BIOSYNEX COVID-19 Ag BSS
Manufactured by BIOSYNEX S.A., Switzerland - www.biosynex.com
Device identification number
1223
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Lineages detected
B.1.351 (Beta), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
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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
Analysis of cross reactivity
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