BD Kit For Rapid Detection of SARS-CoV-2
Manufactured by Becton Dickinson, United States - https://www.bd.com/en-us
Device identification number
2282
CE Marking
✓Yes
HSC common list
✓Yes
HSC mutual recognition
✓Yes
Format
Manual
Physical Support
Cartridge, Cassette
Target
Antigen
Specimen
Nasal swab
Lineages detected
Commercial Status
Commercialised
Last Update
2021-11-12 12:29:38 CET
Comments
As part of surveillance activities, BD is monitoring the emergence of new mutations of SARS-CoV-2. No impact of the mutations on the performance of the device has been observed so far.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
1400 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1 AU
Fn
5 AU
Precision
Evaluated
Accuracy
98.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.1 %
Clinical Specificity
99.6 %
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