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,
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
1214,"Wondof SARS-CoV-2 Antigen Test (Lateral Flow Method)",124,"Guangzhou Wondfo Biotech Co., Ltd",China,"en.wondfo.com.cn/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,,,,2021-05-10 13:04:00 CET,998,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,,,,,,,,,,,,,,,,,,,
1312,"Wondof 2019-nCoV Antigen Test (Lateral Flow Method)",124,"Guangzhou Wondfo Biotech Co., Ltd",China,"en.wondfo.com.cn/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,,,,2021-05-10 13:04:00 CET,1082,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,Colloidal gold,,,,,,,,,,,,,,,,,,,,
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,,,
1276,"Willi Fox COVID-19 Antigen rapid test",549,"Willi Fox GmbH",Switzerland,"willifox.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,,,,2021-05-10 13:04:00 CET,1051,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,,,,99.2 %,100 %,,nucleoprotein
2162,"Wellion SARS-CoV-2 PLUS ANTIGEN Rapid Test",1005,"MED TRUST Handelsges.m.b.H.",Austria,"www.wellion.at",Yes,Commercialised,No,No,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);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.1 (Japan/Brazil);,2021-06-08 15:16:34 CET,1863,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,,Validity test kit,15,75.5 AU,,,,Evaluated,,,Evaluated,0 % ((431 negative samples were tested and 0 of them were false positive)),3 % ((135 positive samples were tested and 5 of them were false negative)),Evaluated,99 % ( (Antigen)),Evaluated,Evaluated,96.3 % ( (Antigen)),99.9 % ( (Antigen)),,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
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,Nasal swab; Other,,,2021-07-14 14:19:53 CET,1237,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Fluorescence,,,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
1096,"VTRUST COVID-19 Antigen Rapid Test TD-4531",588,"TaiDoc Technology Corp.",Taiwan ROC,"taidoc.com/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,877,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,126 TCID50/ml,,,,,,,"0% for virus, microorganisms and negatives matrices tested; Evaluated",,,,,,,93.1 %,99.6 %,,nucleocapsid recombinant Antigen (NP)
1379,"Vstrip Covid-19 Antigen Rapid Test",658,"Panion & BF Biotech Inc",Taiwan ROC,"www.pbf.com.tw/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab; Other,,,2021-05-10 13:04:00 CET,1145,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,10,157 U/ml,,,,,,,,1.8 %,8.7 %,,96.2 %,,,91.3 %,,,nucleoprotein
2163,"VivaDiag Wellion SARS-CoV-2 Antigen Rapid Test",1006,"VivaChek Biotech (Hangzhou) Co., Ltd.",China,"www.vivachek.com",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Adenovirus 3; Adenovirus 7; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); MERS-CoV; Mycobacterium Tuberculosis; Mycoplasma Pneumoniae; Parainfluenza Virus Type; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Parainfluenza Virus Type 4,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);,2021-06-08 15:11:09 CET,1864,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,,Validity test kit,15,675 AU,,,,Not evaluated,,,Evaluated,4.54 % ((154 positive samples were tested and 7 of them were false negative)),0 % ((431 negative samples were tested and 0 of them were false positive)),Not evaluated,98.8 % ( (Antigen)),Evaluated,Evaluated,95.45 % ( (Antigen)),99.99 % ( (Antigen)),,Nucleoprotein
2105,"VivaDiag SARS-CoV-2 Ag FIA Test",175,"VivaChek Biotech (Hangzhou) Co., Ltd",China,"www.vivachek.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC; Semi-automated,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Adenovirus 3; Adenovirus 7; Adenovirus Subtype B; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); MERS-CoV; Mycobacterium Tuberculosis; Mycoplasma Pneumoniae; Parainfluenza Virus Type; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Parainfluenza Virus Type 4,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);,2021-06-04 15:04:04 CET,1788,Immuno-Antigen,Yes,,Yes,Immunochromatography,Qualitative,Sandwich,Fluorescence,Validity test kit,15,135 AU,,,,Evaluated,,,Evaluated,0 % (431 negative Sample were tested and 0 of them were false positive),3.03 % (66 positive Sample were tested and 2 of them were false negative.),Evaluated,99.6 % ( (Antigen)),Evaluated,Evaluated,96.97 % ((Antigen)),99.9 % ((Antigen)),,Nucleoprotein
1246,"Vivadiag SARS CoV 2 Ag Rapid Test",175,"VivaChek Biotech (Hangzhou) Co., Ltd",China,"www.vivachek.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,,,2021-06-02 18:10:38 CET,1075,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,,,,,,,,,,,,,,,,,,nucleoprotein
2100,"Verino Pro SARS CoV 2 Ag Rapid Test",175,"VivaChek Biotech (Hangzhou) Co., Ltd",China,"www.vivachek.com",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Coronaviruses (HCoV),B.1.1.7 (United Kingdom);B.1.351 (South Africa);,2021-05-27 14:47:58 CET,1783,Immuno-Antigen,Yes,,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),3.7 % (135 positive Sample were tested and 5 of them were false negative.),Evaluated,99.12 % ( (Antigen)),Evaluated,Evaluated,96.3 ( (Antigen)),99.9 ((Antigen)),,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
1326,"V-CHEK, 2019-nCoV Ag Rapid Test Kit (Fluorescence Immunochromatographic Assay)",382,"Guangzhou Decheng Biotechnology Co., LTD",China,"www.dochekbio.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1095,Immuno-Antigen,Yes,,Yes,Immunochromatography,Qualitative,,Fluorescence,,10,90 AU,,,,,,,,,,,,,,95.06 %,,,nucleoprotein
1883,"V-CHEK, 2019-nCoV Ag Rapid Test Card (Immunochromatography)",382,"Guangzhou Decheng Biotechnology Co., LTD",China,"www.dochekbio.com",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Saliva,,,2021-05-10 13:04:00 CET,1562,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,100 %,,,,Evaluated,,,Evaluated,A reaction time of less than 15 minutes may lead to a false negative result,A reaction time of more than 15 minutes may lead a false positive result.,Evaluated,97.12 %,Evaluated,Evaluated,95.65 %,98.44 %,,Nucleoprotein
1325,"V-CHEK, 2019-nCoV Ag & FLU A/B Combo Rapid",382,"Guangzhou Decheng Biotechnology Co., LTD",China,"www.dochekbio.com",Yes,Commercialised,No,No,Card,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1092,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,,,,15,1000,,,,,,,,,,,,,,96.67(Antigen);85.42(FLU A);85.34(FLU B),,,nucleoprotein
1317,"V-Chek SARS-CoV-2 Rapid Ag Test (IFA)",405,"SGA Medikal",Turkey,"www.sgadx.com/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,557,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,Fluorescence,,,10,50 AU,,,,,,,,1 AU,1 AU,,98.5 %,,,97.5 %,,,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
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
1314,"V-CHEK SARS-CoV-2 Ag Rapid Test Kit",382,"Guangzhou Decheng Biotechnology Co., LTD",China,"www.dochekbio.com",Yes,Commercialised,No,No,Card,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1084,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,,,,96.67 % (Antigen),,,nucleoprotein
1316,"V-CHEK 2019-nCoV Ag Rapid Test Kit",382,"Guangzhou Decheng Biotechnology Co., LTD",China,"www.dochekbio.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,527,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,Fluorescence,,,10,90 AU,,,,,,,,,,,,,,95.06 % ((Antigen)),,,nucleoprotein
1318,"V-CHEK 2019-nCoV Ag & FLU A/B Combo Rapid Test",382,"Guangzhou Decheng Biotechnology Co., LTD",China,"www.dochekbio.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1086,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,100 AU,,,,,,,,,,,,,,96.67 % ([85.42(FLU A);85.34(FLU B)]),,,nucleoprotein
1170,"UNICELL-2019-nCoV Ag",379,"SHENZHEN YHLO BIOTECH CO., Ltd",China,"http://www.szyhlo.com",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,954,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,Fluorescence,,,15,160 TCID50/ml,,,,,,,,2 %,3 %,,99.03 %,,,97.37 %,,,
1497,"Trueline COVID-19 Ag Rapid Test",689,"TP Medicare GmbH",Germany,"www.tp-medicare.de/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1247,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,0 % (0 of 21),2.7 % (1 of 37),,98.1 %,,,93.8 %,100 %,,nucleocapside
1722,"TOYO Covid-19 Ag Test",758,"Turklab",Turkey,"www.turklab.com.tr/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab; Other,,,2021-05-10 13:18:20 CET,1402,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,20,0 AU,,,,not evaluated,,,evaluated,,,not evaluated,97.57 %,evaluated,not evaluated,93.18 %,,,nucleoprotein
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
1290,"Tigsun COVID-19 Antigen Saliva Rapid Test",47,"Beijing Tigsun Diagnostics Co. Ltd",China,"www.tigsun.com/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Saliva,,,2021-05-10 13:04:00 CET,1064,Immuno-Antigen,Yes,,,Immunoassay,,,,,,,,,,,,,,,,,,,,,,,N protein
1292,"Tigsun COVID-19 Antigen Rapid Test",47,"Beijing Tigsun Diagnostics Co. Ltd",China,"www.tigsun.com/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-05-10 13:04:00 CET,1065,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,,,,,,,,,,,,,,,,,,,N protein
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%))",,,
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 %,,
1226,"Test Rapid Combo Covid-19/Influenza A+B Antigen (tampon nazofaringian))",577,"DDS DIAGNOSTIC",Romania,"www.ddsdiagnostic.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1010,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,98.95 %,,,98.77 %,99.03 %,,
1305,"Test Rapid Combo Covid-19/Influenza A+B Antigen",577,"DDS DIAGNOSTIC",Romania,"www.ddsdiagnostic.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1077,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,1 AU,3 AU,,99 %,,,98.77 %,99.03 %,,
1275,"SureScreen COVID-19 Antigen Rapid Test Cassette",288,"SureScreen Diagnostics",United Kingdom,"www.surescreen.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-05-10 13:04:00 CET,1050,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,,,,,,,
2299,"SURE STATUS COVID-19 ANTIGEN CARD TEST",1072,"PREMIER MEDICAL CORPORATION PRIVATE LIMITED",India,"www.premiermedcorp.com",Yes,Commercialised,No,No,Cassette,Manual; Near POC / POC,Antigen,Nasopharyngeal swab,SARS-CoV,,2021-06-25 13:08:00 CET,2000,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,20,353 AU,,,,Not evaluated,,,Evaluated,3 %,9 %,Evaluated,91% SENSTIVITY AND 97% SPECIFICITY In comparison with the RT-PCR,Evaluated,Evaluated,91 %,97 %,,Nucleoprotein
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
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 %,,
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 
502,"Sona Nanotech COVID-19 Lateral Flow Assay Lateral flow screening test for S1 domain of SARS-CoV-2 S1 protein",301,"Sona Nanotech",Canada,"sonanano.com/",Yes,In development,No,No,Lateral flow,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,396,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,214 TCID50/ml,,,,,,,,,,,,,,84.6 %,90 %,,
2226,"SOFTEC Sars Cov-2 (Covid-19) Antigen Test Kit",1034,"ZET medikal tekstil dis tic ltd sti",Turkey,"www.zetmedikal.com/en",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,SARS-CoV,A.23.1 (United Kingdom);B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.427 (USA);B.1.616 (France);P.1 (Japan/Brazil);P.2 (Brazil);P.3 (The Philippines);,2021-06-10 17:48:52 CET,1927,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,2300 AU,,,,Not evaluated,,,Evaluated,3.61 % (False positive 18 at totally 498 Positive Specimens detected with RT-PCR),0.82 % (False Negative 6 at totally 726 Negative Specimens detected with RT-PCR),Evaluated,98 %,Evaluated,Not evaluated,96 %,99 %,,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
1344,"SMARAPIDTEST",650,"APLUS Diagnostics Laboratuvar San.Tic.A.S.",Turkey,"www.aplustbd.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-10 13:04:00 CET,1111,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,15,,,,,,,,5 (2 out of 40 samples of Gold standard reagent ),2.5 (2 out of 80 samples of Gold standard reagent ),,96 %,,,95 %,,,
1344,"SMARAPIDTEST",650,"APLUS Diagnostics Laboratuvar San.Tic.A.S.",Turkey,"www.aplustbd.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-10 13:04:00 CET,1112,Immuno-Antibody,Yes,,No,Immunoassay,Qualitative,,,,15,0.1 (0.1),,,,not evaluated,,,evaluated,1.47 % (1 out of 68 samples of Gold standard reagent ),10.1 % (10 out of 99 samples of Gold standard reagent),not evaluated,98 % IgG 93 % IgM,not evaluated,evaluated,97 % IgG 87 % IgM,,,
1650,"SINGUWAY COVID-19 Ag Test",604,"SINGUWAY BIOTECH Inc",China,"www.singuway.com/english/index.php",Yes,Commercialised,No,No,Card,Near POC / POC,Antigen,Nasal swab; Other; Saliva,,,2021-05-10 13:18:20 CET,1331,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,,Colorimetry,,15,1.25 AU,,,,evaluated,,,evaluated,,,evaluated,96 %,evaluated,evaluated,92.59 %,,,nucleoprotein
2127,"Sienna COVID-19 Antigen Rapid Test Cassette",567,"Salofa Oy",Finland,"https://www.salofa.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Manual,Antigen,Nasopharyngeal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);,2021-07-08 11:04:13 CET,1817,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich,,,10,40 AU,,,,Evaluated,,,Evaluated,3.44 % (5 of 145),1.34 % (6 of 446),Evaluated,98.1 %,Evaluated,Evaluated,95.9 %,98.9 % ((>99.99% (100%))),,Nucleoprotein
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 %,,
2003,"SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based)",921,"SG Diagnostics Pte Ltd",Singapore,"https://www.sgdiagnostics.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Deep (cough) sputum; Nasal swab; Nasopharyngeal swab; Oropharyngeal swab; Saliva,,,2021-05-10 13:04:00 CET,1680,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,Colloidal gold,,10,75 AU,,,,Not evaluated,,,Evaluated,,,Evaluated,98.99 %,Evaluated,Not evaluated,97.57 %,99.29 %,,Nucleoprotein
1849,"Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)",184,"Nanjing Vazyme Medical Technology Co., Ltd",China,"www.vazyme.com",Yes,Commercialised,No,No,Cassette,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal 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.1.526.1 (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);P.1 (Japan/Brazil);P.2 (Brazil);P.3 (The Philippines);,2021-07-05 18:13:22 CET,1529,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,Colloidal gold,Other,10,50 AU,,,,Not evaluated,,,Evaluated,2.43 %,0.71 %,Evaluated,98.99 %,Evaluated,Evaluated,97.57 %,99.29 %,,Nucleoprotein
1272,"Sensitest Joysbio Antigen Rapid Test for Covid-19",638,"Sensitest",Netherlands,"www.sensitest.com/index.php?p=sensitest-covid-corona-Antigen-test",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1048,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,,,,,99 %,,
1590,"Screentest Covid-19+FLU A/B",701,"SCREEN ITALIA S.r.l.",Italy,"www.screenitalia.it",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1270,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,98 %,evaluated,,96.4 %,99.2 %,,
