Atellica IM SARS-CoV-2 Antigen (CoV2Ag)
Manufactured by Siemens Healthineers, Germany - www.siemens-healthineers.com
Device identification number
2015
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
26 minutes
Subclass
Sandwich
Detection Principle
Chemiluminescence
LOD
18.2 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
97.55 % ((CI: 94.37–99.20%))
Clinical Specificity
100 % ((CI:99.03%–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