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 (RAT)
✓Yes
Format
Manual
Physical Support
Cartridge, Cassette
Target type
Antigen
Specimen
Nasal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
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