaluated,96.9 % (629/649 (CI: 95.29%-98.00%)),96.6 % (168/174 (CI: 92.68%-98.41%)),Evaluated,,Evaluated,Evaluated,96.6 %,,,nucleoprotein
2031,"Coronavirus Ag Rapid Test Cassette (Swab)",934,"Bio-Rad Laboratories / Zhejiang Orient Gene Biotech",China,"www.bio-rad.com",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-07-07 17:08:22 CET,1709,Immuno-Antigen,,,No,Immunoassay,Qualitative,Membrane-based,,,15,115 AU,,,,Evaluated,,,Evaluated,"0.4 % (Nasopharyngeal Swab: 3/743 , Nasal Swab: 0/128)","1.71 % (Nasopharyngeal Swab: 2/117 , Nasal Swab: 3/106)",Evaluated,"99 % (Nasopharyngeal Swab: 99,42% / Nasal Swab: 98,73%)",Evaluated,Evaluated,"98 % (Nasopharyngeal Swab: 98,32% / Nasal Swab: 97,25%)","99 % (Nasopharyngeal Swab: 99,6% / Nasal Swab: 100%)",,Nucleoprotein
2247,"CoviGnost AG Test Device 1x20",1046,"BioGnost Ltd",Croatia,"www.biognost.com",Yes,Commercialised,Yes,Yes,Cassette,Manual,Antigen,Nasopharyngeal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-07-22 13:11:38 CET,1948,Immuno-Antigen,,,No,Immunochromatography,Qualitative,Membrane-based,,,15,0 AU,,,,Not evaluated,,,Evaluated,2.44 % (3/123),1.23 % (1/81),Evaluated,98 %,Evaluated,Not evaluated,96 %,99 %,,
1286,"SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)",53,"BIOHIT HealthCare (Hefei) Co., Ltd",China,"www.biohit.cn",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Serum,,,2021-07-22 13:12:43 CET,1060,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,Fluorescence,,,15,20 TCID50/ml 3.5 pg (per ml),,,,,,,,,,,,,,96.77 %,98.9 %,,
2035,"SARS-CoV-2 Ag Rapid Test",937,"BioMaxima SA",Poland,"www.biomaxima.com",Yes,Commercialised,Yes,Yes,Cassette,Manual; Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-07-22 13:13:31 CET,1713,Immuno-Antigen,,,No,Immunochromatography,Qualitative,Capture,,,10,160 AU,,,,Not evaluated,,,Evaluated,2 AU,5 AU,Evaluated,97 %,Evaluated,Evaluated,95 %,99 %,,Nucleoprotein
1599,"Biomerica COVID-19 Antigen Rapid Test (nasopharyngeal swab)",708,"Biomerica, Inc.",United States,"biomerica.com/index.asp",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-07-07 17:10:27 CET,1280,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,0.0001 AU,,,,evaluated,,,evaluated,1 AU,8 AU,evaluated,98 %,evaluated,evaluated,94.7 %,,,nucleoprotein
1242,"NowCheck COVID-19 Ag Test",633,"Bionote, Inc",South Korea,"bionote.co.kr",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.617.1 (India);B.1.617.2 (India);P.1 (Japan/Brazil);,2021-07-07 17:07:07 CET,1023,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,247 TCID50/ml,,,,,,,Evaluated,0.57 % (3/527),9 % (2/22),,,Evaluated,,90.91 %,99.43 %,,
1223,"BIOSYNEX COVID-19 Ag BSS",651,"BIOSYNEX S.A.",France,"www.biosynex.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Other,,,2021-05-10 13:18:20 CET,1007,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,15,,,,,,,,,,,,,,,,,,nucleocapsid protein 
1494,"BIOSYNEX COVID-19 Ag+ BSS",651,"BIOSYNEX S.A.",France,"www.biosynex.com",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Other,,,2021-07-07 17:08:11 CET,1244,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,10,750 AU,,,,not evaluated,,,evaluated,0 % (Clinical data: 0 false positive result out of 583 negative samples confirmed by RT-PCR),2.53 % (Clinical data: 2 false negative results out of 79 positive samples confirmed by RT-PCR),evaluated,99.7 % (95%CI: 98.9-100%),evaluated,evaluated,97.5 % (95%CI: 91.1-99.7%),,,nucleoprotein
2067,"SARS-CoV-2 Antigen Test Kit (colloidal gold method)",955,"BIOTEKE CORPORATION (WUXI) CO., LTD",China,"https://www.bioteke.cn/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,Coronaviruses (HCoV),B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-07-13 17:51:35 CET,1747,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich, Double,Colloidal gold,Validity test kit,15,175 AU,,,,Evaluated,,,Evaluated,0.72 %,3.51 %,Evaluated,98.47 % ((95%CI: 96.70%～99.44%)),Evaluated,Evaluated,96.49 ((95%CI: 91.26%～99.04%)),99.28 ((95%CI: 97.43%～99.91%)),,Nucleoprotein
2013,"biotical SARS-CoV-2 Ag Card",925,"Biotical Health S.L.U.",Spain,"https://biotical.es/es/",Yes,Commercialised,Yes,Yes,Card; Lateral flow,Manual; Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-07-22 13:14:13 CET,1691,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,10,1000 TCID50/ml 1 ng/mL,,,,Not evaluated,,,Evaluated,0 %,3 %,Evaluated,99 %,Evaluated,Evaluated,96 %,99 %,,Nucleoprotein
1989,"AFIAS COVID-19 Ag",22,"Boditech Med Inc",South Korea,"https://www.boditech.co.kr/en",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC; Semi-automated,Antigen,Nasopharyngeal swab,SARS-CoV,,2021-07-22 13:15:14 CET,1665,Immuno-Antigen,Yes,,Yes,Immunochromatography,Semiquantitative,Sandwich,,Other,12,35.15 AU,,,,Evaluated,,,Evaluated,3 AU,11 AU,Evaluated,95.5 %,Evaluated,Not evaluated,91.7 %,98.7 %,,Nucleoprotein
1236,"Rapid Response COVID-19 Antigen Rapid Test",62,"BTNX Inc",Canada,"www.btnx.com/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,,,2021-07-07 17:20:40 CET,1018,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,,,15,502.38 TCID50/ml,,,,,,,Evaluated,0 AU,5 AU,Evaluated,97.2 %,Evaluated,Evaluated,90.2 %,100 %,,Nucleoprotein
1173,"CerTest SARS-CoV-2 Card test",737,"CerTest Biotec",Spain,"www.certest.es",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:18:20 CET,957,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Magnetic Electrochemical,,10,1000 TCID50/ml 1 ng/mL,,,,,,,0 AU,,,,,,,92.9 %,99.6 %,,
1919,"Coretests COVID-19 Ag Test",420,"Core Technology Co., Ltd",China,"www.coretests.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 20:12:51 CET,1595,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich,,,15,22.5 AU,,,,Evaluated,,,Evaluated,0.4 %,1.9 %,Evaluated,99.2 %,Evaluated,Evaluated,98.1 %,99.6 %,,Nucleoprotein
1581,"OnSite COVID-19 Ag Rapid Test",79,"CTK Biotech, Inc",United States,"https://ctkbiotech.com/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.427 (USA);B.1.429 (USA);B.1.525 (Nigeria);B.1.526 (USA);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.1 (Japan/Brazil);,2021-07-07 17:10:05 CET,1260,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich, Double,Colorimetry,,15,280 %,,,,Evaluated,,,Evaluated,0 %,7.7 %,Evaluated,100 % 98.9 %,Evaluated,Evaluated,92.3 %,100 %,,nucleoprotein
1225,"Test Rapid Covid-19 Antigen (tampon nazofaringian)",577,"DDS DIAGNOSTIC",Romania,"www.ddsdiagnostic.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:20:47 CET,1009,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,98.95 %,,,98.77 %,99.03 %,,
