SARS-CoV-2 Virus Neutralization Test Kit (Colloidal gold method)
Manufactured by Nanjing Synthgene Medical Technology Co. Ltd., China - http://www.syngenemed.com/
Device identification number
2822
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Card, Cassette, Lateral flow, Strip
Target type
Antibody
Specimen
Plasma, Serum, Whole blood, Whole blood with anti-coagulants
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 does not require any equipment, and is used to qualitatively detect the neutralizing antibody of the new coronavirus (SARS-CoV-2) in the human body. The entire detection process only takes 10-15 minutes. It is easy to operate and has high sensitivity. It is convenient for the screening of people vaccinated with the new coronavirus vaccine and the judgment of the effect after vaccination
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Colloidal gold
LOD
100 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.67 %
False negatives
0.5 %
Precision
Evaluated
Accuracy
99.45 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.33 %
Clinical Specificity
99.5 %
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