Rapid COVID-19 IgM/IgG Combo Test Kit (Antibody)
Manufactured by Megna Health Inc., United States - www.megnahealth.com
Device identification number
1063
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody, IgG, IgM
Specimen
ACD plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The Megna Rapid COVID-19 IgM/IgG Combo Test Kit has been exhaustively tested - by Megna Health and by independent testing conducted by National Institute of Health and National Cancer Society - as required by FDA prior to issuing an Emergency Use Authorization letter on July 17, 2020.; https://www.megnahealth.com/wp-content/uploads/2020/07/MegnaHealth-Test-Kit_-IFU.pdf
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Sensitivity
83.3 % IgM
Clinical Sensitivity
100 % IgG
Clinical Specificity
95 %
Clinical Specificity
97.5 % IgM
Clinical Specificity
97.5 % IgM
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