COVID-19 IgG Confirmation
Manufactured by DIA.PRO Diagnostic Bioprobes Srl, Italy - www.diapro.it
Device identification number
539
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Microplate
Target type
Antibody, IgG
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Module-based Enzyme-Immuno-Assay (ELISA) for the confirmation of samples positive for IgG antibodies to COVID-19 in first screening. The test can be used in addition to identify the specificity of antibodies to the major immunodominant COVID-19 antigens
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Quantitative
Time
105 minutes
Detection Principle
Fluorescence
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Specificity
100 %
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