Rapid antigen tests for the diagnosis of a SARS-CoV-2 infection

Welcome! On this webpage we try to summarize the results of manufacturer independent evaluations of antigen detecting rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2.

Background

Since the beginning of the COVID-19 pandemic, numerous Ag-RDTs have appeared on the market. On their homepage, the Federal Institute for Drugs and Medical Devices (BfArM) provides a list of Ag-RDTs that fulfill certain minimum requirements. These requirements were jointly determined by the Paul-Ehrlich-Institute (PEI) and Robert-Koch-Institute (RKI) to include a sensitivity of >70% and a specificity >97% (Paul-Ehrlich-Institute, 2021).

Manufacturer independent evaluations are important to provide an objective assessment of a test’s accuracy. Thus far only evaluations by the tests’ manufacturers themselves are summarized. Therefore, on this webpage we try to give an overview on the data published by manufacturer independent researchers. Using the linked calculator, it is also possible to convert the shown sensitivity and specificity into the concrete amount of true and false test results.

We are aware that some of the studies presented below differ widely in their methods. Thus, we advise especially for Ag-RDTs that have only been evaluated by a small amount of studies to judge their sensitivity not only based on clinical accuracy below, but also to take their limit of detection as found in analytical studies into consideration.

Author Study location QUADAS Independent Sample condition Sample type Sample size Sensitivity (95% CI) Specificity (95% CI)
AAZ, COVID-VIRO®
Schwob, J.M., et al. Switzerland low concern yes fresh NP 248 96.7% (95% CI 91.8*-99.1*) 100% (95% CI 97.1*-100*)
                 
Abbott, BinaxNOW™
Pollock, N.R., et al. USA low concern yes fresh AN 2308 78.1% (95% CI 77.4-72.2) 99.4% (95% CI 99.0-99.7)
Pilarowski, G., et al. USA low concern no fresh AN 878 57.7% (95% CI 36.9*-76.7*) 100%* (95% CI 99.6*-100*)
James, A. E., et al. USA low concern yes fresh AN 2339 56.5% (95% CI 48.7-64.5) 99.9% (95% CI 99.7-100)
Prince-Guerra, J.L., et al. USA low concern yes stored AN 3419 52.5% (95% CI 46.7-58.3) 99.9% (95% CI 99.7-100)
                 
