Table 1.
General information on the five RATs used in this study
| Study name | Clongene | nal von minden | Glallergen | Saier | Egens |
|---|---|---|---|---|---|
| Manufacturer | Hangzhou Clongene Biotech Co | nal von minden GmbH | Glallergen Co | Suzhou Soochow University Saier Immuno Biotech Co., Ltd | Nantong Egens Biotechnology Co |
| Authorized representative | Shanghai International Holding Corp.GmbH | – | Osmunda Medical Technology Services GmbH | ZWL GmbH | Shanghai International Holding Corp. GmbH |
| Test name | Lungene-COVID-19 Antigen Rapid Test Cassette | Nadal COVID-19 Ag Test (test cassette) | Novel Corona Virus (2019-nCoV) Antigen Test Kit (Colloidal Gold Immunochromatography) | InstantSure COVID-19 Ag CARD | EGENS Sars-CoV-2 Antigen Rapid Test |
| Device identification (European Commission) | 1610 | 2848 | 2695 | 3015 | 1573 |
| BfArM Test-ID | AT079/20 | AT021/20 | AT755/21 | AT830/21 | AT425/21 |
| Ref. No | ICOV5002-B025 | 243103 N-20 | 600,010 | n.a | n.a |
| HSC common list (RAT)a [27] | Yes | No | Yes | Yes | Yes |
| PEI evaluated (last update 02.07.2022)b [25, 26] | Yes, but LOT 2,020,110,090 | Yes, but AT470/20, REF 243104D-20 | Yes, but Ref. No 600008 | Yes | Yes |
| Bridging-evaluationc [26] | Yes | Yes | Pending | Yes | Yes |
| Antibody used | Monoclonal | Monoclonal | Monoclonal | Monoclonal | SARS-CoV-2 antibodies |
| Detected antigen | Nucleocapsid protein | Nucleocapsid protein | Nucleocapsid protein | Nucleocapsid protein | SARS-CoV-2 antigen |