Coronavirus (SARS-CoV 2) Antigen - Swab Specimen
Manufactured by Tody Laboratories Int., Romania - www.todylaboratories.com/
Device identification number
1935
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Detection limit: 100 TCID50/ml. Performance characteristics using the nasal swab specimen: Sensitivity: 92.9% Specificity: >99.9% Accuracy: 96.2% False positives (nasal swab specimen): From studies performed by manufacturer, the false positive rate is <0.1% (specificity = >99.9%) False negatives (nasal swab specimen): From studies performed by manufacturer, the false negative rate is 7.1% (sensitivity = 92.9%)
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 % (From studies performed by manufacturer, the false positive rate is 1.0% (specificity = 99.0%))
False negatives
3.6 % (From studies performed by manufacturer, the false negative rate is 3.6% (sensitivity = 96.4%))
Precision
Evaluated
Accuracy
98.2 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.4 %
Clinical Specificity
99 %
Type of antigen
Nucleocapsid (N) 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