Atellica IM SARS-CoV-2 IgG (sCOVG)
Manufactured by Siemens Healthineers, Germany - www.siemens-healthineers.com
Device identification number
2023
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Good correlation and strong relationship between Index values and neutralizing antibody titers.
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Quantitative
Time
25 minutes
Subclass
Sandwich
LOD
0.5 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.41 % (@ 21 days after PCR: (95% CI):92.74%–98.54%)))
Clinical Specificity
99.9 % ((95% CI: 99.64%–99.99%))
Notes
support: Magnetic particles
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