Sars_Cov_2 NEUTRALIZING ANTIBODY Rapid Test Cassette GCCOV(NAb)-402b
Manufactured by Zhejiang Orient Gene Biotech Co. Ltd., China - https://www.orientgene.com/
Device identification number
2497
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC, Semi-automated
Physical Support
Lateral flow
Target type
Antibody, IgG
Specimen
Peripheral blood, Plasma, Serum, Venous whole blood, 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.1.526.1, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow immunochromatographic assay based on the principle of competitive binding. Neutralizing antibodies which may be present in the specimen compete against S-RBD conjugate for binding sites on the ACE2. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action along the cassette. Neutralizing antibodies to SARS-CoV-2, if not present in the specimen, will not saturate the binding sites of S-RBD coated on the particles. The S-RBD coated particles will then be captured by the ACE2, which is pre-coated on test line region, and a visible colored line will show up in the test line region. The color intensity of the test line decreases as the concentration of neutralizing antibodies increases. The colored line will not form in the test line region if there are sufficient neutralizing antibodies in the specimen, because they will saturate all the binding sites of the S-RBD coated on the particles. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking has occurred.
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Neutralization Antibody (NAb)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 0 on 68
False negatives
0 % 0 on 59
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Specificity
100 %
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