SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold Method)
Manufactured by Hunan Zhongke Lanhai Biotechnology Co. Ltd., China - www.zoonkr.net
Device identification number
3046
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antibody
Antibody type
Monoclonal
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Sample collection device
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Colloidal gold
LOD
0.25 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
10 %
False negatives
5.5 %
Precision
Evaluated
Accuracy
92 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90 %
Clinical Specificity
94.5 %
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