Abbott, Panbio™ (NP sampling)
Alemany, A., et al. Spain intermediate concern yes banked NP 919 93.4% (95% CI 91.5-95.0) 100% (95% CI 95.8-100)
FINDdx Germany low concern yes fresh NP 281 90.9% (95% CI 78.8-96.4) 99.2% (95% CI 97.0-99.8)
Merino-Amador, P., et al. Spain low concern no fresh NP 958 90.5% (95% CI 87.5-93.6) 98.8% (95% CI 98.0-99.7)
Krüger, L.J., et al. Germany low concern yes fresh NP 1034 87.5% (95% CI 79.8-92.5) 99.9% (95% CI 99.4-100)
Schwob, J.M., et al. Switzerland low concern yes fresh NP 271 86.1% (95% CI 78.6-91.7) 100% (95% CI 97.6*-100*)
Berger, A., et al. Switzerland low concern yes fresh NP 535 85.5% (95% CI 78.0-91.2) 100% (95% CI 99.1-100)
Abdulrahman, A., et al. Bahrain intermediate concern yes fresh AN 4183 82.1% (95% CI 79.2-84.8) 99.1% (95% CI 98.8-99.4)
Gremmels, H., et al. Netherlands intermediate concern yes fresh NP 208 81.0% (95% CI 69.0-89.9) 100% (95% CI 97.5-100)
Ngo Nsoga, M.T., et al. Switzerland intermediate concern yes fresh OP 402 81.0% (95% CI 74.2-86.6) 99.1% (95% CI 96.9-99.9)
Albert, E., et al. Spain low concern no fresh NP 412 79.6% (95% CI 67.0-88.8) 100% (95% CI 98.7-100)
Alemany, A., et al. Spain intermediate concern yes banked MT 487 79.5% (95% CI 71.0-86.4) 98.7% (95% CI 96.9-99.6)
Fenollar, F., et al. France low concern yes fresh NP 341 75.5% (95% CI 69.5-81.5) 94.9% (95% CI 91.2-98.6)
Linares, M., et al. Spain unclear yes fresh NP 255 73.3% (95% CI 62.2-83.8) 100% (95% CI 98.1*-100*)
Gremmels, H., et al. Netherlands intermediate concern yes fresh NP 1367 72.6% (95% CI 64.5-79.9) 100% (95% CI 99.7-100)
Halfon, P. et al. France intermediate concern yes unclear NP 200 72.0% (95% CI 62.0-81.0) 99.0% (95% CI 95.0-100)
Bulilete, O., et al. Spain low concern yes fresh NP 1362* 71.4% (95% CI 63.2*-78.7) 99.8% (95% CI 99.4-99.9)
Akingba, O.L., et al. Southafrica unclear yes fresh NP 677 69.2% (95% CI 61.4-75.8) 99.0% (95% CI 98.8-99.2)
Favresse, J., et al. Belgium intermediate concern yes fresh NP 188 67.7% (95% CI 57.4-76.9) 100% (95% CI 96.1-100)
Drevinek, P., et al. Czech Republic low concern yes fresh NP 591 66.4% (95% CI 59.9-72.2) 100% (95% CI 99.0-100)
Agullo, V., et al. Spain low concern yes fresh NP 652* 57.3% (95% CI 48.3-65.8) 99.8% (95% CI 98.8-100)
Schildgen, V., et al. Germany high concern yes unclear BAL/TW 73 50.0% (95% CI 34.2*-65.8*) 77.4% (95% CI 58.9*-90.4*)
Krüger, L.J., et al. Germany high concern yes fresh OP 74 50.0% (95% CI 1.3-98.7) 100% (95% CI 94.9-100)
Torres, I., et al. Spain  low concern no fresh NP 634 48.1% (95% CI 37.4-58.9) 100% (95% CI 99.3-100)
Agullo, V., et al. Spain intermediate concern yes fresh AN 659 44.7% (95% CI 36.1-53.6) 100% (95% CI 99.1-100)
Olearo, F., et al. Germany intermediate concern yes unclear OP 184 44.6% (95% CI 34.3-55.3) 100% (95% CI 96.3-100)
Caruana, G., et al. Switzerland intermediate concern yes fresh NP 532 41.2% (not provided) 995% (not provided)
Baro, B., et al. Spain intermediate concern yes banked NP 286 38.6% (95% CI 29.1-48.8) 99.5% (95% CI 97-100)
Agullo, V., et al. Spain intermediate concern yes fresh saliva 610 23.1% (95% CI 16.2-31.9) 100% (95% CI 99.0-100)
                 
Abbott, Panbio™ (nasal sampling)
FINDdx Germany low concern yes fresh AN/MT 281 86.4% (95% CI 73.3-93.9) 99.2% (95% CI 97-99.8)
                 
Becton, Dickinson and Company, BD Veritor™
Pekosz, A., et al. USA high concern no fresh NP 251 96.4% (95% CI 82.3-99.4) 98.7% (95% CI 96.1-99.7)
Van der Moeren, N., et al. Netherlands intermediate concern yes banked NP/OP 351* 94.1% (95% CI 71.1-100) 100% (95% CI 98.9-100)
Young, S., et al. USA intermediate concern no banked NP 251 76.3%* (95% CI 60.8*-87.0*) 99.5%* (95% CI 97.4*-99.9*)
Caruana, G., et al. Switzerland intermediate concern yes fresh NP 532 41.2% (not provided) 99.7% (not provided)
                 
Beijing Savant Biotechnology, SARS-CoV-2 detection kit
Weitzel, T., et al. Chile high concern no banked NP/OP 109 16.7% (95% CI 10.0-26.5*) 100% (95% CI 89.0-100)
                 
Bionote, NowCheck®
FINDdx Brazil low concern yes fresh NP 400 89.2% (95% CI 81.7-93.9) 97.3% (95% CI 94.8-98.6)
                 
Biotical Health, SARS-CoV-2 Ag Card
Favresse, J., et al. Belgium intermediate concern yes fresh NP 188 66.7% (95% CI 56.3-76.0) 98.8% (95% CI 94.1-99.9)
                 