1847,"SCREEN TEST COVID-19 SALIVA",701,"SCREEN ITALIA S.r.l.",Italy,"www.screenitalia.it",Yes,Commercialised,No,No,Cassette,Manual,Antigen,Saliva; Sputum,,,2021-05-10 13:18:20 CET,1527,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Other,,Other,15,0 AU (0),,,,Not evaluated,,,Evaluated,2.15 % (2 on 93),0.96 % (10 on 313),Evaluated,97 % ((95% CI*: 94.9%~98.5%)),Evaluated,Not evaluated,90.1 % ((95% CI*:82.5%~95.1%)),99.3 % ((95% CI*: 97.7%~99.9%)),,Nucleoprotein
1681,"SCREEN TEST COVID-19 AG - COVID-19 ANTIGEN RAPID TEST",701,"SCREEN ITALIA S.r.l.",Italy,"www.screenitalia.it",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab; Other,,,2021-05-10 13:18:20 CET,1360,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,50 AU,,,,not evaluated,,,evaluated,1.23 % (1 on 81),2.44 % (3 on 123),evaluated,98 % ((95%CI: 95.1%-99.5%)),not evaluated,not evaluated,96.4 % ((95%CI: 89.8%- 99.2%)),,,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
1320,"SARS-CoV2 Antigen Rapid Test",410,"Monocent, Inc",United States,"www.monocent.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,564,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,20,AU (1),,,,,,,,AU (0),% (1),,99.25,,,98.25 %,,,nucleoprotein
2145,"SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)",993,"Shen Zhen Zi Jian Biotechnology Co., Ltd.",China,"",Yes,Commercialised,No,No,Card; Cassette; Lateral flow; Strip,Near POC / POC,Antigen,Nasal swab; Oropharyngeal swab; Saliva,Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus OC43 (HCoV-OC43); Human Metapneumovirus (HMPV); MERS-CoV; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Parainfluenza Virus Type 4,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-06-03 09:53:56 CET,1835,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,,,10,25.55 AU,,,,Evaluated,,,Evaluated,2.31 %,2.35 %,Evaluated,97.66 %,Evaluated,Evaluated,97.69 %,97.65 %,,Nucleoprotein
1473,"SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test",659,"CITEST DIAGNOSTICS INC",China,"www.citestdiagnostics.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1222,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,0 AU (0),,,,Not evaluated,,,evaluated,0.8 % ((0.9% Influenza A; 0.9% Influenza B; 3.8% RSV; 1.4% Adenovirus; 2% M.pneumoniae)),3.6 % ((5% Influenza A; 7.1% Influenza B; 5.7% RSV; 3.1% Adenovirus;8.2% M.pneumoniae)),evaluated,98 % ((98.4 Influenza A; 98.1influenza B; 95.9 RSV; 98.4 Adenovirus; 97 M.pneumoniae)),evaluated,not evaluated,96.4 % ((95 Influenza A; 92.9% Influenza B; 94.3 RSV; 96.9 Adenovirus; 91.8 M.pneumoniae)),,,nucleoprotein
1472,"SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen",659,"CITEST DIAGNOSTICS INC",China,"www.citestdiagnostics.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1221,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,0,,,,Not evaluated,,,evaluated,0.8 % ((S0.9% Influenza A; 0.9% Influenza B; 3.8% RSV; 1.4% Adenovirus)),3.6 % ((5% Influenza A; 7.1% Influenza B; 5.7% RSV; 3.1% Adenovirus)),evaluated,98 % ((98.4 Influenza A; 98.1 Influenza B; 95.9 RSV; 98.4 Adenovirus)),evaluated,not evaluated,96.4 % ((95 Influenza A; 92.9 Influenza B; 94.3 RSV; 96.9 Adenovirus)),,,
1474,"SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test",659,"CITEST DIAGNOSTICS INC",China,"www.citestdiagnostics.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1223,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,0 AU,,,,Not evaluated,,,evaluated,0.8 % ((0.9% Influenza A; 0.9% Influenza B; 3.8% RSV)),3.6 % ((5% Influenza A; 7.1% Influenza B; 5.7% RSV)),evaluated,98 % ((98.4 Influenza A; 98.1 Influenza B; 95.9 RSV)),evaluated,not evaluated,96.4 % ((95 Influenza A; 92.9 Influenza B; 94.3 RSV)),,,nucleoprotein
1777,"SARS-COV-2/Influenza A&B Rapid Antigen Test",44,"Joinstar Biomedical Technology Co., Ltd",China,"www.joinstar.cn",Yes,Commercialised,No,No,Lateral flow,Manual,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1456,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,15,0 U/ml,,,,Not Evaluated,,,Evaluated,3 %,1 %,Evaluated,98.9 %,Evaluated,Evaluated,97.1 %,,,
1228,"SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay)",563,"Shenzhen Microprofit Biotech Co., Ltd",China,"www.microprofit-bio.com/",Yes,Commercialised,No,No,,,Antigen,,,,2021-05-10 13:04:00 CET,1013,Immuno-Antigen,Yes,,,Immunoassay,,,,,,,,,,,,,,,,,,,,,,,
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,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,960,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,Colorimetry,,,,,,,,,,,,,,,,,,,,
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
1946,"SARS-COV-2 rapid antigen test (Swab)",126,"Hangzhou AllTest Biotech Co., Ltd",Germany,"https://www.goldstandarddiagnostics.com/home/products/covid-19-antigen-rapid-test/",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:18:20 CET,1622,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,,,,15,100 AU,,,,Evaluated,,,Evaluated,0.006 AU,0.066 AU,Evaluated,97.9 %,Evaluated,Evaluated,93.4 %,99.4 %,,Nucleoprotein
2097,"SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method)",972,"Sansure Biotech Inc.",China,"www.sansure.com.cn",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,Adenovirus; Bordetella Pertussis; Chlamydia Pneumoniae; Coronaviruses (HCoV); Hemophilus Influenzae; Human Metapneumovirus (HMPV); Influenza A; Influenza B; Mycoplasma Pneumoniae; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Parainfluenza Virus Type 4; Respiratory Syncytial V (RSV) Type A; Rhinovirus,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-05-31 11:16:53 CET,1780,Immuno-Antibody,Yes,,No,Immunochromatography,Qualitative,Membrane-based,Colloidal gold,,15,8 AU,,,,Evaluated,,,Evaluated,1.6 %,1.9 %,Evaluated,98.2 %,Evaluated,Evaluated,98.4 %,98.1 %,,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
2143,"SARS-CoV-2 Antigen Test Kit（Lateral Flow Assay）",991,"Wuxi Biohermes Bio & Medical Technology Co., Ltd.",China,"www.biohermes.com",Yes,Commercialised,No,No,Card; Cassette; Lateral flow,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Hemophilus Influenzae; Influenza A; Influenza B; Mycobacterium Tuberculosis; Respiratory Syncytial V (RSV),B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-05-31 10:50:36 CET,1833,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,,,15,2.5 AU,,,,Evaluated,,,Evaluated,4.69 %,1.98 %,Evaluated,97.11 % ((Antigen)),Evaluated,Evaluated,95.31 % ((Antigen)),98.02 % ((Antigen)),,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
1968,"SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay)",563,"Shenzhen Microprofit Biotech Co., Ltd",China,"www.microprofit-bio.com/",Yes,Commercialised,No,No,Cassette; Lateral flow,Manual,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,,,2021-05-10 13:18:20 CET,1644,Immuno-Antibody,Yes,,,Immunochromatography,,,Fluorescence,,15,25 AU,,,,Evaluated,,,Evaluated,0 %,4.3 %,Evaluated,97.6 %,Evaluated,Evaluated,95.65 % (Clinical sensitivity at Ct<40=352/368=95.65% (95%CI:93.04%~97.49%)),100 % (Clinical specificity = 300/300 = 100% (95%CI:98.78% ~100%)),,
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,,,2021-07-07 17:08:01 CET,1690,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colloidal gold,,15,180 AU,,,,Evaluated,,,Evaluated,0.98 %,8.85 %,Evaluated,94.88 %,Evaluated,Evaluated,91.15 %,99.02 %,,Nucleoprotein
1487,"SARS-CoV-2 Antigen Test Kit (colloidal gold method)",848,"Bioteke Taizhou Biotechnology Co., Ltd",China,"www.bioteke.cn/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-10 13:18:20 CET,1230,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,15,175,,,,evaluated,,,evaluated,2,3,evaluated,98.58 %,evaluated,evaluated,95.95 %,,,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
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
1759,"SARS-CoV-2 Antigen Test Kit",786,"Hubei Jinjian Biology Co., Ltd",China,"en.jinjianbio.com/",Yes,Commercialised,No,No,Cassette,Automated,Antigen,Nasal swab,,,2021-05-10 13:04:00 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
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
1644,"SARS-CoV-2 Antigen Test Cassette (Nasal Swab Specimen)",753,"Jiangsu Mole Bioscience CO., LTD",China,"en.molechina.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:18:20 CET,1324,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,15,100 AU,,,,evaluated,,,evaluated,0.08 %,0.6 %,evaluated,99 %,evaluated,evaluated,100 %,,,nucleoprotein
1146,"SARS-CoV-2 Antigen Test",252,"LumiraDX",United Kingdom,"www.lumiradx.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,315,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,,Immunofluorescence,,12,32 TCID50/ml,,,,,,,no crossreactivity with Human coronavirus 229E; Human coronavirus OC43; Human coronavirus NL63; MERS coronavirus; Adenovirus (e.g. C1 Ad. 71); Human Metapneumovirus (hMPV); Parainfluenza virus Type 1; Parainfluenza virus Type 2; Parainfluenza virus Type ,,,,96.9 %,,,97.6 %,96.6,,nucleocapsid protein (N-protein)
1766,"SARS-CoV-2 Antigen Rapid Test Kit - Saliva (Colloidal Gold)",516,"JOYSBIO (Tianjin) Biotechnology Co., Ltd",China,"en.joysbio.com/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Saliva,,,2021-05-10 13:18:20 CET,1445,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,320 U/ml,,,,Evaluated,,,Evaluated,0 % (0 out of 260 RT-PCR negative specimens),4.9 % (5 out of 102 RT-PCR positive specimens),Evaluated,98.62 %,Evaluated,Evaluated,95.1 %,,,Nucleoprotein
1286,"SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)",53,"BIOHIT HealthCare (Hefei) Co., Ltd",China,"www.biohit.cn",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Serum,,,2021-05-10 13:04:00 CET,1060,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,Fluorescence,,,15,20 TCID50/ml 3.5 pg (per ml),,,,,,,,,,,,,,96.77 %,98.9 %,,
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 %,,,,,,
1595,"SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)",704,"Genesprint Group Limited",Hong Kong S.A.R,"www.gsprint.co",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1275,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,5,103 AU,,,,evaluated,,,evaluated,5 % ((Less than 5%)),5 % ((Less than 5%)),evaluated,99 %,evaluated,not evaluated,98.96 %,,,nucleoprotein
1595,"SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)",704,"Genesprint Group Limited",Hong Kong S.A.R,"www.gsprint.co",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1276,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,5,103 AU,,,,evaluated,,,evaluated,5 % ((Less than 5%)),5 % ((Less than 5%)),evaluated,99 %,evaluated,not evaluated,98.96 %,,,nucleoprotein
2203,"SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)",906,"Diasia Biomedical Technology Co., Ltd.",China,"www.diasia.com.cn",Yes,Commercialised,No,No,,,Antigen,Anterior nasal swab,SARS-CoV,B.1.1.7 (United Kingdom);,2021-06-10 15:59:36 CET,1904,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,,Colloidal gold,,15,36 %,,,,Not evaluated,,,Evaluated,"0.82 % (122 specimens were negative by both test reagent and control reagent, and there is 1 specimen of fal)","0.76 % (131 specimens were negative by both test reagent and control reagent, and there is 1 specimen of fal)",Evaluated,97.63 %,Evaluated,Evaluated,95.9 %,99.24 %,,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,,,2021-05-10 13:04:00 CET,1100,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colloidal gold,,15,,,,,,,,,,,,96.67 %,,,92 %,,,
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
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
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; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Bordetella Pertussis; Chlamydia Pneumoniae; 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; MERS-CoV; 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
1780,"SARS-Cov-2 Antigen Rapid Test Cassette (swab)",381,"Spring Healthcare Services AG",Switzerland,"www.springhealthcare.org/",Yes,Commercialised,No,No,Card; Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1459,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,125 U/ml,,,,Evaluated,,,Evaluated,0 AU,1 AU,Evaluated,99.55 %,,Evaluated,97.82 %,,,
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
1887,"SARS-CoV-2 Antigen Rapid Test (Sputum/Saliva/Stool)",862,"Xiamen Wiz Biotech Co., Ltd",China,"www.wizbiotech.com",Yes,Commercialised,No,No,Card,Manual,Antigen,Saliva; Sputum; Stool,,,2021-05-10 13:04:00 CET,1566,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,,Colorimetry,,15,170 AU,,,,Evaluated,,,Evaluated,,,Evaluated,,Evaluated,Evaluated,,,,Other
1886,"SARS-CoV-2 Antigen Rapid Test (Saliva)",862,"Xiamen Wiz Biotech Co., Ltd",China,"www.wizbiotech.com",Yes,Commercialised,No,No,Card,Manual,Antigen,Saliva,,,2021-05-10 13:04:00 CET,1565,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,,Colorimetry,,20,170 AU,,,,Evaluated,,,Evaluated,0 % (No false positives were found in 899 samples tested.),1.78 % (16 false negatives were found in 899 samples tested.),Evaluated,98.22 %,Evaluated,Evaluated,95.35 %,100 %,,
1895,"SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)",230,"Selfdiagnostics Deutschland GmbH",Germany,"selfdiagnostics.com",Yes,Commercialised,No,No,Cassette; Lateral flow; Strip,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-17 09:46:14 CET,1572,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,,,,15,160 AU,,,,Evaluated,,,Evaluated,,,Evaluated,98 %,Evaluated,Evaluated,97.1 % ((95% CI: 93.1%-98.9%)),99.5 % ((95% CI: 98.2%-99.9%)),,nucleocapsid
1908,"SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)",683,"ACON Laboratories, Inc",United States,"www.aconlabs.com",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-10 13:18:20 CET,1583,Immuno-Antigen,Yes,,,Immunoassay,,Membrane-based,,,15,160 AU,,,,,,,,0.46 (2 out of 435(Nasal Swab); 1 out of 236(Saliva)),2.94 (5 out of 170(Nasal Swab); 9 out of 105(Saliva)),Evaluated,98.8 % (98.8%(Nasal Swab); 97.1%(Saliva)),Evaluated,Evaluated,97.1 % (97.1%(Nasal Swab); 91.4%(Saliva); ),99.5 % (99.5%(Nasal Swab); 99.6%(Saliva); ),,Nucleoprotein
2257,"SARS-CoV-2 Antigen Rapid Test (Nasal Swab)",1003,"Hangzhou AllTest Biotech Co., Ltd.",China,"www.alltests.com.cn",Yes,Commercialised,No,No,Cassette; Latex,Near POC / POC,Antigen,Nasal swab,Adenovirus 3; Adenovirus 7; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Influenza A H1N1; Influenza A H3N2; Influenza B; MERS-CoV; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Respiratory Syncytial V (RSV),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);,2021-07-08 11:27:01 CET,1958,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich,,Validity test kit,15,100 AU,,,,Evaluated,,,Evaluated,0.046 AU,0.006 AU,Evaluated,97.8 % (（Antigen）),Evaluated,Evaluated,95.4 % (（Antigen）),99.4 % ((Antigen）),,Nucleoprotein
2166,"SARS-CoV-2 Antigen Rapid Test (Lateral Flow Assay)",1009,"Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.",China,"",Yes,Commercialised,No,No,Cassette,Lab-based; Manual; Near POC / POC,Antigen,Anterior nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Adenovirus 7; Chlamydia Pneumoniae; Epstein-Barr Virus (EBV); Influenza A H1N1; Influenza A H3N2; Influenza B Victoria; Influenza B Yamagata; MERS-CoV; Mumps Virus (MuV); Mycoplasma Pneumoniae; 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,B.1.1.7 (United Kingdom);B.1.351 (South Africa);,2021-06-03 10:02:44 CET,1867,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,0.05 AU,,,,Not evaluated,,,Evaluated,1 %,4.81 %,Evaluated,96.71 % ((Antigen)),Evaluated,Evaluated,95.19 % ((Antigen)),98.17 % ((Antigen)),,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
