ID Screen® SARS-CoV-2-N IgG Indirect
Manufactured by Innovative Diagnostics, France - www.innovative-diagnostics.com/
Device identification number
1726
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgG
Specimen
Plasma, Serum
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
95 minutes
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.4 % IgG (5 false positive on 1242 samples tested negative by PCR)
False negatives
4.8 % IgG (4 false negative on 84 samples tested positive by PCR)
Precision
Evaluated
Accuracy
99.6
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.2 % IgG
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