Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)
Manufactured by Medakit Ltd., Hong Kong S.A.R - www.medakit.com
Device identification number
1784
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.aphp.fr/contenu/evaluation-de-la-performance-diagnostique-de-neuf-tests-rapides-antigeniques-covid-19
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0.5 AU
False positives
0 AU
False negatives
1 AU
Accuracy
98.12 %
Clinical Sensitivity
95.07 %
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