TODA Covdiag Saliva
Manufactured by TODA PHARMA, France - https://www.todapharma.com/
Device identification number
1913
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein, spike protein
Specimen
Saliva, Sputum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Please kindly note that the above mentioned performance rates were assessed on saliva specimens.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
Detection Principle
Colorimetry
LOD
125 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.42 % (On 236 negative samples confirmed by RT-PCR, 235 were also negative with our test : 1 false positive)
False negatives
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
93.9 %
Clinical Specificity
99.9 %
Type of antigen
Nucleocapsid protein
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