1375,"DIAQUICK COVID-19 Ag Cassette",526,"DIALAB GmbH",Austria,"www.dialab.at/en/home/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 20:07:30 CET,1139,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,15,,,,,,,,,,,,,,,,,,SARS-CoV-2
2242,"COVID-19 Antigen Detection Kit",1042,"DNA Diagnostic",Denmark,"https://dna-diagnostic.com/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-07-22 13:16:00 CET,1943,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,160 TCID50/ml,,,,Not evaluated,,,Evaluated,0.44 % (1 out of 226 true negatives compared to PCR),6.25 % (9 out of 144 true positives compared to PCR),Evaluated,97.3 %,Evaluated,Not evaluated,93.8 %,99.6 %,,Nucleoprotein
1243,"ActivXpress+ COVID-19 Antigen Complete Testing Kit",88,"Edinburgh Genetics Limited",United Kingdom,"eggenetics.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,SARS-CoV,,2021-08-26 18:44:52 CET,1024,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,3 AU,,,,Evaluated,,,Evaluated,Specificity 99.24%,Sensitivity 96.17%,Evaluated,,Evaluated,Evaluated,96.17 % (Saliva) 97.27 (Nasopharyngeal swab) 95.63 (Oropharyngeal swab),99.24 % (Saliva) 99.62 (Nasopharyngeal swab) 99.24 (Oropharyngeal swab),,Nucleoprotein
1739,"EBS SARS-CoV-2 Ag Rapid Test",294,"Eurobio Scientific",France,"https://www.eurobio-scientific.com/",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:06:15 CET,1417,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,,Colorimetry,,10,95 AU,,,,not evaluated,,,evaluated,,,not evaluated,,evaluated,not evaluated,95.7 % (A/(A+C) x 100= 95.7% (95% CI 90.2 98.1%)),,,nucleoprotein
2147,"ESPLINE SARS-CoV-2",994,"Fujirebio",Japan,"https://www.fujirebio.com/en",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,Adenovirus; Adenovirus 3; Adenovirus 7; Adenovirus Subtype B; Adenovirus Subtype C; Bordetella Pertussis; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus OC43 (HCoV-OC43); MERS-CoV; Enterovirus A71 (EV-A71); Hemophilus Influenzae; Human Metapneumovirus (HMPV); Influenza A H1N1; Influenza A H3N2; Mycoplasma Pneumoniae; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Respiratory Syncytial V (RSV) Type A; Rhinovirus,,2021-07-07 17:12:38 CET,1837,Immuno-Antigen,,,No,Immunochromatography,Qualitative,Enzyme-linked,,,30,50 PFU/mL ((Viral Copy equivalent = 1.09 x 10 exp5 copies/ml)),,,,Evaluated,,,Evaluated,"0 % (Specificity = 100% (n=644, no false positives))","12.2 % (Sensitivity = 87.8% (n=98, Ct<33))",Evaluated,98.3 %,Evaluated,Evaluated,"87.8 % ( (n=98, Ct<33))",100 %,,Nucleoprotein
1855,"GA CoV-2 Antigen Rapid Test",351,"GA Generic Assays GmbH",Germany,"www.genericassays.com",Yes,Commercialised,Yes,Yes,Lateral flow,Manual,Antigen,Nasopharyngeal swab,,,2021-07-22 13:16:51 CET,1535,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,,N.A.,15,10 AU,,,,Not evaluated,,,Evaluated,0.8 % (4/500),2.94 % (3/102),Evaluated,98 %,Not evaluated,Evaluated,97.059 %,99.2 %,,Nucleoprotein
1244,"Genbody COVID-19 Ag Test",97,"GenBody, Inc",South Korea,"www.genbody.co.kr/index.php?&LANGUAGE=en",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-07-07 17:20:53 CET,1025,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich, Double,,,20,2870 TCID50/ml,,,,,,,,,,,94 %,,,90 %,98 %,,
2012,"SARS-CoV-2 Antigen Test Kit (Colloidal Gold)",472,"Genrui Biotech Inc",China,"www.genrui-bio.com",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Adenovirus; Bordetella Pertussis; Chlamydia Pneumoniae; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); MERS-CoV; Enterovirus A71 (EV-A71); Influenza A; Influenza B; Hemophilus Influenzae; Parainfluenza Virus Type; Respiratory Syncytial V (RSV); Rhinovirus,B.1.351 (South Africa);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);,2021-07-20 14:00:56 CET,1690,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,Colloidal gold,Validity test kit,15,180 AU,,,,Evaluated,,,Evaluated,0.98 %,8.85 %,Evaluated,94.88 % (Nasal Swab) 97.15 % (NP Swab),Evaluated,Evaluated,91.15 % (Nasal Swab) 95.03 % (NP Swab),99.02 % (Nasal Swab) 99.02 % (NP Swab),,Nucleoprotein
1253,"GenSure COVID-19 Antigen Rapid Kit",340,"GenSure Biotech Inc",China,"www.gensbio.com/",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:20:59 CET,1029,Immuno-Antigen,Yes,,,Immunoassay,,,,,15,,,,,,,,,,,,,,,,,,
1820,"SARS-CoV-2 Antigen (Colloidal Gold)",112,"Getein Biotech, Inc",China,"en.bio-gp.com.cn",Yes,Commercialised,Yes,Yes,Lateral flow,Manual,Antigen,Nasal swab; Saliva,,B.1.1.7 (United Kingdom);B.1.351 (South Africa);,2021-07-13 18:00:24 CET,1498,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich,Colloidal gold,Visualisation system,10,200 AU,,,,Evaluated,,,Evaluated,2.9 % (5 of 170),2.9 % (5 of 170),Evaluated,98.13 %,Evaluated,Evaluated,97.06 %,98.71 %,,nucleoprotein
2183,"One Step Test for SARS-CoV-2 Antigen (Colloidal Gold)",1017,"Getein Biotech, Inc.",China,"en.bio-gp.com.cn",Yes,Commercialised,Yes,Yes,Lateral flow; Strip,Manual,Antigen,Nasal swab; Saliva,,B.1.1.7 (United Kingdom);B.1.351 (South Africa);,2021-07-07 17:21:07 CET,1884,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich,Colloidal gold,Visualisation system,10,200 AU,,,,Evaluated,,,Evaluated,2.9 % ((5 of 170)),2.9 % ((5 of 170)),Evaluated,98.13 %,Evaluated,Evaluated,97.06 %,98.71 %,,Nucleoprotein
1197,"SARS-CoV-2 Antigen Kit (Colloidal Gold)",117,"Goldsite Diagnostics Inc",China,"en.goldsite.com.cn/",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Nasal swab; Other,,,2021-07-13 18:05:32 CET,983,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,12,,,,,,,,,,,,,,,,,,
1144,"GENEDIA W COVID-19 Ag",600,"Green Cross Medical Science Corp.",South Korea,"www.greencrossms.com/eng/main.do?lang=EN",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Anterior nasal swab; Nasopharyngeal swab,,,2021-05-11 09:31:09 CET,921,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,10,750 TCID50/ml,,,,Evaluated,,,Evaluated,,,Evaluated,95.3 %,,Evaluated,100 % 90.1 %,,,Nucleoprotein
1747,"2019-nCoV Antigen Test Kit (colloidal gold method)",779,"Guangdong Hecin Scientific, Inc.",China,"www.hecin-scientific.cn/",Yes,Commercialised,Yes,Yes,Card,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-07-07 17:21:29 CET,1425,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,175 TCID50/ml,,,,,,,Evaluated,2 AU,2 AU,Evaluated,98.51 %,Evaluated,Evaluated,96.23 %,,,Nucleoprotein
1216,"COVID-19 Ag Rapid Test Kit (Immuno-Chromatography)",569,"Guangdong Longsee Biomedical Co., Ltd",China,"www.longseemed.com",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Saliva,,,2021-07-13 17:42:33 CET,1001,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,,Colloidal gold,,,,,,,,,,,,,,,,,,,,
