IdyllaTM SARS-COV-2 Test
Manufactured by Biocartis, Belgium - Biocartis.com
Device identification number
2662
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Fully automated (robot)
Physical Support
Cartridge
Target type
Nucleic acid
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
No cross reactivity with other human respiratory viruses (with homology >80% to SARS-COV-2), except for SARS-CoV-1, if based upon in-silico analysis. SARS-CoV-1 is not known to be currently circulating in the human population, and therefore is highly unlikely to be present in patient specimens.
Assay Type
Nucleic acid-PCR
Reader Required
N.A.
Subcategory
Other ()
Method
RT-PCR
Measurement
Qualitative
Time
90 minutes
LOD
500 cpm
Positive control
MS2 bacteriphage SPC and Accuplex TM SARS COV 2control CAT n°0505-0126
Negative control
NA
Analytical Sensitivity
99 %
Analytical Specificity
100 %
Clinical Sensitivity
96 %
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