IDK® anti-SARS-CoV-2 IgG ELISA
Manufactured by Immundiagnostik AG, Germany - www.immundiagnostik.com
Device identification number
1881
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Microtiter plate
Target type
IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Eberhardt KE et al 2021 medRxiv, 2021
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
ELISA
Measurement
Quantitative
Time
130 minutes
Subclass
Enzyme-linked
LOD
0.4 %
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.9 %
False negatives
0 %
Precision
Evaluated
Accuracy
99.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Specificity
99.1 %
Type of antigen
Other
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