Vaxxitest 2019-nCoV Neutralizing Antibody Test
Manufactured by Unibioscience AS, Turkey - www.unibioscience.com
Device identification number
2521
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Fingertip, Lateral flow, Strip
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-08-03 09:11:49 CET
Comments
MAIN COMPONENTS of Vaxxitest™ Reagent: composed of test strips, plastic parts (box), buffer, and dropper; Test Strip main components: 1. Recombinant protein ACE-2 (fixed in the nitrocellulose membrane detection area), Goat anti-rabbit lgG polyclonal antibody (fixed on nitrocellulose membrane quality control area). 2. Colloidal gold-labelled novel coronavirus protein RBD (located on polyester cellulose membrane); colloidal gold-labelled rabbit lgG. Buffer: mainly composed of disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride. Colorimetric Card Additional preparation for testing: specimen collection containers and timer.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
20 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
6 %
Fn
2 %
Precision
Evaluated
Accuracy
96.24 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
97.98 %
Clinical Specificity
94.74 %
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