Toda Coronadiag +
Manufactured by TODA PHARMA, France - https://www.todapharma.com/
Device identification number
1959
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antibody, IgG, IgM
Specimen
Peripheral blood, Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
Please kindly note that the above mentioned performance rates are valid for IgG and IgM. Please kindly note that the performance rates are based on specimen which have been assessed between Day 14 and Day 19 after onset of symptoms.
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
0 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
0 %
Precision
Evaluated
Accuracy
100 % IgG
Accuracy
100 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
100 % IgM
Clinical Specificity
100 % IgG
Clinical Specificity
100 % IgM
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