SARS-CoV-2 Neutralizing antibody Test KIT (Colloidal gold)
Manufactured by Biosino Bio-Technology and Science Inc., China - www.sinobio.com.cn/
Device identification number
2865
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product with Colloidal Gold is used in the qualitative analysis of SARS-CoV-2 Neutralizing antibody in the samples about serum, plasma and whole blood. It is also used to monitor the process of different immune stages and evaluate the effect after vaccination. If there is a positive result, it indicates that there may be neutralizing antibody in the sample, but it cannot rule out the false positive caused by inhibitory peptides or small molecule inhibitors. If there is negative result, it indicates that the amount of neutralizing antibody is lower than the detection limit. The negative result can not rule out the possibility that there is neutral antibody in subjects.
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
0.1 ng/mL
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90 %
Clinical Specificity
98 %
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