INGEZIM COVID RBD-DR
Manufactured by EUROFINS INGENASA, Spain - https://ingenasa.eurofins-technologies.com
Device identification number
2552
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Microtiter plate
Target type
Antibody
Specimen
Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
THE PRODUCT IS UNDER CE MARKING
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
75 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 %
False negatives
0.1 % (<0.1% Fifteen days after finishing the vaccination protocol)
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.9 % ( Fifteen days after finishing the vaccination protocol)
Clinical Specificity
99 %
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