DigiGENE™ COVID-19 Integrated Molecular Test
Manufactured by Canary Global Inc., Canada - www.canarydetect.com
Device identification number
2948
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge
Target type
Nucleic acid
Specimen
Mid-turbinates swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A, Influenza B, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Canary Global Inc’s DigiGENE™ COVID-19 Integrated Molecular Test Hub is an easy-to-use rapid molecular diagnostic test with cloud-based analytics to track COVID-19 spread in real- time. This test utilizes RT-LAMP technology to detect RNA of the N-gene & E-gene from SARS-CoV-2 virus. This technology can create a signal from a few copies of RNA within 20 minutes. This test consists of reusable DigiGENE Hub device and single use sample holder and sensor cartridge.
Assay Type
Nucleic acid-Other
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other ()
Method
LAMP
Measurement
Qualitative
Time
20 minutes
LOD
600 copies/ml
Clinical Sensitivity
96 %
Clinical Specificity
98 %
Throughput
Lower than 24 samples per run
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