SARS-CoV-2 Ultra Rapid Mobile Antigen Test
Manufactured by Canary Global Inc., Canada - www.canarydetect.com
Device identification number
2547
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge
Target type
Antigen
Specimen
Nasopharyngeal swab, Saliva
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), 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
Our device is equipped with Sensor coated system having monoclonal antibody against SARS-CoV-2 nucleocapsid protein. During testing SARS-CoV-2 antigens possibly present in the Saliva and Nasopharyngeal specimens react with the bio receptor antibodies nanoparticles present in the test. The resulting complex results in a digital electrical signal that is recognized by the systems software on the mobile app, which results in a plus (+) sign on the mobile app indicating a positive result. If the antigens are not present in the specimens, no digital electrical signal is generated which appears as a minus (-) sign on the display of the app, indicating a negative result.
Assay Type
Immuno-Antigen
Method
Immunoassay
Measurement
Qualitative
Time
2 minutes
Subclass
Other ()
LOD
AU 100
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.83 % (Saliva: 1 False Positive out of 120 Negative)
False positives
0.83 % (Nasopharyngeal: 1 False Positive out of 120 Negative)
False negatives
3.6 % (Saliva: 4 False Negative out of 111 Positive)
False negatives
2.7 % (Nasopharyngeal: 3 False Negative out of 111 Positive)
Precision
Evaluated
Accuracy
99 % (Saliva: >99 (Antigen))
Accuracy
99 % (Nasopharyngeal: >99 (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.4 % (Saliva: 96.4 (Antigen))
Clinical Sensitivity
97.3 % (Nasopharyngeal: 97.3 (Antigen))
Clinical Specificity
99.17 % (Saliva: 99.17 (Antigen))
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