COVID-19 Real-time PCR Testing Kit
Manufactured by Edinburgh Genetics Limited, United Kingdom - eggenetics.com
Device identification number
155
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
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Positive control
endogenous internal control detection systemPositive control: pseudovirus containing target sequences
Negative control
Negative control: pseudovirus with internal control fragments
Analytical Sensitivity
100 % (Coincidence rate 100% with 5 positive references and 12 negative references)
Analytical Specificity
100 % (tested negative with 16 species of microorganisms)
Clinical Specificity
Coincidence rate 100% with 5 positive references and 12 negative references
Throughput
single tubes
Type of antigen
SARS-CoV-2 antigen
Notes
https://img1.wsimg.com/blobby/go/0bb0cb4f-fcc3-4a80-a429-81e323b73197/downloads/COVID-19%20Real-time%20PCR%20Testing%20Kit%20%20v2.0%20.pdf?ver=1586095524802
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