BioSpeedia COVID19 Nasal Antigen Test_BSD-506
Manufactured by BioSpeedia International, Switzerland - www.biospeedia.com
Device identification number
2381
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab
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
2021-07-09 09:42:10 CET
Comments
.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
4510.6851
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
8.7 %
Fn
0.5 %
Precision
Evaluated
Accuracy
97.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.3 %
Clinical Specificity
99.5 %
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