Flu+COVID-19 Ag Test Kit
Manufactured by Guangdong Wesail Biotech Co. Ltd., China - http://en.wesailbio.com/
Device identification number
1470
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
560 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
10
False negatives
0.8
Precision
Evaluated
Accuracy
95.6 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
91.1 %
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