COVID-19 Neutralizing Antibody Test Kit (Colloidal Gold)
Manufactured by Bioneovan Co. Ltd., China - www.bioneovan.com
Device identification number
2205
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Near POC / POC
Physical Support
Card, Cassette
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This kit is used for in-vitro semi-quantitative determination of novel corona virus neutralizing antibodies in human serum, plasma, venous whole blood or peripheral whole blood.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Sample preparation
Method
Immunochromatography
Measurement
Semiquantitative
Time
15 minutes
Subclass
Capture
Detection Principle
Colloidal gold
LOD
1.1 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.9 %
False negatives
1.3 %
Precision
Not evaluated
Accuracy
98.9 % ((95% CI: 98.0%~99.4%))
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
98.7 % (（95% CI: 96.6%~99.5%）)
Clinical Specificity
99.1 % (（95% CI: 97.9%~99.6%）)
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