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 | Sensitivity (CI 95%) | Specificity (CI 95%) | Cross reactivity | LOD [log10 copies/swab] | LOD 50% by viral load (CI 95%) * | LOD 95% by viral load (CI 95%) * | Source |
| Abbott, Panbio | Germany | n/a | 100,00% (n/a) | - RSV-A | 6,551 | 5,61 (5,27-5,95) | 7,45 (6,79-8,20) | Corman, V.M., et al. |
| Germany | n/a | n/a | n/a | 6,07 | n/a | n/a | Haage, V., et al. | |
| Abbott, BinaxNOW | Germany | n/a | n/a | n/a | 4,6 - 4,92 | n/a | n/a | Perchetti. G.A., et al. |
| BIONOTE, NowCheck | Germany | n/a | n/a | n/a | 6,0 | n/a | n/a | Haage, V., et al. |
| Boditech Med, ichroma | Germany | n/a | n/a | n/a | 5,91 | n/a | n/a | Haage, V., et al. |
| Coris BioConcept, Respi-Strip | Germany | n/a | 100,00% (n/a) | none detected | 7,461 | 7,60 (7,37-7,82) | 8,36 (8,00-8,76) | Corman, V.M., et al. |
| Germany | n/a | n/a | n/a | 7,90 | n/a | n/a | Haage, V., et al. | |
| Edinburgh Genetics, ActivXpress | Germany | n/a | n/a | n/a | 6,15 | n/a | n/a | Haage, V., et al. |
| GMCS Genedia, COVID-19 Ag | Germany | n/a | n/a | n/a | 7,66 | n/a | n/a | Haage, V., et al. |
| Healgen, Rapid Test | Germany | n/a | 91,42% (n/a) |
| 6,371 | 4,48 (3,41-5,32) | 7,27 (6,27-8,40) | Corman, V.M., et al. |
| JOYSBIO (Tianin), COVID-19 Ag-RTK | Germany | n/a | n/a | n/a | 6,15 | n/a | n/a | Haage, V., et al. |
| NAL von minden, NADAL | Germany | n/a | 97,12% (n/a) | none detected | 6,971 | 7,19 (6,97-7,43) | 7,87 (7,52-8,23) | Corman, V.M., et al. |
| RapiGEN, Biocredit | Germany | n/a | 100,00% (n/a) | none detected | 10,21 | 9,51 (8,84-12,26) | 11,10 (9,71-17,01) | Corman, V.M., et al. |
| R-Biopharm, RIDA QUICK | Germany | n/a | 82,86% (n/a) | - Influenzavirus A H1 - Influenzavirus A H3 | 6,321 | 5,40 (4,99-5,77) | 7,22 (6,57-7,96) | Corman, V.M., et al. |
| SD Biosensor / Roche, Standard Q | Germany | n/a | 97,12% (n/a) | - Parainfluenzavirus 3 | 6,781 | 5,64 (5,23-6,00) | 7,68 (6,96-8,50) | Corman, V.M., et al. |
| Germany | n/a | n/a | n/a | 6,0 | n/a | n/a | Haage, V., et al. | |
| Shenzen Bioeasy, FIA | Germany | n/a | n/a | n/a | 6,85 | n/a | n/a | Haage, V., et al. |
| Siemens Healthineers, CLINITEST | Germany | n/a | n/a | n/a | 6,04 | n/a | n/a | Haage, V., et al. |
* The values “LOD 50% and 95% by viral load” were only determined in study [37]. However, their sample preparation included a step of dilution that was not taken into account for the “LOD 50% and 95% by viral load” values. Thus, these values are eight-fold lower. Still, they can be usefull to estimate the confidence interval and as a rough guide on how far the viral load can decrease to still be detected in 50% of the samples. All values are shown in log10 SARS-CoV-2 RNA copies per swab.
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.