AFIAS COVID-19/Flu Ag Combo
Manufactured by Boditech Med Inc, South Korea - https://www.boditech.co.kr/en
Device identification number
1449
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual, Semi-automated
Physical Support
Cartridge, Cassette, Chip
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Lineages detected
Commercial Status
Commercialised
Last Update
2021-06-25 10:23:05 CET
Comments
The sens/spec of this kit can be compared with AFIAS Covid 19 Ag product (Device Identification number : 1989). https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/1989
Assay Type
Immuno-Antigen
Rapid Diagnostic
No
Reader Required
Yes
Method
Immunochromatography
Measurement
Semiquantitative
Time
12 minutes
Subclass
Membrane-based
LOD
56 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1 AU
Fn
1 AU
Precision
Evaluated
Accuracy
99.3 %
Reproducibility
Evaluated
Robustness
Not Evaluated
Clinical Sensitivity
% (95%CI:81.5% - 99.8%)
Clinical Specificity
% (95%CI: 96.0% - 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