1360,"COVID-19 Ag Test Kit",655,"Guangdong Wesail Biotech Co., Ltd",China,"en.wesailbio.com",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:21:35 CET,1132,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,552 AU,,,,,,,,4/500,5/500,,98.4 %,,,90 %,98 %,,nucleoprotein
1324,"V-CHEK, 2019-nCoV Ag Rapid Test Kit (Immunochromatography)",382,"Guangzhou Decheng Biotechnology Co., LTD",China,"www.dochekbio.com",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:06:03 CET,1091,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,,,,15,100 %,,,,,,,,,,,,,,96.67 % ((Antigen)),,,nucleoprotein
1437,"Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)",124,"Guangzhou Wondfo Biotech Co., Ltd",China,"en.wondfo.com.cn/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Other,,,2021-05-10 20:07:30 CET,1189,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Fluorescence,,15,850 AU,,,,evaluated,,,evaluated,,,evaluated,see IFU,evaluated,evaluated,see IFU,,,
1257,"COVID-19 Antigen Rapid Test",126,"Hangzhou AllTest Biotech Co., Ltd",China,"www.alltests.com.cn",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-08-10 09:23:51 CET,1033,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,,,,,,,
1610,"COVID-19 Antigen Rapid Test Cassette",413,"Hangzhou Clongene Biotech Co., Ltd",China,"en.clongene.com/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-07-07 17:10:38 CET,1290,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,N.A.,15,2338 TCID50/ml,,,,,,,,0 % (0 of 64),2.71 % (6 of 221),,,,,91.4 %,100 %,,nucleocapside protein
1363,"Covid-19 Antigen Rapid Test Kit",413,"Hangzhou Clongene Biotech Co., Ltd",China,"en.clongene.com/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1122,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,2300 AU,,,,,,,,0 %,1.5 % (Ct<33),,99.6 % (Ct<33),,,98.5 % (Ct <33),,,nucleoprotein
1365,"COVID-19/Influenza A+B Antigen Combo Rapid Test",413,"Hangzhou Clongene Biotech Co., Ltd",China,"en.clongene.com/",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-07-07 17:21:41 CET,1125,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,2300 TCID50/ml,,,,,,,,,,,,,,91 % (95% CI: 82.8%-95.6%),100 % (95% CI: 98.2%-100%),,"SARcov2, influenza A+B viral nucleoprotein antigens"
1844,"Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive)",843,"Hangzhou Immuno Biotech Co.,Ltd",China,"www.seinofy.com",Yes,Commercialised,Yes,Yes,Cassette,Manual,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-07-07 17:21:47 CET,1521,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,10,6 AU,,,,Evaluated,,,Evaluated,"5.61 % (94,39)",0 % (100),Evaluated,97.67 %,Evaluated,Evaluated,94 %,100 %,,Nucleoprotein
2317,"SARS-CoV-2 Antigen Rapid Test",843,"Hangzhou Immuno Biotech Co.,Ltd",China,"www.seinofy.com",Yes,Commercialised,Yes,Yes,Cartridge; Cassette; Lateral flow,Manual,Antigen,Anterior nasal swab; Nasopharyngeal swab; Oropharyngeal swab; Sputum,SARS-CoV,,2021-07-23 12:29:27 CET,2018,Immuno-Antigen,,,No,Immunoassay,Qualitative,,,,15,0 AU,,,,Evaluated,,,Evaluated,The relative Sensitivity and Specificity have been compared with the Gold Standard PCR Test,The relative Sensitivity and Specificity have been compared with the Gold Standard PCR Test,Evaluated,99 %,Evaluated,Evaluated,98 %,100 %,,Nucleoprotein
1215,"LYHER Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold)",302,"Hangzhou Laihe Biotech Co., Ltd",China,"www.lyherbio.com/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:21:53 CET,1041,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,,,,,,,,,,,,,,,,,,,
2139,"COVID-19 Antigen Rapid Test Device（Colloidal Gold）",990,"HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD.",China,"http://www.lysunbio.com/",Yes,In development,Yes,Yes,Cassette,Manual; Near POC / POC,Antigen,Nasal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.617.1 (India);,2021-07-07 17:22:14 CET,1829,Immuno-Antigen,Yes,,Yes,Immunochromatography,Qualitative,Sandwich, Double,Colloidal gold,Extraction kit,10,150 AU,,,,Evaluated,,,Evaluated,0 %,3.54 %,Evaluated,98.44 % ( (95%CI: 96.92%~99.96%)) (98.44% (95%CI: 96.92%~99.96%)),Evaluated,Evaluated,96.46 ( (95%CI: 93.05%~99.87%)),100 ( (95%CI: 100%~100%)),,Nucleoprotein
1392,"COVID-19 Antigen Test Cassette",131,"Hangzhou Testsea Biotechnology Co., Ltd",China,"www.testsealabs.com/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:22:21 CET,1158,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,10,0.1 AU,,,,Not evaluated,,,,2 AU,8 AU,,96.5 %,,,92.1 %,98.1 %,,nucleoprotein
1767,"Coronavirus Ag Rapid Test Cassette",554,"Healgen Scientific",United States,"www.healgen.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-09-28 09:21:22 CET,1446,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,,,,,,,,,,,,98.73 % (Nasal swab) 99.42 % (Nasopharyngeal swab),,,97.25 % (Nasal swab) 98.32 % (Nasopharyngeal swab),100 % (Nasal swab) 99.6 % (Nasopharyngeal swab),,
1759,"SARS-CoV-2 Antigen Test Kit",786,"Hubei Jinjian Biology Co., Ltd",China,"en.jinjianbio.com/",Yes,Commercialised,Yes,Yes,Cassette,Automated,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-08-25 09:42:56 CET,1437,Immuno-Antigen,Yes,,Yes,Immunochromatography,Qualitative,,Colorimetry,,15,115 U/ml,,,,Not Evaluated,,,Evaluated,1 % (1 out of 100),1.35 % (2 out of 148),Evaluated,98.8 %,Evaluated,Evaluated,98.02 %,,,Nucleoprotein
1263,"Humasis COVID-19 Ag Test",140,"Humasis",South Korea,"http://www.humasis.com/en/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 20:07:30 CET,1038,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,,,,15,0 AU,,,,,,,,0 %,5.6 %,,97.4 %,,,95.3 %,,,
2107,"Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit",975,"Jiangsu Bioperfectus Technologies Co., Ltd.",China,"https://www.bioperfectus.com/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC; Other,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab; Other,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.617.1 (India);P.1 (Japan/Brazil);,2021-07-13 17:43:08 CET,1790,Immuno-Antigen,,,No,Immunochromatography,Qualitative,Sandwich, Double,,Other,15,AU (100),,,,Evaluated,,,Evaluated,Past medical history and other diagnostic information is necessary to determine infection status.,Negative results should be treated as presumptive and confirmed with other diagnostic techniques.,Evaluated,98.79 %,Evaluated,Evaluated,97.06 %,99.15 %,,Nucleoprotein
