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 [1] which 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% [2].

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 [link to the analytical studies page] into consideration.

Author Study location Time horizon QUADAS Independent Sample condition Sample type Sample size Sensitivity (95% CI) Specificity (95% CI)
AAZ, COVID-VIRO®
Schwob, J.M., et al. Switzerland prosp. low concern yes unclear NP 248 96.7% (95% CI 91.8*-99.1*) 100% (95% CI 97.1*-100*)
Courtellemont, L., et al. France prosp. intermediate concern yes fresh NP 324 84.1% (95% CI 76.9-89.7) 100% (95% CI 98.0*-100*)
                   
Abbott, BinaxNOW™
Pollock, N.R., et al. USA prosp. 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 prosp. low concern no unclear AN 878 57.7% (95% CI 36.9*-76.7*) 100%* (95% CI 99.6*-100*)
James, A. E., et al. USA prosp. 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 prosp. low concern yes stored AN 3419 52.5% (95% CI 46.7-58.3) 99.9% (95% CI 99.7-100)
                   
Abbott, Panbio™
Alemany, A., et al. Spain prosp. intermediate concern yes frozen NP 919 93.4% (95% CI 91.5-95.0) 100% (95% CI 95.8-100)
Merino-Amador, P., et al. Spain prosp. low concern no unclear NP 958 90.5% (95% CI 87.5-93.6) 98.8% (95% CI 98.0-99.7)
Krüger, L.J., et al. Germany prosp. 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 prosp. low concern yes unclear NP 271 86.1% (95% CI 78.6-91.7) 100% (95% CI 97.6*-100*)
Berger, A., et al. Switzerland prosp. 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 prosp. 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 prosp. 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 prosp. 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 prosp. 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 prosp. intermediate concern yes frozen MT 487 79.5% (95% CI 71.0-86.4) 98.7% (95% CI 96.9-99.6)
Fenollar, F., et al. France prosp. 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 prosp. unclear yes fresh NP 255 73.3% (95% CI 62.2-83.8) 100% (95% CI 98.1*-100*)
Gremmels, H., et al. Netherlands prosp. 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 unclear 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 prosp. low concern yes fresh NP 1362* 71.4% (95% CI 63.2*-78.7) 99.8% (95% CI 99.4-99.9)
Drevinek, P., et al. Czech Republic prosp. low concern yes fresh NP 591 66.4% (95% CI 59.9-72.2) 100% (95% CI 99.0-100)
Lanser, L., et al. Austria prosp. intermediate concern yes fresh NP 53 60.8% (95% CI 46.1-74.2) 100%* (95% CI 15.8*-100*)
Agullo, V., et al. Spain prosp. 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 retro. 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 prosp. 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  prosp. low concern no unclear NP 634 48.1% (95% CI 37.4-58.9) 100% (95% CI 99.3-100)
Agullo, V., et al. Spain prosp. 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 prosp. intermediate concern yes unclear OP 184 44.6% (95% CI 34.3-55.3) 100% (95% CI 96.3-100)
Agullo, V., et al. Spain prosp. intermediate concern yes fresh saliva 610 23.1% (95% CI 16.2-31.9) 100% (95% CI 99.0-100)
                   
Becton, Dickinson and Company, BD Veritor™
Pekosz, A., et al. USA retro. high concern no frozen 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 prosp. intermediate concern yes frozen NP/OP 351* 94.1% (95% CI 71.1-100) 100% (95% CI 98.9-100)
Van der Moeren, N., et al. Netherlands prosp. intermediate concern yes frozen NP/OP 123 78.9% (95% CI 70.6-85.7) not provided
Young, S., et al. USA prosp. intermediate concern no frozen NP 251 76.3%* (95% CI 60.8*-87.0*) 99.5%* (95% CI 97.4*-99.9*)
                   
Beijing Savant Biotechnology, SARS-CoV-2 detection kit
Weitzel, T., et al. Chile retro. high concern no frozen NP/OP 109 16.7% (95% CI 10.0-26.5*) 100% (95% CI 89.0-100)
                   
Bionote, NowCheck®
FIND Brazil prosp. low concern yes fresh NP 400 89.2% (95% CI 81.7-93.9) 97.3% (95% CI 94.8-98.6)
                   
