VITROS Immunodiagnostic Products SARS-CoV-2 Antigen
Manufactured by Ortho Clinical Diagnostics, United Kingdom - www.orthoclinicaldiagnostics.com/
Device identification number
1200
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Automated, Lab-based
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.orthoclinicaldiagnostics.com/en-us/home/technical-documents
Assay Type
Immuno-Antigen
Rapid Diagnostic
No
Reader Required
Yes
Method
CLIA
Measurement
Qualitative
Time
48 minutes
Subclass
Sandwich, Double
Detection Principle
Chemiluminescence
LOD
25 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Clinical Sensitivity
95 % (CI: 92.0% - 100%)
Clinical Sensitivity
98 % (95% CI: 92.2–99.4%)
Clinical Specificity
98.9 % (95% CI: 96.3-99.9%)
Type of antigen
Nucleocapsid protein
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