COVID-19 & Influenza A/B Antigen Combo Test Device
Manufactured by Assure Tech. (Hangzhou) Co., Ltd - http://www.diareagent.com/
Device identification number
1371
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antigen
Specimen
Other
Commercial Status
Commercialised
Last Update
03/25/2021 05:58
Comments
immunochromatography?
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
Fp
Not available
Fn
Not available
Accuracy
98.5 % (COVID-19:98.5%, Influenza A:88.4%, Influenza B:88.9%)
Clinical Sensitivity
97.3 % (COVID-19:97.3%, Influenza A:83.3%, Influenza B:82.4%)
Notes
Rapid diagnostic test colloidal gold
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