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29th July 2020  Product update: rapidmicrobiology staff writer

Two Clinical Trials Show 100% Diagnostic Accuracy for COVID-19 Multiplex qPCR Assay 


Bruker has announced the launch of the CE-IVD marked FluoroType® SARS-CoV-2 plus next-generation 6-plex PCR assay for detection of SARS-CoV-2.

In two clinical trials involving approximately ninety COVID-19 (CV19) positive patients and over 100 CV19 negative individuals, this advanced CV19 infection assay showed 100% sensitivity and 100% specificity. Actual clinical results may be lower, as all PCR tests depend on properly timed and executed nasopharyngeal or oropharyngeal sampling.

The FluoroType SARS-CoV-2 plus assay has been validated for respiratory samples (nasopharyngeal swabs and oropharyngeal swabs in viral transport medium) using commonly available laboratory real-time PCR thermocyclers.

The kit includes all necessary reagents to produce up to 96 results in under two hours. It is validated for use on Bruker´s GenoXtract® (GXT) automated nucleic acid extraction devices with associated extraction kits.

The FluoroType SARS-CoV-2 plus assay can also be used with Bruker´s novel, high-precision FluoroCycler® XT real-time PCR system or with other commonly available real-time thermocyclers.

The assay 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) using four different HCoV gene locations.

In a pilot phase and in collaboration with several partners, Bruker has recently also begun to offer CE-IVD marked serology antibody tests to detect previous COVID-19 infection in selected European countries, as well as a CE-IVD point-of-care (POC) antigen tests to screen for active CV19 infections in under two hours.


    

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Date Published: 29th July 2020

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.


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