COVID-19 Ag Rapid Test
Manufactured by Celltrion DiaTrust, South Korea - www.celltrion.com
Device identification number
1614
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-10-18 08:48:39 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
False positives
100 % (82/82) (95% CI: 95.5%-100.0%)
False negatives
97 % (161/166) (95% CI: 93.1%-98.7%)
Clinical Sensitivity
94.3 % (82/87) (95% CI: 87.2%-97.5%)
Clinical Specificity
100 % (161/161) (95% CI: 97.7%-100.0%)
Type of antigen
nucleocapside protein
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