布鲁克在 ASM Microbe 会议上推出 MALDI Biotyper Sirius
- 推出具有额外负离子模式的新型 MALDI Biotyper sirius? 系统，以支持 MALDI 研究和 RUO 验证研究，例如用于粘菌素耐药性检测
- 美国推出用于兽医学真正最低抑菌浓度 （MIC） 抗生素敏感性检测 （AST） 的 Micronaut? 产品
- 美国推出基于 MALDI Biotyper 的 RUO 版本的抗生素耐药性快速选择性检测 （MBT-STAR）? 检测，用于验证研究碳青霉烯类耐药和头孢菌素耐药
加利福尼亚州旧金山 – 2019 年 6 月 20 日：在 2019 年 ASM 微生物大会上 （www.asm.org），布鲁克推出了新的 MALDI Biotyper sirius 系统，适用于所有先前获得 FDA 批准的，以及所有仅供研究使用 （RUO） 的 MALDI Biotyper （MBT） 参考文库，用于从微生物学培养物中进行近乎通用、快速且经济高效的微生物鉴定。MALDI Biotyper? sirius 现在首次支持新型负离子模式测定研究和快速抗生素耐药性测试的临床研究。这种新的高端系统补充了标准的 MALDI Biotyper 和高通量 MALDI Biotyper smart。
抗生素耐药性的全球传播是一个日益严重的医疗保健问题，开发和实施新的、快速且具有成本效益的耐药性检测对于推进抗生素管理非常重要。对于革兰氏阴性菌，耐药性问题在许多国家非常严重，以至于像粘菌素这样的抗生素，具有肾毒性副作用的风险，越来越多地不得不用作“最后的抗生素”。抗生素管理的目的是在可能的情况下尽早降低治疗质量，或者在检测到耐药性时将患者转向其他治疗选择。
除了所有经 FDA 批准的常规临床鉴定检测外，现在还可以在同一台仪器上?进一步开发和验证用于检测革兰氏阴性菌粘菌粘菌素耐药性的新型快速检测方法。新的 RUO 粘菌素耐药测定法使用负离子模式下的脂质分析，已在英国伦敦帝国理工学院开发（Larrouy-Maumus 等人，在 ECCMID 2019 上发表，已提交发表）。
新型 MALDI Biotyper? sirius 使用专有的 smartbeam? 固态激光器，重复频率为 200 Hz，使用寿命为 5 亿次。这基本上使 smartbeam 成为典型微生物实验室中的“终身激光器”。高性能真空系统允许在实验室工作流程中更快地更换靶板，其中多名技术人员独立制备靶标。此外，高性能真空系统减少了维修或预防性维护后的停机时间，这些维护通常可以在同一天完成。MBT sirius 采用新的电子元件，LED 灯条指示系统状态。在 RUO MBT sirius 中，极性切换到负离子模式由软件控制，只需一分钟。
英国帝国理工学院MRC-分子细菌学与感染中心的组长Gerald Larrouy-Maumus博士评论道。“MALDI Biotyper? sirius 是一种多功能的 MALDI-TOF MS 系统，它不仅能够非常快速地进行近乎通用的细菌鉴定，而且凭借其额外的负离子模式，我们还使我们能够开发一种快速而稳定的检测方法，以检测粘菌素耐药菌，作为监管部门批准后潜在的未来重要常规检测方法。正如我的学生所说，新的 MALDI Biotyper? sirius 简直是'哇！'
此外，布鲁克还推出了用于碳青霉烯类抗生素和头孢菌素类药物耐药性选择性检测的 MBT-STAR 检测试剂盒，作为仅供研究使用的 （RUO） 检测试剂盒，以支持美国研究和验证研究，以快速检测抗生素耐药性。功能性 MBT-STAR 检测可监测在细菌对 β-内酰胺类抗生素产生耐药性的情况下发生的酶促代谢引起的分子量变化。
两种 MBT-STAR 检测的结果时间 （TTR） 在培养阳性后仅约 60 分钟。与基因靶向分子耐药性检测不同，MBT-STAR检测是一种功能检测，不仅可以检测已知的耐药机制，还可以检测新出现的耐药性。
Bruker Daltonics微生物学与诊断执行副总裁Wolfgang Pusch博士说：“多年来，Bruker一直在推动微生物学中近乎普遍、快速且具有成本效益的MALDI鉴定的广泛实施。我们致力于实现重要的新工作流程，通过 MBT-STAR RUO 检测，我们的美国客户现在可以进行研究和验证研究，以快速、功能性地检测重要的 β-内酰胺酶耐药性。我们很高兴新的 MALDI Biotyper? sirius 旨在进一步研究革兰氏阴性菌的快速粘菌素耐药性检测，一旦得到充分验证并获得监管批准，它很可能成为未来重要的临床 MBT 检测。
此外，布鲁克还向美国市场推出了 Micronaut? 兽用抗生素敏感性测试 （AST） 产品组合（不用于人类诊断）。用于兽医学的 Micronaut 产品可以帮助选择伴侣动物、牲畜和马的微生物感染的针对性治疗方法。Micronaut 板通过肉汤微量稀释分析真正的最低抑菌浓度 （MIC）。
真正的 MIC 检测正日益成为兽医检测的“黄金标准”。随着兽医学中耐药细菌的日益流行，Micronaut AST 检测片有助于指导兽医选择合适的抗生素治疗。Micronaut VET Com 检测支持分析从伴侣动物中分离的细菌，而 Micronaut VET CSH 板可用于从家畜和马中分离的细菌。Micronaut VET Mas 能够分析乳制品行业中引起牛乳腺炎的细菌的抗生素耐药性。
关于布鲁克 MALDI Biotyper （MBT） 平台
MALDI Biotyper 能够对培养物中的细菌、酵母菌和真菌进行分子鉴定。通过高通量 MALDI-TOF 质谱法进行蛋白质组学指纹图谱，可以可靠、快速地实现微生物的分类和鉴定。MALDI Biotyper 使用基于细菌菌株的特定蛋白质组学指纹的分子方法。许多已发表的研究都强调了更高的准确性和更低的成本，以及通常更快的结果时间 （TTR）。
各种 MALDI Biotyper 解决方案的应用包括临床和兽医微生物鉴定、环境和药物分析、分类学研究、食品和消费品安全和质量控制以及海洋微生物学。在许多欧洲和国际实验室中，MALDI Biotyper 因其准确性、速度、广泛的物种覆盖范围、易用性和成本效益，在过去几年中取代了传统的生化检测进行细菌鉴定。传统的生化技术检测微生物的不同代谢特性，可能需要数小时甚至数天，而且往往缺乏特异性。
坚固耐用的 MALDI Biotyper 只需最少的样品制备，耗材成本低。MALDI Biotyper 系列产品有仅供研究使用 （RUO） 版本，即美国 FDA 批准的 MALDI Biotyper CA 系统，或根据欧盟指令 EC/98/79 的 IVD-CE 版本。MALDI Biotyper 还在许多其他国家/地区进行了医疗器械注册。