Coris BioConcept, COVID-19 Ag Respi-Strip
Mertens, P., et al. Belgium intermediate concern no banked NP 328 57.6% (95% CI 48.7*-66.1*) 99.5% (95% CI 97.2*-100*)
Lambert-Niclot, S., et al. France unclear yes fresh NP 138 50.0% (95% CI 39.5-60.5) 100% (95% CI 91.8-100)
Krüger, L.J., et al. Germany/England intermediate concern yes unclear NP/OP 417 50.0% (95% CI 21.5-78.5) 95.8% (95% CI 93.4-97.4)
Ciotti, M., et al. Italy unclear yes fresh NP 50 30.8% (95% CI 17.0-47.6) 100% (95% CI 71.5-100)
Scohy, A., et al. Belgium intermediate concern no fresh NP 148 30.2% (95% CI 21.7-39.9) 100% (95% CI 91.6*-100*)
Veyrenche, N., et al. France high concern yes fresh NP 65 29.0% (95% CI 15.7-42.3) 100% (95% CI 83.2*-100*)
                 
Denka, Quick Navi
Takeuchi, Y., et al. Japan low concern no fresh NP 1186 86.7% (95% CI 78.6-92.5) 100% (95% CI 99.7-100)
                 
EcoDiagnostica, COVID-19 Ag
Filgueiras, P.S., et al. Brazil unclear no fresh NP 150 69.0% (95% CI 55.0-81.0) 98.0% (95% CI 94.0-100)
                 
Fujirebio, ESPLINE® SARS-CoV-2
Takeda, Y., et al. Japan high concern no unclear NP 162 80.7%* (95% CI 68.6*-89.6*) 100%* (95% CI 96.4*-100*)
Yokota, I., et al. Japan high concern no banked NP 17 58.8%* (95% CI 32.9*-81.6*) not provided
Yokota, I., et al. Japan high concern no banked saliva 17 23.5%* (95% CI 6.8*-49.9*) not provided
                 
Fujirebio, Lumipulse® G SARS-CoV-2 Ag
Yokota, I., et al. Japan high concern no banked NP 17 100% (95% CI 80.5*-100) not provided
Yokota, I., et al. Japan high concern no banked saliva 17 82.4%* (95% CI 56.6*-96.2*) not provided
Basso, D., et al. Italy low concern yes fresh NP 234 81.6% (95% CI 71.0-89.5) 93.8% (95% CI 86.2-98.0)
Menchinelli, G., et al. Italy intermediate concern yes banked NP 594 79.9% (95% CI 73.6-85.3) 99.3% (95% CI 97.8-99.8)
Basso, D., et al. Italy low concern yes fresh saliva 223 41.3% (95% CI 30.4-52.8) 98.6% (95% CI 95.0-99.8)
                 
Guangzhou Wondfo Biotech, 2019-nCoV Antigen Test
FINDdx Switzerland low concern yes fresh NP 328 85.7% (95% CI 74.3-92.6) 100% (95% CI 98.6-100)
                 
Healgen, Rapid COVID-19 Ag Test
Favresse, J., et al. Belgium intermediate concern yes fresh NP 188 77.1% (95% CI 67.4-85.1) 96.7% (95% CI 90.8-99.3)
                 
ichroma, COVID-19 AG
FINDdx Switzerland low concern yes fresh NP 232 73.2% (95% CI 58.1-84.3) 100% (95% CI 98.0-100)
                 
Innova Medical Group, INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test
Houston, H., et al. United Kingdom low concern yes fresh NP 242 86.4% (CI 95% 81.1-90.0) 95.1% (CI 95% 92.6-96.7)
Peto, T., et al. United Kingdom unclear yes unclear unclear 6954 not provided 99.7% (not provided)
Peto, T., et al. United Kingdom unclear yes unclear unclear 198 78.8% (95% CI 72.4-84.3) not provided
Peto, T., et al. United Kingdom unclear yes unclear unclear 223 70.0% (95% CI 63.5-75.9) not provided
Peto, T., et al. United Kingdom unclear yes unclear unclear 372 57.5% (95% CI 52.3-62.6) not provided
                 
