COVID-19 Salivary Antigen Rapid Test Kit（Colloidal Gold）
Manufactured by Jiangsu Konsung Bio-Medical Science And Technology Co. Ltd., China - www.konsung.com
Device identification number
1924
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
N/A
Assay Type
Immuno-Antigen
Reader Required
Yes
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
50 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
8 AU
False negatives
5 AU
Precision
Evaluated
Accuracy
99.03 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.3 %
Clinical Specificity
99.34 %
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