MALDI Biotyper 软件的 RUO 版本允许进行选定的、高价值的抗菌素耐药性测试。CE-IVD MBT STAR-Cepha? 试剂盒可针对头孢菌素进行快速、功能性的抗生素耐药性检测，而 CE-IVD MBT STAR-Carba 试剂盒用于快速碳青霉烯类耐药性检测。
关于布鲁克公司（纳斯达克股票代码：BRKR）
布鲁克使科学家能够取得突破性发现并开发新的应用，以改善人类生活质量。布鲁克的高性能科学仪器和高价值的分析和诊断解决方案使科学家能够在分子、细胞和微观水平上探索生命和材料。通过与客户的密切合作，布鲁克在生命科学分子研究、应用和制药应用、显微镜和纳米分析、工业应用以及细胞生物学、临床前成像、临床表型组学和蛋白质组学研究以及临床微生物学方面实现创新、提高生产力和客户成功。欲了解更多信息，请访问：www.bruker.com.
Bruker Launches MALDI Biotyper Sirius at ASM Microbe Conference
June 20, 2019
- Introduction of new MALDI Biotyper sirius? system with additional negative-ion mode to support MALDI research and RUO validation studies, e.g. for colistin-resistance testing
- US introduction of Micronaut? products for true minimum inhibitory concentration (MIC) antibiotic susceptibility testing (AST) in veterinary medicine
- US introduction of RUO versions of MALDI Biotyper-based rapid Selective-Testing of Antibiotic Resistance (MBT-STAR?) assays for validation studies on carbapenem resistance and cephalosporine resistance
SAN FRANCISCO, June 20, 2019 /PRNewswire/ -- At the ASM Microbe Conference 2019 (www.asm.org), Bruker launches the new MALDI Biotyper sirius system for all previously FDA-cleared, and for all research-use-only (RUO) MALDI Biotyper (MBT) reference libraries, which are used for near-universal, fast and cost-effective microbial identification from cultures in microbiology. The MALDI Biotyper sirius for the first time now also supports novel negative-ion mode assay research and clinical studies in fast antibiotic-resistance testing. This new high-end system complements the standard MALDI Biotyper and the high-throughput MALDI Biotyper smart.
The global spreading of antibiotic resistances is a growing healthcare problem, and the development and implementation of new, fast and cost-efficient resistance tests are important for advancing antibiotic stewardship. For gram-negative bacteria, the resistance-problem is so serious in many countries that antibiotics like colistin, with the risk of nephrotoxic side effects, increasingly must be used as an 'antibiotic of last resort'. Antibiotic stewardship aims to de-escalate the therapy in such cases early, if possible, or switch patients to other therapeutic options, if resistance is detected.
New, fast assays to detect colistin resistance in gram-negative bacteria can now be further developed and validated on the MALDI Biotyper Sirius, in addition to all routine clinical FDA-cleared identification assays, on the same instrument. The new RUO colistin-resistance assay uses lipid analysis in negative-ion mode, and has been developed at Imperial College London, UK (Larrouy-Maumus et al., presented at ECCMID 2019, submitted for publication).
