CovBELD
Manufactured by EMBIO Diagnostics Ltd., Cyprus - www.embiodiagnostics.eu
Device identification number
1313
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
spike protein
Specimen
Nasopharyngeal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Prospective study and Retrospective evaluation of 300+ samples with the new variants is currently performed on Italy
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
3 minutes
Subclass
Membrane-based
LOD
4000 U/ml
Calibration
Evaluated
Analysis of cross reactivity
Not evaluated
False positives
2.2 % (3 on 136)
False negatives
7.27 % (8 of 110)
Precision
Evaluated
Accuracy
95.52 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.73 %
Clinical Specificity
97.8 %
Type of antigen
Spike 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