COVID-19 Antigen test
Manufactured by RDSM nv, Belgium - www.rdsm.eu/
Device identification number
1238
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.rdsm.eu/covid19-Antigen-test.html
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Time
15 minutes
Clinical Sensitivity
99.9 %
Clinical Specificity
80.2 %
Clinical Specificity
97.6 % ((CT < 30))
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements