COVID-19 & M. pneumoniae Antigen Combo Test Device
Manufactured by Assure Tech (Hangzhou) Co. Ltd., China - www.diareagent.com
Device identification number
1372
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
0 AU
Accuracy
87.8 % ((COVID-19:87.8%; M. pneumoniae:96.6%))
Clinical Sensitivity
75.8 % ((COVID-19:75.8%, M. pneumoniae:91.4%))
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