INGEZIM COVID 19 DR
Manufactured by Eurofins, Spain - https://ingenasa.eurofins-technologies.com
Device identification number
1683
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Microtiter plate
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
75 minutes
Subclass
Other ()
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 %
False negatives
1 %
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.3 %
Clinical Specificity
99.2 %
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