1920,"COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)",877,"Jiangsu Diagnostics Biotechnology Co.,Ltd.",China,"diagnostics-bio.com",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab; Throat swab,,,2021-07-13 17:48:08 CET,1596,Immuno-Antigen,,,No,Immunoassay,Qualitative,Capture,,Sample preparation,15,2338 AU,,,,Evaluated,,,Evaluated,10 AU (There were 10 false positive cases),0 % (There was no false negative),Evaluated,98.39 %,Evaluated,Evaluated,97.58 %,100 %,,Nucleoprotein
2006,"SARS-CoV-2 antigen Test Kit (LFIA)",923,"Jiangsu Medomics medical technology Co.,Ltd.",China,"http://www.medomics-dx.com/",Yes,Commercialised,Yes,Yes,Card; Lateral flow,Near POC / POC,Antigen,Anterior nasal swab; Nasopharyngeal swab; Throat swab,,,2021-07-07 17:13:27 CET,1684,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,Colloidal gold,Validity test kit,15,10 AU,,,,Not evaluated,,,Evaluated,0.49 %,2.27 %,Evaluated,98.88 %,Not evaluated,Not evaluated,97.73 %,99.51 %,,Nucleoprotein
1333,"COVID-19 Rapid Antigen Test (Colloidal Gold)",44,"Joinstar Biomedical Technology Co., Ltd",China,"www.joinstar.cn",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Coronaviruses (HCoV),A.23.1 (United Kingdom);B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.427 (USA);B.1.429 (USA);B.1.525 (Nigeria);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.1 (Japan/Brazil);,2021-09-30 11:35:12 CET,1105,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Membrane-based,Colorimetry,,15,100 (pg/mL),,,,,,,Evaluated,1.86 % ((From 215 samples tested there were 4 false positives)),1.39 % ((From 215 samples tested there were 3 false negatives)),Evaluated,97.6 %,Evaluated,Evaluated,96.1 %,98.1 %,,Nucleocapsid protein
1764,"SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)",516,"JOYSBIO (Tianjin) Biotechnology Co., Ltd",China,"en.joysbio.com/",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:22:26 CET,1442,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,160 AU,,,,,98.13 %,,0 AU,3 AU,2 AU,,98.98 %,,,,,,
1266,"SARS-CoV-2 Antigen Rapid Test Kit",346,"Labnovation Technologies Inc",China,"www.labnovation.com/",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-07-07 17:22:32 CET,1040,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,Colloidal gold,,15,,,,,,,,,,,,,,,,,,nucleocapsid protein
2128,"PocRoc®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)",986,"Lumigenex (Suzhou) Co., Ltd",China,"http://www.lumigenex.com/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,SARS-CoV,A.23.1 (United Kingdom);B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.616 (France);C.37 (Peru);P.1 (Japan/Brazil);,2021-07-07 17:22:40 CET,1818,Immuno-Antigen,,,No,Immunochromatography,Qualitative,Membrane-based,Colloidal gold,Other,20,121 AU,,,,Evaluated,,,Evaluated,0.84 %,6.67 %,Evaluated,97.38 % ((Antigen)),Evaluated,Evaluated,93.33 % ((Antigen)),99.16 % ((Antigen)),,Nucleoprotein
1267,"QuickProfile COVID-19 Antigen Test",167,"LumiQuick Diagnostics Inc",United States,"lumiquick.co/",Yes,Commercialised,Yes,Yes,Strip,Near POC / POC,Antigen,,,,2021-05-10 20:07:30 CET,1042,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,15,380 TCID50/ml,,,,,,,,,,,,,,,,,
1268,"LumiraDx SARS-CoV-2 Ag Test",252,"LumiraDX",United Kingdom,"www.lumiradx.com",Yes,Commercialised,Yes,Yes,Strip,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:18:20 CET,1043,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Fluorescence,,,12,32 TCID50/ml,,,,,,,,,,,,,,97.6 %,96.6 %,,nucleocapsid
1180,"MEDsan SARS-CoV-2 Antigen Rapid Test",617,"MEDsan GmbH",Germany,"www.medsan.eu/en/",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-05-10 20:07:30 CET,961,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,14.4 TCID50/ml,,,,,,,,,,,98.4 %,,,92.5 %,99.8 %,,
2029,"SARS-CoV-2 Antigen Rapid Test Cassette",933,"Merlin Biomedical (Xiamen) Co., Ltd.",China,"http://www.merlinbio.com.cn/en/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-07-07 17:23:09 CET,1707,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,160 AU,,,,Evaluated,,,Evaluated,5 AU,1 AU,Evaluated,97 %,Evaluated,Evaluated,95.05 %,98.99 %,,Nucleoprotein
1775,"MEXACARE COVID-19 Antigen Rapid Test",794,"MEXACARE GmbH",Germany,"www.mexacare.com",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:13:13 CET,1454,Immuno-Antigen,Yes,,No,Chromatography,Qualitative,,,,20,130 TCID50/ml,,,,Not Evaluated,,,Evaluated,4.35 % (5 of 115),0.62 % (2 of 321),Evaluated,98.39 %,Evaluated,Evaluated,Evaluated 96.17 %,,,Nucleoprotein
1190,"mö-screen Corona Antigen Test",532,"möLab",Germany,"www.moelab.de/startseite.html",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-07-07 17:23:14 CET,974,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,,,,,,,
1481,"Rapid SARS-CoV-2 Antigen Test Card",367,"MP Biomedicals",Germany,"https://www.mpbio.com/eu/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Anterior nasal swab; Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,,,2021-06-18 11:09:34 CET,1232,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,1 AU,,,,Evaluated,,,Evaluated,,,Evaluated,98.25 %,Evaluated,Evaluated,96.17 %,99.16 %,,nucleoprotein
2104,"NADAL COVID -19 Ag +Influenza A/B Test",182,"Nal von minden GmbH",Germany,"https://www.nal-vonminden.com/de/",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasopharyngeal swab,Influenza A; Influenza B,B.1.1.7 (United Kingdom);B.1.351 (South Africa);,2021-07-07 17:23:20 CET,1787,Immuno-Antigen,,,No,Immunochromatography,Qualitative,Sandwich,,,15,0.4 AU,,,,Not evaluated,,,Evaluated,"2.43 % (COVID: 3 out of 123, Influenza A: 13 out of 78, Influenza B: 15 out of 85)","0 % (COVID: 0 out of 161, Influenza A: 9 out of 112, Influenza B: 6 out of 105)",Evaluated,99 % ((over 99 %)),Evaluated,Evaluated,"97 % ((COVID); 83,3 %(Influenza A); 82,4 % (Influenza B))","98 % ((COVID); 92 %(Influenza A); 94,3 % (Influenza B))",,Nucleoprotein
1162,"NADAL COVID-19 Ag Test",182,"Nal von minden GmbH",Germany,"https://www.nal-vonminden.com/de/",Yes,Commercialised,Yes,Yes,Card; Lateral flow,Near POC / POC,Antigen,Nasal swab; Serum; Whole blood,,,2021-05-10 13:04:00 CET,943,Immuno-Antigen,Yes,,No,Chromatography,Qualitative,,,,15,,,,,,,,,,,,,,,97.56 % (Ct-value: 20-30),99.9 %,,Nucleoprotein
