COVID - 19 Antigen Test Kit
Manufactured by Artron Laboratories Inc - http://www.artronlab.com
Device identification number
1618
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
03/25/2021 05:48
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Crossreactivity
Evaluated
Fp
Evaluated
Fn
Evaluated
Precision
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.27 % CI95%: 84.92% - 95.56%
Clinical Specificity
100 % CI95%: 99.22% - 100%
Type of antigen
nucleoprotein
Notes
Rapid diagnostic test cassette
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