Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)
Manufactured by BN Santé, France - www.biogyne.fr
Device identification number
1828
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
No additional information to update.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
0.5 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1
False negatives
8
Precision
Evaluated
Accuracy
97.81 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
95 %
Clinical Specificity
99.6 %
Type of antigen
Nucleoprotein
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