1420,"FREND COVID-19 Ag",354,"NanoEntek",South Korea,"www.nanoentek.com",Yes,Commercialised,Yes,Yes,Cartridge,Automated,Antigen,Nasopharyngeal swab,Adenovirus 3; Adenovirus 7; MERS-CoV; Influenza A; Influenza A H1N1; Influenza A H3N2; Influenza B; Mycoplasma Pneumoniae; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Parainfluenza Virus Type 4; Respiratory Syncytial V (RSV); Respiratory Syncytial V (RSV) Type A; Respiratory Syncytial V (RSV) Type B; Rhinovirus; Rhinovirus A; Rhinovirus B,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.2 (Brazil);,2021-07-07 17:23:26 CET,1180,Immuno-Antigen,Yes,,Yes,Immunoassay,Quantitative,,,Other,3,147 AU,,,,Evaluated,,,0 % (Evaluated),0 %,5.9 %,Evaluated,97.06 % ( (antigen)),Evaluated,Evaluated,94.12 % 94.12 %,100 % 100 %,,Nucleoprotein
2200,"NanoRepro SARS-CoV-2 Antigen Rapid Test",1027,"NanoRepro AG",Germany,"https://www.nanorepro.com/",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Anterior nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Adenovirus; Bordetella Pertussis; Chlamydia Pneumoniae; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus OC43 (HCoV-OC43); MERS-CoV; SARS-CoV; Hemophilus Influenzae; Human Metapneumovirus (HMPV); Influenza A; Influenza B; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Parainfluenza Virus Type 4; Respiratory Syncytial V (RSV); Respiratory Syncytial V (RSV) Type A; Respiratory Syncytial V (RSV) Type B; Rhinovirus,,2021-07-13 17:55:54 CET,1901,Immuno-Antigen,,,Yes,Immunochromatography,Qualitative,Sandwich, Double,,Other,15,30 AU,,,,Evaluated,,,Evaluated,"1.63 % (Among 550 specimens, 9 test results were false positives.)","2.8 % (Among 250 specimens, 7 test results were false regatives.)",Evaluated,98 % ((Antigen)),Evaluated,Evaluated,97.2 % ( (Antigen)),98.4 % ( (Antigen)),,Nucleoprotein
2241,"MARESKIT",1041,"NESAPOR EUROPA SL",Spain,"",Yes,Commercialised,Yes,Yes,Cassette,Manual,Antigen,Nasal swab,SARS-CoV,,2021-07-22 13:17:55 CET,1942,Immuno-Antigen,,,No,Immunoassay,Qualitative,,,,15,130 AU,,,,Evaluated,,,Evaluated,0 % (Positive Predictive Value 100.00%),1.18 % (Negative Predictive Value 98.82%),Evaluated,99.05 % ( (95% CI: 96.21% to 99.92%)),Evaluated,Evaluated,95.24 % ( (95% CI: 83.84% to 99.42%)),100 % ( (95% CI: 97.22% to 100.00%)),,Nucleoprotein
1501,"COVID-19 Antigen Detection Kit",690,"New Gene (Hangzhou) Bioengineering Co., Ltd",China,"www.new-gene.net/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow; Strip,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab; Saliva; Sputum,Adenovirus; Adenovirus 3; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); MERS-CoV; SARS-CoV; Influenza A H1N1; Influenza A H3N2; Influenza A H5N1; Influenza B Victoria; Influenza B Yamagata; Mumps Virus (MuV); Mycobacterium Tuberculosis; Mycoplasma Pneumoniae; Parainfluenza Virus Type; Parainfluenza Virus Type 2; Respiratory Syncytial V (RSV); Rhinovirus,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.427 (USA);B.1.429 (USA);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.1 (Japan/Brazil);,2021-09-14 08:47:13 CET,1251,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich, Double,,Sample collection device,30,0.05 ng/mL,,,,Evaluated (Evaluated),,,Evaluated (Evaluated),0.87 % (1 out of 114),2.02 % (5 out of 247),Evaluated,98.3 %,Evaluated,Evaluated,98 % (Antigen),99.1 % (Antigen),,Nucleocapsid protein
1762,"SARS CoV-2 Antigen Rapid Test",661,"Novatech",Turkey,"www.novadiag.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.2 (Brazil);,2021-07-23 09:12:05 CET,1441,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,1.7 U/ml,,,,,97.54 %,,Evaluated,0 % ((0/517 with negative PCR result There was no false positiv sample from the sample)),4.09 ((14/342 positive PCR result 14 false negative samples did not come out of the sample) ),Evaluated,98 %,,Evaluated (Not evaluated),95 %,100 %,,Nucleoprotein
1199,"CAT",610,"Oncosem Onkolojik Sistemler San. ve Tic. A.S.",Turkey,"www.oncosem.com",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:23:41 CET,985,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,0.01 AU,,,,,,,,6.25 % (out of 32 confirmed positive people 2 of them were diagnosed as negative 30 of them succesful),1.96 % (out of 204 confirmed negative people 4 of them were diagnesed as positive 200 of them succesful),,97.46 %,,,93.75 %,98.04 %,,
308,"PCL COVID19 Ag Rapid FIA",202,"PCL Inc",South Korea,"www.pclchip.com/",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,,,,2021-05-10 20:07:30 CET,260,Immuno-Antigen,Yes,,,Immunoassay,,,,,,,,,,,,,,,,,,,,,,,
2243,"PCL COVID19 Ag Gold",1043,"PCL Inc.",South Korea,"www.pclchip.com",Yes,Commercialised,Yes,Yes,,,,Nasal swab; Nasopharyngeal swab; Saliva,SARS-CoV,A.23.1 (United Kingdom);AT.1 (Russia);B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.427 (USA);B.1.429 (USA);B.1.525 (Nigeria);B.1.526 (USA);B.1.526.1 (USA);B.1.526.1 (USA);B.1.616 (France);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);B.1.621 (Colombia);C.36 (Egypt);C.37 (Peru);P.1 (Japan/Brazil);P.2 (Brazil);P.3 (The Philippines);,2021-07-07 17:12:48 CET,1944,Immuno-Antigen,,,No,Immunochromatography,Qualitative,,,,10,0.1 AU,,,,Evaluated,,,Evaluated,0 %,0 %,Evaluated,96.25 % ( (Antigen)),Evaluated,Evaluated,90.83 % ( (Antigen)),99.5 % ( (Antigen)),,Nucleoprotein
2116,"SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay)",981,"PerGrande BioTech Development Co., Ltd.",China,"www.pergrande.com.cn",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-07-07 17:23:47 CET,1806,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,Colloidal gold,,20,20 AU,,,,Not evaluated,,,Evaluated,0.89 %,5.72 %,Evaluated,96.41 % (( 95.24%-97.30%)（Antigen）),Evaluated,Evaluated,94.28 % (( 92.33%-95.76% )（Antigen）),99.11 % (( 97.94%-99.62%)（Antigen）),,Nucleoprotein
1271,"Exdia COVID-19 Ag",637,"Precision Biosensor, Inc",South Korea,"www.precision-bio.com/en/",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-07-07 17:23:54 CET,1046,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,20,,,,,,,,,,,,,,,93.9 %,98 %,,
1495,"Rapid Test Ag 2019-nCov",688,"Prognosis Biotech",Greece,"www.prognosis-biotech.com/",Yes,Commercialised,Yes,Yes,Strip,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:06:58 CET,1245,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,2870 AU,,,,evaluated,,,evaluated,6 %,2 %,evaluated,98.69 %,evaluated,evaluated,95.56 %,,,nucleoprotein
1341,"SARS-CoV-2 Antigen Rapid Test (Immunochromatography)",286,"Qingdao Hightop Biotech Co., Ltd",China,"www.hightopbio.com/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:23:59 CET,1119,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,2000 U/ml,,,,,,,,,,,,,,95 %,,,nucleoprotein
1097,"Sofia SARS Antigen FIA",216,"Quidel Corporation",United States,"www.quidel.com",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,878,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,Fluorescence,,,15,113 TCID50/ml,,,,Evaluated,,,Evaluated,0 %,3.3 %,,99.5 %,Evaluated,Evaluated,96.7 %,100 %,,Nucleoprotein
