COVIDual COVID-19 IgM/IgG Rapid Test
Manufactured by Eternal Materials Co. Ltd., Taiwan ROC - www.eternal-group.com/Home/EngIndex
Device identification number
1066
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
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
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
Calibration
Not evaluated
Analysis of cross reactivity
Not evaluated
Precision
Evaluated
Accuracy
98.76 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
93.94 %
Clinical Specificity
99.31
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