Epithod SARS-CoV-2 qAg Test Kit
Manufactured by DxGen Corp., South Korea - www.dxgenco.com
Device identification number
1717
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
3 minutes
LOD
10000 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
A measured immunochromatic intensity is larger than cut-off value mainly due to non-specific binding
False negatives
A measured immunochromatic intensity is lower than cut-off value mainly due to limit of sensitivity
Precision
Not evaluated
Accuracy
100 % ((Antigen))
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
96 % ((Antigen))
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