ADVIA Centaur CP SARS-CoV-2 IgG (sCOVG)
Manufactured by Siemens Healthineers, Germany - www.siemens-healthineers.com
Device identification number
2022
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Other
Physical Support
Other
Target
Antibody, IgG
Specimen
Other, Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
Good correlation and strong relationship between Index values and neutralizing antibody titers
Assay Type
Immuno-Antibody
Method
Immunoassay
Measurement
Quantitative
Time
50 minutes
Subclass
Sandwich
LOD
0.5 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
-
Fn
-
Precision
Evaluated
Accuracy
IgG
Reproducibility
Evaluated
Robustness
Not 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%))
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