2019-nCoV Antigen Test Kit
Manufactured by Chongqing M&D Biotechnology Co. Ltd., China - www.MDfastcheck.com
Device identification number
1674
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0.05 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
99.26 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.83 %
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