COVID-19 Antigen Rapid Test Kit
Manufactured by FUJIAN ERCON MEDICAL MANAGEMENT Co. Ltd., China - www.erconmedical.com
Device identification number
3028
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cartridge
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
No additional information
Assay Type
Immuno-Antigen
Self Test
Yes
Method
Immunoassay
Time
15 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
2 %
Precision
Evaluated
Accuracy
99.56 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.26 %
Clinical Specificity
100 %
Type of antigen
Nucleocapsid 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