- 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
- 用布鲁克 - 哈恩（Bruker-Hain）进行了验证GenoXtract®NA和GenoXtract®96X3nucleic acid extraction system and kits
- 用新颖的布鲁克 - 哈恩（Bruker-Hain）验证FluoroCycler®XT实时PCR热环生
NEHREN, Germany--(BUSINESS WIRE)--Bruker Corporation（纳斯达克：BRKR）今天宣布发射FluoroType® SARS-CoV-2 plusnext-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).
TheFluoroType® SARS-CoV-2 plusassay 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.
TheFluoroType® SARS-CoV-2 plus使用常见的实验室实时PCR热环球仪，已对呼吸样品（鼻咽拭子和口咽拭子）进行了验证。该套件包括所有必要的试剂，可在不到两个小时内产生多达96个结果。它已被验证用于Bruker的GenoxTract®（GXT）automated nucleic acid extraction devices with associated extraction kits. TheFluoroType® SARS-CoV-2 plus测定也可以与布鲁克的小说高精油一起使用FluoroCycler® XT实时PCR系统或与其他常用的实时热环生物系统。该测定法靶向SARS-COV-2基因组的两个独立基因，同时允许使用四个不同的HCOV基因位置检测四个特有的人冠状病毒（HCOV），从而允许非SARS-COV-2患者分化非SARS-COV-2患者。
德国Suhl的PCR诊断中心（MVZ）PCR诊断中心（MVZ）的负责人Steffi Czieschnek博士解释说：“我们已经实施了Bruker的FluoroType® SARS-CoV-2 plusassay 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 theFluoroCycler® XT和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 ourGenoxTract®（GXT）products for nucleic acid extraction, our latestFluoroCycler® XT实时热环生和专用检测试验，布鲁克为样品制备和检测SARS-COV-2病毒提供了完整的解决方案。与FluoroType® SARS-CoV-2 plusassay 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.”
在试点阶段,与几个合作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 theFluoroCycler® XT,MTBDR 2.0测定，GXT核酸制备试剂盒和FluoroType SARS-CoV-2 plusassays. 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.fatactor.com.
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