JOYSBIO Biotechnology, COVID-19 Antigen Rapid Test Kit
FINDdx Switzerland low concern yes fresh NP 265 70.5% (95% CI 55.8-81.8) 99.1% (95% CI 96.8-99.8)
                 
Lepu Medical, SARS-CoV-2 Antigen Rapid Test Kit
Baro, B., et al. Spain intermediate concern yes banked NP 286 45.5% (95% CI 35.6-55.8) 89.2% (95% CI 83.8-93.3)
                 
Liming Bio, SARS-CoV-2 Ag-RDT
Weitzel, T., et al. Chile high concern no banked NP/OP 19 0.0% (95% CI 0.0-29.9) 90.0% (95% CI 59.6-98.2)
                 
LumiraDx, COVID-19 SARS-CoV-2 Antigen Test
Kohmer, N., et al. Germany intermediate concern yes fresh NP 100 50.0% (95% CI 38.1-61.9) 100% (95% CI 86.8-100)
                 
MEDsan®, SARS-CoV-2 Antigen Rapid Test
Olearo, F., et al. Germany intermediate concern yes unclear OP 184 45.8% (35.5%-56.5%) 97.0% (91.5%-98.9%)
                 
NAL von minden, NADAL
Strömer, A., et al. Germany high concern yes banked NP 124 73.1% (not provided) not provided
Kohmer, N., et al. Germany intermediate concern yes fresh NP 100 24.3% (95% CI 15.1-35.7) 100% (95% CI 86.8-100)
                 
Ortho Clinical Diagnostics, VITROS® SARS-CoV-2 Antigen Test
Favresse, J., et al. Belgium intermediate concern yes fresh NP 188 83.3% (95% CI 74.4-90.2) 100% (95% CI 96.1-100)
                 
Precision Biosensors, Exdia COVID-19 Ag
Caruana, G., et al. Switzerland intermediate concern yes fresh NP 532 48.3% (not provided) 99.5% (not provided)
                 
QUIDEL, Sofia SARS Antigen FIA
Porte, L., et al. Chile high concern no banked NP/OP 64 93.8% (95% CI 79.9-98.3) 96.9% (95% CI 84.3-99.4)
Beck, E.T., et al. USA intermediate concern yes fresh NP 346 77.0% (95% CI 64.5*-86.9*) 99.6% (95% CI 98.1*-100*)
Herrera, V., et al. USA unclear yes unclear unclear 1172 76.8% (95% CI 72.6-80.5) 99.2% (95% CI 98.2-99.7)
                 
RapiGEN, Biocredit Covid-19 Antigen Detection Kit
Shrestha, B., et al. Nepal intermediate concern yes fresh NP 113 85.0% (95% CI 71.7*-93.8*) 100% (95% CI 94.6*-100*)
FINDdx Brazil low concern yes fresh NP 476 74.4% (95% CI 65.8-81.4) 99.0% (95% CI 97.2-99.6)
Weitzel, T., et al. Chile high concern no banked NOP 109 62.0% (95% CI 51.0-71.9) 100% (95% CI 88.7-100)
Schildgen, V., et al. Germany high concern yes unclear BAL/TW 73 33.3% (95% CI 19.6*-49.6*) 87.1% (95% CI 70.2*-94.6*)
                 
R-Biopharm, RIDA®QUICK SARS-CoV-2 Antigen
Toptan, T., et al. Germany intermediate concern no banked unclear 67 77.6% (95% CI 64.7*-87.5*) 100% (95% CI 66.4*-100*)
Toptan, T., et al. Germany unclear no banked NP/OP 70 50.0% (95% CI 31.9*-68.1*) 100% (95% CI 90.8*-100*)
Kohmer, N., et al. Germany intermediate concern yes fresh NP 100 39.2% (95% CI 28.0-51.2) 96.2% (95% CI 80.4-99.9)
                 
Salofa, Salocor SARS-CoV-2 Antigen
Ahava, M.J., et al. Finland high concern yes frozen serum 148 96.2% (95% CI 80.4-99.9) 98.0% (95% CI 94.2-99.6)
                 
