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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

ANTIGEN RAPID TEST CASSETTE SARS-COV-2 (SWAB)

Manufactured by A. Menarini Diagnostics, Italy - www.menarinidiagnostics.com 

Device identification number
1608
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Accuracy
98.74 % (95%CI: 96.80%-99.66%)
Clinical Sensitivity
96.72 % (95%CI: 88.65%-99.60%)
Clinical Specificity
99.22 % (95%CI: 97.21%-99.91%)
Type of antigen
nucleocapside 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