COVID-19 Neutralizing Antibody Test Kit
Manufactured by Guangdong Wesail Biotech Co., Ltd. - http://www.wesailbio.com
Device identification number
1668
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
03/18/2021 09:03
Assay Type
Other
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0
Calibration
not evaluated
Crossreactivity
not evaluated
Fp
1.6 %
Fn
4.6 %
Precision
evaluated
Accuracy
97.9 %
Reproducibility
not evaluated
Robustness
evaluated
Clinical Sensitivity
95.4 %
Notes
rapid diagnostic test cassette colloidal gold
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