Rapid SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold)
Manufactured by Zhejiang Gene Science Co., Ltd, China - http://www.gene-science.com/
Device identification number
2569
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Target
Antibody, IgG
Specimen
Plasma, Serum, Whole blood
Pathogens detected
Coronaviruses (HCoV)
Commercial Status
Commercialised
Last Update
2021-08-25 10:19:21 CET
Comments
None
Assay Type
Immuno-Antibody
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Colloidal gold
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
0 %
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Specificity
100 %
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