FluoroType® SARS-CoV-2 varID Q
Manufactured by Hain Lifescience a Bruker company, Germany - https://www.bruker.com
Device identification number
2970
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Semi-automated
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
Targets: RdRp gene, N gene and S gene mutations ( N501Y, del69-70, D80A, E484K). The performance characteristics of FluoroType® SARS-CoV-2 varID Q is unaffected by the mutations of the SARS-CoV-2 line age B.1.1.7 (United Kingdom), as well as the variants B.1.351 (South Africa), P.1 (Brazil) or B.1.617 (India) (in silico analysis). The assay was analyzed with 35 bacterial and viral strains potentially present in the nasopharynx or representing common respiratory pathogens. No unintended cross-reactivity was detected. Please contact us for further information.
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Measurement
Quantitative
Time
120 minutes
Positive control
C+ provided with the kit
Clinical Sensitivity
98 %
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