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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Anti-SARS-CoV-2 QuantiVac ELISA (IgG)

Manufactured by EUROIMMUN AG, Germany - www.coronavirus-diagnostics.com 

Device identification number
2743
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, IgG
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 Anti-SARS-CoV-2-QuantiVac-ELISA IgG (order no. EI 2606-9601-10 G) is suitable for the quantitative detection of antibodies against the S1 antigen of SARS-CoV-2 and enables the results to be given in standardized units (BAU / ml).
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
ELISA
Measurement
Quantitative
Time
120 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.2 % IgG (90.3-93.2)
Clinical Specificity
99.8 % IgG

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