1366,"SARS-CoV-2 Antigen Rapid Test (Immunochromatography)",654,"SHANDONG KANGHUA BIOTECHNOLOGY CO., LTD",China,"WWW.KHBIO.COM",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-05-10 13:04:00 CET,1129,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,1400 AU,,,,,,,,0.25 % (1 false positive to 400 negative samples),5 % (5 false negatives to 100 positive samples),,98.8 % ((Antigen)),,,95 % ((Antigen)),99.75 %,,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)
1338,"SARS-CoV-2 Antigen Rapid Test",649,"TBG BIOTECHNOLOGY XIAMEN Inc",China,"www.tbgxm.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1107,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,20,,,,,,,,,,,,,,,,,,nucleoprotein
1616,"SARS-COV-2 Antigen Rapid Test",719,"Zhuhai Encode Medical Engineering Co., Ltd",China,"www.encode.com.cn/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1296,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,,,,,,,,,,,,,,,95 %,100 %,,
1964,"SARS-CoV-2 Antigen Rapid test",834,"BN Santé",France,"www.biogyne.fr",Yes,Commercialised,No,No,,,Antigen,Nasal swab,,,2021-05-26 16:14:54 CET,1640,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,160 AU,,,,Not evaluated,,,Evaluated,0.5 %,2.9 %,Evaluated,98.8 %,Evaluated,Evaluated,97.1 %,99.5 %,,Nucleoprotein
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
1685,"SARS-CoV-2 Antigen Rapid Qualitative Test",756,"Xiamen Biotime Biotechnology Co., Ltd.",China,"www.biotime.cn/En_",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab; Other,,,2021-05-10 13:04:00 CET,1364,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,20,0 AU,,,,evaluated,,,evaluated,0,4 %,evaluated,98.98 % ((95%CI: 97.06%-99.79%)),evaluated,evaluated,96 % ((95%CI: 88.75%-99.17%)),,,nucleoprotein
1801,"SARS-CoV-2 Antigen Rapid Qualitative Test",821,"Innova Medical Group, Inc.",United States,"www.innovamedgroup.com",Yes,Commercialised,No,No,,Lab-based,Antigen,Nasal swab; Sputum; Throat swab,,,2021-05-10 13:04:00 CET,1480,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,,Colorimetry,,,,,,,,,,Evaluated,,,,,,,96 % (CI95%:8 8.75%-99.17%),100 % (CI95%: 98.34%-100.00%),,nucleocapsid
2151,"SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method)",996,"JINAN BABIO BIOTECHNOLOGY CO., LTD.",China,"",Yes,Commercialised,No,No,Card,Near POC / POC,Antigen,Nasal swab; Oropharyngeal swab; Saliva,Adenovirus; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus OC43 (HCoV-OC43); Influenza A H1N1; Influenza B; MERS-CoV; Respiratory Syncytial V (RSV),B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-05-31 13:31:10 CET,1841,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,Membrane-based,Colloidal gold,,15,0 AU,,,,Evaluated,,,Evaluated,3.62 %,0 %,Evaluated,98.79 %,Evaluated,Evaluated,96.38 % (（Antigen）),100 %,,Nucleoprotein
2152,"SARS-CoV-2 Antigen Rapid Detection Kit",997,"Shenzhen CAS-Envision Medical Technology Co., Ltd.",China,"www.cas-envision.com",Yes,Commercialised,No,No,Card; Cassette; Strip,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Human Metapneumovirus (HMPV); MERS-CoV; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Parainfluenza Virus Type 4,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-05-31 13:35:57 CET,1842,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colloidal gold,,15,34 AU,,,,Evaluated,,,Evaluated,1.9 %,0.5 %,Evaluated,98.8 %,Evaluated,Evaluated,98.1 %,99.5 %,,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,,,,,,,,,,,,,,,,,,
2026,"SARS-CoV-2 antigen IVD kit SWAB",930,"Shenzhen Reagent Technology Co.,Ltd.",China,"www.reagen.cn",Yes,Commercialised,No,No,Card,Manual,Antigen,Nasopharyngeal swab; Oropharyngeal 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);P.2 (Brazil);,2021-06-25 11:00:56 CET,1704,Immuno-Antigen,Yes,,Yes,Immunochromatography,Qualitative,Membrane-based,,Sample preparation,15,312.5 AU,,,,Evaluated,,,Evaluated,2.2 % (3 false positives were detected in 155 negative samples),4.76 % (5 false negatives were detected in 105 positive samples),Evaluated,96.9 %,Evaluated,Evaluated,95.2 % (（95%CI:85.94%-98.86%）),98.1 % (（95%CI:86.75%-99.12%）),,Nucleoprotein
1235,"SARS-Cov-2 Antigen Fluorescence Rapid Detection Kit",414,"Beijing Savant Biotechnology Co., Ltd",China,"www.huaketai.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Oropharyngeal swab,,,2021-05-10 13:04:00 CET,1017,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Fluorescence,,15,50 ng/mL,,,,,,,,,,,,,,,,,
1575,"SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)",693,"Wenzhou OJA Biotechnology Co., LTD.",China,"www.ojabio.net",Yes,Commercialised,No,No,Card,Near POC / POC,Antigen,Nasal swab; Other,,,2021-05-10 13:04:00 CET,1254,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,Sample preparation,15,1 AU,,,,evaluated,,,evaluated,1.71 (2 of 117),0.45 (1 of 220),evaluated,99.1 %,evaluated,evaluated,98.29 %,99.55 %,,nucleoprotein
1588,"SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)",699,"Xiamen Jiqing Biomedical Technology Co., Ltd.",China,"www.wikang.com.cn",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab; Saliva; Throat swab,,,2021-05-10 13:04:00 CET,1268,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,10 AU,,,,evaluated,,,evaluated,5.75 AU,0 AU,evaluated,97.58 % ((Antigen)),evaluated,evaluated,94.25 % ((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
1660,"SARS-Cov-2 Antigen Assay kit by Latex Immunochromatography method",743,"Sichuan Xincheng Biological Co., LTD",China,"www.xinchengbio.com/en/",Yes,Commercialised,No,No,Latex,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1339,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,500 AU,,,,evaluated,,,evaluated,0.95 %,5.7 %,evaluated,96.9 % ((Antigen)),evaluated,evaluated,94.2 % ((Antigen)),,,nucleoprotein
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
2111,"SARS-CoV-2 Ag Rapid Test",175,"VivaChek Biotech (Hangzhou) Co., Ltd",China,"www.vivachek.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Adenovirus 3; Adenovirus 7; Adenovirus Subtype B; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); MERS-CoV; Mycobacterium Tuberculosis; Mycoplasma Pneumoniae; Parainfluenza Virus Type; Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Parainfluenza Virus Type 4,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);,2021-06-04 14:41:24 CET,1801,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,,Validity test kit,15,675 AU,,,,Not evaluated,,,Evaluated,0 % (431 negative Sample were tested and 0 of them were false positive),4.54 % (154 positive Sample were tested and 7 of them were false negative.),Evaluated,98.8 % ( (Antigen)),Evaluated,Not evaluated,95.45 % (97.04(Antigen)),99.9 % ((Antigen)),,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
1774,"SARS-CoV-2 / Influenza Virus A/ Influenza Virus B Antigen Assay Kit (Immunochromatography)",792,"Wuhan Life Origin Biotech Joint Stock Co., Ltd.",China,"www.szybio.com",Yes,Commercialised,No,No,Card; Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1453,Immuno-Antigen,Yes,,Yes,Immunochromatography,Qualitative,,,,15,0 U/ml,,,,Evaluated,,,Evaluated,1.7 %,,Evaluated,"96.6 % ((483/500), 95%CI(94.61%-98.01%).)",Evaluated,Evaluated,"92.67 % ((139/150), 95%CI(87.26%-96.28%).)",,,
2157,"SARS CoV-2 Antigen Rapid Test",1001,"Novatech Tıbbi Cihaz Ürünleri Sanayi ve Ticaret A.Ş.",Turkey,"www.novadiag.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Anterior nasal swab; Nasal swab; Nasopharyngeal swab; Oropharyngeal 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);,2021-06-29 12:10:32 CET,1858,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,,Extraction kit,15,1.7 AU,,,,Not evaluated,,,Evaluated,0 % (517 with negative PCR result There was no false positiv sample from the sample. 0/517),4.09 % (342 positive PCR result 14 false negative samples did not come out of the sample. 14/342),Evaluated,98.37 %,Not evaluated,Evaluated,95.91 %,100 %,,N-protein
2240,"Salocor SARS-CoV-2 Antigen Rapid Test Kit",567,"Salofa Oy",Finland,"https://www.salofa.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Manual; Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab; Serum,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);,2021-06-23 11:05:42 CET,1941,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,Sandwich,,,10,40 AU,,,,Evaluated,,,Evaluated,0.4 % ( 249/250 (Nasopharyngeal swab negative specimens) ) 1 % ((186/188 serum negative specimens)),2.88 % ((135/139 Nasopharyngeal swab positive specimens) ) 3.9 % ((97/101 serum positive specimens)),Evaluated,99.5 % ((Nasopharyngeal swab) ) 97.9 % ((serum)),Evaluated,Evaluated,96.04 % ( (serum)) 97.12 % ( (Nasopharyngeal swab) ),98.9 % ( (serum)) 99.6 % ( (Nasopharyngeal swab) ),,Nucleoprotein
1782,"Saligen",798,"Bakter Medical s.r.o.",Czechia,"www.saligen.com",Yes,Commercialised,No,No,Card,Near POC / POC,Antigen,Saliva,,,2021-06-07 17:49:21 CET,1461,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,10,0.1 AU,,,,0,,,0,0 %,1 AU,0,98.55 %,,0,97.1 %,,,0
1493,"S1 Covid-19 Rapid Antigen Test Kit",687,"Sensing Self Pte., Ltd",Singapore,"www.sensingself.me",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab; Other; Saliva,,,2021-05-10 13:04:00 CET,1243,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,0.005 AU,,,,evaluated,,,evaluated,1 %,5 %,evaluated,96.9 %,evaluated,evaluated,94 %,,,nucleoprotein
2214,"RIDA®QUICK SARS-CoV-2 Antigen",217,"R-Biopharm AG",Germany,"www.r-biopharm.com",Yes,Commercialised,No,No,Dipstick,Manual,Antigen,Nasal swab; Nasopharyngeal swab,SARS-CoV,,2021-06-10 16:48:42 CET,1915,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,,Sample preparation,30,237 AU,,,,Not evaluated,,,Evaluated,bei hohen Konzentrationen an S.aureus (> 5 Mio Keime/ml),bei Antigenkonzentrationen unterhalb 237 TCID50/ml,Evaluated,95 %,Evaluated,Evaluated,93 %,97 %,,Nucleoprotein
1846,"RIDA®@QUICK SARS-CoV-2 Antigen",217,"R-Biopharm AG",Germany,"www.r-biopharm.com",Yes,Commercialised,No,No,Dipstick; Lateral flow,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab; Throat swab,,,2021-05-10 13:04:00 CET,1522,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,20,237 AU,,,,Evaluated,,,Evaluated,N/A,N/A,Evaluated,100 %,Evaluated,Evaluated,93.7 % (ct<30 ),97.4 %,,Nucleoprotein
1295,"reOpenTest COVID-19 Antigen Rapid Test",624,"Zhejiang Anji Saianfu Biotech Co., Ltd",China,"www.seinofy.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Plasma; Saliva,,,2021-07-07 17:26:30 CET,1094,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,Colorimetry,,15,,,,,,,,,95.8 %,99 %,,97.9 %,,,95.8 %,,,nucleoprotein
2256,"Redtest Professional Sars-CoV-2 Antigen Rapid Test (Covid-19 Ag) ",1051,"Sigmed Sp. z o.o.",Poland,"https://redtest.eu",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal 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);,2021-06-23 12:29:09 CET,1957,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,,Validity test kit,10,6 AU,,,,Evaluated,,,Evaluated,1 %,0 %,Evaluated,96 %,Evaluated,Evaluated,98 %,100 %,,Nucleoprotein
1453,"RAPIDTECH Test Rapide Antigène SARS-CoV-2",675,"Weifang Kanghua Biotech",China,"www.khbio.com/EN/yxwl.aspx",Yes,Commercialised,No,No,Card,Near POC / POC,Antigen,Nasal swab; Other,,,2021-05-10 13:04:00 CET,1202,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,2000 IU/ml,,,,evaluated,,,evaluated,9.1 % (3/33),0.1 % (1/1002),evaluated,97 %,evaluated,evaluated,91 %,,,nucleoprotein
1823,"RAPIDIGEN COVID19 AG IMMUNOASSAY",830,"Pharmaline AS",Turkey,"pharmaline.com.tr/en",Yes,Commercialised,No,No,Cassette; Lateral flow,Automated,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab; Throat swab,,,2021-05-10 13:04:00 CET,1501,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Magnetic Electrochemical,Visualisation system,15,30 AU,,,,Evaluated,,,Evaluated,Sample contamination or not following the IFU protocol,Sample contamination or not following the IFU protocol,Evaluated,98 %,Evaluated,Evaluated,93 %,99 %,,
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
1458,"RapidFor SARS-CoV-2 Antigen Test Kit",678,"Vitrosens Biotechnology Co., Ltd",Turkey,"www.vitrosens.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-10 13:04:00 CET,1210,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,10,100 IU/ml,,,,evaluated,,,evaluated,1 %,1 %,evaluated,98 %,evaluated,evaluated,97.3 %,,,nucleoprotein
1751,"RAPIDAN TESTER Covid-19 Ag Test",758,"Turklab",Turkey,"www.turklab.com.tr/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Throat swab,,,2021-05-10 13:18:20 CET,1429,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,20,30 U/ml,,,,Not evaluated,,,Evaluated,12 AU,3 AU,Evaluated,97.57 %,,Evaluated,93.18 %,,,Nucleoprotein
1602,"Rapid Test SARS-CoV-2 Ag",531,"AMEDA Labordiagnostik GmbH",Austria,"www.amp-med.com/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:18:20 CET,1283,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,115 TCID50/ml,,,,,,,"no cross reaction with RSV type A, RSV type B, novel influenza A H1N1,, Influenza A H3N2, Influenza A H5N1, Influenza B yamagata, Influenza B Victoria, Rhinovirus, Adenovirus 3, Adenovirus 7, EV-A71, Mycobacterium tuberculosis, Micoplasma pneumoniae, Mum",2.7 % (3 of 111),0 % (0 of 139),,98.8 %,,,97.3 %,100 %,,nucleocapside protein
1240,"RAPID TEST AntigenE GCCOV-502a",760,"Zhezhiang Orient Gene Biotech Co., Ltd",China,"www.orientgene.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:18:20 CET,1022,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,,,,86.7 %,100 %,,spike proteins
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
1791,"Rapid SARS-Cov2 Antigen Test",806,"Immunospark s.r.l.",Italy,"www.immunospark.com",Yes,Commercialised,No,No,Card,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-10 13:04:00 CET,1470,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Chemiluminescence,,10,3.22 IU/ml,,,,,,,,0 AU,0 AU,,98.5 %,,,94.12 %,,,
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,,,,,,,,,,,,,,,,,
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
1783,"Rapid SARS-CoV-2 Antigen Test",147,"InTec Products, Inc",China,"http://www.intecasi.com",Yes,Commercialised,No,No,Card; Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-05-29 14:30:38 CET,1462,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich,Colorimetry,,15,0.13 AU,,,,,,,,,,,,,,,,,
1684,"Rapid Response COVID-19 Antigen Rapid Test Cassette (Oral Fluid)",62,"BTNX Inc",Canada,"www.btnx.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Saliva,,,2021-05-10 13:18:20 CET,1363,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,10,1000 AU,,,,evaluated,,,evaluated,0 %,5 %,evaluated,99.5 %,evaluated,evaluated,95 %,,,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
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,,,,,,,,,,,,,,,,,,,,,,,