The new MALDI Biotyper sirius uses the proprietary smartbeam? solid-state laser with a 200 Hz repetition rate, and a lifetime of 500 million shots. This essentially makes the smartbeam a 'lifetime laser' in typical microbiology laboratories. The high-performance vacuum system allows for an even faster exchange of target plates in laboratory workflows, where multiple technicians prepare targets independently. Moreover, the high-performance vacuum system reduces downtime after service or preventive maintenance, which typically can be completed on the same day. The MBT sirius features new electronics, and LED strips indicate the system status. In the RUO MBT sirius, polarity switching to negative-ion mode is software-controlled and just takes a minute.
Dr. Gerald Larrouy-Maumus, Group Leader at the MRC-Centre for Molecular Bacteriology & Infection at Imperial College London, UK, commented. "The MALDI Biotyper sirius is a versatile MALDI-TOF MS system, which is not only able to perform near-universal bacterial identification very rapidly, but with its additional negative-ion mode also has allowed us to develop a fast and robust assay to detect colistin-resistant bacteria as an important, potential future routine assay after regulatory approvals. As my students say, the new MALDI Biotyper sirius is just 'Wow!'"
In addition, Bruker introduces the MBT-STAR assays for Selective-Testing of Antibiotic Resistance for carbapenems and for cephalosporins as research-use-only (RUO) assays to support US research and validation studies for the fast detection of antibiotic resistance. The functional MBT-STAR assays monitor molecular mass shifts due to the enzymatic metabolization that occurs in the case of bacterial resistance against the beta-lactam class of antibiotics.
Time-to-result (TTR) for both MBT-STAR assays is only about 60 minutes after positive culture. Unlike gene-targeted molecular resistance tests, the MBT-STAR assays are functional tests that can detect not only known resistance mechanisms, but also new, emerging resistances.
Dr. Wolfgang Pusch, Executive Vice President for Microbiology & Diagnostics at Bruker Daltonics, said: "Bruker has been driving the broad implementation of near-universal, fast and cost-effective MALDI identification in microbiology for many years. We are committed to enable important new workflows, and with the MBT-STAR RUO assays, our US customers now have access to research and validation studies for fast, functional assays of important beta-lactamase resistances. We are excited that the new MALDI Biotyper sirius is designed for further research on fast colistin-resistance testing in gram-negative bacteria, which is likely to become an important future clinical MBT assay, once it is fully validated and has regulatory approvals."
Moreover, Bruker introduces the Micronaut? portfolio of veterinary antibiotic susceptibility tests (AST) to the US market (not for human diagnostic use). The Micronaut products for veterinary medicine can assist in selecting targeted treatments of microbial infections in companion animals, livestock and horses. The Micronaut plates analyze true minimum inhibitory concentrations (MIC) by broth microdilution.
True MIC testing is increasingly becoming the 'gold standard' in veterinary testing. With the growing prevalence of resistant bacteria in veterinary medicine, the MicronautAST plates help to guide veterinarians with the appropriate selection of antibiotic therapy. Micronaut VET Com assays support the analysis of bacteria isolated from companion animals, while Micronaut VET CSH plates can be used for bacteria isolated from live-stock animals and horses. Micronaut VET Mas enables the analysis of antibiotic resistance in bacteria that are causing bovine mastitis in the dairy industry.
About the Bruker MALDI Biotyper (MBT) Platform
The MALDI Biotyper enables molecular identification of bacteria, yeasts and fungi from cultures. Classification and identification of microorganisms is achieved reliably and quickly using proteomic fingerprinting by high-throughput MALDI-TOF mass spectrometry. The MALDI Biotyper uses a molecular approach based on specific proteomic fingerprints from bacterial strains. Many published studies have highlighted the greater accuracy and lower cost, as well as the typically much faster time-to-result (TTR).
Applications of various MALDI Biotyper solutions include clinical and veterinary microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology. In many European and international laboratories, the MALDI Biotyper has replaced classical biochemical testing for bacterial identification in the past few years due to its accuracy, speed, extensive species coverage, ease of use and cost effectiveness. Traditional biochemical techniques detect different metabolic properties of microorganisms, can take many hours or even days, and often lack specificity.
The robust MALDI Biotyper requires minimal sample preparation and offers low consumables cost. The products of the MALDI Biotyper family are available in a research-use-only (RUO) version, as the U.S. FDA-cleared MALDI Biotyper CA System, or in an IVD-CE version according to EU directive EC/98/79. The MALDI Biotyper also has medical device registrations in many other countries.
RUO versions of the MALDI Biotyper software allow selected, high-value antimicrobial resistance tests. The CE-IVD MBTSTAR?-Cepha kit allows rapid, functional antibiotic resistance testing against Cephalosporins,and the CE-IVDMBT STAR-Carba kit is for fast Carbapenem-resistance testing.
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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布鲁克?道尔顿公司是由在纳斯达克上市（NASDAQ：BRKR）的布鲁克生物科技公司（Bruker BioSciences Corporation）控股经营的一个子公司，专门开发和提供基于质谱的创新性生命科学研究工具，是业界的领先者。我们设...