SARS-CoV-2 IgM/IgG Test Kit(Colloidal Gold)
Manufactured by Foregene Co. Ltd., China - www.foregene.com
Device identification number
1872
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
IgG, IgM
Specimen
Venous whole blood, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
EC Representative SUNGO Europe B.V. Address: Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other ()
Method
Other ()
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
200
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
91.07 %
False negatives
95.37 %
Precision
Evaluated
Accuracy
92.75 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
91.07 %
Clinical Specificity
95.37 %
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