Virusee® SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)
Manufactured by Genobio Pharmaceutical Co. Ltd., China - www.era-bio.com
Device identification number
2642
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The product is listed by BfArM with AT1100/21 ,and has positive results by PEI.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.74 % (4/538)
False negatives
2.8 % (9/321)
Precision
Evaluated
Accuracy
98.49 % (846/859)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.2 %
Clinical Specificity
99.26 %
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