MAUVE COVID-19 Ag Test
Manufactured by InTelos Inc., South Korea - www.intelos.co.kr
Device identification number
1882
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Antigen Rapid Diagnostic Test
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Magnetic Electrochemical
LOD
5.8 %
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
10 %
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90 %
Clinical Specificity
100 %
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