COVID-19 (SARS-CoV-2) Neutralizing Antibody (Double Antigen Sandwich) Test Kit (Colloidal Gold)
Manufactured by Anhui Deep Blue Medical Technology Co. Ltd., China - www.dbluemedical.com
Device identification number
2189
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card, Cassette, Dipstick, Lateral flow, Strip
Target type
Antibody
Specimen
Plasma, Serum, Venous whole blood, 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
This product is used for in vitro qualitative detection of novel coronavirus(COVID-19)(Sars-CoV-2) neutralizing antibody in human serum, plasma, whole blood and/or fingertip blood. This product uses double antigen sandwich method for detection. The gold label pad is marked with S-RBD-mFc C-terminal, and the detection line is coated with S-RBD-mFc N-terminal. When the sample contains neutralizing antibody, it will bind to S-RBD-mFc C-terminal, then the complex will be captured by pre-coated S-RBD-mFc N-terminal and the T line will show color. When the sample does not contain neutralizing antibodies, the T line will not show color. The quality control line is coated with goat anti-mouse polyclonal antibody. The C line will show color regardless of whether the sample contains neutralizing antibody.
Assay Type
Immuno-Antibody
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Colloidal gold
LOD
20 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
3 %
False negatives
7 %
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93 %
Clinical Specificity
97 %
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