qCOVID-19
Manufactured by Genomica Sau, Spain - genomica.com/
Device identification number
185
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Targets
spike protein/gene
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
validated at the National Center for Microbiology (Instituto de Salud Carlos III, Spanish National Reference Center) with a panel of 80 samples https://sonanano.com/wp-content/uploads/2020/09/Sona-Nanotech-COVID-19-LFA-Procedure-Card-PC-CV2-V00-04-sept-2020-2.pdf
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
Positive control
positive control, not specified
Clinical Sensitivity
100 %
Clinical Specificity
98 %
Throughput
48 samples/run
Type of antigen
spike protein antigen from SARS-CoV and SARS-CoV2
Notes
http://genomica.com/covid-19/?lang=en
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