COVID-19 Lyophilised Nucleic Acid Kit
Manufactured by Prestige Diagnostics UK Ltd., United Kingdom - www.prestigediagnostics.co.uk
Device identification number
1075
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
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