EDR COVID 19 Rapid Test Kit (IgM/IgG)
Manufactured by Sensing Self Pte. Ltd., Singapore - www.sensingself.me
Device identification number
351
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody, IgG, IgM
Specimen
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
Detection Principle
Colorimetry
Analysis of cross reactivity
Reported as not possible
Accuracy
92.8 % IgM
Accuracy
96.5 % IgG
Clinical Sensitivity
82 % IgM
Clinical Sensitivity
93 % IgG
Clinical Specificity
96 % IgM
Clinical Specificity
97 % IgG
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