COVID-19 Neutralizing Antibody Rapid Test Device
Manufactured by Innovation Biotech(Beijing) Co. Ltd., China - www.invbio.com
Device identification number
2287
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The COVID-19 Neutralizing Antibody Rapid Test is a lateral flow chromatographic immunoassay for qualitative detection of neutralizing antibody to SARS-CoV-2 in human whole blood,serum,or plasma as an aid in the evaluation of human anti-SARS-CoV-2 neutralizing antibody titer.
Assay Type
Immuno-Antibody
Time
15 minutes
LOD
1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4.61 %
False negatives
0.01 %
Precision
Evaluated
Accuracy
93.36 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.39 %
Clinical Specificity
99.9 %
Type of antigen
Nucleoprotein
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