COVID-19/Influenza A+B Antigen Combo Rapid Test
Manufactured by Hangzhou Clongene Biotech Co. Ltd., China - http://en.clongene.com/
Device identification number
1365
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Target type
Antigen
Specimen
Nasopharyngeal 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
LOD
2300 TCID50/ml
Clinical Sensitivity
91 % (95% CI: 82.8%-95.6%)
Clinical Specificity
100 % (95% CI: 98.2%-100%)
Type of antigen
SARcov2, influenza A+B viral nucleoprotein antigens
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