Rapid SARS-CoV-2 Antigen Test Card
Manufactured by Xiamen Boson Biotech Co. Ltd., China - http://www.bosonbio.com
Device identification number
2264
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
CE0123 by notified body TUV SUD Product Service GmbH Please set HSC to yes.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
130 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.8 %
False negatives
3.23 %
Precision
Evaluated
Accuracy
98.72 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.77 % ( (Antigen))
Clinical Specificity
99.2 %
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