COVID-19 Neutralizing Antibody Rapid Detection Kit（Colloidal Gold）
Manufactured by Pro-med (Beijing) Technology Co. Ltd., China - www.pmdt.com.cn
Device identification number
2485
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card, Cassette
Target type
Antibody
Specimen
Peripheral blood, Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
None
Assay Type
Immuno-Antibody
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Colloidal gold
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.33 %
False negatives
4.9 %
Precision
Evaluated
Accuracy
97.22 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.1 %
Clinical Specificity
98.67 %
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