Diagnostics Global… Analytical studies …

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
[Ct-value]
Source
Abbott,
Panbio
Germany - RSV-A 6,551 n/a n/a Corman, V.M., et al.
Germany n/a 6,07 n/a n/a Haage, V., et al.
Hong Kong n/a n/a n/a 26,29 Mak, G.C.K., et al.
England n/a n/a 5.0 * 10^3 n/a Cubas-Atienzar, A.I., et al.
Abbott,
BinaxNOW
Germany n/a 4,6 - 4,92 n/a n/a Perchetti. G.A., et al.
BIONOTE,
NowCheck
Germany n/a 6,0 n/a n/a Haage, V., et al.
England n/a n/a 5.0 * 10^3 n/a Cubas-Atienzar, A.I., et al.
Boditech Med,
ichroma
Germany n/a 5,91 n/a n/a Haage, V., et al.
England n/a n/a 1.0 * 10^4 n/a Cubas-Atienzar, A.I., et al.
Coris BioConcept,
Respi-Strip
Germany none detected 7,461 n/a n/a Corman, V.M., et al.
Germany n/a 7,90 n/a n/a Haage, V., et al.
Hong Kong n/a n/a n/a 18,44 Mak, G.C.K., et al.
England n/a n/a 5.0 * 10^3 n/a Cubas-Atienzar, A.I., et al.
Edinburgh Genetics,
ActivXpress
Germany n/a 6,15 n/a n/a Haage, V., et al.
England n/a n/a 1.0 * 10^4 n/a Cubas-Atienzar, A.I., et al.
Excalibur Healthcare Services, Rapid SARS-CoV-2 Antigen test card England n/a n/a 1.0 * 10^3 n/a Cubas-Atienzar, A.I., et al.
Fujirebio, ESPLINE® SARS-CoV-2 England n/a n/a 5.0 * 10^2 n/a Cubas-Atienzar, A.I., et al.
Guangzhou Wondfo Biotech, 2019-nCoV Antigen Test England n/a n/a 2.5 * 10^3 n/a Cubas-Atienzar, A.I., et al.
GMCS Genedia,
COVID-19 Ag
Germany n/a 7,66 n/a n/a Haage, V., et al.
Green Cross Medical Science, Genedia W COVID-19 Ag England n/a n/a 2.5 * 10^4 n/a Cubas-Atienzar, A.I., et al.
Innova Medical Group, INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test England n/a n/a 1.0 * 10^3 n/a Cubas-Atienzar, A.I., 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 Corman, V.M., et al.
JOYSBIO (Tianin),
COVID-19 Ag-RTK
Germany n/a 6,15 n/a n/a Haage, V., et al.
England n/a n/a 2.5 * 10^5 n/a Cubas-Atienzar, A.I., et al.
Mologic, Mologic COVID-19 Ag Test device England n/a n/a 2.5 * 10^2 n/a Cubas-Atienzar, A.I., et al.
NAL von minden,
NADAL
Germany none detected 6,971 n/a n/a Corman, V.M., et al.
Hong Kong n/a n/a n/a 18,44 Mak, G.C.K., et al.
Premier Medical Corporation, Sure Status COVID-19 Antigen Card Test England n/a n/a 5.0 * 10^2 n/a Cubas-Atienzar, A.I., et al.
RapiGEN,
Biocredit
Germany none detected 10,21 n/a n/a Corman, V.M., et al.
Hong Kong n/a n/a n/a 18,44 Mak, G.C.K., et al.
England n/a n/a 5.0 * 10^4 n/a Cubas-Atienzar, A.I., et al.
R-Biopharm,
RIDA QUICK
Germany - Influenzavirus A H1
- Influenzavirus A H3
6,321 n/a n/a Corman, V.M., et al.
SD Biosensor / Roche,
Standard F
England n/a n/a 2.5 * 10^4 n/a Cubas-Atienzar, A.I., et al.
SD Biosensor / Roche,
Standard Q
Germany - Parainfluenzavirus 3 6,781 n/a n/a Corman, V.M., et al.
Germany n/a 6,0 n/a n/a Haage, V., et al.
Hong Kong n/a n/a n/a 28,67 Mak, G.C.K., et al.
Hong Kong n/a n/a n/a 26,29 Mak, G.C.K., et al.
England n/a n/a 5.0 * 10^3 n/a Cubas-Atienzar, A.I., et al.
Shenzen Bioeasy,
FIA
Germany n/a 6,85 n/a n/a Haage, V., et al.
England n/a n/a 5.0 * 10^3 n/a Cubas-Atienzar, A.I., et al.
Siemens Healthineers,
CLINITEST
Germany n/a 6,04 n/a n/a Haage, V., et al.
Zhejiang Orient Gene Biotech, Coronavirus Ag Rapid Test England n/a n/a 2.5 * 10^3 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.