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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

BIOSYNEX COVID-19 Ag BSS

Manufactured by BIOSYNEX S.A., Switzerland - www.biosynex.com 

Device identification number
1223
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual
Physical Support
Other
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-11-03 09:29:38 CET
Comments
/
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colorimetry
LOD
115 TCID50/ml
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
98 % (Nasopharyngeal)
Accuracy
98.8 % (Nasal)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 % (Nasopharyngeal)
Clinical Sensitivity
97.2 % (Nasal)
Clinical Specificity
100 % (Nasopharyngeal)
Clinical Specificity
100 % (Nasal)
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