COV19-ID Kit
Manufactured by genedrive, United Kingdom - www.genedrive.com
Device identification number
2524
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cartridge
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
Simple, rapid POC test with early positive detection (from 7.5 mins). Standard nasal swab into buffer, dispense into lyophilised, RT cartridge and into instrument reader. Displays result in 17 minutes as negative, contains internal control for test validity and kit contains all reagents needed for 25 tests, as well as containing control swabs. User training is minimal and the 600g instrument is highly portable, making it ideal for deployment in any testing location.
Assay Type
Unknown
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Other ()
Method
LAMP
Measurement
Qualitative
Time
17 minutes
LOD
500 copies/ml
Positive control
PROCEEDx™ FLOQ® SARS-CoV-2 Swab Positive Sample
Negative control
PROCEEDx™ FLOQ® SARS-CoV-2 Swab Negative Sample
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
98 %
Clinical Specificity
99 %
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