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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG

Manufactured by Ortho Clinical Diagnostics, United Kingdom - www.orthoclinicaldiagnostics.com/ 

Device identification number
795
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Lab-based
Target type
Antibody, IgG
Specimen
Serum
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-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
CLIA
Measurement
Qualitative
Time
37 minutes
Subclass
Sandwich, Double
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Accuracy
100 % (95% CI: 99,1–100,0%)
Reproducibility
Evaluated
Clinical Specificity
90 % (95% CI: 76,3–97,2%)
Type of antigen
Spike protein

Related Scientific Literature

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