2019- nCoV and Flu A/B Antigen Combo Rapid Test Kit (Colloid Gold Immunoassay)
Manufactured by Ustar Biotechnologies (Hangzhou) Ltd, China - en.bioustar.com
Device identification number
1874
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
The 2019- nCoV and Flu A/B Antigen Combo Rapid Test is used for in vitro qualitative detection of the nucleoprotein antigen of influenza A, influenza B and Novel Coronavirus (2019- nCoV) in samples from human oropharyngeal swabs, nasopharyngeal swabs and saliva.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colorimetry
LOD
960 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
NA
Fn
NA
Precision
Evaluated
Accuracy
97.94 % ((96.12%-99.05%）)
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
95.65 % ((91.25%-98.23%))
Clinical Specificity
99.27 % ((97.40%-99.91%))
Type of antigen
Nucleoprotein
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