2290,"LIAISON® Quick Detect Covid Ag Assay",1068,"Rapid Pathogen Screening, Inc.",United States,"www.lumosdiagnostics.com",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow; Strip,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,SARS-CoV,B.1.1.7 (United Kingdom);,2021-07-22 13:18:29 CET,1991,Immuno-Antigen,,,Yes,Immunoassay,Qualitative,Other,,Other,15,950 AU,,,,Not evaluated,,,Evaluated,4 AU,3 AU,Evaluated,96.7 %,Evaluated,Evaluated,96.1 %,97 %,,Nucleoprotein
1604,"SARS-CoV-2 Rapid Antigen Test",854,"Roche (SD BIOSENSOR)",Switzerland,"https://diagnostics.roche.com/",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-06-30 10:21:31 CET,1285,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,,,,96.52 %,99.2 %,,nucleocapside protein
2228,"SARS-CoV-2 Rapid Antigen Test Nasal",854,"Roche (SD BIOSENSOR)",Switzerland,"https://diagnostics.roche.com/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.427 (USA);B.1.617.1 (India);B.1.621 (Colombia);P.1 (Japan/Brazil);,2021-07-07 17:05:08 CET,1929,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,146.6 AU,,,,Not evaluated,,,Evaluated,0.91 % (5 false positives out of 546 PCR negative samples.),10.68 % (14 false negative results out of 131 PCR-positive samples for Ct ≤ 30),Evaluated,95.5 % ( (95% CI: 93.7 % - 97.0 %)),Evaluated,Evaluated,89.6 % ( (Ct ≤ 30) and 93.1 % (for Ct below LOD 27)),99.1 %,,Nucleoprotein
1489,"COVID-19 Antigen Rapid Test Kit (Swab)",546,"Safecare Biotech (Hangzhou) Co. Ltd",China,"www.safecare.com.cn",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Nasal swab,,,2021-05-12 12:58:25 CET,1234,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,10,0.5 AU,,,,Not Evaluated,,,Evaluated,2.96 %,0.56 %,Evaluated,98.41 %,Evaluated,Evaluated,97.04 %,,,nucleoprotein
1490,"Multi-Respiratory Virus Antigen Test Kit(Swab)  (Influenza A+B/ COVID-19)",546,"Safecare Biotech (Hangzhou) Co. Ltd",China,"www.safecare.com.cn",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:24:07 CET,1235,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,10,1.5 AU (1.5),,,,evaluated,,,evaluated,2.96 % (COVID-19),0.56 % (COVID-19),evaluated,98.41 % (COVID-19:),evaluated,evaluated,97.04 % (COVID-19),,,nucleoprotein
1201,"ScheBo SARS CoV-2 Quick Antigen",359,"ScheBo Biotech AG",Germany,"www.schebo.de/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab; Serum,,,2021-07-07 17:24:39 CET,987,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Fluorescence,,,15,3.5 U/ml,,,,Evaluated,,,Evaluated,1.12 % (6/534),3.44 % (4/116),Evaluated,,Evaluated,Evaluated,96.77 % 96.6 % (Ct 30),,,Nucleoprotein
344,"STANDARD F COVID-19 Ag FIA",224,"SD BIOSENSOR Inc",South Korea,"http://sdbiosensor.com/xe/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,666,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,Fluorescence,,,15,,,,,,,,,,,,,,,,,,nucleoprotein 
345,"STANDARD Q COVID-19 Ag Test",224,"SD BIOSENSOR Inc",South Korea,"http://sdbiosensor.com/xe/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,672,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Magnetic Electrochemical,,30,1981 TCID50/ml,,,,,,,Evaluated,,,,,,,96.52 %,99.68 %,,
2052,"STANDARD Q COVID-19 Ag Test Nasal",224,"SD BIOSENSOR Inc",South Korea,"http://sdbiosensor.com/xe/",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.1 (Japan/Brazil);,2021-07-07 17:13:37 CET,1730,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,146.6 AU,,,,Evaluated,,,Evaluated,0 %,2 %,Evaluated,99 %,Evaluated,Evaluated,97.12 %,100 %,,Nucleoprotein
1319,"V-Chek SARS-CoV-2 Ag Rapid Test Kit (Colloidal Gold)",405,"SGA Medikal",Turkey,"www.sgadx.com/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:24:45 CET,560,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,,,,,,,,,1 %,1 %,,98.4 %,,,96.6 %,,,nucleoprotein
1357,"V-Chek SARS-CoV-2 Rapid Ag Test (colloidal gold)",405,"SGA Medikal",Turkey,"www.sgadx.com/",Yes,Commercialised,Yes,Yes,Card,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:10:17 CET,1117,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,100 AU,,,,,,,,1 %,1 %,,98.40%,,,96.60%,,,nucleoprotein
2109,"Green Spring SARS-CoV-2 Antigen-Rapid test-Set",977,"Shenzhen Lvshiyuan Biotechnology Co., Ltd.",China,"https://www.lsybt.com/",Yes,Commercialised,Yes,Yes,Lateral flow,Manual; Near POC / POC,Antigen,Anterior nasal swab; Nasal swab; Nasopharyngeal swab; Oropharyngeal swab; Saliva,Coronaviruses (HCoV); SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.1 (Japan/Brazil);,2021-08-06 08:51:49 CET,1799,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Capture,,,15,400 AU,,,,Evaluated,,,Evaluated,0 % (0 of 210 (100% specificity)),2 % (2 of 100 (98% sensitivity)),Evaluated,99 % (Antigen) 99.35 % (Antigen),Evaluated,Evaluated,98 % (Antigen),100 % (Antigen),,Nucleoprotein (Nucleocapsid protein)
1967,"SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)",563,"Shenzhen Microprofit Biotech Co., Ltd",China,"www.microprofit-bio.com",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Manual,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,,,2021-07-07 17:07:15 CET,1643,Immuno-Antibody,Yes,,,Immunochromatography,,,Colloidal gold,,15,49 AU,,,,Evaluated,,,Evaluated,0 %,7 %,Evaluated,96.11 %,Evaluated,Evaluated,92.93 % (Clinical sensitivity at Ct<40=342/368=92.93% (95%CI:89.82%~95.33%)),100 % (Clinical specificity = 300/300 = 100% (95%CI:98.78% ~100%)),,Nucleoprotein
1178,"SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay)",563,"Shenzhen Microprofit Biotech Co., Ltd",China,"www.microprofit-bio.com",Yes,Commercialised,Yes,Yes,Cassette,Manual,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.617.2 (India);C.37 (Peru);P.1 (Japan/Brazil);,2021-09-03 13:08:25 CET,960,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,Sandwich, Double,Colorimetry,,15,39 TCID50/ml,,,,Evaluated,,,Evaluated,0 %,13.71 %,Evaluated,95.99 % ((Antigen)),Evaluated,Evaluated,86.29 % ((Antigen)),100 % ( (Antigen)),,Spike protein
2017,"SARS-CoV-2 Antigen Test Kit",926,"Shenzhen Ultra-Diagnostics Biotec.Co.,Ltd",China,"www.ud-bio.com",Yes,Commercialised,Yes,Yes,Card; Cassette; Lateral flow,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Saliva,,,2021-05-19 17:15:38 CET,1695,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,,Validity test kit,15,625 AU,,,,Not evaluated,,,Evaluated,Reading result after 30 minutes,the concentration of virus is below LOD,Evaluated,"97.35 % (Nasal),97.94(Nasopharyngeal),97.36(Saliva)",Evaluated,Evaluated,"95.33 % (Nasal),95.48(Nasopharyngeal),94.83(Saliva)","99.16 % (Nasal),99.61(Nasopharyngeal),99.33(Saliva)",,Nucleoprotein
