EXON SARS CoV-2 Rapid Antigen Test (Colloidal Gold)
Manufactured by EXON BÄ°YOTEKNOLOJÄ°, Turkey - www.exonbiyotek.com
Device identification number
2953
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal 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
EXON SARS-CoV-2 Rapid Antigen Test is intended for the qualitative detection of SARS-CoV-2 Antigen in nasopharyngeal swab specimens in vitro.
Assay Type
Immuno-Antigen
Method
Immunochromatography
Time
15 minutes
Detection Principle
Colloidal gold
LOD
200 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
3.65 %
Precision
Evaluated
Accuracy
98.22 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97 %
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