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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

genesig Real-Time PCR COVID-19

Manufactured by Genesig, United Kingdom - www.genesig.com/ 

Device identification number
301
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Includes data on reproducibility and repeatability
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
0.58 copies/μl
Positive control
yes
Negative control
yes
Analytical Sensitivity
95 %
Analytical Specificity
tested negative with 10 species of microorganisms
Clinical Sensitivity
98 %
Clinical Specificity
100 %
Throughput
single tubes
Notes
https://www.genesig.com/products/10039-coronavirus-covid-19-ce-ivd; https://www.genesig.com/assets/files/Path_COVID_19_CE_IVD_IFU_Issue_3.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