BIOSYNEX COVID-19 Ag+ BSS
Manufactured by BIOSYNEX S.A., Switzerland - www.biosynex.com
Device identification number
1494
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
0 % Clinical data: 0 false positive result out of 583 negative samples confirmed by RT-PCR
False negatives
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