Covid19Check-MG
Manufactured by Multi-G bvba, Belgium - www.covid19check-mg.com
Device identification number
2262
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
All additional data is available on demand. This test is validated by the French Health agency : https://covid-19.sante.gouv.fr/tests#e786994f-fc19-4c68-a3f5-74ce44fc3bb7
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
LOD
22.5 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
3 % ((NPA 97%))
False negatives
7 % ((PPA 93%))
Precision
Evaluated
Accuracy
96.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93 %
Clinical Specificity
97 %
Type of antigen
Other
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