COVID-19 Antigen Saliva Test Kit
Manufactured by Assure Tech. (Hangzhou) Co., Ltd - http://www.diareagent.com/
Device identification number
1579
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Other
Target
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
03/25/2021 06:03
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
Not available
Fn
Not available
Precision
evaluated
Accuracy
95.3 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
90 %
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