ADVIA Centaur XP/XPT SARS-CoV-2 IgG (sCOVG)
Manufactured by Siemens Healthineers, United States - https://www.siemens-healthineers.com
Device identification number
2024
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Other
Physical Support
Other
Target
IgG
Specimen
Other, Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-05-03 11:48:03
Comments
Good correlation and strong relationship between Index values and neutralizing antibody titers. Detection: Chemiluminescence
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Quantitative
Time
58 minutes
Subclass
Sandwich
Detection Principle
Chemiluminescence
LOD
0.5 AU ()
Calibration
Evaluated
Crossreactivity
Evaluated
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%))
Type of antigen
Other
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