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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

EasyCOV

Manufactured by Sys2diag, France - www.sys2diag.cnrs.fr/ 

Device identification number
1045
CE Marking
×No
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Data provided by the Manufacturer; https://www.skillcell-alcen.com/sites/skillcell-alcen/files/pdf/press/Clinical-assessment-of-EasyCov-v10_1.pdf https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 information provided by the manufacturer; https://www.skillcell-alcen.com/products-licensing/easycov-covid-19-salivary-rapid-molecular-test
Assay Type
Nucleic acid-Other
Method
RT-PCR
Time
60 minutes
Positive control
positive saliva sample
Negative control
Negative saliva sample
Analytical Sensitivity
72.7 %
Analytical Specificity
95.7 %
Throughput
1 single tube
Type of antigen
nucleocapsid recombinant antigen
Notes
https://www.skillcell-alcen.com/sites/skillcell-alcen/files/pdf/EasyCOV-process-EN.pdf

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