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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CHORUS SARS-CoV-2 ANTIGEN

Manufactured by DIESSE Diagnostica Senese SPA, Italy - www.diesse.it 

Device identification number
2708
CE Marking
Yes
HSC common list (RAT)
×No
Format
Semi-automated
Physical Support
Microtiter plate
Target type
Antigen
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
ELISA
Measurement
Semiquantitative
Time
90 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
100 % (Antigen)
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
100 % (Antigen)
Clinical Specificity
100 % (Antigen)

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