SD Biosensor, Standard F
Porte, L., et al. Chile high concern no banked NP/OP 64 90.6% (95% CI 75.8-96.8) 96.9% (95% CI 84.3-99.4)
FINDdx Brazil low concern yes fresh NP 453 77.5% (95% CI 69.2-84.1) 97.9% (95% CI 95.7-99.0)
Drevinek, P., et al. Czech Republic low concern yes fresh NP 591 62.3% (95% CI 55.8-68.4) 99.5% (95% CI 98.0-99.9)
Osterman, A., et al. Germany high concern yes unclear NP/OP 360 60.9% (95% CI 53.7-67.5) 97.8% (95% CI 95.7-98.9)
Liotti, F.M., et al. Italy intermediate concern yes banked NP 359 47.1% (95% CI 37.1-57.1) 98.4% (95% CI 96.0-99.6)
                 
SD Biosensor / Roche, Standard Q (NP sampling)
Chaimayo, C., et al. Thailand intermediate concern yes banked NP/OP 454 98.3% (95% CI 91.1-100) 98.7% (95% CI 97.1-99.6)
Schwob, J.M., et al. Switzerland low concern yes fresh NP 333 92.9% (95% CI 86.4-96.9) 100% (95% CI 98.3*-100*)
Nikolai, O., et al. Germany low concern yes fresh NP 96 91.2% (95% CI 77.0-97.0) 100% (95% CI 94.2-100)
Berger, A., et al. Switzerland low concern yes fresh NP 529 89.0% (95% CI 83.7-93.1) 99.7% (95% CI 98.4-100)
FINDdx Brazil low concern yes fresh NP 400 88.7% (95% CI 81.3-93.4) 97.6% (95% CI 95.2-98.8)
Schildgen, V., et al. Germany high concern yes unclear BAL/TW 73 88.1% (95% CI 74.4*-96.0*) 19.4% (95% CI 7.5*-37.5*)
Lindner, A.K., et al. Germany low concern yes fresh NP 139 85.0% (955 CI 70.9-92.9) 99.1% (95% CI 94.8-99.5)
Iglὁi, Z., et al. Netherlands low concern yes fresh NP 970 84.9% (95% CI 79.1-89.4) 99.5% (95% CI 98.7-99.8)
Gupta, A., et al. India low concern yes fresh NP 330 81.8% (95% CI 71.3-89.6) 99.6% (95% CI 97.8-99.9)
Turcato, G., et al. Italy unclear unclear fresh NP 3410 80.3% (95% CI 74.9-85.4) 99.1% (95% CI 98.6-99.3)
Lindner, A.K., et al. Germany low concern yes fresh NP 289 79.5% (95% CI 64.5-89.2) 99.6% (95% CI 97.8-100)
Krüger, L.J., et al. Germany/England intermediate concern yes unclear NP/OP 1263 76.6% (95% CI 62.8-86.4) 99.3% (95% CI 98.6-99.6)
Möckel, M., et al. Germany intermediate concern yes fresh NP/OP 271 75.3% (95% CI 65.8-83.4) 100% (95% CI 98.4-100)
Lindner, A.K., et al. Germany intermediate concern yes fresh AN 289 74.4% (95% CI 58.9-85.4) 99.2% (95% CI 97.1-99.8)
Lindner, A.K., et al. Germany low concern yes fresh NP 180 73.0% (95% CI 58.1-84.3) 99.3% (95% CI 96.0-100)
Cerutti, F., et al. Italy unclear yes unclear NP 185 72.1% (95% CI 62.5*-80.5*) 100% (95% CI 95.6*-100*)
Möckel, M., et al. Germany intermediate concern yes fresh NP/OP 2020 72.0% (95% CI 53.3-86.7) 99.4% (95% CI 97.3-99.9)
Krüttgen, A., et al. Germany high concern yes banked NP 150 70.7% (95% CI 59.0*-80.6*) 96.0% (95% CI 88.9*-99.2*)
Nalumansi, A., et al. Uganda low concern yes fresh NP 262 70.0% (95% CI 60.0-79.0) 92.0% (95% CI 87.0-96.0)
Pena, M., et al. Chile low concern yes fresh NP 842 69.8% (95% CI 58.5-79.2) 99.6% (95% CI 98.86-99.87)
Favresse, J., et al. Belgium intermediate concern yes fresh NP 188 69.8% (95% CI 59.6-78.8) 100% (95% CI 96.1-100)
Osterman, A., et al. Germany high concern yes unclear NP/OP 386 64.5% (95% CI 58.4-70.1) 97.7% (95% CI 95.6-98.8)
Kannian, P., et al. India high concern yes unclear saliva 37 56.0% (not provided) 100% (not provided)
Olearo, F., et al. Germany intermediate concern yes unclear OP 184 49.4% (95% CI 38.9-59.9) 100% (95% CI 96.3-100)
Baro, B., et al. Spain intermediate concern yes banked NP 286 43.6% (95% CI 33.7-53.8) 96.2% (95% CI 92.4-98.5)
Kohmer, N., et al. Germany intermediate concern yes fresh NP 100 43.2% (95% CI 37.8-55.3) 100% (95% CI 86.8-100)
Caruana, G., et al. Switzerland intermediate concern yes fresh NP 532 41.2% (not provided) 99.7%  (not provided)
Cerutti, F., et al. Italy unclear yes fresh NP 145 40.0% (95% CI 5.3*-85.3*) 100% (95% CI 97.4*-100*)
                 
