SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
Manufactured by Foregene Co. Ltd., China - www.foregene.com
Device identification number
1871
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
EC Representative SUNGO Europe B.V. Address: Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other ()
Method
Other ()
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
150 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
100 %
False negatives
95 %
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
100 %
Clinical Specificity
95 %
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