SARS-COV-2 Antigen Rapid Test (Saliva)
Manufactured by Zhuhai Encode Medical Engineering Co., Ltd, China - http://www.encode.com.cn/
Device identification number
1616
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Saliva
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-08-27 09:38:32 CET
Comments
We update the information of our product
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colorimetry
LOD
530 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
97.14 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.86 %
Clinical Specificity
100 %
Type of antigen
Nucleocapsid protein
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