Coris BioConcept, COVID-19 Ag Respi-Strip
Mertens, P., et al. Belgium retro. intermediate concern no stored NP 328 57.6% (95% CI 48.7*-66.1*) 99.5% (95% CI 97.2*-100*)
Lambert-Niclot, S., et al. France prosp. 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 prosp. intermediate concern yes fresh or transported NP/OP 417 50.0% (95% CI 21.5-78.5) 95.8% (95% CI 93.4-97.4)
Ciotti, M., et al. Italy prosp. unclear yes fresh NP 50 30.8% (95% CI 17.0-47.6) 100% (95% CI 71.5-100)
Scohy, A., et al. Belgium prosp. intermediate concern no cooled (4°C) NP 148 30.2% (95% CI 21.7-39.9) 100% (95% CI 91.6*-100*)
Veyrenche, N., et al. France retro. 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 prosp. 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 prosp. 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 retro. 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 retro. high concern no frozen NP 17 58.8%* (95% CI 32.9*-81.6*) not provided
Yokota, I., et al. Japan retro. high concern no frozen saliva 17 23.5%* (95% CI 6.8*-49.9*) not provided
Nagura-Ikeda, M., et al. Japan retro. high concern yes frozen saliva 103 11.7% (95% CI 6.2-19.5) not provided
                   
Fujirebio, Lumipulse® G SARS-CoV-2 Ag
Yokota, I., et al. Japan retro. high concern no frozen NP 17 100% (95% CI 80.5*-100) not provided
Yokota, I., et al. Japan retro. high concern no frozen saliva 17 82.4%* (95% CI 56.6*-96.2*) not provided
Basso, D., et al. Italy prosp. 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 unclear intermediate concern yes stored NP 594 79.9% (95% CI 73.6-85.3) 99.3% (95% CI 97.8-99.8)
Basso, D., et al. Italy prosp. low concern yes fresh saliva 223 41.3% (95% CI 30.4-52.8) 98.6% (95% CI 95.0-99.8)
                   
Innova Medical Group, INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test
Houston, H., et al. United Kingdom prosp. 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 unclear yes unclear unclear 6954 not provided 99.7% (not provided)
Peto, T., et al. United Kingdom unclear unclear yes unclear unclear 198 78.8% (95% CI 72.4-84.3) not provided
Peto, T., et al. United Kingdom unclear unclear yes unclear unclear 223 70.0% (95% CI 63.5-75.9) not provided
Peto, T., et al. United Kingdom unclear unclear yes unclear unclear 372 57.5% (95% CI 52.3-62.6) not provided
                   
Liming Bio, SARS-CoV-2 Ag-RDT
Weitzel, T., et al. Chile retro. high concern no frozen NP/OP 19 0.0% (95% CI 0.0-29.9) 90.0% (95% CI 59.6-98.2)
                   
MEDsan®, SARS-CoV-2 Antigen Rapid Test
Olearo, F., et al. Germany prosp. 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 retro. high concern yes frozen NP 124 73.1% (not provided) not provided
                   
QUIDEL, Sofia SARS Antigen FIA
Porte, L., et al. Chile retro. high concern no frozen 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 prosp. 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 prosp. 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 prosp. intermediate concern yes unclear NP 113 85.0% (95% CI 71.7*-93.8*) 100% (95% CI 94.6*-100*)
FIND Brazil prosp. 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 retro. high concern no frozen NOP 109 62.0% (95% CI 51.0-71.9) 100% (95% CI 88.7-100)
Abdelrazik, A.M., et al. Egypt unclear high concern yes cooled (4°C) NP 188 43.1% (95% CI 35.9*-50.5*) not provided
Schildgen, V., et al. Germany retro. 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 retro. intermediate concern no frozen unclear 67 77.6% (95% CI 64.7*-87.5*) 100% (95% CI 66.4*-100*)
Toptan, T., et al. Germany retro. unclear no cooled (4°C) NP/OP 70 50.0% (95% CI 31.9*-68.1*) 100% (95% CI 90.8*-100*)
                   
Salofa, Salocor SARS-CoV-2 Antigen
Ahava, M.J., et al. Finland retro. 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 retro. high concern no frozen NP/OP 64 90.6% (95% CI 75.8-96.8) 96.9% (95% CI 84.3-99.4)
FIND Brazil prosp. 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 prosp. 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 retro. 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 retro. intermediate concern yes cooled (4°C) NP 359 47.1% (95% CI 37.1-57.1) 98.4% (95% CI 96.0-99.6)
                   
