TODA Autotest Nasal Covid-19
Manufactured by TODA PHARMA, France - https://www.todapharma.com/
Device identification number
2054
CE Marking
×No
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Anterior nasal swab, Nasal swab
Lineages detected
Commercial Status
Commercialised
Last Update
2021-05-11 09:51:12 CET
Comments
Please kindly note that the above mentioned performance rates are based on nasal swab.
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
0 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
3.38 % (On 59 negative samples confirmed by RT-PCR, 57 were also negative with our test : 2 false positives)
Fn
0 % On 34 positive samples confirmed by RT-PCR, 34 were also negative with our test : 0 false negative
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94 %
Clinical Specificity
99 %
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