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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Artron COVID-19 Antigen Test

Manufactured by Artron Laboratories Inc, Canada - http://www.artronlab.com/ 

Device identification number
1618
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-07-13 05:53:59 CET
Comments
The unit of LoD is TCID50/mL
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
1000 AU
Crossreactivity
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Precision
Evaluated
Accuracy
99.67 % ( (Nasal), )
Accuracy
98.25 % ((Nasopharyngeal))
Reproducibility
Evaluated
Robustness
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.67 % ( (Nasal))
Clinical Sensitivity
91.67 % ( (Nasopharyngeal))
Clinical Specificity
100 % ((Nasal, Nasopharyngeal))
Type of antigen
nucleoprotein
Type of antigen
Nucleoprotein
Notes
Rapid diagnostic test cassette

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