CoV-Check - COVID-19 IgG/IgM Test
Manufactured by Spark Diagnostics LLC, India - www.sparkdiagnostics.com
Device identification number
1086
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://sparkdiagnostics.com/cov-check/
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
94.74 % (IgG,IgM)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
70.6 % IgM
Clinical Sensitivity
90.4 % 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