ichroma COVID-19/Flu Ag Combo
Manufactured by Boditech Med Inc, South Korea - https://www.boditech.co.kr/en
Device identification number
1448
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Fluorescence
LOD
55 IU/ml
Calibration
evaluated
Crossreactivity
evaluated
Precision
evaluated
Accuracy
98.6 % ((antigen) )
Reproducibility
evaluated
Robustness
not evaluated
Clinical Sensitivity
100 % ( (antigen))
Type of antigen
nucleoprotein
Notes
Accuracy: 98.1 (Flu A) 98.1 (Flu B). Clinical sensitivity 93.8 (Flu A) 93.8 (Flu B)
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