SARS-CoV-2 Neutralizing Antibodies Test
Manufactured by Xiamen Wiz Biotech Co., Ltd, China - www.wizbiotech.com
Device identification number
1885
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Card
Target
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Fluorescence
LOD
0.3 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.53 (7 false positives were found in 1311 samples tested.)
Fn
0.46 (6 false negatives were found in 1311 samples tested.)
Precision
Evaluated
Accuracy
99.01 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.8 %
Clinical Specificity
99.14 %
Type of antigen
Other
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