SARS-CoV-2 Antigen ELISA
Manufactured by EUROIMMUN AG, Germany - www.coronavirus-diagnostics.com
Device identification number
2289
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Fully automated (robot), Lab-based, Manual, Semi-automated
Physical Support
Microtiter plate
Target type
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Laboratory diagnostic assay for direct pathogen detection by semiquantitative determination of the SARS-CoV-2-specific nucleocapsid protein in swab samples of the upper respiratory tract Supporting acute diagnostics, especially during COVID-19 outbreaks Established ELISA method – suitable for any diagnostic laboratory and completely automatable
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
ELISA
Measurement
Semiquantitative
Time
195 minutes
LOD
0.45 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.6 % ( (Antigen))
Clinical Specificity
100 % ( (Antigen))
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