bKIT Virus Finder COVID-19
Manufactured by Hyris Limited, Italy - https://www.hyris.net/
Device identification number
2513
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cartridge
Target type
Nucleic acid
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The bKIT Virus Finder COVID-19 assay allows specimen processing based on a direct amplification workflow.
Assay Type
Unknown
Method
RT-PCR
Measurement
Qualitative
LOD
10 copies/μl
Positive control
Mix of SARS-CoV-2 N targets and RP
Negative control
Not template control
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
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