COVID-19-CHECK-1 test
Manufactured by VEDALAB, France - www.vedalab.com
Device identification number
1069
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Variable Cut off setting in IgG to increase the diagnostic value in different prevalence situations https://www.vedalab.com/videos/performing-covid-19-check-1-test/
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Chromatography
Measurement
Qualitative
Time
10 minutes
LOD
0 AU
Analysis of cross reactivity
Evaluated
False positives
3 % (CI 95% range: 91.06-99.61, using samples collected prior to September 2019)
False negatives
7 % (CI 95% range: 85.09-94.46 versus PCR method)
Accuracy
94.42 % ( (IgM+IgG) (CI 95%[90.92-96.80]))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
60.87 % IgM
Clinical Sensitivity
91.3 % IgG
Type of antigen
nucleoprotein
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