Dimension Vista SARS-CoV-2 IgG (CV2G)
Manufactured by Siemens Healthineers, Germany - www.siemens-healthineers.com
Device identification number
2025
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
-
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Semiquantitative
Time
16 minutes
LOD
600 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
IgG
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
100 % (@ 14 days after PCR: 100.0% (CI 95%: 96.2%–100.0%))
Clinical Specificity
100 % (Clinical specificity: 100.0% (CI 95% : 99.8%–100.0%))
Type of antigen
Other
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