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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 IgM/IgG Rapid Test

Manufactured by BioMedomics, Inc, United States - www.biomedomics.com 

Device identification number
90
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
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
2022-04-20 12:09:38 CET
Comments
THis is an update to the BioMedomics COVID-19 IgM-IgG Rapid Test
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
Detection Principle
Colorimetry
LOD
not applicable
Calibration
Evaluated
Crossreactivity
Reported as not possible
Crossreactivity
Evaluated
Fp
0.125 % (1 out of 80 samples produced a false positive)
Fn
0 % (0 out of 26 samples produced false negatives)
Precision
Evaluated
Accuracy
99.1 % (combined)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % (combined)
Clinical Specificity
98.75 % (combined)

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