MEXACARE COVID-19 Antigen Rapid Test
Manufactured by MEXACARE GmbH, Germany - www.mexacare.com
Device identification number
1775
CE Marking
✓Yes
HSC common list
✓Yes
HSC mutual recognition
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-07-07 05:13:13 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Chromatography
Measurement
Qualitative
Time
20 minutes
LOD
130 TCID50/ml
Calibration
Not Evaluated
Crossreactivity
Evaluated
Fp
4.35 % (5 of 115)
Fn
0.62 % (2 of 321)
Precision
Evaluated
Accuracy
98.39 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
Evaluated
Clinical Sensitivity
96.17 %
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