SARS-CoV-2 NeutraLISA
Manufactured by EUROIMMUN AG, Germany - www.coronavirus-diagnostics.com
Device identification number
2751
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Fully automated (robot), Lab-based, Manual, Semi-automated
Physical Support
Microtiter plate
Target type
Antibody, IgA, IgG, IgM
Specimen
Plasma, Serum
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The EUROIMMUN SARS-CoV-2-NeutraLISA is a surrogate neutralisation test for the detection of neutralising antibodies, which inhibit binding if the receptor binding domain (RBD) of SARS-CoV-2 to ACE2 receptors of human cells. The SARS-CoV-2-NeutraLISA can be processed in a standardized and automated manner in every routine laboratory.
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
ELISA
Measurement
Semiquantitative
Time
105 minutes
Subclass
Neutralization Antibody (NAb)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.9 %
Clinical Specificity
99.7 %
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