Bruker Launches FluoroType® SARS-CoV-2/Flu/RSV PCR Pane

Bruker Launches FluoroType® SARS-CoV-2/Flu/RSV PCR Panel in Europe with CE-IVD Mark


Published: Dec 18, 2020
NEHREN, Germany--(BUSINESS WIRE)-- Bruker Corporation (Nasdaq: BRKR) today announced the launch of the
FluoroType SARS-CoV-2/Flu/RSV winter four-plex PCR panel, which enables the sensitive and simultaneous detection of the SARS-CoV-2 virus, of both influenza A and B viruses, as well as of the respiratory syncytial virus (RSV). In the winter season, multiple viruses need to be differentiated in one assay to facilitate diagnosis and patient management.
Figure 1: FluoroType SARS-CoV-2/Flu/RSV Test Kit (Photo: Business Wire)
The
FluoroType SARS-CoV-2/Flu/RSV panel is CE-IVD labelled according to European IVD Directive (98/79/EC). It has been validated for nasopharyngeal swabs, oropharyngeal swabs and saliva samples. The kit includes all reagents to generate up to 96 PCR result panels in under two hours after nucleic acid extraction. In evaluations, the sensitivity and specificity from 112 nasopharyngeal or oropharyngeal swabs have achieved 100% for all four viruses with very low limits of detection. In addition, the winter four-plex panel has also been validated with an RNA extraction-free protocol on 60 saliva samples with 100% sensitivity and 97.5% specificity. In large scale patient sampling and diagnostic use, sensitivity and specificity near 100% may not always be achievable, but swab and saliva PCR protocols remain the most sensitive assays.

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