FluoroType® SARS-CoV-2 plus
Manufactured by Hain Lifescience a Bruker company, Germany - https://www.bruker.com
Device identification number
2880
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Semi-automated
Target type
Nucleic acid
Targets
Unknown
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The test targets two independent genes of the SARS-CoV-2 genome, while simultaneously allowing for the differentiation of non-SARS-CoV-2 patients by detecting four endemic human coronaviruses (HCoVs). The performance characteristics of FluoroType® SARS-CoV-2 plus is unaffected by the mutations of SARS-CoV-2 strain B.1.1.7 as well as the B.1.351 strain (in silico analysis). Please contact us for further information.
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Measurement
Qualitative
Time
120 minutes
LOD
Depending on the validated extraction methode 1.2 or 8.4 cpu for SARS-CoV-2
Positive control
A positive control sample is included in the kit
Clinical Sensitivity
100 %
Clinical Specificity
96 %
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