Rapid Response COVID-19 Antigen Rapid Test
Manufactured by BTNX Inc., Canada - www.btnx.com/
Device identification number
1236
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.btnx.com/files/1110032811V5_COVID-19_Antigen_Rapid_Test_Device.pdf
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
502.38 TCID50/ml
Analysis of cross reactivity
Evaluated
False positives
0 AU
False negatives
5 AU
Precision
Evaluated
Accuracy
97.2 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.2 %
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