Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Lyophilised Nucleic Acid Kit

Manufactured by Prestige Diagnostics UK - www.prestigediagnostics.co.uk 

Device identification number
1075
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
03/26/2021 09:05
Comments
Information provided by the manufacturer: qualitative assay; human respiratory tract secreation sample; Sensitivity limit: 500copies/ml; coincidence rate of Positive reference: 98%; Coincidence rate ofNegativereference: 100%; Precision: CV% ?5%. https://f95fa0e3-ef79-4e7f-a6df-88d8f019025a.filesusr.com/ugd/ca8cd1_d64bc7a5da794aa5be81bcc37b468717.pdf
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
500 cpm
Positive control
SARS-CoV-2 ORF1ab and Nucleoprotein gene
Negative control
RNase-free and nuclease-free distilled water
Throughput
48 samples/run
Notes
https://f95fa0e3-ef79-4e7f-a6df-88d8f019025a.filesusr.com/ugd/ca8cd1_d64bc7a5da794aa5be81bcc37b468717.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