COVID-19 Ag Saliva Test Kit
Manufactured by Guangdong Wesail Biotech Co. Ltd., China - http://www.wesailbio.com
Device identification number
2266
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
no
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
1600 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
5 AU
False negatives
10 AU
Precision
Evaluated
Accuracy
97.5 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
90.1 %
Clinical Specificity
99 %
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