COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)
Manufactured by BN Santé, France - www.biogyne.fr
Device identification number
1830
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Antigen
Specimen
Nasal swab, Saliva
Commercial Status
In development
Last Update
2022-08-24 09:08:01 CET
Comments
No additional information
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
20 minutes
Detection Principle
Colloidal gold
LOD
320 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
3
False negatives
1
Precision
Evaluated
Accuracy
99.22 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.1 %
Clinical Specificity
99.8 %
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