Coronavirus (SARS-CoV 2) Antigen - Oral Fluid
Manufactured by Tody Laboratories Int., Romania - www.todylaboratories.com/
Device identification number
1934
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Deep (cough) sputum, Saliva, Sputum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Minimum detection limit = 100 pg/ml
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
From studies performed by manufacturer, the false positive rate is 0.7% (specificity = 99.3%)
False negatives
From studies performed by manufacturer, the false negative rate is 9.9% (sensitivity = 90.1%)
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.1 %
Clinical Specificity
99.3 %
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