1735,"Rapid COVID-19 Antigen Test",554,"Healgen Scientific",United States,"www.healgen.com",Yes,Commercialised,No,No,Card; Cassette,Near POC / POC,Antigen,Nasal swab; Other,,,2021-05-10 13:18:20 CET,1414,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,15,115 U/ml,,,,Not Evaluated,,,Evaluated,0.35 % (3 of 865),0.23 % (2 of 865),Not Evaluated,99.42 %,Not evaluated,Not Evaluated,98.32 %,,,Nucleoprotein
1182,"Rapid COVID-19 Antigen Qualitative Test Kit",77,"Megna Health Inc",United States,"www.megnahealth.com",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab; Other; Saliva,,,2021-05-10 13:04:00 CET,964,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,20,,,,,,,,,,,,,,,,,,
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,,,,,,,,,,,,,,,,,
2217,"PixoTest® POCT COVID-19 Antigen Test",1031,"iXensor",Taiwan ROC,"https://www.ixensor.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC; Semi-automated,Antigen,Anterior nasal swab; Nasal swab; Nasopharyngeal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.526 (USA);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.1 (Japan/Brazil);P.2 (Brazil);,2021-06-28 10:51:07 CET,1918,Immuno-Antigen,Yes,,Yes,Immunochromatography,Qualitative,Membrane-based,,,15,125 AU,,,,Evaluated,,,Evaluated,2 AU,5 AU,Evaluated,97 % ((Antigen)),Evaluated,Evaluated,95 % ( (Antigen)),98 % ( (Antigen) Taipei),,Nucleoprotein
1264,"PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit",145,"Jiangsu Bioperfectus Technologies Co. Ltd",China,"www.bioperfectus.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,,,,2021-05-10 13:04:00 CET,1039,Immuno-Antigen,Yes,,,Immunoassay,,,,,,,,,,,,,,,,,,,,,,,
2283,"Pelican COVID-19 Ultra-Rapid Mobile Test",1065,"Canary Global Inc",Canada,"pelicancovidtest.com",Yes,Commercialised,No,No,Cartridge,Near POC / POC,Antigen,Saliva,,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);P.2 (Brazil);,2021-06-29 13:23:58 CET,1984,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,Other,,,2,100 AU,,,,Evaluated,,,Evaluated,"0.83 % (When 120 negative samples were tested, 1 sample showed false positive result)","1.8 % (When 111 positive samples were tested, 2 samples showed false negative result)",Evaluated,98.7 %,Evaluated,Evaluated,98.2 %,99.17 %,,Nucleocapside protein
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,,,,,,,,,,,,,,,,,,,,,,,
2320,"PathoCatch",1081,"Mylab Discovery Solutions Pvt. Ltd.",India,"https://mylabdiscoverysolutions.com/",Yes,Commercialised,No,No,Cassette; Lateral flow,Manual; Near POC / POC,Antigen,Mid-turbinates swab; 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);,2021-06-29 13:50:26 CET,2021,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Capture,,Visualisation system,15,21.25 AU,,,,Evaluated,,,Evaluated,0 %,8 %,Evaluated,100 % ((Antigen)),Evaluated,Evaluated,100 % ((Antigen)),100 % ((Antigen)),,Nucleoptotein
1270,"Pantest Coronavirus Ag",599,"Pantest SA",Portugal,"www.pantest.pt",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-05-10 13:04:00 CET,1045,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,20,,,,,,,,,,,,,,,96 %,100 %,,
1232,"Panbio COVID-19 Ag Rapid Test",628,"Abbott Rapid Diagnostics",United States,"www.globalpointofcare.abbott/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-05-17 11:01:42 CET,1015,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,,,,,,,,,,,,97.8 % (Nasopharyngeal swab) 99.4 % (Nasal swab (Ct values ≤ 33),,,91.4 % (Nasopharyngeal swab (Ct values ≤ 33) 98.1 % (Nasal swab (Ct values ≤ 33),99.8 % (Nasopharyngeal swab (Ct values ≤ 33) 99.8 % (Nasal swab (Ct values ≤ 33),,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
1195,"OneStep COVID-19 Antigen RapiCard InstaTest",582,"Diagnostic Automation/Cortez Diagnostics, Inc",United States,"www.rapidtest.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,980,Immuno-Antigen,Yes,,Yes,Immunoassay,,,,,15,38.55 AU,,,,,,,,,,,,,,95.52 %,,,
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
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 %,,
1289,"Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor)",642,"Apollo Biomedical LLC",United States,"www.apollobiomedical.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Sputum; Stool; Throat swab,,,2021-05-10 13:04:00 CET,1063,Immuno-Antigen,Yes,,N.A.,Immunoassay,Qualitative,,,,,,,,,,,,,,,,,,,,,,ACE2 receptor
1259,"Novel Coronavirus S Glycoprotein Detection Kit",634,"Hangzhou Deangel Biological Engineering Co., Ltd",China,"dagbio.en.alibaba.com/company_profile.html",Yes,Commercialised,No,No,,Near POC / POC,Antigen,,,,2021-05-10 13:04:00 CET,1035,Immuno-Antigen,Yes,,,Immunoassay,,,,,,,,,,,,,,,,,,,,,,,
1798,"Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) - Saliva",328,"Beijing Hotgen Biotech Co., Ltd",China,"www.hotgen.com.cn/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Saliva,,,2021-05-10 13:18:20 CET,1477,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,250,,,,Not evaluated,,,Evaluated,0,0,Evaluated,98.79,Evaluated,Evaluated,96 %,99.78 %,,
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); Cytomegalovirus (CMV); Enterovirus A71 (EV-A71); 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
1796,"Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva)",344,"Hangzhou Realy Tech Co., Ltd",China,"www.realytech.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Saliva,,,2021-05-10 13:04:00 CET,1475,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,20,125 IU/ml,,,,,,,,0.42 %,7.1 %,,96.79 %,,,92.9 %,,,
1220,"Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab)",344,"Hangzhou Realy Tech Co., Ltd",China,"www.realytech.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1005,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,15,1250 TCID50/ml,,,,Not evaluated,96.17 %,,Evaluated,0 % (450 samples are proven negative of 450 negative specimens),3.83 % (8 samples are proven negative of 209 positive specimens),Evaluated,98.79 %,,Evaluated,,,,Nucleorpotein
1743,"Novel Coronavirus (SARS-Cov-2) Antigen rapid test",344,"Hangzhou Realy Tech Co., Ltd",China,"www.realytech.com/",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1421,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,1250 U/ml,,,,Evaluated,,,Evaluated,Not Found,Not Found,Evaluated,98.79 %,Not Evaluated,Evaluated,97.14 %,,,
1972,"Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit(Colloidal Gold)",30,"Avioq Bio-Tech Co., Ltd",China,"www.avioqbio.com/",Yes,Commercialised,No,No,Cassette,Manual,Antigen,Anterior nasal swab; Nasopharyngeal swab,,,2021-05-10 13:18:20 CET,1648,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,Colloidal gold,Other,15,100 AU,,,,Not evaluated,,,Evaluated,0 %,10.64 % ((5/47)),Evaluated,96.84 %,Evaluated,Not evaluated,89.36 %,100 %,,Nucleoprotein
2224,"Novel Coronavirus (COVID-19) Antigen Testkit (Colloidal Gold",1033,"Hangzhou Laihe Biotech Co., Ltd.",China,"www.lyherbio.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab; Throat swab,,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.1.616 (France);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);P.1 (Japan/Brazil);P.2 (Brazil);,2021-06-25 13:21:51 CET,1925,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,Colloidal gold,Other,15,135,,,,Not evaluated,,,Evaluated,"10% prevalence, no more than 0,1%","10% prevalence, no more than 5,0%",Evaluated,97 % ((96% to 98%)),Not evaluated,Evaluated,95 ((>95%)),98 ((>98%)),,Nucleoprotein
1828,"Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)",834,"BN Santé",France,"www.biogyne.fr",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-06-25 13:11:31 CET,1505,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,15,0.5 AU,,,,Evaluated,,,Evaluated,1,8,Evaluated,97.81 %,Evaluated,Not evaluated,95 %,99.6 %,,Nucleoprotein
1795,"Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (Quantum Dot-based Fluorescence Immunochromatography)",344,"Hangzhou Realy Tech Co., Ltd",China,"www.realytech.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1474,Immuno-Antigen,Yes,,No,Immunochromatography,,Fluorescence,,,20,1250 IU/ml,,,,,,,,0 %,3.83 %,,98.79 %,,,96.17 %,,,
1362,"Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Quantum Dot-Based Fluorescence Immunochromatography)",652,"Beijing WSWY Technology Co.,.Ltd",China,"www.wswygs.com",Yes,Commercialised,No,No,Card,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1121,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Fluorescence,,,15,60 AU,,,,,,,,0 % (0),8.43 %,,98.21 % ((Antigen)),,,91.57 % ((Antigen)),,,nucleoprotein
1189,"Novegent COVID-19 Antigen Rapid Test Kit",620,"Chongqing Novegent Biotech Company Limited",China,"www.novegent.cn",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,970,Immuno-Antigen,Yes,,No,Immunoassay,Quantitative,,Colloidal gold,,15,7 AU,,,,,,,,,,,98.7 %,,,98.3 %,100 %,,
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
2281,"Ninonasal-Autotest",572,"NG Biotech",France,"https://ngbiotech.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);B.1.427 (USA);B.1.429 (USA);B.1.617.1 (India);B.1.617.2 (India);P.1 (Japan/Brazil);,2021-07-08 11:08:36 CET,1982,Immuno-Antigen,Yes,Yes,No,Immunochromatography,Qualitative,,,Other,20,1,,,,Not evaluated,,,Evaluated,0.51 ((2 out of 390)),2.34 % ((3 out of 128)),Evaluated,,Evaluated,Not evaluated,98 %,99 %,,Nucleoprotein
1880,"Ninonasal",572,"NG Biotech",France,"https://ngbiotech.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,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);P.1 (Japan/Brazil);,2021-07-16 10:42:04 CET,1559,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,20,1 AU,,,,Not evaluated,,,Evaluated,0.51 % ((2 false positive result out of 390 negative samples confirmed by RT-PCR)),2.34 % ((3 false negative results out of 128 positive samples confirmed by RT-PCR)),Evaluated,,Evaluated,Not evaluated,98 %,99 %,,Nucleoprotein
1646,"NG-Test SARS-CoV-2 Ag",572,"NG Biotech",France,"https://ngbiotech.com/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasopharyngeal swab,,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);,2021-06-23 14:36:31 CET,1327,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,,,20,1 AU,,,,not evaluated,,,evaluated,0 % (0 false positive result out of 100 negative samples confirmed by RT-PCR),17 % (17 false negative results out of 100 positive samples confirmed by RT-PCR),evaluated,,evaluated,not evaluated,87 % (for Ct<30 and ) 83 % 100 %,,,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
1490,"Multi-Respiratory Virus Antigen Test Kit(Swab)  (Influenza A+B/ COVID-19)",546,"Safecare Biotech (Hangzhou) Co. Ltd",China,"en.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
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,,,,,,,,,,,,,,,,,,
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
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 %,,
1749,"Mednano",840,"Wuhan NanoDiagnosis for Health Biotechnology Co., Ltd",China,"ndh-biotech.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,,,,2021-05-10 13:18:20 CET,1427,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,3581.5 AU,,,,,,,0 AU,1 AU,0 AU,0 AU,100 %,,,96.88 %,,,
1234,"MARK-B COVID-19 Ag S",629,"BBB INC; Obelis S.A.(BE)",South Korea,"www.bbbtech.com/",Yes,Commercialised,No,No,,Other,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1016,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,,Photonic ring resonance,,10,24 TCID50/ml,,,,,,,,,,,,,,98.5 %,98.5 %,,
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 %,,
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,,,,,,,,,,,,,,,,,,,,
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
1667,"LooK SPOT",746,"Laipac Technology Inc.",Canada,"www.laipac.com",Yes,Commercialised,No,No,Cassette,Automated,Antigen,Nasal 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);,2021-07-05 18:46:06 CET,1346,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,Other,Colorimetry,Other,1,129000 TCID50/ml,,,,evaluated,,,evaluated,2 % (Limited to less than 2%),2 % (Limited to less than 2%),evaluated,95 %,evaluated,evaluated,97.4 %,98.3 %,,nucleoprotein
1442,"Livzon Test for SARS-CoV-2 Antigen (Fluorescence Immunochromatographic Assay)",225,"Zhuhai Livzon Diagnostics Inc",China,"www.livzondiagnostics.com/en-us/list/39.html",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1193,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,Fluorescence,,,15,100 AU (100),,,,evaluated,,,evaluated,,,evaluated,not found,evaluated,not evaluated,97 %,98.3 %,,nucleoprotein
1441,"Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow)",225,"Zhuhai Livzon Diagnostics Inc",China,"www.livzondiagnostics.com/en-us/list/39.html",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1192,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,100 %,,,,evaluated,,,evaluated,,,evaluated,not found,evaluated,not evaluated,90.9 %,100 %,,nucleoprotein
1605,"Lab-On-Time COVID-19 Antigen Rapid Test Device (Integrated Throat Swab)",611,"BMT Diagnostics",Israel,"www.bmtdiagnostics.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Other; Throat swab,,,2021-05-10 13:04:00 CET,1286,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,1000 AU,,,,evaluated,,,evaluated,2.43 % (3 of 123),1.23 % (1 of 81),evaluated,98 %,evaluated,evaluated,96.4 %,,,nucleoprotein
1322,"Kwork Covid-19 Ag Rapid Test Device(Saliva/Sputum/Feces)",648,"Zhejiang Quark Biotechnology Co., Ltd",China,"www.zjkuake.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Saliva,,,2021-05-10 13:04:00 CET,1088,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,96.7 %,,,90 %,,,
1285,"Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence)",43,"Beijing Kewei Clinical Diagnostic Reagent Inc",China,"en.keweidiagnostic.com/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab; Throat swab,,,2021-05-10 13:04:00 CET,1059,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,Fluorescence,,,15,,,,,,,,,,,,,,,85 %,100 %,,nucleocapsid
70,"Kewei COVID-19 Antigen Rapid Test Kit (FIA)",43,"Beijing Kewei Clinical Diagnostic Reagent Inc",China,"en.keweidiagnostic.com/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab; Oropharyngeal swab,,,2021-05-10 13:04:00 CET,390,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,Fluorescence,,,15,140 TCID50/ml,,,,,,,,,,,97.5 %,,,85 %,100 %,,
1284,"Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold)",43,"Beijing Kewei Clinical Diagnostic Reagent Inc",China,"en.keweidiagnostic.com/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab; Throat swab,,,2021-05-10 13:04:00 CET,1058,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,Colorimetry,,15,,,,,,,,,,,,,,,85 %,100 %,,nucleocapsid
2085,"KaiBiLi COVID-19 Antigen",964,"Hangzhou GENESIS Biodetection and Biocontrol CO.,LTD",China,"www.hgb.com.cn/EN",Yes,Commercialised,No,No,Cassette,Manual; 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.1.526.1 (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);,2021-05-27 13:20:14 CET,1768,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Capture,,,15,74.8 AU,,,,,,,,0 % (Zero),0.4 % ((clinical sensitivity 96.6)),Evaluated,98.9 %,Evaluated (Evaluated),Evaluated (Evaluated),96.6 %,100 %,,Nucleoprotein
1725,"Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test",765,"Beijing Jinwofu Bioengineering Technology Co.,Ltd",China,"www.jwfbio.com/en/",Yes,Commercialised,No,No,Card,Near POC / POC,Antigen,Nasal swab; Other,,,2021-05-10 13:04:00 CET,1405,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,100,,,,evaluated,,,evaluated,0 AU,10 AU,evaluated,98.82 %,evaluated,evaluated,96.88 %,,,nucleoprotein
