Bruker Launches Second-Generation FluoroType® SARS-CoV-2 plus PCR Test for Detection of SARS-CoV-2 Viral Infections in Europe
July 27 2020 - 7:00AM
Business Wire
- Detects two independent SARS-CoV-2 viral RNA targets from
respiratory samples for increased confidence
- Differentiates SARS-CoV-2 from four other endemic human
coronaviruses for specificity
- Validated with Bruker-Hain GenoXtract® NA
and GenoXtract® 96 X3 nucleic acid extraction
system and kits
- Validated with novel Bruker-Hain FluoroCycler® XT
real-time PCR thermocycler
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.
About Bruker-Hain Diagnostics
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.
About Bruker Corporation (Nasdaq: BRKR)
Bruker is enabling scientists to make breakthrough discoveries
and develop new applications that improve the quality of human
life. Bruker’s high-performance scientific instruments and
high-value analytical and diagnostic solutions enable scientists to
explore life and materials at molecular, cellular and microscopic
levels. In close cooperation with our customers, Bruker is enabling
innovation, improved productivity and customer success in life
science molecular research, in applied and pharma applications, in
microscopy and nanoanalysis, and in industrial applications, as
well as in cell biology, preclinical imaging, clinical phenomics
and proteomics research and clinical microbiology. For more
information, please visit: www.bruker.com.
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Investor Contact: Miroslava Minkova Director of Investor
Relations and Corporate Development T: +1 (978) 663–3660, ext. 1479
E: Investor.Relations@bruker.com
Contact for Media and Customers: Philip Perry Bruker
Daltonics T: +49-172-313-7216 E: Philip.Perry@bruker.com
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