TODA CORONADIAG Ag
Manufactured by TODA PHARMA, France - https://www.todapharma.com/
Device identification number
1466
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
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 figures are based on patients having symptoms between 1 and 4 days after its onset.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Extraction kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
502.377 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % (On 129 negative samples confirmed by RT-PCR, 129 were also negative with our test : 0 false positive)
False negatives
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 %
Clinical Specificity
100 %
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