FluoroType® SARS-CoV-2/Flu/RSV
Manufactured by Hain Lifescience a Bruker company, Germany - https://www.bruker.com
Device identification number
2971
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Semi-automated
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva
Pathogens detected
Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, SARS-CoV
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
The assay was analyzed with 30 bacterial and viral strains potentially present in the nasopharynx or representing common respiratory pathogens. No unintended cross-reactivity was detected. Targets: Flu A Subtypes H1N1 and H3N2, Flu B Lineages Victoria and Yamagata, RSV RSV-A and RSV-B, SARS-CoV-2. The performance characteristics of FluoroType® SARS-CoV-2/Flu/RSV 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
Positive control
A positive control sample is included in the kit
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