BioSpeedia
Manufactured by BioSpeedia International, Switzerland - www.biospeedia.com
Device identification number
2196
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Fully automated (robot)
Physical Support
Lateral flow
Target
Antigen
Pathogens detected
SARS-CoV
Lineages detected
A.23.1 (United Kingdom), AT.1 (Russia), B.1.1.7 (United Kingdom), B.1.351 (South Africa), B.1.427 (USA), B.1.429 (USA), B.1.525 (Nigeria), B.1.526 (USA), B.1.526.1 (USA), B.1.526.2 (USA), B.1.616 (France), B.1.617.1 (India), B.1.617.2 (India), B.1.617.3 (India), B.1.621 (Colombia), C.36 (Egypt), C.37 (Peru), P.1 (Japan/Brazil), P.2 (Brazil), P.3 (The Philippines),
Commercial Status
Commercialised
Last Update
2021-06-09 10:48:34 CET
Comments
No additional Information
Assay Type
Immuno-Antigen
Method
Immunochromatography
Time
15 minutes
LOD
0 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1.2 %
Fn
0 %
Precision
Not evaluated
Accuracy
99.37 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.8 %
Clinical Specificity
100 %
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