MEDsan SARS-CoV-2 Antigen Rapid Test
Manufactured by MEDsan GmbH - https://www.medsan.eu/en/
Device identification number
1180
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
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
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
14.4 TCID50/ml
Accuracy
98.4 %
Clinical Sensitivity
92.5 %
Clinical Specificity
99.8 %
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