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 (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
NA
False negatives
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