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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 IgM

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

Device identification number
2711
CE Marking
Yes
HSC common list (RAT)
×No
Format
Semi-automated
Physical Support
Microtiter plate
Target type
IgM
Specimen
Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N.A
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
40 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
97.8 % IgM
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
93.8 % IgM
Clinical Specificity
99.4 % IgM

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