1769,"SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold)",793,"Shenzhen Watmind Medical Co., Ltd",China,"www.watmind.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-10 20:07:30 CET,1448,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,10,150 U/ml,,,,Evaluated,,,Evaluated,1 AU,5 AU,Evaluated,93.7 %,,,95.15 % (for onset of symptoms within 7 days),,,Nucleoprotein
1768,"SARS-CoV-2 Ag Diagnostic Test Kit (Immuno-fluorescence)",793,"Shenzhen Watmind Medical Co., Ltd",China,"www.watmind.com",Yes,Commercialised,Yes,Yes,Card; Lateral flow,Automated; Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:10:50 CET,1447,Immuno-Antigen,,,Yes,Immunochromatography,Qualitative,Fluorescence,,,10,80 U/ml,,,,Evaluated,,,Evaluated,1 AU,9 AU,Evaluated,96.3 %,Evaluated,,97.83 % (CT value ≤33) 90.08 % (CT value ≤36),,,Nucleoprotein
1574,"Zhenrui ®COVID-19 Antigen Test Cassette",692,"Shenzhen Zhenrui Biotechnology Co., Ltd",China,"en.zr-bio.com/en/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-07-07 17:24:58 CET,1253,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,,,,15,12 AU,,,,evaluated,,,evaluated,,,evaluated,96.5 % (Antigen),evaluated,evaluated,96 % (Antigen),,,nucleoprotein
1218,"CLINITEST Rapid Covid-19 Antigen Test",444,"Siemens Healthineers",Germany,"www.siemens-healthineers.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1002,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,,,,,,,,,0.23 % (2 out of 865),0 % (0),,98.74 %,,,97.25 % (Nasal Swab) 98.32 % (Nasopharyngeal swab),100 % (Nasal Swab),,"S1, S1-RBD, S2, N proteins"
1114,"SGTi-flex COVID-19 Ag",261,"Sugentech, Inc",South Korea,"sugentech.com/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-07-07 17:25:03 CET,1019,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Magnetic Electrochemical,,20,,,,,,,,,,,,,,,100 %,100 %,,
1466,"TODA CORONADIAG Ag",681,"TODA PHARMA",France,"https://www.todapharma.com/",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 20:07:30 CET,1216,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,502.377 AU,,,,Not evaluated,,,evaluated,"0 % ((On 129 negative samples confirmed by RT-PCR, 129 were also negative with our test : 0 false positive))","1.37 % (On 73 positive samples confirmed by RT-PCR, 72 were also negative with our test : 1 false negative)",evaluated,99.5 %,evaluated,evaluated,98.6 %,,,nucleoprotein
2074,"SARS-CoV-2 Antigen Rapid Test Kit",959,"Triplex International Biosciences (China) Co., LTD.",China,"www.tibchina.com",Yes,Commercialised,Yes,Yes,Card,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Adenovirus; Adenovirus 3; Adenovirus 7; Bordetella Pertussis; Chlamydia Pneumoniae; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); MERS-CoV; Enterovirus A71 (EV-A71); Epstein-Barr Virus (EBV); Hemophilus Influenzae; Human Metapneumovirus (HMPV); Influenza A H1N1; Influenza A H3N2; Influenza B Victoria; Influenza B Yamagata; Mycobacterium Tuberculosis; Mycoplasma Pneumoniae; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Parainfluenza Virus Type 4; Respiratory Syncytial V (RSV); Respiratory Syncytial V (RSV) Type A; Respiratory Syncytial V (RSV) Type B; Rhinovirus,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-07-07 17:25:18 CET,1756,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich, Double,,,15,0 AU,,,,Evaluated,,,Evaluated,1.67 %,0 %,Evaluated,99.58 % (Antigen),Evaluated,Evaluated,98.33 % (Antigen),100 % (Antigen),,Nucleoprotein
1465,"SARS-CoV-2 Antigen Rapid Test Kit",677,"Triplex International Biosciences Co., Ltd",China,"www.tibchina.com/index_en.aspx",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Nasal swab,,,2021-07-13 17:59:28 CET,1207,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,0 AU,,,,Not evaluated,,,evaluated,0 %,1.49 %,evaluated,99.52 %,evaluated,evaluated,98.51,,,nucleoprotein
1443,"RapidFor SARS-CoV-2 Rapid Ag Test",678,"Vitrosens Biotechnology Co., Ltd",Turkey,"www.vitrosens.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-07-07 17:25:23 CET,1194,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,10,100 IU/ml,,,,evaluated,,,evaluated,1 AU,1 AU,evaluated,98.3 %,evaluated,evaluated,97.3 %,,,nucleoprotein
2103,"VivaDiag Pro SARS-CoV-2 Ag Rapid Test",175,"VivaChek Biotech (Hangzhou) Co., Ltd",China,"www.vivachek.com",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Adenovirus 3; Adenovirus 7; Adenovirus Subtype B; Beta Coronavirus OC43 (HCoV-OC43); Beta Coronavirus HKU1 (HCoV-HKU1); Alpha Coronavirus Nl63 (HCoV-Nl63); Alpha Coronavirus 229E (HCoV-229E); MERS-CoV; Mycobacterium Tuberculosis; Mycoplasma Pneumoniae; Parainfluenza Virus Type 4; Parainfluenza Virus Type 3; Parainfluenza Virus Type 2; Parainfluenza Virus Type 1; Parainfluenza Virus Type,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.1 (Japan/Brazil);,2021-07-07 17:25:29 CET,1786,Immuno-Antigen,,,No,Immunochromatography,Qualitative,Sandwich,,Validity test kit,15,75.5 AU,,,,Evaluated,,,Evaluated,0 % (431 negative Sample were tested and 0 of them were false positive),2.96 % (135 positive Sample were tested and 4 of them were false negative.),Evaluated,99.29 % ( (Antigen)),Evaluated,Evaluated,97.04 % ((Antigen)),99.9 % ((Antigen)),,Nucleoprotein
2098,"COVID-19 (SARS-CoV-2) Antigen Test Kit",973,"Wuhan EasyDiagnosis Biomedicine Co., Ltd.",China,"http://www.easydiagnosis.com.cn/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow; Other,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.2 (Brazil);,2021-07-07 17:25:36 CET,1781,Immuno-Antigen,,,No,Immunochromatography,Qualitative,Sandwich,,,15,500 AU,,,,Not evaluated,,,Evaluated,Not yet found,Not yet found,Evaluated,98 %,Evaluated,Evaluated,96.1 %,100 %,,Nucleoprotein
1773,"The SARS-CoV-2 Antigen Assay Kit (Immunochromatography)",792,"Wuhan Life Origin Biotech Joint Stock Co., Ltd.",China,"www.szybio.com",Yes,Commercialised,Yes,Yes,Card; Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-07-13 18:02:47 CET,1452,Immuno-Antigen,Yes,,Yes,Immunochromatography,Qualitative,,,,15,0 U/ml,,,,Evaluated,,,Evaluated,"1.71 % ((6/350),95%CI(0.63%-3.69%))","7.33 % ((11/150),95%CI(3.72%-12.74%))",Evaluated,,"96.6 % ((483/500), 95%CI (94.61%-98.01%))",Evaluated,"92.67 % ((139/150), 95%CI (87.26%-96.28%))",,,
