OraWell COVID-19 NEUTRALIZING ANTIBODY Rapid Test Device - CO_04 (Check vaccination coverage)
Manufactured by Jiangsu Well Biotech Co. Ltd., China - https://www.wellbioscience.com/
Device identification number
2496
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC, Semi-automated
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG
Specimen
Peripheral blood, Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.616, B.1.617.1 (Kappa), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
COVID-19 neutralizing antibody Test is a chromatographic immunoassay for the detection of neutralizing antibodies to COVID-19 in human whole blood, serum and plasma. The test device contains: 1) Colloidal gold-labeled recombinant SARS-CoV-2 RBD antigen; 2) Detection line (T line) immobilized with SARS-CoV-2 RBD antigen for detecting COVID-19 neutralizing antibody and Control line(C line) immobilized with quality contro! antibody on nitrocellulose membrane. Ifthe sample contains COVID-19 neutralizing antibody, it will bind to antigens coated on colloidal gold, and a pink colored band will develop in the test region (T) on the membrane.If there is no COVID-19 neutralizing antibody in the sample, the pink colored band in the test region (T) will not appears and that suggests a negative result.
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4.6 % (7 on 152)
False negatives
0 % 0 on 371
Precision
Evaluated
Accuracy
97.65 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.39 %
Clinical Specificity
99.9 %
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