NEHREN, Germany - July 27th, 2020: Bruker Corporation (Nasdaq: BRKR) today announced the launch of the FluoroType® SARS-CoV-2 plus next-generation 6-plex PCR assay for the highly specific detection of the SARS-CoV-2 virus, which causes the respiratory and systemic disease COVID-19 (CV19).
The FluoroType® SARS-CoV-2 plus assay is CE-IVD labelled according to the European IVD Directive (98/79/EC). In two clinical trials involving approximately ninety 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 alternatively 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.
Dr. Steffi Czieschnek, the Head of PCR Diagnostics at Medical Health Care Center (MVZ) for Clinical Chemistry and Microbiology in Suhl, Germany, explained: "We have implemented Bruker´s FluoroType® SARS-CoV-2 plus assay since several weeks now as our standard routine approach for COVID-19 testing. We like the added value of a second gene target and of the discrimination of potential other human coronaviruses. We use this second generation COVID-19 assay on the FluoroCycler® XT and are impressed by the capabilities and performance of this new cutting-edge real-time PCR platform."
Dr. Wolfgang Pusch, Executive Vice President Microbiology & Diagnostics at Bruker Daltonics, commented: "With the combination of our GenoXtract® (GXT)products for nucleic acid extraction, our latest FluoroCycler® XT real-time thermocycler and dedicated detection assays, Bruker offers a complete solution for the sample preparation and detection of the SARS-CoV-2 virus. With the FluoroType® SARS-CoV-2 plus assay we expand our portfolio by an assay with added value by detecting two gene targets. Additionally, the differentiation from other human coronaviruses, which for example can cause a common cold, reduces the risk of false positive results due to potential cross-reactivity. We expect that these analytical features enable a very robust second-generation PCR assay with highest sensitivity and specificity."
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.
Bruker-Hain Diagnostics is focused on Molecular Diagnostics (MDx) products within Bruker´s Microbiology & Diagnostics business. Hain Lifescience GmbH is the legal manufacturer of the FluoroCycler® XT, MTBDR 2.0 assay, GXT nucleic acid preparation kits and of the FluoroType SARS-CoV-2 plus assays. For more information, please visit, www.hain-lifescience.de.
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