1678,"Instant-view® PLUS COVID-19 Antigen Test",17,"Alfa Scientific Designs Inc",United States,"www.alfascientific.com/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:18:20 CET,1357,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,3,2800 AU,,,,not evaluated,,,evaluated,3 out of 171,3 out of 40,not evaluated,97.2 %,evaluated,not evaluated,92.5,,,nucleoprotein
1444,"Instant SARS-CoV-2 Rapid Ag Test",678,"Vitrosens Biotechnology Co., Ltd",Turkey,"www.vitrosens.com",Yes,Commercialised,No,No,Dipstick,Near POC / POC,Antigen,Nasal swab; Other; Saliva,,,2021-05-10 13:18:20 CET,1195,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,5,100 IU/ml,,,,evaluated,,,evaluated,1 AU,1 AU,evaluated,98.3 %,evaluated,evaluated,97.3 %,,,nucleoprotein
1301,"Influenza A+B Antigen Test Kit (Colloidal Gold)",851,"Nantong Diagnos Biotechnology Co., Ltd",China,"www.diagnosbio.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:18:20 CET,1071,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,,,,15,0.05 AU,,,,,,,,,,,97.6 %,,,96.67 %,,,Nucleoprotein
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
1928,"ImmTek COVID-19 Antigen Rapid Test",882,"Metas Biomedical Inc.",Taiwan ROC,"www.metasbiomedical.com",Yes,Commercialised,No,No,Cassette; Dipstick; Lateral flow; Strip,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.1.526 (USA);P.1 (Japan/Brazil);,2021-06-18 12:25:20 CET,1604,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,,,10,313 AU,,,,Evaluated,,,Evaluated,0.86 AU,6.52 AU,Evaluated,97.53 %,Evaluated,Evaluated,93.48 %,99.14 %,,Nucleoprotein
1169,"iFlash-2019-nCoV Antigen",379,"SHENZHEN YHLO BIOTECH CO., Ltd",China,"http://www.szyhlo.com",Yes,Commercialised,No,No,Cassette,Automated,Antigen,Nasal swab,Cytomegalovirus (CMV),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);,2021-06-23 14:28:17 CET,948,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,Sandwich,Chemiluminescence,,30,120 AU,,,,Evaluated,,,Evaluated,0.46 % ((1/215)),2.94 % ((1/34)),Evaluated,,Evaluated,Evaluated,97.1 %,99.5 %,,Nucleoprotein
1728,"iD Rapid® COVID-19 Antigen",766,"Innovative Diagnostics",France,"www.innovative-diagnostics.com/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1408,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,1800 AU,,,,not evaluated,,,evaluated,0 %,2.47 % (2 false negative on 81 samples tested positive by PCR),evaluated,96.9 %,evaluated,evaluated,97.7 %,,,
1990,"ichroma™ COVID-19 Ag",22,"Boditech Med Inc",South Korea,"https://www.boditech.co.kr/en",Yes,Commercialised,No,No,Cassette; Chip; Lateral flow,Manual; Near POC / POC,Antigen,Nasopharyngeal swab,SARS-CoV,A.23.1 (United Kingdom);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);,2021-06-21 10:16:55 CET,1666,Immuno-Antigen,Yes,,Yes,Immunochromatography,Semiquantitative,Sandwich,,Other,12,35.15 AU,,,,Evaluated (Evaluated),,,Evaluated (Evaluated),2 AU,12 AU,Evaluated,95.2 % (95.2 %),Evaluated,Not evaluated,90.9 %,98.7 %,,Nucleoprotein
1262,"Humasis COVID-19/Flu Ag Combo Test",140,"Humasis",South Korea,"http://www.humasis.com/en/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1037,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,,,,,,,
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 %,,,
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,Coronaviruses (HCoV); SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-07-07 17:24:52 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
1854,"Gmate® COVID-19 Ag Saliva",715,"Philosys Co., Ltd.",South Korea,"www.philosys.com",Yes,Commercialised,No,No,Cartridge,Manual,Antigen,Saliva,,,2021-05-10 13:04:00 CET,1534,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,N.A.,15,5.07 AU,,,,Not evaluated,,,Evaluated,-,-,Evaluated,98.87 %,Evaluated,Evaluated,95.83 %,99.6 %,,Nucleoprotein
1611,"Gmate® COVID-19 Ag",715,"Philosys Co., Ltd.",South Korea,"www.philosys.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1291,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,5.07 U/ml,,,,Not Evaluated,,,Evaluated,,,Evaluated,96.67 %,Evaluated,Evaluated,91.11 %,,,
1893,"GLINE-2019-nCoV Ag Saliva",379,"SHENZHEN YHLO BIOTECH CO., Ltd",China,"http://www.szyhlo.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Manual; Near POC / POC,Antigen,Saliva,Coronaviruses (HCoV),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);,2021-06-23 14:00:58 CET,1850,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,Sandwich,,,20,425 TCID50/ml,,,,,,,Evaluated,0 % ((0 out of 123)),5.2 % ((26 out of 500)),,,,Evaluated,95.27 % ( (95%CI: 93.15%-96.89%)),100 % ( (95%CI: 97.05%-100%)),,Nucleoprotein
1347,"GLINE-2019-nCoV Ag",379,"SHENZHEN YHLO BIOTECH CO., Ltd",China,"http://www.szyhlo.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,Coronaviruses (HCoV),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);,2021-06-23 14:07:20 CET,1849,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,Sandwich,,,15,200 AU,,,,,,,Evaluated,0.75 % ((3/400)),3.5 % ((4/114)),,,,Evaluated,97.37 % ( (95%CI: 92.50% - 99.45%)),99.25 % ( (95%CI: 97.82% - 99.85%)),,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,,,,,,,,,,,,,,,,,,
1593,"GeneFinder COVID-19 Ag Rapid Test",702,"OSANG Healthcare Co., Ltd",South Korea,"www.osanghc.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,,,,2021-05-10 13:04:00 CET,1273,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,0 AU,,,,not evaluated,,,evaluated,,,,,evaluated,not evaluated,96.7 % ((PPA)),,,nucleoprotein
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
1297,"GenBody FIA COVID-19 Ag",97,"GenBody, Inc",South Korea,"www.genbody.co.kr/index.php?&LANGUAGE=en",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-05-10 13:04:00 CET,1067,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,20,898 TCID50/ml,,,,,,,,,,,92.95 %,,,89.47 %,96.43 %,,
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 %,,
1585,"GenaBio SARS-CoV-2 Antigen Lateral Flow Test",698,"GenaBio Diagnostics Inc.",United States,"www.genabio.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1265,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,15,1 AU,,,,evaluated,,,evaluated,4.93 %,0.26 %,evaluated,,evaluated,evaluated,95.07 % ((Antigen)),,,nucleoprotein
1855,"GA CoV-2 Antigen Rapid Test",351,"GA Generic Assays GmbH",Germany,"www.genericassays.com",Yes,Commercialised,No,No,Lateral flow,Manual,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 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
1580,"GA CoV-2 Antigen Rapid",351,"GA Generic Assays GmbH",Germany,"www.genericassays.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1259,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,70 AU,,,,not evaluated,,,evaluated,3.6 % (It was compared with results of the RT-PCR reference method and found a sensitivity 96.4%),0.8 % (It was compared with results of the RT-PCR reference method and found a specificity 99.2%),99 % (>99%),98 %,evaluated,evaluated,96.4 %,99.2 %,,nucleoprotein
2428,"FUJIFILM COVID-19 Ag Test",1110,"FUJIFILM Corporation",Japan,"https://www.fujifilm.com/",Yes,Commercialised,No,No,Cartridge; Lateral flow,Manual; Near POC / POC,Antigen,Nasopharyngeal swab,SARS-CoV,,2021-07-14 17:48:44 CET,2131,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Other,,,11,110 AU,,,,Evaluated,,,Evaluated,0 % (- Specificity 100% (104/104)),"9.1 % (- Sensitivity 90.9% Ct-value <35, n=121)",Evaluated,100 % ( (Antigen)),Evaluated,Evaluated,90.9 % ( (Antigen)),100 % ( (Antigen)),,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; Influenza A; Influenza A H1N1; Influenza A H3N2; Influenza B; MERS-CoV; 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
1208,"Formosa One Sure SARS-CoV-2 Ag Rapid Test Kit",626,"Formosa Biomedical Technology Corp.",Taiwan ROC,"www.fbc.com.tw ",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,993,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,,,,88 %,,,
1192,"FORA COVID-19 Antigen Rapid Test",588,"TaiDoc Technology Corp.",Taiwan ROC,"taidoc.com/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,978,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,Magnetic Electrochemical,,15,126 TCID50/ml,,,,,,,,,,,,,,91.3 % ((CT<30)),98.6 %,,nucleocapsid recombinant Antigen
1664,"FluCov2",529,"DyonMed SA",Greece,"dyonmedical.com/en/home/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1343,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,1 AU,,,,evaluated,,,evaluated,7.75 % (Compared to PCR (n=142) 11 FP),0 % (Compared to PCR (n=66) no false negatives),evaluated,95 % ((Antigen)),evaluated,evaluated,92.25 % ((Antigen)),,,nucleoprotein
1370,"FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device",455,"Assure Tech. (Hangzhou) Co., Ltd",China,"www.diareagent.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Other,,,2021-05-10 13:04:00 CET,1141,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,2102.4 AU,,,,,,,,Not available,Not available,,"98.5 % ((COVID-19:98.5%; Influenza A:88.4%, Influenza B:88.9%, RSV:97.4%, Adenovirus:96.3%))",,,"97.3 % ((COVID-19:97.3%; Influenza A:83.3%, Influenza B:82.4%, RSV:96.2%, Adenovirus:95.2%))",,,
1470,"Flu+COVID-19 Ag Test Kit",655,"Guangdong Wesail Biotech Co., Ltd",China,"en.wesailbio.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1217,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,15,560 AU,,,,Not evaluated,,,evaluated,10,0.8,evaluated,95.6 %,not evaluated,not evaluated,91.1 %,,,
1713,"Flu A/Flu B/SARS-CoV-2 Antigen (GICA)",761,"MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.",China,"www.medcaptain.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1393,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,15,1250 AU,,,,not evaluated,,,evaluated,1.9 %,2.8 %,evaluated,98 %,evaluated,evaluated,97.2 % ((Antigen)),,,nucleoprotein
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)
1724,"First Sign SARS-CoV-2-Antigen-Test",726,"WHPM",United States,"www.whpm.com",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1404,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,160000 AU,,,,not evaluated,,,evaluated,98.82 % (2/170),98.82 % (2/170),evaluated,97.6 % (Antigen),not evaluated,evaluated,94.6 % (Antigen),,,nucleoprotein
1669,"FIAflex SARS-CoV-2 Antigen FIA",565,"Acon Biotech (Hangzhou) Co., Ltd",China,"www.aconbio.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:18:20 CET,1348,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,95 AU,,,,not evaluated,,,Evaluated,,,evaluated,98.9 %,evaluated,evaluated,97.5 %,,,nucleoprotein
1670,"FIAflex SARS-CoV-2 Antigen FIA",683,"ACON Laboratories, Inc",United States,"www.aconlabs.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1349,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,95 %,,,,not evaluated,,,evaluated,,,evaluated,98.9 %,evaluated,evaluated,97.5 %,,,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 %,,
2161,"EONBT COVID-19 ANTIGEN-SALIVA",1004,"Manufactured by Eon Biotechnology Limited",United Kingdom,"www.eonbt.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Manual; Near POC / POC,Antigen,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.1.526.2 (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);,2021-06-03 12:27:03 CET,1862,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,,,20,4 AU,,,,Not evaluated,,,Evaluated,"0.7 % ( (In trial of 428 negative samples compared with RTqPCR test ,3 False Positives were detected))","8.05 % ( (In trial of 149 positive samples compared with RTqPCR test, 12 False negatives were detected))",Evaluated,99.04 %,Evaluated,Evaluated,91.95 %,99.27 %,,Nucleoprotein
2156,"Elecsys® SARS-CoV-2 Antigen",221,"ROCHE Diagnostics",Germany,"https://diagnostics.roche.com/global/en/products/params/elecsys-anti-sars-cov-2-s.html",Yes,Commercialised,No,No,Cartridge,Automated; Lab-based,Antigen,Nasopharyngeal swab; Oropharyngeal 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);,2021-06-01 14:18:59 CET,1857,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,Sandwich, Double,,,12,22.5 TCID50/ml,,,,Evaluated,,,Evaluated,,,Evaluated,,Evaluated,Evaluated,94.5 % ( (95% CI: 90.4-97.2)),99.9 % ( (95% CI: 99.6-100)),,Nucleoprotein
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; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Bordetella Pertussis; Chlamydia Pneumoniae; 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,No,No,Lateral flow,Manual; Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,Adenovirus; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Chlamydia Pneumoniae; Epstein-Barr Virus (EBV); 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),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);,2021-07-02 18:44:51 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
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
1651,"DyonCovidAg",529,"DyonMed SA",Greece,"dyonmedical.com/en/home/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1332,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,15,2000 AU,,,,evaluated,,,evaluated,,,evaluated,97 %,evaluated,evaluated,91 %,,,nucleoprotein
1250,"Dynamiker SARS-CoV-2 Ag Rapid Test",86,"Dynamiker Biotechnology (Tianjin) Co., Ltd",China,"en.dynamiker.com/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-05-10 13:04:00 CET,1028,Immuno-Antigen,Yes,,,Immunoassay,,,,,10,,,,,,,,,,,,,,,,,,
1733,"DROP-TECH",768,"Promoitalia Group SpA",Italy,"www.webpromoitalia.com",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-10 13:04:00 CET,1412,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,320 AU,,,,evaluated,,,evaluated,"Based on the accuracy confirmed by studies, fales positives are not likely to occur.","Based on the accuracy confirmed by studies, fales negatives are not likely to occur.",evaluated,98 %,evaluated,evaluated,92.59 %,,,nucleoprotein
2273,"Dräger Antigen Test SARS-CoV-2",1060,"Dräger Safety AG & Co. KGaA",Germany,"www.draeger.com",Yes,Commercialised,No,No,Cassette; Lateral flow; Strip,Manual; Near POC / POC,Antigen,Nasal swab,SARS-CoV,B.1.1.7 (United Kingdom);,2021-06-18 11:03:36 CET,1974,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,,Sample collection device,15,200 pg,,,,Not evaluated,96.8 % ( (Ct values < 26)),,Evaluated,0.32 (1 out of 308 samples (symptomatic and asymptomatic PCR negative)),10.1 (7 out of 69 samples (symptomatic PCR positive)),Evaluated,97.1 ( (symptomatic overall); ) 98.9 % ( (symptomatic Ct values < 26)),Evaluated,Evaluated,89.9 % ((overall); ),99.7 % ( (overall)),,Nucleoprotein
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
1274,"Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay)",262,"Sure Bio-Tech (USA) Co., Ltd",United States,"www.surebiotech.com/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-05-10 13:04:00 CET,1049,Immuno-Antigen,Yes,,,Immunoassay,,Fluorescence,,,,,,,,,,,,,,,,,,,,,
1663,"CovidAg",529,"DyonMed SA",Greece,"dyonmedical.com/en/home/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1342,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,0 AU,,,,evaluated,,,evaluated,9.4 % (Compared to PCR (n=117) 11 FP),0.55 % (Compared to PCR (n=183) 1 false negatives),evaluated,96 % ((Antigen)),evaluated,evaluated,90.59 % ((Antigen)),,,nucleoprotein
