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 (RAT)
×No
Format
Manual, Near POC / POC
Target type
Antibody, IgG
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
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