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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
1494
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-10-11 11:13:26 CET
Comments
Please note the update consists in: - Correction of the legal manufacturer which is BIOSYNEX SWISS SA (it has been incorrectly entered on the database) - Type of specimens = nasopharyngeal and nasal swabs
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
LOD
750 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 % Clinical data: 0 false positive result out of 583 negative samples confirmed by RT-PCR
Fn
2.53 % (Clinical data: 2 false negative results out of 79 positive samples confirmed by RT-PCR)
Precision
Evaluated
Accuracy
99.7 % (Nasopharyngeal)
Accuracy
98.7 % (Nasal)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.5 % (Nasopharyngeal)
Clinical Sensitivity
95.4 % (Nasal)
Clinical Specificity
100 % (Nasopharyngeal)
Clinical Specificity
99.8 % (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