Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
Manufactured by Medakit Ltd., Hong Kong S.A.R - www.medakit.com
Device identification number
1785
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Evaluated by Institut Pasteur in France, the Medakit antibody tests is regulated by the ANSM . Medakit tests are published on the official website of the French Ministry of Health, on their approved covid test list
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
0.5 AU
False positives
3 AU
False negatives
10 AU
Accuracy
98.12 %
Clinical Sensitivity
96.98 %
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