2261,"Covid19Check-SAL",1052,"Multi-G bvba",Belgium,"www.covid19check-mg.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Manual,Antigen,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.1.526.2 (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);,2021-06-16 17:24:42 CET,1962,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,,,15,22.5 AU,,,,Not evaluated,,,Evaluated,0.9 % ( (NPA 99.1%)),"2.4 % ( (PPA 97.6%, 99.35% for Ct values ≤25))",Evaluated,98.7 %,Evaluated,Evaluated,97.6 %,99.1 %,,Nucleoprotein
2260,"Covid19Check-NAS",1052,"Multi-G bvba",Belgium,"www.covid19check-mg.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Manual,Antigen,Nasal 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);,2021-06-16 17:21:17 CET,1961,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,,,15,1600 AU,,,,Not evaluated,,,Evaluated,0.5 % ( (NPA 99.5%)),"3 % ( (PPA 97%, 99.35% for Ct values ≤25))",Evaluated,98.97 %,Evaluated,Evaluated,97 % ( (99.35% for Ct values ≤25)),99.5 %,,Nucleoprotein
2258,"Covid19Check-GEN",1052,"Multi-G bvba",Belgium,"www.covid19check-mg.com",Yes,Commercialised,No,No,Cassette,Manual,Antigen,Nasopharyngeal swab; Oropharyngeal 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);,2021-06-16 17:15:22 CET,1959,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,,,15,30 AU,,,,Not evaluated,,,Evaluated,0.7 % ((NPA 99.3%)),"6.8 % ( (PPA 93.18%, 100% for Ct values ≤33))",Evaluated,97.57 %,Evaluated,Evaluated,93.18 % ( (100% for Ct values ≤33)),99.3 %,,Nucleoprotein
1778,"COVID19 Antigen Rapid Test Kit",43,"Beijing Kewei Clinical Diagnostic Reagent Inc",China,"en.keweidiagnostic.com/",Yes,Commercialised,No,No,Card; Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1457,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,15,19.3 U/ml,,,,Evaluated,,,Evaluated,0 %,3.82 %,Evaluated,98.56 %,Evaluated,Evaluated,96.18 %,,,
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
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"
1454,"COVID-19/Flu A/B Antigen Combo Rapid Test",340,"GenSure Biotech Inc",China,"www.gensbio.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1204,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,50 AU,,,,Not evaluated,,,evaluated,"The samples collected were contaminated, do not follow the instructions manual, etc. ","Samples collected contained low levels of the virus, do not follow the instructions manual, etc. ",evaluated,98.9 % ((COVID-19)),not evaluated,not evaluated,96.9 % ((COVID-19)),,,nucleoprotein
1956,"COVID-19-CHECK-1 Antigen",574,"VEDALAB",France,"www.vedalab.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Manual,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-06-09 10:56:46 CET,1632,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,,,20,0.05 AU,,,,Evaluated,,,Evaluated,0 % (Specificity 100%),1.75 % ([98.25% sensitivity (Ct value <=25)]),Evaluated,98.7 % ( (at Ct value <=25)),Evaluated,Evaluated,98.25 % ((Ct value <=25)),100 %,,Nucleoprotein
1281,"COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography)",640,"Beijing Abace Biology Co., Ltd",China,"www.abace-biology.com/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,,,,2021-05-10 13:04:00 CET,1056,Immuno-Antigen,Yes,,,Immunochromatography,,,,,,,,,,,,,,,,,,,,,,,
1237,"COVID-19 Viral Antigen Test Kit",415,"Camtech",Singapore,"covid19-test.com/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Oropharyngeal swab,,,2021-05-10 13:18:20 CET,1020,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,Fluorescence,,,20,ng/mL (100 ng/ml),,,,,,,,,,,82.4 %,,,88.66 %,94.55 %,,
1333,"COVID-19 Rapid Antigen Test (Colloidal Gold)",44,"Joinstar Biomedical Technology Co., Ltd",China,"www.joinstar.cn",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 20:07:30 CET,1105,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,,,,,,,,,1.86 % (From 215 samples tested there were 4 false positives),1.39 % (From 215 samples tested there were 3 false negatives),,97.6 %,,,96.1 %,98.1 %,,nucleoprotein
1756,"COVID-19 Antigen/Flu A+B Antigen Combo Rapid Test Cassette",840,"Wuhan NanoDiagnosis for Health Biotechnology Co., Ltd",China,"ndh-biotech.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:18:20 CET,1434,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,1774 TCID50/ml (SARS-CoV-2 ),,,,Not evaluated,,,Evaluated,1 AU,0 AU,Evaluated,100 (Antigen),,Not evaluated,96.88 % (Antigen),,,
1279,"COVID-19 Antigen Test Kit (Rare Earth Nano Fluorescence Immunochromatography)",790,"Xiamen AmonMed Biotechnology Co., Ltd",China,"www.amonmed.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,,,,2021-05-10 13:18:20 CET,1054,Immuno-Antigen,Yes,,,Immunoassay,,Fluorescence,,,,,,,,,,,,,,,,,,,,,
1648,"COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)",739,"Lansion Biotechnology Co., Ltd.",China,"www.lansionbio.com/",Yes,Commercialised,No,No,Strip,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1329,Immuno-Antigen,Yes,,Yes,Immunoassay,Quantitative,Fluorescence,,,15,0 AU,,,,evaluated,,,evaluated,3 %,2 %,evaluated,98 %,evaluated,evaluated,95 %,,,nucleoprotein
1353,"COVID-19 Antigen Test Kit (Colloidal Gold)",851,"Nantong Diagnos Biotechnology Co., Ltd",China,"www.diagnosbio.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Throat swab,,,2021-05-10 13:18:20 CET,1127,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,0.05,,,,,,,,,,,96 % ((Antigen)),,,92.59 % ((Antigen)),,,nucleoprotein
2333,"COVID-19 Antigen Test Kit (Colloidal Gold)",1085,"Shenzhen Yilifang Biotech Co., LTD.",China,"http://www.yilifangbio.com/en/",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,Adenovirus 3; Adenovirus 7; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Enterovirus A71 (EV-A71); Epstein-Barr Virus (EBV); Influenza A; Influenza A H1N1; Influenza A H3N2; Influenza B; Influenza B Victoria; Influenza B Yamagata; MERS-CoV; Mumps Virus (MuV); Mycoplasma Pneumoniae; Respiratory Syncytial V (RSV); Rhinovirus A; Rhinovirus B; SARS-CoV; Varicella Zoster Virus (VZV),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.1.526 (USA);B.1.526.1 (USA);B.1.617.1 (India);B.1.617.2 (India);B.1.617.3 (India);,2021-07-01 09:46:54 CET,2034,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,Colloidal gold,Validity test kit,15,35 AU,,,,Evaluated,,,Evaluated,7.18 % ((12 false positives in 167 sample)),1.5 % ((5 false negatives in 333 sample)),Evaluated,97 %,Evaluated,Evaluated,96.88 %,96.47 %,,Nucleoprotein
1700,"COVID-19 Antigen Test Cassette (For Analyzer)",890,"Acro Biotech Inc",United States,"www.acrobiotech.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:18:20 CET,1380,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,,,,10,0 AU,,,,evaluated,,,evaluated,6.7 AU,1.6 AU,evaluated,96.2 ((Antigen)),evaluated,evaluated,93.3 % ((Antigen)),,,nucleoprotein
1254,"COVID-19 Antigen Test cassette (FIA)",126,"Hangzhou AllTest Biotech Co., Ltd",Germany,"https://www.goldstandarddiagnostics.com/home/products/covid-19-antigen-rapid-test/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1030,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,Fluorescence,,15,,,,,,,,,,,,,,,,,,
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
1476,"COVID-19 Antigen Test Cassette",659,"CITEST DIAGNOSTICS INC",China,"www.citestdiagnostics.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1225,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,10,0 AU,,,,evaluated,,,evaluated,4.4 %,1.6 %,evaluated,97.2 % ((Antigen)),evaluated,evaluated,95.6 % ((Antigen)),,,nucleoprotein
1455,"COVID-19 Antigen Test (Nasopharyngeal Swab)",657,"Ulti Med Products GmbH",Germany,"www.ultimed.org",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1205,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,100 AU,,,,Not evaluated,,,evaluated,0.61 % (2 from 330),6.01 % (8 from 133),evaluated,97.8 %,evaluated,evaluated,94 %,,,
1238,"COVID-19 Antigen test",631,"RDSM nv",Belgium,"www.rdsm.eu/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-05-10 13:04:00 CET,1021,Immuno-Antigen,Yes,,No,Immunoassay,,,,,15,,,,,,,,,,,,,,,99.9 %,80.2 % 97.6 % ((CT < 30)),,
1378,"COVID-19 Antigen test",657,"Ulti Med Products GmbH",Germany,"www.ultimed.org",Yes,Commercialised,No,No,N.A.,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1143,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,100 AU,,,,,,,Eavaluated,1.23 %,2.44 %,,98 %,,,96.4 %,99.2 %,,
1715,"COVID-19 Antigen Test",762,"Redcell Biyoteknoloji",Turkey,"en.redcell.com.tr/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1395,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,50000 AU,,,,not evaluated,,,evaluated,1.15 % (Out of 261 samples 3 of them were false positives),4.92 % (Out of 122 samples 6 of them were false negatives),evaluated,99.2 %,evaluated,evaluated,95.08 %,,,nucleoprotein
2075,"COVID-19 Antigen Sealing tube test strip (Colloidal Gold)",960,"Amazing Biotech (Shanghai) Co.,LTD",China,"",Yes,Commercialised,No,No,Strip,Near POC / POC,Antigen,Nasal swab; Oropharyngeal swab; Saliva,Adenovirus; Adenovirus Subtype C; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Influenza A; Influenza A H3N2; Influenza A H5N1; Influenza B Victoria; MERS-CoV; Parainfluenza Virus Type; 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);P.1 (Japan/Brazil);,2021-05-20 15:10:47 CET,1757,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,Colloidal gold,,15,0 AU,,,,Not evaluated,,,Evaluated,2.885 % ( (Nasal Swab)),0.746 % ( (Nasal Swab)),Evaluated,98.2 % ( (Antigen) (Nasal Swab)),Evaluated,Evaluated,97.115 % ( (Antigen) (Nasal Swab)),99.254 % ((Antigen) (Nasal Swab)),,Nucleoprotein
1617,"COVID-19 Antigen Saliva Test Kit (Colloidal Gold)",851,"Nantong Diagnos Biotechnology Co., Ltd",China,"www.diagnosbio.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Saliva,,,2021-05-10 13:18:20 CET,1297,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,0.05 AU,,,,not evaluated,,,evaluated,0.67 %,1.9 %,evaluated,98.82 % ((Antigen) ),evaluated,not evaluated,98.1 % ((Antigen) ),,,nucleoprotein
1579,"COVID-19 Antigen Saliva Test Kit",455,"Assure Tech. (Hangzhou) Co., Ltd",China,"www.diareagent.com",Yes,Commercialised,No,No,,Manual,Antigen,Saliva,,,2021-05-10 13:04:00 CET,1258,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,0 AU,,,,evaluated,,,evaluated,,,evaluated,95.3 %,evaluated,evaluated,90 %,,,
1598,"COVID-19 Antigen Rapid Test, Sienna",873,"T&D diagnostics Canada Pvt., Canada",Canada,"www.td-diagnostics.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,,,,2021-05-10 13:04:00 CET,1279,Immuno-Antigen,Yes,,,Immunoassay,,,,,,,,,,,,,,,,,,,,,,,
2249,"COVID-19 ANTIGEN RAPID TEST NASAL",1047,"Unioninvest Ltd.",Turkey,"www.unibioscience.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Manual,Antigen,Nasal swab,SARS-CoV,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.2 (Brazil);,2021-06-15 13:49:03 CET,1950,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,,Visualisation system,15,7.57 AU,,,,Evaluated,,,Evaluated,0.25 % (1/400),1 % (4/400),Evaluated,99 ( (Antigen)),Evaluated,Evaluated,99 % ( (Antigen)),99 % ( (Antigen)),,Nucleoprotein
1937,"COVID-19 Antigen Rapid Test Kit(Swab)",886,"Chongqing iSIA BIO-Technology Co., Ltd",China,"www.isiabio.com.cn",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,,,,2021-06-01 11:17:35 CET,1613,Immuno-Antigen,Yes,,,Immunoassay,,,,,15,0.9 AU,,,,Not evaluated,,,Evaluated,0 %,0 %,Evaluated,98 %,Not evaluated,Evaluated,97 %,100 %,,Other
1819,"COVID-19 Antigen Rapid Test Kit(Saliva)",546,"Safecare Biotech (Hangzhou) Co. Ltd",China,"en.safecare.com.cn/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Saliva,,,2021-05-10 13:18:20 CET,1497,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich,,Visualisation system,15,0.25 AU,,,,Evaluated,,,Evaluated,0.55 %,1.5 %,Evaluated,99.05 %,Evaluated,Evaluated,98.5 %,99.45 %,,
1489,"COVID-19 Antigen Rapid Test Kit (Swab)",546,"Safecare Biotech (Hangzhou) Co. Ltd",China,"en.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
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
1899,"COVID-19 Antigen Rapid Test Kit (Colloidal Gold)",867,"Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.",China,"en.konsung.com/",Yes,Commercialised,No,No,Card,Manual,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,,,2021-05-10 13:04:00 CET,1575,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,,Colorimetry,Other,15,50 AU,,,,Not evaluated,,,Evaluated,8 AU,5 AU,Evaluated,99.06 %,Not evaluated,Not evaluated,97.14 %,99.34 %,,Nucleoprotein
1310,"Covid-19 Antigen Rapid Test Kit",35,"Beijing Beier Bioengineering Co., Ltd",China,"www.mediport.com",Yes,Commercialised,No,No,Lateral flow,Manual; Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1080,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,Colloidal gold,,15,,,,,,,,,,,,98.5 %,,,96.5 % (95% CI: 93.7%~99.3%),,,Nucleoprotein
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
1573,"COVID-19 Antigen Rapid Test Kit",691,"Nantong Egens Biotechnology Co.,Ltd",China,"www.egens-bio.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1252,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colloidal gold,,15,38.5 AU,,,,evaluated,,,evaluated,0.2 %,4.2 %,evaluated,98.5 %,evaluated,evaluated,95.8 %,,,
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
678,"COVID-19 Antigen Rapid Test Device; SARS-CoV-2 (N)protein Antigen rapid test (Fluorescence Immunochromatics assay)",166,"LOMINA AG",Switzerland,"www.lomina.ch/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Oropharyngeal swab,,,2021-05-10 13:04:00 CET,807,Immuno-Antigen,Yes,,Yes,Immunochromatography,Qualitative,Fluorescence,,N.A.,15,100 ng/mL,,,,Evaluated,,,,,,,96.63 %,,,94.55 %,99.9 %,,SARS-CoV-2 Nucleocapsid Protein Antigen
263,"COVID-19 Antigen Rapid Test Device",160,"Liming Bio-Products Co., Ltd",China,"www.limingbio.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab; Oropharyngeal swab,,,2021-05-10 13:04:00 CET,212,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,Evaluated,,,,,,,Evaluated,,,,,,,93.1 %,100 %,,
1261,"COVID-19 Antigen Rapid Test Device",635,"Hangzhou Genesis Biodetection & Biocontrol Co., Ltd",China,"www.hgb.com.cn/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal aspiration; Throat swab,,,2021-05-10 13:04:00 CET,1036,Immuno-Antigen,Yes,,,Immunoassay,,,,,15,,,,,,,,,,,,,,,,,,
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
2270,"COVID-19 Antigen Rapid Test Device",1059,"Assure Tech. (Hangzhou) Co., Ltd.",China,"www.diareagent.com",Yes,Commercialised,No,No,Cassette,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Oropharyngeal swab,Adenovirus; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Bordetella Pertussis; Chlamydia Pneumoniae; 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); 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);,2021-06-25 11:34:13 CET,1971,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,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.)","2.34 % (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
1746,"COVID-19 Antigen Rapid Test Cassette(Saliva)",413,"Hangzhou Clongene Biotech Co., Ltd",China,"en.clongene.com/",Yes,Commercialised,No,No,Card; Cassette; Lateral flow,Near POC / POC,Antigen,Saliva,,,2021-05-10 13:04:00 CET,1424,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,3470 U/ml,,,,Not Evaluated,,,Evaluated,3.2 AU,0.4 AU,Evaluated,99 %,Evaluated,Not Evaluated,96.8 %,,,Nucleoprotein
