TODA CORONADIAG Ag
Manufactured by TODA PHARMA, France - https://www.todapharma.com/
Device identification number
1466
CE Marking
✓Yes
HSC common list
✓Yes
HSC mutual recognition
✓Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 08:07:30 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
502.377 AU
Calibration
Not evaluated
Crossreactivity
evaluated
Fp
0 % (On 129 negative samples confirmed by RT-PCR, 129 were also negative with our test : 0 false positive)
Fn
1.37 % (On 73 positive samples confirmed by RT-PCR, 72 were also negative with our test : 1 false negative)
Precision
evaluated
Accuracy
99.5 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
98.6 %
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