Aria COVID-19 Ag Rapid Test
Manufactured by CTK Biotech Inc. - https://ctkbiotech.com/about/ctk-branding/
Device identification number
1853
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-03-15 01:42:35
Comments
Study has shown that the CTK Aria COVID-19 Ag Rapid Test can detect both the Sars-Cov-2 UK variant and South Africa variant. The test is registered Australia, Brazil, EU and 20 other additional countries.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
280 AU ()
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
7.7 % ()
Precision
Evaluated
Accuracy
100 % ()
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.3 % ()
Clinical Specificity
100 % ()
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