CoV-Check - COVID-19 IgG/IgM Test
Manufactured by Spark Diagnostics LLC - https://www.sparkdiagnostics.com
Device identification number
1086
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
N.A.
Target
Antibody
Specimen
N.A.
Commercial Status
Commercialised
Last Update
03/15/2021 09:14
Comments
https://sparkdiagnostics.com/cov-check/
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
94.74(IgG/IgM)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
70.6(IgM), 90.4(IgG)
Type of antigen
Notes
Rapid diagnostic test cassette Colloidal Gold
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