SARS-CoV-2 PLUS ELITe MGB® Kit
Manufactured by ELITechGroup, France - www.elitechgroup.com
Device identification number
1862
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Fully automated (robot), Lab-based, Semi-automated
Physical Support
Cartridge, Cassette, Microplate
Target type
Nucleic acid
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Multiplex assay detecting SARS-CoV-2 in combination with Flu A, Flu B, RSV. Endogenous internal control RNase_P Validated in combination with S2R platform ELITe InGenius®
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
150 minutes
LOD
111 cpm
Positive control
SARS-CoV-2 PLUS – ELITe Positive Control
Negative control
Molecular Biology grade water
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