COVID-19 IgG/IgM Rapid Test (colloidal gold-based)
Manufactured by Spring Healthcare Services AG, Switzerland - www.springhealthcare.org/
Device identification number
618
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
Fp
Evaluated
Fn
Evaluated
Accuracy
97 %
Clinical Sensitivity
91 %
Clinical Specificity
99 %
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