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Analytical studies

Besides the clinical studies listed on the homepage, antigen rapid diagnostic tests (Ag-RDTs) are also evaluated in specific laboratory settings. In addition to sensitivity and specificity, such analytical studies analyze the lowest virus concentration an Ag-RDT is able to detect (Limit of Detection, LOD) and whether it incorrectly recognizes any pathogens other than SARS-CoV-2 (cross reactivity). In the following, we would like to give an overview of the results of analytical studies evaluating Ag-RDTs.

Manufacturer,
Test		 Study
location		 Cross reactivity LOD [log10
copies/swab]		 LOD [viral load in pfu/ml] LOD [log10 pfu/ml] LOD
[Ct-value]		 LOD [viral load in RNA copies/ml] LOD [log GE/test] Source
Abbott,
Panbio		 Germany - RSV-A 6,551 n/a n/a n/a n/a n/a Corman, V.M., et al.
Germany n/a 6,07 n/a n/a n/a n/a n/a Haage, V., et al.
Hong Kong n/a n/a n/a n/a 26,29 n/a n/a Mak, G.C.K., et al.
England n/a n/a 5.0 * 10^3 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
Germany n/a n/a n/a n/a n/a 9.8*10^5 n/a Jungnick, S., et al.
Germany n/a n/a n/a n/a n/a 8.5*10^5
based on B.1.351 variant		 n/a Jungnick, S., et al.
Germany n/a n/a n/a n/a n/a 8.9*10^5
based on B.1.1.7 variant		 n/a Jungnick, S., et al.
United Kingdom n/a n/a n/a n/a n/a n/a 6,26
based on B.1.1.7 variant		 Rodgers, M.A., et al.
United Kingdom n/a n/a n/a n/a n/a n/a 5,66-5,93
based on B.1.351 variant		 Rodgers, M.A., et al.
United Kingdom n/a n/a n/a n/a n/a n/a 5,56
based on P.1 variant		 Rodgers, M.A., et al.
Switzerland n/a n/a n/a 3,63 based on B.1.610 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,03 based on B.1.1.7 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,03 based on B.1.351 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,43 based on P.2 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,43 based on P.1 variant n/a n/a n/a Beklitz, M., et al.
unclear n/a n/a 5*10^1 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
Abbott,
BinaxNOW		 Germany n/a 4,6 - 4,92 n/a n/a n/a n/a n/a Perchetti. G.A., et al.
United Kingdom n/a n/a n/a n/a n/a n/a 6,26
based on B.1.1.7 variant		 Rodgers, M.A., et al.
United Kingdom n/a n/a n/a n/a n/a n/a 4,66 - 5,93
based on B.1.351 variant		 Rodgers, M.A., et al.
United Kingdom n/a n/a n/a n/a n/a n/a 5,56
based on P.1 variant		 Rodgers, M.A., et al.
BIONOTE,
NowCheck		 Germany n/a 6,0 n/a n/a n/a n/a n/a Haage, V., et al.
England n/a n/a 5.0 * 10^3 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
Switzerland n/a n/a n/a 3,63 based on B.1.610 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,03 based on B.1.1.7 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,03 based on B.1.351 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,73 based on P.2 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,13 based on P.1 variant n/a n/a n/a Beklitz, M., et al.
unclear n/a n/a 5*10^2 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
Boditech Med,
ichroma		 Germany n/a 5,91 n/a n/a n/a n/a n/a Haage, V., et al.
England n/a n/a 1.0 * 10^4 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
Coris BioConcept,
Respi-Strip		 Germany none detected 7,461 n/a n/a n/a n/a n/a Corman, V.M., et al.
Germany n/a 7,90 n/a n/a n/a n/a n/a Haage, V., et al.
Hong Kong n/a n/a n/a n/a 18,44 n/a n/a Mak, G.C.K., et al.
England n/a n/a 5.0 * 10^3 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
unclear n/a n/a 1*10^3 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
Edinburgh Genetics,
ActivXpress		 Germany n/a 6,15 n/a n/a n/a n/a n/a Haage, V., et al.