1868,"COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab)",128,"Hangzhou Biotest Biotech Co., Ltd",China,"en.biotests.com.cn",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:18:20 CET,1545,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,10,0 AU,,,,Not evaluated,,,Evaluated,0.83 % (3/363),5 % (2/40),Evaluated,98.8 %,Evaluated,Evaluated,95 %,99.2 %,,Nucleoprotein
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
1467,"Covid-19 Antigen Rapid Test Cassette",682,"Swedicine AB",Sweden,"www.swedicine.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1218,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,5.07 AU,,,,evaluated,,,evaluated,,,evaluated,98 %,evaluated,evaluated,96.4 %,,,nucleoprotein
1451,"COVID-19 Antigen Rapid Test (Vstrip)",676,"AnTaimmu BioMed",Taiwan ROC,"www.antaimmu.com",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1203,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,10,1.571035 AU,,,,evaluated,,,evaluated,92.31 % (Positive predictive value: % (95%CI: 62.97%- 98.83%) ),96.49 % (Negative predictive value: 96.49% (95%CI: 88.40%-99.00%) ),evaluated,95.71 % (CI95%:: 87.98%-99.11%),evaluated,evaluated,85.71 % (CI95%: 57.19%- 98.22%),,,nucleoprotein
2300,"COVID-19 Antigen Rapid Test (Swab)",659,"CITEST DIAGNOSTICS INC",China,"www.citestdiagnostics.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,Adenovirus 3; Adenovirus 7; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Influenza A H1N1; Influenza A H3N2; Influenza B; MERS-CoV; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Respiratory Syncytial V (RSV),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);,2021-06-25 13:30:33 CET,2001,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich,,Validity test kit,15,100 AU,,,,Evaluated,,,Evaluated,0.036 AU (Nasopharyngeal Swab) 0.071 AU (Nasal Swab),0.01 AU (Nasopharyngeal Swab) 0.001 AU (Nasal Swab),Evaluated,96.2 % (Nasal Swab) 98.2 % (Nasopharyngeal Swab),Evaluated,Evaluated,96.4 % (Nasopharyngeal Swab) 92.9 % (Nasal Swab),99 % (Nasopharyngeal Swab) 99.9 % (Nasal Swab),,Nucleoprotein
2159,"COVID-19 Antigen Rapid Test (Oral Fluid) SELFTESTING",1003,"Hangzhou AllTest Biotech Co., Ltd.",China,"www.alltests.com.cn",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Saliva,Adenovirus 3; Adenovirus 7; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Influenza A H1N1; Influenza A H3N2; Influenza B; MERS-CoV; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Respiratory Syncytial V (RSV),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.1.526.1 (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);,2021-06-01 14:55:29 CET,1860,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich,,Validity test kit,15,100 AU,,,,Evaluated,,,Evaluated,0.099 %,0.007 %,Evaluated,97 % ((Antigen）),Evaluated,Evaluated,90.1 % ((Antigen）),99.3 % ((Antigen）),,Nucleoprotein
1947,"COVID-19 Antigen Rapid Test (Oral Fluid)",126,"Hangzhou AllTest Biotech Co., Ltd",Germany,"https://www.goldstandarddiagnostics.com/home/products/covid-19-antigen-rapid-test/",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Saliva,,,2021-05-10 13:18:20 CET,1623,Immuno-Antigen,Yes,,,Immunochromatography,Qualitative,,,,15,100 AU,,,,Evaluated,,,Evaluated,0.007 AU,0.0099 AU,Evaluated,97 %,Evaluated,Evaluated,90.1 %,99.3 %,,Nucleoprotein
1949,"COVID-19 Antigen Rapid Test (Oral Fluid)",890,"Acro Biotech Inc",United States,"www.acrobiotech.com",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC,Antigen,Saliva,Adenovirus 3; Adenovirus 7; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Influenza A H1N1; Influenza A H3N2; Influenza B; Mumps Virus (MuV); Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Respiratory Syncytial V (RSV),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);,2021-07-09 10:48:04 CET,1625,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich,,Validity test kit,15,100 AU,,,,Evaluated,,,Evaluated,0.007 AU,0.097 AU,Evaluated,96.8 %,Evaluated,Evaluated,90.3 %,99.3 %,,Nucleoprotein
1205,"COVID-19 Antigen Rapid Test (Latex)",44,"Joinstar Biomedical Technology Co., Ltd",China,"www.joinstar.cn",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Other; Saliva,,,2021-05-10 13:04:00 CET,990,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,"0 % (Compared to PCR (n=60) no FP in each of saliva, and sputum.sputum, samples)",13.33 % (Compared to PCR (n=60) 5 false negatives in saliva and 3 in sputum),,,,,,,,
1480,"COVID-19 Antigen Rapid Test (For Reader)",659,"CITEST DIAGNOSTICS INC",China,"www.citestdiagnostics.com",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1229,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,,,,15,0 AU,,,,evaluated,,,evaluated,0.08 %,3.6 %,evaluated,98 %,evaluated,evaluated,96.4 %,,,nucleoprotein
1702,"COVID-19 Antigen Rapid Test (For Reader)",890,"Acro Biotech Inc",United States,"www.acrobiotech.com",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:18:20 CET,1382,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,,,,15,0 AU,,,,evaluated,,,evaluated,2.3 AU,1 AU,evaluated,98.6 %,evaluated,evaluated,97.7 %,,,nucleoprotein
1446,"COVID-19 Antigen Rapid Test (Colloidal Gold Method)",533,"Hangzhou Singclean Medical Products Co., Ltd",China,"www.singclean.net",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-10 13:04:00 CET,1196,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,4 AU,,,,evaluated,,,evaluated,1.44 % (98.56),0.97 % (99.03),evaluated,98.84 %,evaluated,evaluated,98.56 %,,,nucleoprotein
1257,"COVID-19 Antigen Rapid Test",126,"Hangzhou AllTest Biotech Co., Ltd",Germany,"https://www.goldstandarddiagnostics.com/home/products/covid-19-antigen-rapid-test/",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-06-18 12:47:01 CET,1033,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,,,,,,,
1792,"COVID-19 Antigen Rapid Test",503,"DIAsource ImmunoAssays",Belgium,"www.diasource-diagnostics.com/",Yes,Commercialised,No,No,Card,Near POC / POC,Antigen,Nasal swab,,,2021-06-09 11:12:22 CET,1749,Immuno-Antigen,Yes,,,Immunoassay,,,,,,,,,,,,,,,,,,,,,,,
1198,"COVID-19 Antigen Rapid Test",624,"Zhejiang Anji Saianfu Biotech Co., Ltd",China,"www.seinofy.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab; Other; Saliva,,,2021-05-10 13:04:00 CET,984,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,7200 AU/mL,,,,,,,,,,,91 %,,,90 %,98 %,,
1387,"COVID-19 Antigen Rapid Test",659,"CITEST DIAGNOSTICS INC",China,"www.citestdiagnostics.com",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1153,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,0 AU,,,,Not evaluated,,,,0.08 %,3.6 %,,98 %,,,96.4 %,,,
1596,"COVID-19 Antigen Rapid Test",705,"KitL&H Biotech Limited",China,"www.lhbiotech.com.cn/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,,,,2021-05-10 13:04:00 CET,1277,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,,,,,,,,,,,,,,,,,,,
1797,"COVID-19 Antigen Rapid Test",808,"PRIMA Lab",Switzerland,"primahometest.com/en/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab; Other,,,2021-05-10 13:04:00 CET,1476,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,100 IU/ml,,,,,,,,0,0,,98 %,,,96.4 %,,,
1688,"COVID-19 Antigen Rapid Test",890,"Acro Biotech Inc",United States,"www.acrobiotech.com",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab; Other,,,2021-05-10 13:18:20 CET,1367,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,0,,,,not evaluated,,,evaluated,1 AU,2.3 AU,evaluated,98.6 % ((Antigen)),evaluated,evaluated,97.7 % ((Antigen)),,,
2277,"COVID-19 Antigen Nasal Test Kit",1059,"Assure Tech. (Hangzhou) Co., Ltd.",China,"www.diareagent.com",Yes,Commercialised,No,No,Lateral flow,Manual; Near POC / POC,Antigen,Other,Adenovirus; Adenovirus 3; Adenovirus 7; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus OC43 (HCoV-OC43); Bordetella Pertussis; Chlamydia Pneumoniae; Enterovirus A71 (EV-A71); Epstein-Barr Virus (EBV); Human Metapneumovirus (HMPV); Influenza A H1N1; Influenza A H3N2; 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; SARS-CoV,,2021-06-21 10:25:15 CET,1978,Immuno-Antigen,Yes,,,Immunoassay,,,,,15,251 AU,,,,Not evaluated,,,Evaluated,0 % (None),"5.82 % ((A total of 103 SARS-CoV-2 positive samples were tested, 6 samples were negative by this RDT))",Evaluated,97.3 %,Evaluated,Evaluated,94.5 %,100 %,,Nucleoprotein
1187,"COVID-19 Antigen Detection Kit (Immunofluorescence Assay)",619,"Zhuhai Lituo Biotechnology Co., Ltd",China,"www.lituo.com.cn",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,971,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,Fluorescence,,,15,,,,,,,,,,,,,,,,,,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; Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Bordetella Pertussis; Chlamydia Pneumoniae; Coronaviruses (HCoV); Enterovirus A71 (EV-A71); Hemophilus Influenzae; Hepatitis B Virus (HBV); Human Metapneumovirus (HMPV); Influenza A; Influenza A H1N1; Influenza B Yamagata; MERS-CoV; 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; SARS-CoV,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
1501,"COVID-19 Antigen Detection Kit",690,"New Gene (Hangzhou) Bioengineering Co., Ltd",China,"www.new-gene.net/",Yes,Commercialised,Yes,Yes,Lateral flow,Near POC / POC,Antigen,Nasal swab,,,2021-07-07 17:23:34 CET,1251,Immuno-Antigen,Yes,,No,Chromatography,,,,,30,0.05 AU,,,,not evaluated,,,evaluated,2 %,0.9 %,evaluated,98.3 %,evaluated,evaluated,98 %,,,nucleocapside
2242,"COVID-19 Antigen Detection Kit",1042,"DNA Diagnostic",Denmark,"https://dna-diagnostic.com/",Yes,Commercialised,No,No,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);,2021-06-23 13:23:51 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
1258,"COVID-19 and Influenza A+B Antigen Combo Rapid Test with Reader",126,"Hangzhou AllTest Biotech Co., Ltd",Germany,"https://www.goldstandarddiagnostics.com/home/products/covid-19-antigen-rapid-test/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,,,,2021-05-10 13:04:00 CET,1034,Immuno-Antigen,Yes,,,Immunoassay,,,,,,,,,,,,,,,,,,,,,,,
1471,"COVID-19 and Influenza A+B Antigen Combo Rapid Test Cassette",659,"CITEST DIAGNOSTICS INC",China,"www.citestdiagnostics.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1220,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,0 AU,,,,Not evaluated,,,evaluated,0.08 % ((0.9% Influenza A); (0.9% Influenza B)),3.6 % ((5.0% Influenza A); (7.1% Influenza B)),evaluated,98 % ((98.4 Influenza A); (98.1 Influenza B)),evaluated,evaluated,96.4 % ((95.0 Influenza A); (92.9 Influenza B)),,,
1391,"COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)",657,"Ulti Med Products GmbH",Germany,"www.ultimed.org",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1157,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,100 AU,,,,,,,,0.82 %,3.61 %,,98 %,,,96.4 %,99.2 %,,
1256,"COVID-19 and Influenza A+B Antigen Combo Rapid Test",126,"Hangzhou AllTest Biotech Co., Ltd",Germany,"https://www.goldstandarddiagnostics.com/home/products/covid-19-antigen-rapid-test/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,,,,2021-06-08 15:56:19 CET,1032,Immuno-Antigen,Yes,,,Immunoassay,,,,,,,,,,,,,,,,,,,,,,,
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
1689,"Covid-19 Ag Test ",758,"Turklab",Turkey,"www.turklab.com.tr/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab; Other,,,2021-05-10 13:18:20 CET,1368,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,20,30 AU,,,,,,,,,,,,,,,,,
133,"COVID-19 Ag Respi-Strip",73,"Coris BioConcept",Belgium,"www.corisbio.com/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,92,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,30,5000 TCID50/ml 0.25 ng/mL,,,,Not Reported,,,"Cross-reactivity: no cross-reactivity for bacteria and virus tested including seasonal Coronaviruses (HKU1, 229E, OC43, NL63), positive for SARS-CoV",,,,97.9 %,,,91.2 %,99.4 %,,
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,,Colorimetry,,,,,,,,,,,,,,,,,,,,
2144,"COVID-19 Ag Rapid Test Device",992,"Jiangsu Well Biotech Co., Ltd.",China,"",Yes,Commercialised,No,No,Strip,Near POC / POC,Antigen,Nasal swab,Alpha Coronavirus 229E (HCoV-229E); Alpha Coronavirus Nl63 (HCoV-Nl63); Beta Coronavirus HKU1 (HCoV-HKU1); Beta Coronavirus OC43 (HCoV-OC43); Coronaviruses (HCoV); Human Metapneumovirus (HMPV); Parainfluenza Virus Type 1; Parainfluenza Virus Type 2; Parainfluenza Virus Type 3; Parainfluenza Virus Type 4,B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-06-02 18:18:10 CET,1834,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Sandwich, Double,,,15,1 AU,,,,Evaluated,,,Evaluated,5.26 %,1 %,Evaluated,97.9 %,Evaluated,Evaluated,94.74 %,99 %,,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
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
1589,"COVID-19 (Sars-CoV-2) Antigen Test Kit (Colloidal Gold)",24,"Anhui Deep Blue Medical Technology Co., Ltd",China,"www.dbluemedical.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-10 13:18:20 CET,1269,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,20,320 AU,,,,evaluated,,,evaluated,0,3.6,evaluated,99.03 %,evaluated,evaluated,96.4 %,,,nucleoprotein
1372,"COVID-19 & M. pneumoniae Antigen Combo Test Device",455,"Assure Tech. (Hangzhou) Co., Ltd",China,"www.diareagent.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Other,,,2021-05-10 13:04:00 CET,1146,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,0 AU,,,,,,,,,,,87.8 % ((COVID-19:87.8%; M. pneumoniae:96.6%)),,,"75.8 % ((COVID-19:75.8%, M. pneumoniae:91.4%))",,,
1371,"COVID-19 & Influenza A/B Antigen Combo Test Device",455,"Assure Tech. (Hangzhou) Co., Ltd",China,"www.diareagent.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Other,,,2021-05-10 13:04:00 CET,1144,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,,,,,,,,,Not available,Not available,,"98.5 % ((COVID-19:98.5%, Influenza A:88.4%, Influenza B:88.9%))",,,"97.3 % ((COVID-19:97.3%, Influenza A:83.3%, Influenza B:82.4%))",,,
1354,"COVID-19 & Influenza A+B Antigen Combo Test Kit (Colloidal Gold)",851,"Nantong Diagnos Biotechnology Co., Ltd",China,"www.diagnosbio.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab; Throat swab,,,2021-05-10 13:18:20 CET,1128,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,0.05 %,,,,,,,,,,,96 %,,,92.59 %,,,nucleoprotein
1313,"CovBELD",647,"EMBIO Diagnostics LTD",Cyprus,"www.embiodiagnostics.eu",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-10 13:04:00 CET,1083,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,,,,3,4000 U/ml,,,,Evaluated,,,Not Evaluated,2.2 % (3 on 136),7.27 % (8 of 110),Evaluated,95.52 %,Evaluated,Evaluated,92.73 %,,,nucleoprotein
1196,"CoV-Check DIRECT Covid-19 Antigen Test",623,"Spark Diagnostics LLC",India,"www.sparkdiagnostics.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,981,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,380 AU,,,,,,,,0.9 %,8.6 %,,95.7 %,,,93.1 %,,,
1343,"Coronavirus Ag Rapid Test Cassette (Swab)",760,"Zhezhiang Orient Gene Biotech Co., Ltd",China,"www.orientgene.com/",Yes,Commercialised,Yes,Yes,Cassette; Lateral flow,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-05-10 13:18:20 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
