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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



DROP-TECH

Manufactured by Promoitalia Group SpA, Italy - www.webpromoitalia.com 

Device identification number
1733
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
320 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
Based on the accuracy confirmed by studies, fales positives are not likely to occur.
Fn
Based on the accuracy confirmed by studies, fales negatives are not likely to occur.
Precision
evaluated
Accuracy
98 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
92.59 %
Type of antigen
nucleoprotein

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