GenaBio SARS-CoV-2 Antigen Lateral Flow Test
Manufactured by GenaBio Diagnostics Inc., United States - www.genabio.com
Device identification number
1585
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Issue between the data (colloidal gold and the website link provided: immunofluorescence
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4.93 %
False negatives
0.26 %
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.07 % ((Antigen))
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