NAISSA SARS-COV-2 S1/S2/RBD Neutralizing antibodies
Manufactured by Neomedica d.o.o., Serbia - www.neomedica.rs
Device identification number
2377
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Cartridge
Target type
Antibody, IgG
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Enzyme-linked immunosorbent assay for quantitative determination of neutralizing IgG antibodies to S1/S2/RBD antigens of SARS-CoV-2 virus
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
ELISA
Measurement
Quantitative
Time
105 minutes
Subclass
Enzyme-linked
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % There are no false positives
False negatives
0 % There are no false negatives
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.4 %
Clinical Specificity
100 %
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