Flowflex SARS-CoV-2 Antigen rapid test
Manufactured by ACON Laboratories, Inc - www.aconlabs.com
Device identification number
1468
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
03/15/2021 03:53
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
160 U/ml
Calibration
Not Evaluated
Crossreactivity
Evaluated
Fp
0.5 %
Fn
3.1 %
Precision
Evaluated
Accuracy
98.8
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.9
Type of antigen
Nucleoprotein
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