COVID-19 IgG/IgM Rapid Test Device
Manufactured by Azure Biotech Inc., United States - www.azure.bio
Device identification number
1912
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Not available
Assay Type
Immuno-Antibody
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
98.7 % IgG
Accuracy
97.7 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.7 % IgM
Clinical Sensitivity
98.8 % IgG
Clinical Specificity
99.1 % IgM
Clinical Specificity
98.7 % IgG
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