Dixion SARS-CoV-2 Neutralizing antibody test kit
Manufactured by Dixion Vertrieb medizinischer Geräte GmbH and Shenzhen Dymind Biotechnology Co. Ltd., China - www.dixion.de
Device identification number
2492
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The kit is used to detect the neutralizing antibody to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma or whole blood sample qualitatively. It is mainly used to identify individuals with acquired immune response to the SARS-CoV-2, and to evaluate the effectiveness of the vaccine clinical trials and mass vaccination. The novel coronavirus (SARS-CoV-2) belongs to the β genus. Structural proteins include spike protein (S), envelope protein (E), membrane protein (M), and nucleocapsid protein (N). The spike protein is the most important surface membrane protein of the novel coronavirus, which undertakes the function of binding the virus to the host cell membrane receptor and membrane fusion, and is an important site for host neutralizing antibodies. The SARS-CoV-2 neutralizing antibody can prevent the receptor binding domain (RBD) protein from binding to ACE2, thereby blocking the virus from contacting the host cell, and ultimately preventing the virus infection. This reagent uses the principle of colloidal gold immunochromatography to detect SARS-CoV-2 neutralizing antibodies in samples. The kit does not need to be carried out in the biosafety level 3 laboratory (BSL-3). It has the advantages of simple operation, strong specificity, high safety and low cost, and can realize rapid detection
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
9.3 %
False negatives
1.36 %
Precision
Evaluated
Accuracy
95.74 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.7 %
Clinical Specificity
98.63 %
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