England n/a n/a 1.0 * 10^4 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
Switzerland n/a n/a n/a 3,93 based on B.1.610 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,63 based on B.1.1.7 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,63 based on B.1.351 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,03 based on P.2 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,43 based on P.1 variant n/a n/a n/a Beklitz, M., et al.
unclear n/a n/a 5*10^2 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
Excalibur Healthcare Services, Rapid SARS-CoV-2 Antigen test card England n/a n/a 1.0 * 10^3 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
unclear n/a n/a 5*10^2 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
Fujirebio, ESPLINE® SARS-CoV-2 England n/a n/a 5.0 * 10^2 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
unclear n/a n/a 2,5*10^2 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
Guangzhou Wondfo Biotech, 2019-nCoV Antigen Test England n/a n/a 2.5 * 10^3 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
Switzerland n/a n/a n/a 3,63 based on B.1.610 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,33 based on B.1.1.7 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,63 based on B.1.351 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,03 based on P.2 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,43 based on P.1 variant n/a n/a n/a Beklitz, M., et al.
unclear n/a n/a 1*10^3 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
Green Cross Medical Science, Genedia W COVID-19 Ag Germany n/a 7,66 n/a n/a n/a n/a n/a Haage, V., et al.
England n/a n/a 2.5 * 10^4 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
Switzerland n/a n/a n/a 4,54 based on B.1.610 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 4,24 based on B.1.1.7 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,93 based on B.1.351 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,33 based on P.2 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,03 based on P.1 variant n/a n/a n/a Beklitz, M., et al.
unclear n/a n/a 5*10^2 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
Healgen,
Rapid Test		 Germany - Adenovirus
- Entero / Rhinovirus
- Influenzavirus A H1
- Influenzavirus A H3
- Parainfluenzavirus 1
- Parainfluenzavirus 2
- Parainfluenzavirus 3		 6,371 n/a n/a n/a n/a n/a Corman, V.M., et al.
ichroma, COVID-19 AG Switzerland n/a n/a n/a 3,33 based on B.1.610 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,03 based on B.1.1.7 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,03 based on B.1.351 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,13 based on P.2 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,13 based on P.1 variant n/a n/a n/a Beklitz, M., et al.
unclear n/a n/a 2,5*10^2 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
Innova Medical Group, INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test England n/a n/a 1.0 * 10^3 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
unclear n/a n/a 2,5*10^2 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
JOYSBIO (Tianjin),
COVID-19 Ag-RTK		 Germany n/a 6,15 n/a n/a n/a n/a n/a Haage, V., et al.
England n/a n/a 2.5 * 10^5 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
Switzerland n/a n/a n/a 4,24 based on B.1.610 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 4,54 based on B.1.1.7 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 4,24 based on B.1.351 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,73 based on P.2 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,73 based on P.1 variant n/a n/a n/a Beklitz, M., et al.
unclear n/a n/a 1*10^2 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
Mologic, Mologic COVID-19 Ag Test device England n/a n/a 2.5 * 10^2 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
unclear n/a n/a 2,5*10^2 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
NAL von minden,
NADAL		 Germany none detected 6,971 n/a n/a n/a n/a n/a Corman, V.M., et al.
Hong Kong n/a n/a n/a n/a 18,44 n/a n/a Mak, G.C.K., et al.
Germany n/a n/a n/a n/a n/a 9.8*10^5 n/a Jungnick, S., et al.
Germany n/a n/a n/a n/a n/a 8.5*10^5
based on B.1.351 variant		 n/a Jungnick, S., et al.
Germany n/a n/a n/a n/a n/a 8.9*10^5
based on B.1.1.7 variant		 n/a Jungnick, S., et al.