2090,"SARS-CoV-2 Antigen Rapid Test Kit",968,"Wuhan UNscience Biotechnology Co., Ltd.",China,"www.uni-science.com",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Lab-based; Manual,Antigen,Mid-turbinates swab; Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Adenovirus; Adenovirus 3; Adenovirus 7; Adenovirus Subtype B; Adenovirus Subtype C; Anti-Nuclear Antibody; Bordetella Pertussis; Chlamydia Pneumoniae; Coronaviruses (HCoV); Alpha Coronavirus 229E (HCoV-229E); Beta Coronavirus OC43 (HCoV-OC43); Beta Coronavirus HKU1 (HCoV-HKU1); Alpha Coronavirus Nl63 (HCoV-Nl63); Cytomegalovirus (CMV); SARS-CoV; MERS-CoV; Epstein-Barr Virus (EBV); Hemophilus Influenzae; Hepatitis C Virus (HCV); Hepatitis B Virus (HBV); Hepatitis A Virus (HAV); Herpes Simplex (HSV); Human Immunodeficiency Virus (HIV); Human Metapneumovirus (HMPV); Influenza B Yamagata; Influenza B Victoria; Influenza B; Influenza A H5N1; Influenza A H3N2; Influenza A H1N1; Influenza A; Mumps Virus (MuV); Mycobacterium Tuberculosis; Parainfluenza Virus Type 4; Parainfluenza Virus Type 3; Parainfluenza Virus Type 2; Parainfluenza Virus Type 1; Respiratory Syncytial V (RSV) Type B; Respiratory Syncytial V (RSV) Type A; Respiratory Syncytial V (RSV); Varicella Zoster Virus (VZV); Rhinovirus B; Rhinovirus A; Rhinovirus,A.23.1 (United Kingdom);B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.526 (USA);B.1.526.1 (USA);B.1.526.2 (USA);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.1 (Japan/Brazil);P.2 (Brazil);,2021-07-07 17:13:58 CET,1773,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,,Other,10,50000 AU,,,,Evaluated,,,Evaluated,0.43 %,3.67 %,Evaluated,100 % ( (Antigen)),Evaluated,Evaluated,96.33 % ( (Antigen)),99.57 % ( (Antigen)),,Nucleoprotein
1763,"COVID-19 Antigen Rapid Test Kit (Colloidal Gold)",790,"Xiamen AmonMed Biotechnology Co., Ltd",China,"www.amonmed.com",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab; Throat swab,,,2021-07-07 17:26:04 CET,1444,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colloidal gold,,15,170 U/ml,,,,Not evaluated,,,Evaluated,0.45 %,6.8 %,,97.52 %,Not evaluated,Not evaluated,93.2 %,99.55,,Nucleoprotein
1278,"Rapid SARS-CoV-2 Antigen Test Card",277,"Xiamen Boson Biotech Co. Ltd",China,"bosonbio.com/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-06-18 12:05:16 CET,1053,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,,,,15,130 TCID50/ml,,,,,,,,,,,,,,,,,
1456,"SARS-CoV-2 Antigen Rapid Test",862,"Xiamen Wiz Biotech Co., Ltd",China,"www.wizbiotech.com",Yes,Commercialised,Yes,Yes,,Near POC / POC,Antigen,Nasal swab; Other,,,2021-07-07 17:26:12 CET,1208,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,,Colorimetry,,15,1.7 AU,,,,evaluated,,,evaluated,"0 % ((338 swabs samples prospectively collected,0 swaps samples False positives))","0.89 % (338 swabs samples prospectively collected,3 swaps samples False positives)",evaluated,99.11 % (Antigen),evaluated,evaluated,96.3 % (Antigen),,,nucleoprotein
1884,"SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)",862,"Xiamen Wiz Biotech Co., Ltd",China,"www.wizbiotech.com",Yes,Commercialised,Yes,Yes,Card,Manual,Antigen,Anterior nasal swab,,,2021-07-07 17:26:18 CET,1563,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,Membrane-based,Colloidal gold,Validity test kit,15,170 AU,,,,Evaluated,,,Evaluated,0 % (No false positives were found in 899 samples tested.),1.56 % (14 false negatives were found in 899 samples tested.),Evaluated,98.37 %,Evaluated,Evaluated,95.91 %,100 %,,Nucleoprotein (nucleocapside protein)
1296,"Andlucky™ COVID-19 Antigen Rapid Test",624,"Zhejiang Anji Saianfu Biotech Co., Ltd",China,"www.seinofy.com",Yes,Commercialised,Yes,Yes,Cassette; Strip,Lab-based,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Beta Coronavirus OC43 (HCoV-OC43); SARS-CoV,A.23.1 (United Kingdom);AT.1 (Russia);B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.427 (USA);B.1.429 (USA);B.1.525 (Nigeria);B.1.526 (USA);B.1.526.1 (USA);B.1.526.2 (USA);B.1.616 (France);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);B.1.621 (Colombia);C.36 (Egypt);C.37 (Peru);P.1 (Japan/Brazil);P.2 (Brazil);P.3 (The Philippines);,2021-09-30 09:30:27 CET,1102,Immuno-Antibody,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,Colorimetry,,15,116 TCID50/ml,,,,Evaluated,,,Evaluated,0.88 % (3/340),3 % (7/228),Evaluated,98.24 %,Evaluated,Evaluated,96.93 %,99.12 %,,ORF1b protein
1295,"reOpenTest COVID-19 Antigen Rapid Test",624,"Zhejiang Anji Saianfu Biotech Co., Ltd",China,"www.seinofy.com",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Automated; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,Coronaviruses (HCoV); SARS-CoV,A.23.1 (United Kingdom);AT.1 (Russia);B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.427 (USA);B.1.429 (USA);B.1.525 (Nigeria);B.1.526 (USA);B.1.526.1 (USA);B.1.526.2 (USA);B.1.616 (France);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);B.1.621 (Colombia);C.36 (Egypt);C.37 (Peru);P.1 (Japan/Brazil);P.2 (Brazil);P.3 (The Philippines);,2021-09-27 09:57:41 CET,1094,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,575 TCID50/ml,,,,,,,Evaluated,2 %,4 AU,Evaluated,98.47 % (Antigen),Evaluated,,97.52 % (Antigen),99.13 % (Antigen),,Nucleocapsid protein
1343,"Coronavirus Ag Rapid Test Cassette (Swab)",1184,"Zhejiang Orient Gene Biotech Co.,Ltd.",,"",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-09-02 10:16:37 CET,1124,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,115 AU,,,,Not evaluated,,,Evaluated,2.5 % (2/120),0.27 % (2/745),Evaluated,99.42 %,Evaluated,Evaluated,98.32 %,99.6 %,,nucleoprotein
1957,"COVID-19 Antigen Detection Kit (Colloidal Gold)",619,"Zhuhai Lituo Biotechnology Co., Ltd",China,"www.lituo.com.cn",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,Adenovirus; Bordetella Pertussis; Chlamydia Pneumoniae; Coronaviruses (HCoV); Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); MERS-CoV; SARS-CoV; Enterovirus A71 (EV-A71); Hemophilus Influenzae; Hepatitis B Virus (HBV); Human Metapneumovirus (HMPV); Influenza A; Influenza A H1N1; Influenza B Yamagata; Mycobacterium Tuberculosis; Mycoplasma Pneumoniae; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Parainfluenza Virus Type 4; Respiratory Syncytial V (RSV); Rhinovirus,A.23.1 (United Kingdom);B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.525 (Nigeria);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.1 (Japan/Brazil);,2021-07-13 18:03:58 CET,1633,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,Colloidal gold,Validity test kit,10,428 AU,,,,Evaluated,,,Evaluated,0.41 %,1 %,Evaluated,99.42 % (NP swab: ) 98.87 % (Nasal swab: ),Evaluated,Evaluated,99 % (NP swab ) 96.12 % (Nasal swab  (CT<= 33)),99.59 % (NP swab ) 100 % (Nasal swab (CT<= 33)),,Nucleoprotein