Imegen SARS-CoV-2 plus
Manufactured by Imegen, Spain - www.imegen.es/
Device identification number
1115
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
https://imegen.es/wp-content/uploads/2020/08/IMG-366-Instructions-for-use.pdf; nasal swab, nasopharyngeal swab, and oropharyngeal swab samples
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
80 minutes
LOD
20 copies/reaction
Positive control
Spike glycoprotein gene (S); small envelope protein gene (E); the ORF1ab gene, and the GUS-B gene ( endogenous positive control a system that detects the human beta-glucuronidase gene).
Negative control
Nuclease-free water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Throughput
96 samples/run
Notes
https://imegen.es/inicio/kits-de-analisis/imegen-sars-cov-2-plus/
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