COVID-19 Antigen Test Kit
Manufactured by Surge Medical Inc.
Device identification number
1942
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Commercial Status
Commercialised
Last Update
03/31/2021 09:27
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
15 minutes
LOD
100000 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
99 %
Fn
93.33 %
Precision
Evaluated
Accuracy
97.69 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.33 %
Clinical Specificity
99 %
Type of antigen
Nucleoprotein
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