Anti-SARS-CoV-2 IgG
Manufactured by Biocheck GmbH, Germany - www.polycheck.de
Device identification number
1099
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
N.A.
Target type
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://polycheck.de/wp-content/uploads/2020/07/Polycheck-Anti-SARS-CoV-2-IgG-Flyer.pdf
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
No
Method
Immunoassay
Measurement
Quantitative
Time
105 minutes
Detection Principle
Magnetic Electrochemical
LOD
0.2 KU/l
Analysis of cross reactivity
Evaluated
Reproducibility
Evaluated
Clinical Sensitivity
98.6 % IgG
Clinical Specificity
98.7 % IgG
Notes
Manual or automated microblot colorimetry
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