1831,"Coronavirus Ag Rapid Test Cassette (Swab)",836,"Van Oostveen Medical B.V.",Netherlands,"www.romed.nl/en",Yes,Commercialised,No,No,Cassette,Manual; Near POC / POC,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1509,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,15,115 AU,,,,Not evaluated,,,Evaluated,0.34 % (3 false positives / 874 true negative (sum of nasopharyngeal and nasal swab samples)),2.19 % (5 false negatives / 228 true positive (sum of nasopharyngeal and nasal swab samples)),Evaluated,"99.42 % (99.42 (antigen-nasopharyngeal), 98.73 (antigen-nasal))",Evaluated,Evaluated,"98.32 % (98.32 (antigen-nasopharyngeal), 97.25 (antigen-nasal))","99.6 % (99.60 (antigen-nasopharyngeal), 100 (antigen-nasal))",,Nucleoprotein
2154,"Coronavirus Ag Rapid Test Cassette (Swab)",999,"Shandong ThinkLab Biotechnology Co.,Ltd.",China,"",Yes,Commercialised,No,No,Card; Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,Adenovirus 3; Adenovirus 7; Adenovirus Subtype C; Coronaviruses (HCoV); Influenza A H1N1; Influenza B; MERS-CoV; Mumps Virus (MuV); Mycoplasma Pneumoniae; 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; Rhinovirus A; Rhinovirus B; SARS-CoV; Varicella Zoster Virus (VZV),B.1.1.7 (United Kingdom);B.1.351 (South Africa);P.1 (Japan/Brazil);,2021-06-01 13:11:23 CET,1855,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,,,15,0 AU,,,,Evaluated,,,Evaluated,5.8 %,1.7 %,Evaluated,96.2 %,Evaluated,Evaluated,94.2 %,98.3 %,,Nucleoprotein
1767,"Coronavirus Ag Rapid Test Cassette",554,"Healgen Scientific",United States,"www.healgen.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:18:20 CET,1446,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,,,,,,,,,,,,,,,"80.6 % (C.I. 95, range: 72.7-86.6)","99.7 % (C.I. 95, range: 98.9-99.9)",,
76,"Coronavirus (SARS-Cov-2) N protein Detection Kit (Fluorescence immunochromatography)",414,"Beijing Savant Biotechnology Co., Ltd",China,"www.huaketai.com/",Yes,Commercialised,No,No,Cassette,Automated; Manual,Antigen,Throat swab,,,2021-05-10 13:04:00 CET,569,Immuno-Antigen,Yes,,Yes,Immunochromatography,Qualitative,Fluorescence,,,15,50 ng/mL,,,,,,,Evaluated,,,,,,,,,,
1935,"Coronavirus (SARS-CoV 2) Antigen - Swab Specimen",885,"Tody Laboratories Int.",Romania,"www.todylaboratories.com/",Yes,Commercialised,No,No,Cassette,Manual,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1611,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,,N.A.,15,100 AU,,,,Evaluated,,,Evaluated,"1 % (From studies performed by manufacturer, the false positive rate is 1.0% (specificity = 99.0%))","3.6 % (From studies performed by manufacturer, the false negative rate is 3.6% (sensitivity = 96.4%))",Evaluated,98.2 %,Evaluated,Evaluated,96.4 %,99 %,,Nucleocapsid (N) protein
1934,"Coronavirus (SARS-CoV 2) Antigen - Oral Fluid",885,"Tody Laboratories Int.",Romania,"www.todylaboratories.com/",Yes,Commercialised,No,No,Cassette,Manual,Antigen,Deep (cough) sputum; Saliva; Sputum,,,2021-07-13 18:06:56 CET,1610,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,,,15,100 AU,,,,Evaluated,,,Evaluated,"From studies performed by manufacturer, the false positive rate is 0.7% (specificity = 99.3%)","From studies performed by manufacturer, the false negative rate is 9.9% (sensitivity = 90.1%)",Evaluated,97 %,Evaluated,Evaluated,90.1 %,99.3 %,,Nucleoprotein
1662,"CORONA-Ag",529,"DyonMed SA",Greece,"dyonmedical.com/en/home/",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab; Other; Saliva,,,2021-05-10 13:04:00 CET,1341,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,0 AU,,,,evaluated,,,evaluated,"0 % (Compared to PCR (n=60) no FP in each of saliva, and sputum.sputum, samples)",8.3 % (Compared to PCR (n=60) 5 false negatives in saliva and 3 in sputum),evaluated,97 % (Antigen),evaluated,evaluated,95 % (Antigen),,,nucleoprotein
1810,"CORMAY RAPID SARS-CoV-2 ANTIGEN TEST KIT",579,"CORMAY",Poland,"cormay.pl/index.php?lang=_en",Yes,Commercialised,No,No,Cassette,Manual,Antigen,Nasopharyngeal swab; Oropharyngeal swab,,,2021-05-10 13:04:00 CET,1489,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Capture,,,15,1.25 AU,,,,Evaluated,,,Evaluated,-,-,Evaluated,96 %,Not evaluated,Evaluated,95 %,98 %,,
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
1781,"CORA-CHECK-19-comfort",777,"fameditec GmbH",Germany,"https://www.fameditec.de/",Yes,Commercialised,No,No,Cassette,Manual; Near POC / POC,Antigen,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.1.526.2 (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);,2021-06-11 17:42:20 CET,1460,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Membrane-based,Colorimetry,Other,15,250 AU,,,,Evaluated,,,Evaluated,0.95 % ( (further results can be provided upon request)),3.3 % ( (further results can be provided upon request)),Evaluated,97.76 %,Evaluated,Evaluated,96.3 %,99.13 %,,Nucleoprotein
1744,"CORA CHECK-19",777,"fameditec GmbH",Germany,"https://www.fameditec.de/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1422,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,15,1.25 U/ml,,,,Evaluated,,,,209 AU,450 AU,Evaluated,98.79 %,Evaluated,Evaluated,96.17 %,,,
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"
1691,"CHIL COVID-19 Antigen Rapid Test (Nasopharyngeal / Oropharyngeal Swab-Casette)",589,"CHIL Medical Supplies Ltd",Turkey,"https://www.chil.com.tr/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,SARS-CoV,,2021-07-12 16:36:06 CET,1370,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,Sandwich,,Other,15,30 %,,,,evaluated,,,evaluated,0.49 % (2 False Positives out of 405),0.85 % (4 False Negatives out of 466),evaluated,99.54 %,evaluated,evaluated,99.01 %,99.57 %,,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 %,,
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 %,,
1988,"Biozek covid-19 Antigen Rapidtest BCOV-502",910,"Inzek International trading",Netherlands,"www.inzek.nl/",Yes,Commercialised,No,No,Cassette; Lateral flow,Manual,Antigen,Nasal swab; Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1664,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,10,100 AU,,,,Not evaluated,,,Evaluated,0.34 ((2 / 589)),5 % ((5 / 100)),Evaluated,98.98 %,Not evaluated,Evaluated,95 %,99.66 %,,nucleocapsid protein 
2013,"biotical SARS-CoV-2 Ag Card",925,"Biotical Health S.L.U.",Spain,"https://biotical.es/es/",Yes,Commercialised,No,No,Card; Lateral flow,Manual; Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-18 17:53:36 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
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
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 
2379,"BioSpeedia COVID19 Non-Invasive Antigen Test_BSD-504",1024,"BioSpeedia International",Switzerland,"www.biospeedia.com",Yes,Commercialised,No,No,Cassette,Manual; Near POC / POC,Antigen,Nasal 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.1.616 (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);,2021-07-09 09:37:58 CET,2081,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,,Sample collection device,15,4510.6851 AU,,,,Not evaluated,,,Evaluated,5.26 %,0.5 %,Evaluated,98.3 %,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
689,"Bioeasy 2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test",393,"Shenzhen Bioeasy Biotechnology Co., Ltd",China,"en.bioeasy.com.tr/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Whole blood,,,2021-05-10 13:04:00 CET,541,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,10,,,,,,,,,,,,,,,,,,
365,"Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence)",393,"Shenzhen Bioeasy Biotechnology Co., Ltd",China,"en.bioeasy.com.tr/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Deep (cough) sputum; Nasal swab; Saliva,,,2021-05-10 13:04:00 CET,681,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,Fluorescence,,Sample preparation,10,,,,,,,,,,,,,,,,,,
1606,"BIOCREDIT COVID-19 Ag - SARS-CoV 2 Antigen test",220,"RapiGEN Inc",South Korea,"rapigen-inc.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-07-13 17:19:06 CET,1287,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,10,,,,,,,,,,,,,,,90.2 %,100 %,,
335,"BIOCREDIT COVID-19 Ag",480,"BioVendor",Czechia,"www.biovendor.com/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,665,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,8,,,,,,,,,,,,,,,90.2 %,100 %,,
1687,"biocomma®COVID-19 Antigen Test Kit",757,"Biocomma limited",China,"www.biocomma.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1366,Immuno-Antigen,Yes,,Yes,Chromatography,Qualitative,,,,15,312.5 AU,,,,Evaluated,,,Evaluated,0.55 %,17.9 %,Evaluated,97.13 %,Evaluated,Evaluated,82.14 %,,,nucleoprotein
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)
1761,"Asan Easy Test Flu/COVID-19 Ag Combo",741,"Asan Pharmaceutical CO., LTD",South Korea,"www.asanpharm.com",Yes,Commercialised,No,No,Cassette,Manual,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1440,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,15,1230 U/ml,,,,Not evaluated,,,Evaluated,,,,,Evaluated,Not evaluated,94.7 %,97.4 %,,
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,,,,,,,,,,,,,,,,,,,,,,,
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)
1594,"Antigen Rapid Test COVID-19 Coretests",420,"Core Technology Co., Ltd",China,"www.coretests.com",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1274,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,,,,,,,
1608,"ANTIGEN RAPID TEST CASSETTE SARS-COV-2 (SWAB)",713,"A. Menarini Diagnostics",Italy,"www.menarinidiagnostics.com",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1288,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,,,,98.74 % (95%CI: 96.80%-99.66%),,,96.72 % (95%CI: 88.65%-99.60%),99.22 % (95%CI: 97.21%-99.91%),,nucleocapside protein
1592,"Antigen Rapid Test Ag SARS-CoV-2",703,"Lifotronic Technology Co, Ltd",China,"en.lifotronic.com/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,,,,2021-05-10 13:04:00 CET,1272,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,,,10,,,,,,,,,,,,,,,91 %,98 %,,
1843,"AndLucky SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non-invasive)",624,"Zhejiang Anji Saianfu Biotech Co., Ltd",China,"www.seinofy.com",Yes,Commercialised,No,No,,Manual,Antigen,Oropharyngeal swab; Sputum; Throat secretion; Throat swab,,,2021-05-10 13:18:20 CET,1520,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,10,6 AU,,,,Evaluated,,,Evaluated,"6.5 % (93,5)","0.6 % (99,40)",Evaluated,97 %,Evaluated,Evaluated,93 %,99 %,,Nucleoprotein
1296,"AndLucky COVID-19 Antigen Rapid Test",624,"Zhejiang Anji Saianfu Biotech Co., Ltd",China,"www.seinofy.com",Yes,Commercialised,Yes,Yes,Cassette,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-07-07 17:26:23 CET,1102,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,Colorimetry,,15,5.75 AU,,,,,,,,95.8 AU,99 AU,,97.9 % (Antigen),,,95.8 % (Antigen),,,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)
1647,"AllCheck COVID19 Ag",738,"CALTH Inc.",South Korea,"www.thecalth.com",Yes,Commercialised,No,No,Cartridge,Near POC / POC,Antigen,Nasopharyngeal swab,,,2021-05-10 13:04:00 CET,1328,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,10,250 TCID50/ml,40 AU,60 AU,,,97.5 %,100 %,,,,,,,,97.12 %,93.98 %,single cartridges,
1989,"AFIAS COVID-19 Ag",22,"Boditech Med Inc",South Korea,"https://www.boditech.co.kr/en",Yes,Commercialised,No,No,Cassette; Lateral flow,Near POC / POC; Semi-automated,Antigen,Nasopharyngeal swab,SARS-CoV,,2021-06-21 10:28:57 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
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,Nasopharyngeal swab; Oropharyngeal swab,,,2021-07-13 17:50:37 CET,1024,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,35 ng/mL,,,,,,,,,,,,,,94.7 %,100 %,,
1981,"Absoludy COVID-19 Ag Rapid",909,"Absology Co., Ltd.",South Korea,"www.absology.co.kr",Yes,Commercialised,No,No,Card; Lateral flow,Manual; Near POC / POC,Antigen,Nasopharyngeal swab; Oropharyngeal swab,SARS-CoV,,2021-07-16 09:57:22 CET,1657,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,Membrane-based,,,15,125 AU,,,,Evaluated,,,Evaluated,0 %,12 % ((12/100)),Evaluated,95.8 %,Evaluated,Evaluated,88 % ((100/100)),100 % ((184/184)),,Nucleoprotein
1809,"2019-nCoV/IAV/IBV Antigen Test Kit (colloidal gold method)",779,"Guangdong Hecin Scientific, Inc.",China,"www.hecin-scientific.cn/",Yes,Commercialised,No,No,Cassette,Near POC / POC,Antigen,,,,2021-05-10 13:04:00 CET,1487,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,Colorimetry,,15,1 AU,,,,Evaluated,,,Evaluated,2 AU,2 AU,Evaluated,98.51 %,Evaluated,Evaluated,96.23 %,99.07 %,,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
1674,"2019-nCoV Antigen Test Kit",750,"Chongqing M&D Biotechnology Co. Ltd.",China,"www.MDfastcheck.com",Yes,Commercialised,No,No,Cassette,Lab-based,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1353,Immuno-Antigen,Yes,,Yes,Immunoassay,Qualitative,,Colorimetry,,15,0.05 AU,,,,Evaluated,,,Evaluated,,,Evaluated,99.26 %,Evaluated,Evaluated,95.83 %,,,Nucleoprotein
1790,"2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)",319,"Beijing Lepu Medical Technology Co., Ltd",China,"en.lepumedical.com/",Yes,Commercialised,No,No,Card,Other,Antigen,Nasal swab; Other,,,2021-05-10 13:04:00 CET,1469,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,Colorimetry,,15,200 IU/ml,,,,Not evaluated,,,Evaluated,0.38 %,4.94 %,Evaluated (Evaluated),97.44 %,Evaluated,Not Evaluated,95.06 %,,,Nucleoprotein
1283,"2019-nCoV Antigen Rapid Test Kit (colloidal gold assay)",38,"Beijing Diagreat Biotechnologies Co., Ltd",China,"www.diagreat.com/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab,,,2021-05-10 13:04:00 CET,1093,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,Colorimetry,,15,,,,,,,,,,,,,,,,,,N protein
1273,"2019-nCoV Antigen Rapid Test (Colloidal Gold)",262,"Sure Bio-Tech (USA) Co., Ltd",United States,"www.surebiotech.com/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab; Throat swab,,,2021-05-10 13:04:00 CET,1047,Immuno-Antigen,Yes,,,Immunoassay,Qualitative,,Colorimetry,,15,,,,,,,,,,,,,,,92.5 %,99.16 %,,
1203,"2019-nCoV Antigen Device",561,"AMS UK (NI) Ltd",United Kingdom,"https://www.amslabs.co.uk/",Yes,Commercialised,No,No,,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-10 13:04:00 CET,989,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,,,,,,,,,0.9 %,9.1 %,,97.5 %,,,90.9 %,,,
1202,"2019-nCoV Antigen Device",575,"Prestige Diagnostics",United Kingdom,"www.prestigediagnostics.co.uk",Yes,Commercialised,No,No,Lateral flow,Near POC / POC,Antigen,Nasal swab; Saliva,,,2021-05-10 13:04:00 CET,988,Immuno-Antigen,Yes,,No,Immunoassay,Qualitative,,,,15,,,,,,,,,0.9 %,9.1 %,,97.5 %,,,90.9 %,,,
1748,"2019-nCoV Ag Rapid Test Kit - REF: CY-F006-AG25",780,"Huachenyang (Shenzhen) Technology Co., Ltd.",China,"www.chenyanglobal.com",Yes,Commercialised,No,No,Cassette,Other,Antigen,Nasal swab; Nasopharyngeal swab; Saliva,,,2021-05-10 13:04:00 CET,1426,Immuno-Antigen,Yes,,No,Immunochromatography,Qualitative,,,,15,50 U/ml,,,,,,,Evaluated,6.6 % (4 false positives out of 61 tests),0.22 % (1 false negatives out of 449 tests),Evaluated,99.02 %,Evaluated,Not Evaluated,96.67 %,,,Nucleoprotein