SARS-CoV-2 Neutralizing Antibody Rapid Detection Kit (Colloidal Gold)
Manufactured by Shen Zhen Zi Jian Biotechnology Co. Ltd., China - http://www.szzijian.com/
Device identification number
2558
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antibody
Targets
spike protein
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://www.szzijian.com/
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunoassay
Time
15 minutes
Detection Principle
Colloidal gold
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.03 AU
False negatives
0.05 AU
Precision
Evaluated
Accuracy
95.47 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.16 %
Clinical Specificity
97.44 %
Type of antigen
Spike protein
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