SD Biosensor / Roche, Standard Q (nasal sampling)
Nikolai, O., et al. Germany low concern yes fresh MT 96 91.2% (95% CI 77.0-97.0) 100% (95% CI 94.2-100)
Nikolai, O., et al. Germany low concern yes fresh MT 132 86.1% (95% CI 71.3-93.9) 100% (95% CI 89.0-100)
Nikolai, O., et al. Germany low concern yes fresh AN 132 86.1% (95% CI 71.3-93.9) 100% (95% CI 89.0-100)
Linder, A.K., et al. Germany low concern yes fresh MT 180 80.5% (95% CI 66-89.8) 98.6% (95% CI 94.9-99.6)
                 
Shenzen Bioeasy Biotechnology, 2019-nCov Antigen Rapid Test Kit
Porte, L., et al. Chile high concern yes banked NP/OP 127 93.9% (95% CI 86.5-97.4) 100% (95% CI 92.1*-100*)
Weitzel, T., et al. Chile high concern no banked NP/OP 111 85.0% (95% CI 75.6-91.2) 100% (95% CI 89.0-100)
Parada-Ricart, E., et al. Spain intermediate concern yes fresh NP 172 73.1%* (95% CI 52.2*-88.4*) 85.6%* (95% CI 78.9*-90.9*)
Krüger, L.J., et al. Germany intermediate concern yes fresh NP/OP 727 66.7% (95% CI 41.7-84.8) 93.1% (95% CI 91-94.8)
                 
Siemens Healthineers, CLINITEST® Rapid COVID-19 Antigen Test
Torres, I. et al. Spain low concern yes fresh NP 178 80.2% (95% CI 70.9-87.1) 100% (95% CI 95.8-100)
Torres, I. et al. Spain low concern yes fresh NP 92 60.0% (95% CI 40.7-76.6) 100% (95% CI 94.6-100)
Olearo, F., et al. Germany intermediate concern yes unclear OP 170 54.9% (95% CI 43.4-65.9) 100% (95% CI 96.3-100)
Baro, B., et al. Spain intermediate concern yes banked NP 286 51.5% (95% CI 41.3-61.6) 98.4% (95% CI 95.3-99.6)
                 
SureScreen, COVID-19 Rapid Antigen Test Cassette
Baro, B., et al. Spain intermediate concern yes banked NP 286 28.8% (95% CI 20.2-38.6) 97.8% (95% CI 94.5-99.4)

* Values differ from those provided in the respective manuscript due to missing or contradictory data.

Abbreviations: NP = nasopharyngeal; OP = oropharyngeal; AN = anterior nasal; MT = mid turbine; LRT = lower respiratory tract; CI = confidence interval

Follow this link to get to the methods and sources section.

Furthermore, the Paul-Ehrlich-Institute has published a list of Ag-RDTs that they consider to perform to the state of the art. A similar list has also been published by the Swiss Federal Institute for Public Health.

In addition to the evaluation of Ag-RDTs, we would also like to call attention to further research relevant to this topic.

Correlation of antigen and RNA concentrations:

Teststrategies:

Evaluation of the Abbott, Panbio in a low prevalence setting for monitoring:

Economic modelling: