Coronavirus COVID-19 lgM/IgG Test Kit (colloidal)
Manufactured by Guangdong Wesail Biotech Co. Ltd., China - http://en.wesailbio.com/
Device identification number
1428
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://en.wesailbio.com/product/82.html
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
6 minutes
Detection Principle
Colloidal gold
Accuracy
97.93 %
Clinical Sensitivity
92.86 %
Clinical Specificity
99 %
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