Premier Medical Corporation, Sure Status COVID-19 Antigen Card Test England n/a n/a 5.0 * 10^2 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
Switzerland n/a n/a n/a 2,43 based on B.1.610 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,43 based on B.1.1.7 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,43 based on B.1.351 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,43 based on P.2 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,43 based on P.1 variant n/a n/a n/a Beklitz, M., et al.
unclear n/a n/a 5*10^1 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
RapiGEN,
Biocredit		 Germany none detected 10,21 n/a n/a n/a n/a n/a Corman, V.M., et al.
Hong Kong n/a n/a n/a n/a 18,44 n/a n/a Mak, G.C.K., et al.
England n/a n/a 5.0 * 10^4 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
Germany n/a n/a 6.8*10^3 n/a n/a n/a n/a FINDdx
Germany n/a n/a n/a n/a n/a 3.1*10^7 n/a Jungnick, S., et al.
Germany n/a n/a n/a n/a n/a 2.6*10^5
based on B.1.351 variant		 n/a Jungnick, S., et al.
Germany n/a n/a n/a n/a n/a 3.4*10^5
based on B.1.1.7 variant		 n/a Jungnick, S., et al.
unclear n/a n/a 5*10^4 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
R-Biopharm,
RIDA QUICK		 Germany - Influenzavirus A H1
- Influenzavirus A H3		 6,321 n/a n/a n/a n/a n/a Corman, V.M., et al.
Roche, SARS-CoV-2 Rapid Antigen Test  Germany n/a n/a n/a n/a n/a 9.8*10^5 n/a Jungnick, S., et al.
Germany n/a n/a n/a n/a n/a 8.5*10^5
based on B.1.351 variant		 n/a Jungnick, S., et al.
Germany n/a n/a n/a n/a n/a 8.9*10^5
based on B.1.1.7 variant		 n/a Jungnick, S., et al.
unclear n/a n/a 2,5*10^2 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
SD Biosensor / Roche,
Standard F		 England n/a n/a 2.5 * 10^4 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
unclear n/a n/a 1*10^2 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
SD Biosensor / Roche,
Standard Q		 Germany - Parainfluenzavirus 3 6,781 n/a n/a n/a n/a n/a Corman, V.M., et al.
Germany n/a 6,0 n/a n/a n/a n/a n/a Haage, V., et al.
Hong Kong n/a n/a n/a n/a 28,67 n/a n/a Mak, G.C.K., et al.
Hong Kong n/a n/a n/a n/a 26,29 n/a n/a Mak, G.C.K., et al.
England n/a n/a 5.0 * 10^3 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
Switzerland n/a n/a n/a 3,03 based on B.1.610 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,73 based on B.1.1.7 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 3,03 based on B.1.351 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,73 based on P.2 variant n/a n/a n/a Beklitz, M., et al.
Switzerland n/a n/a n/a 2,43 based on P.1 variant n/a n/a n/a Beklitz, M., et al.
unclear n/a n/a 2,5*10^2 based on B.1.1.7 variant n/a n/a n/a n/a Kontogianni, K., et al.
Shenzen Bioeasy,
FIA		 Germany n/a 6,85 n/a n/a n/a n/a n/a Haage, V., et al.
England n/a n/a 5.0 * 10^3 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.
Siemens Healthineers,
CLINITEST		 Germany n/a 6,04 n/a n/a n/a n/a n/a Haage, V., et al.
Germany n/a n/a n/a n/a n/a 1.7*10^5 n/a Jungnick, S., et al.
Germany n/a n/a n/a n/a n/a 8.5*10^5
based on B.1.351 variant		 n/a Jungnick, S., et al.
Germany n/a n/a n/a n/a n/a 8.9*10^5
based on B.1.1.7 variant		 n/a Jungnick, S., et al.
Zhejiang Orient Gene Biotech, Coronavirus Ag Rapid Test England n/a n/a 2.5 * 10^3 n/a n/a n/a n/a Cubas-Atienzar, A.I., et al.

1 At the given LOD, the authors accepted a 5% false-negative rate. Thus, the true LOD could vary slightly.

2 The authors allowed no false-negatives. Only a LOD-range could be provided as the estimation of virus concentration of the test specimen was done using two different PCR methods. The true value lies in between.