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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



EONBT COVID-19 Antigen

Manufactured by EON Biotechnology Limited, United Kingdom - eonbt.com 

Device identification number
2032
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab
Lineages detected
A.23.1 AT.1 B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), C.36 P.1 (Gamma), P.2 (Zeta), P.3 (Theta), B.1.1.529 (Omicron), C.37 (Lambda), B.1.616 B.1.526.1 B.1.526.2
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
ISO13485 certified ISO 9001 certified CE marked
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Visualisation system
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
LOD
0.103 ng/mL
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1.76 % (3/170)
Fn
2.2 % (9/408)
Precision
Evaluated
Accuracy
98.95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.89 %
Clinical Specificity
99.25 %
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