Coronavirus COVID-19 IgM/IgG Test Kit
Manufactured by Guangdong Wesail Biotech Co. Ltd., China - http://en.wesailbio.com/
Device identification number
1440
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, 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
6 minutes
Detection Principle
Colloidal gold
LOD
3.125
Calibration
Not evaluated
Analysis of cross reactivity
Not evaluated
Precision
Not evaluated
Accuracy
93 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
93 %
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