2019-nCoV Neutralizing Antibody Assay (Colloidal Gold)
Manufactured by Zybio Inc., China - https://www.zybio.com/en/
Device identification number
2220
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Colloidal gold
LOD
1.25 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.22 %
False negatives
1.67 %
Precision
Evaluated
Accuracy
98.02 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.59 %
Clinical Specificity
98.32 %
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