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 [Ct-value] | Source |
|---|---|---|---|---|---|---|---|
| Abbott, Panbio | Germany | n/a | 100,00% (n/a) | - RSV-A | 6,551 | n/a | Corman, V.M., et al. |
| Germany | n/a | n/a | n/a | 6,07 | n/a | Haage, V., et al. | |
| Hong Kong | n/a | n/a | n/a | n/a | 26,29 | Mak, G.C.K., et al. | |
| Abbott, BinaxNOW | Germany | n/a | n/a | n/a | 4,6 - 4,92 | n/a | Perchetti. G.A., et al. |
| BIONOTE, NowCheck | Germany | n/a | n/a | n/a | 6,0 | n/a | Haage, V., et al. |
| Boditech Med, ichroma | Germany | n/a | n/a | n/a | 5,91 | n/a | Haage, V., et al. |
| Coris BioConcept, Respi-Strip | Germany | n/a | 100,00% (n/a) | none detected | 7,461 | n/a | Corman, V.M., et al. |
| Germany | n/a | n/a | n/a | 7,90 | n/a | Haage, V., et al. | |
| Hong Kong | n/a | n/a | n/a | n/a | 18,44 | Mak, G.C.K., et al. | |
| Edinburgh Genetics, ActivXpress | Germany | n/a | n/a | n/a | 6,15 | n/a | Haage, V., et al. |
| GMCS Genedia, COVID-19 Ag | Germany | n/a | n/a | n/a | 7,66 | n/a | Haage, V., et al. |
| Healgen, Rapid Test | Germany | n/a | 91,42% (n/a) | - Adenovirus - Entero / Rhinovirus - Influenzavirus A H1 - Influenzavirus A H3 - Parainfluenzavirus 1 - Parainfluenzavirus 2 - Parainfluenzavirus 3 | 6,371 | n/a | Corman, V.M., et al. |
| JOYSBIO (Tianin), COVID-19 Ag-RTK | Germany | n/a | n/a | n/a | 6,15 | n/a | Haage, V., et al. |
| NAL von minden, NADAL | Germany | n/a | 97,12% (n/a) | none detected | 6,971 | n/a | Corman, V.M., et al. |
| Hong Kong | n/a | n/a | n/a | n/a | 18,44 | Mak, G.C.K., et al. | |
| RapiGEN, Biocredit | Germany | n/a | 100,00% (n/a) | none detected | 10,21 | n/a | Corman, V.M., et al. |
| Hong Kong | n/a | n/a | n/a | n/a | 18,44 | Mak, G.C.K., et al. | |
| R-Biopharm, RIDA QUICK | Germany | n/a | 82,86% (n/a) | - Influenzavirus A H1 - Influenzavirus A H3 | 6,321 | n/a | Corman, V.M., et al. |
| SD Biosensor / Roche, Standard Q | Germany | n/a | 97,12% (n/a) | - Parainfluenzavirus 3 | 6,781 | n/a | Corman, V.M., et al. |
| Germany | n/a | n/a | n/a | 6,0 | n/a | Haage, V., et al. | |
| Hong Kong | n/a | n/a | n/a | n/a | 28,67 | Mak, G.C.K., et al. | |
| Hong Kong | n/a | n/a | n/a | n/a | 26,29 | Mak, G.C.K., et al. | |
| Shenzen Bioeasy, FIA | Germany | n/a | n/a | n/a | 6,85 | n/a | Haage, V., et al. |
| Siemens Healthineers, CLINITEST | Germany | n/a | n/a | n/a | 6,04 | n/a | Haage, V., 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.