COVID-19 IgM/IgG Rapid Test
Manufactured by BioMedomics Inc., United States - www.biomedomics.com
Device identification number
90
HSC common list (RAT)
× No
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
THis is an update to the BioMedomics COVID-19 IgM-IgG Rapid Test
Assay Type
Immuno-Antibody
Method
Immunochromatography
Subclass
Sandwich, Double
Detection Principle
Colorimetry
Analysis of cross reactivity
Reported as not possible
Analysis of cross reactivity
Evaluated
False positives
0.125 % (1 out of 80 samples produced a false positive)
False negatives
0 % (0 out of 26 samples produced false negatives)
Accuracy
99.1 % (combined)
Reproducibility
Evaluated
Clinical Sensitivity
100 % (combined)
Clinical Specificity
98.75 % (combined)
Related Scientific Literature
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