SARS-CoV-2 Antigen Rapid Test (Saliva)
Manufactured by Xiamen Wiz Biotech Co. Ltd., China - www.wizbiotech.com
Device identification number
1886
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card
Target type
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
NO.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colorimetry
LOD
170 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % No false positives were found in 899 samples tested.
False negatives
1.78 % (16 false negatives were found in 899 samples tested.)
Precision
Evaluated
Accuracy
98.22 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.35 %
Clinical Specificity
100 %
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