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Bruker Gets CE-IVD Mark for Coronavirus, Flu, RSV Combo Panel

NEW YORK — Bruker said on Friday that it has received CE-IVD marking for its FluoroType SARS-CoV-2/Flu/RSV winter respiratory virus panel.

The PCR-based panel is designed to simultaneously detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus in nasopharyngeal swabs, oropharyngeal swabs, and saliva samples, according to the Billerica, Massachusetts-based company.

The test kit comes with reagents to generate up to 96 result panels in less than two hours following nucleic acid extraction.

Bruker said the panel has demonstrated 100 percent sensitivity and specificity in evaluations with 112 nasopharyngeal or oropharyngeal swabs. Using an RNA extraction-free protocol on 60 saliva samples, the test has shown 100 percent sensitivity and 97.5 percent specificity.

The panel can be used with Bruker's FluoroCycler XT RT-PCR system, as well as other common real-time thermocyclers. It is validated for use on Bruker's GenoXtract automated nucleic acid extraction devices and for Qiagen extraction chemistry.