SD Biosensor / Roche, Standard Q
Chaimayo, C., et al. Thailand unclear intermediate concern yes fresh NP/OP 454 98.3% (95% CI 91.1-100) 98.7% (95% CI 97.1-99.6)
Schwob, J.M., et al. Switzerland prosp. low concern yes unclear NP 333 92.9% (95% CI 86.4-96.9) 100% (95% CI 98.3*-100*)
Berger, A., et al. Switzerland prosp. low concern yes fresh NP 529 89.0% (95% CI 83.7-93.1) 99.7% (95% CI 98.4-100)
FIND Brazil prosp. 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 retro. 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 prosp. 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 prosp. 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 prosp. 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 prosp. 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 prosp. 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 prosp. intermediate concern yes fresh or transported NP/OP 1263 76.6% (95% CI 62.8-86.4) 99.3% (95% CI 98.6-99.6)
Möckel, M., et al. Germany prosp. 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 prosp. 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 prosp. 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 prosp. unclear yes fresh or frozen NP 185 72.1% (95% CI 62.5*-80.5*) 100% (95% CI 95.6*-100*)
Möckel, M., et al. Germany prosp. 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 retro. high concern yes frozen NP 150 70.7% (95% CI 59.0*-80.6*) 96.0% (95% CI 88.9*-99.2*)
Nalumansi, A., et al. Uganda prosp. low concern yes cooled (4°C) NP 262 70.0% (95% CI 60.0-79.0) 92.0% (95% CI 87.0-96.0)
Osterman, A., et al. Germany retro. 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 retro. high concern yes unclear saliva 37 56.0% (not provided) 100% (not provided)
Olearo, F., et al. Germany prosp. intermediate concern yes unclear OP 184 49.4% (95% CI 38.9-59.9) 100% (95% CI 96.3-100)
Cerutti, F., et al. Italy prosp. unclear yes fresh NP 145 40.0% (95% CI 5.3*-85.3*) 100% (95% CI 97.4*-100*)
                   
Shenzen Bioeasy Biotechnology, 2019-nCov Antigen Rapid Test Kit
Porte, L., et al. Chile retro. high concern yes cooled (4°C) NP/OP 127 93.9% (95% CI 86.5-97.4) 100% (95% CI 92.1*-100*)
Weitzel, T., et al. Chile retro. high concern no frozen NP/OP 111 85.0% (95% CI 75.6-91.2) 100% (95% CI 89.0-100)
Parada-Ricart, E., et al. Spain unclear 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 prosp. 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 prosp. 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 prosp. 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 prosp. intermediate concern yes unclear OP 170 54.9% (95% CI 43.4-65.9) 100% (95% CI 96.3-100)

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

In data sets with underlined sample sizes the samples were used in head-to-head studies, performing different Ag-RDTs on the same patient.

Abbreviations: prosp. = prospective; retro. = retrospective; 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. The list can be found following this link.

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:

  • Pollock, N.R., et al., Correlation of SARS-CoV-2 nucleocapsid antigen and RNA concentrations in nasopharyngeal samples from children and adults using an ultrasensitive and quantitative antigen assay. medRxiv. 2020. [36]

Teststrategies:

  • Larremore, D.B., et al., Test sensitivity is secondary to frequency and turnaround time for COVID-19 surveillance. medRxiv. 2020. [15]
  • van Beek, J., et al., From more testing to smart testing: data-guided SARS-CoV-2 testing choices. medRxiv. 2020. [16]
  • Paltiel, A.D., Zheng, A. und Walensky, R.P., Assessment of SARS-CoV-2 screening strategies to permit the safe reopening of college campuses in the United States. JAMA network open 3.7. 2020. [17]
  • Pavelka, M., et al., The effectiveness of population-wide, rapid antigen test based screening in reducing SARS-CoV-2 infection prevalence in Slovakia. medRxiv. 2020. [48]

Alternative sampling-methods:

  • Lindner, A.K., et al., Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected anterior nasal swab versus professional-collected nasopharyngeal swab. medRxiv. 2020. [18]
  • Lindner, A.K., et al., Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with professional-collected nasal versus nasopharyngeal swab. medRxiv. 2020. [52]

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

  • Winkel, B.M.F., et al., Screening for SARS-CoV-2 infection in asymptomatic individuals using the Panbio COVID-19 Antigen Rapid Test (Abbott) compared to RT-qPCR. medRxiv. 2020. [50]

Economic modelling:

  • Atkeson, A., et al., Economic Benefits of COVID-19 Screening Tests. medRxiv. 2020. [19]
  • Du, Z., et al., Comparative cost-effectiveness of SARS-CoV-2 testing strategies. Researchgate. 2020. [31]