SARS-CoV-2 IgG/IgM (GICA)
Manufactured by MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd., China - www.medcaptain.com
Device identification number
1712
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Plasma, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
3.7 %
False negatives
0 %
Precision
Evaluated
Accuracy
96.3 % ((IgG, IgM))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % ((IgG, IgM))
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