COVDIAG SALIVA
Manufactured by TODA PHARMA, France - https://www.todapharma.com/
Device identification number
1913
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Saliva, Sputum
Commercial Status
Unknown
Last Update
2021-06-09 08:28:57 CET
Comments
Please kindly note that the above mentioned performance rates were assessed on saliva specimens.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
125 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.42 % (On 236 negative samples confirmed by RT-PCR, 235 were also negative with our test : 1 false positive)
Fn
7.1 % (On 169 positive samples confirmed by RT-PCR,157 were also positive with our test: 12 false negatives)
Precision
Evaluated
Accuracy
96 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92 %
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