COVID-19/Flu A/B Antigen Combo Rapid Test
Manufactured by GenSure Biotech Inc., China - www.gensbio.com/
Device identification number
1454
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
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
LOD
50 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
The samples collected were contaminated, do not follow the instructions manual, etc.
False negatives
Samples collected contained low levels of the virus, do not follow the instructions manual, etc.
Precision
Evaluated
Accuracy
98.9 % ((COVID-19))
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.9 % ((COVID-19))
Type of antigen
nucleoprotein
Notes
Accuracy: 97.5 (Influenza A); 96.9 (Influenza B). Clinical sensitivity: 91.7 (Influenza A); 86.2 (Influenza B)
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