SARS-CoV-2 Antigen Rapid Test Kit (Colloidal gold Immunoassay)
Manufactured by Wuhan UNscience Biotechnology Co. Ltd., China - www.uni-science.com
Device identification number
1655
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
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
10 minutes
Detection Principle
Colorimetry
LOD
0.001 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.43 %
False negatives
3.67 %
Precision
Evaluated
Accuracy
98.53 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.33 %
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