FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device
Manufactured by Assure Tech (Hangzhou) Co. Ltd., China - www.diareagent.com
Device identification number
1370
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antigen
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
immunochromatography?
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
2102.4 AU
False positives
Not available
False negatives
Not available
Accuracy
98.5 % ((COVID-19:98.5%; Influenza A:88.4%, Influenza B:88.9%, RSV:97.4%, Adenovirus:96.3%))
Clinical Sensitivity
97.3 % ((COVID-19:97.3%; Influenza A:83.3%, Influenza B:82.4%, RSV:96.2%, Adenovirus:95.2%))
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