COVID-19 Antigen Saliva Test Kit
Manufactured by Azure Biotech Inc., United States - www.azure.bio
Device identification number
1911
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Target type
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Not available
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
95.3 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90 %
Clinical Specificity
97 %
Type of antigen
Other
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