Press Release Details

MBT STAR-BL software for patented functional beta-lactamase testing is first high-value module in new MBT STAR (Selective Testing of Antibiotic Resistance) family.

BARCELONA, Spain--(BUSINESS WIRE)-- At the 24th European Congress of Clinical Microbiology and Infectious Diseases(ECCMID), Brukerintroduces new and expanded research-use only (RUO) capabilities for theMALDI Biotyper™ platform.

TheMALDI Biotyper(MBT) is the market-leading system for microbial identification based on MALDI-TOF mass spectrometry. It is widely used in industrial microbiology, animal health, food safety and its IVD and FDA-cleared versions are changing the paradigm in clinical microbiology. With nearly 1,200 customer systems, the MBT platform has become an accepted laboratory-standard for next-generation microbial identification and emerging further high-value functional assays. TheMALDI BiotyperRUO and IVD-CE versions cover a broad range of about 2,300 species with more than 5,600 well-characterized microbial isolates from gram-negative bacteria, gram-positive bacteria, yeasts, multicellular fungi and mycobacteria. Microbial identification with theMALDI Biotyperis done using proteomic fingerprinting, where unique species-specific patterns are automatically compared with reference spectra in theMALDI Biotyperlibrary.

Due to the modular design of theMALDI Biotypersoftware, the system can be configured according to the specific needs of each laboratory: the basic microbial identification functionality is now available in versions for clinical routine laboratories (IVD), for industrial applications and for research-use-only (RUO) purposes.

Industrial and research customers can configure theirMALDI Biotypersystems with further functionality by adding various new or expanded RUO software modules or hardware accessories:

• TheMBT Explorermodule provides multiple sophisticated bioinformatics approaches for spectra comparison, statistical data interpretation and for the generation of customer-specific reference library entries (main spectra) of strains of special interest. Such sub-libraries can be exported and re-imported in networks of collaborating laboratories.
• TheMBT Satellitemodule allows for an efficient paperless setup. MultipleMBT Satellitemodules can be used for laboratories with multiple microbiology work-benches.
• TheMBT Sepsitypermodule supports the analyses of data generated from positive blood culture samples. This software complements theMALDI Sepsityper装备与精简数据解释workflow.
• TheMBT STAR-BL(Beta Lactamase) module is part of the newMBT STARassay family forSelectiveTesting ofAntibioticResistance, and enables patented functional beta-lactamase testing for selected antibiotics. TheMBT STAR-BLsoftware monitors the mass shifts introduced by enzymatic degradation of betalactam antibiotics, like some penicillins, 3^rdgeneration cephalosporins and carbapenems. These changes are monitored by direct measurements of molecular weights without the need of any labelling by probes or antibodies. Brukeris currently gathering feedback from infectious disease researchers on its performance. Due to strong demand for this type of resistance information, future IVD versions are planned.
• As use of theMALDI Biotypercontinues to increase for industrial microbiology in pharma, food or consumer goods industries, data integrity topics like user management, audit trail and data archiving are of special importance. For these customers, Brukernow offers the newMBT Compliance Assistance Moduleto support 21 CFR Part 11 requirements.
• MBT TranslatorandMBT Integratormodules provide functionality to connect data generated with theMALDI Biotyperto laboratory information systems (LIS).MALDI Biotyperresults are translated into the language of the LIS and are integrated with information available in the LIS.
• TheMBTPilot™is a hardware accessory to support the light-guided preparation of target plates. In combination with theMBT Satellitesoftware it allows for a paperless and barcode-tracked workflow with full traceability. The ergonomically-shapedMBT Pilotguides users during the preparation of plates, reducing the possibility of specimen transfer errors.
• TheMBT Galaxy™reduces the manual workload during preparation of sample target plates and also introduces significant quality control steps, like controlled reagent droplet size, controlled drying atmosphere and control of quality of the matrix preparation. This bench-top automation device standardizes the preparation of samples with quality controls for reagent additions. TheMBT Galaxy不需要手动试剂移液,reducing repetitive motions and labor costs required for target preparation. TheMBT Galaxyis equipped with on-board barcode reading to connect directly to theMALDI Biotyperserver.

Dr. Ulrich Eigner, Head of Study Departmentat Limbach Laboratoryin Heidelberg, Germany, commented: “We have been working with Bruker´sMALDI Biotypersystem in our network of microbiology laboratories for several years and we are very pleased with the analytical performance. With theMBT PilotandMBT Galaxy Brukernow introduces further smart and convincing workflow improvement tools.”

Dr. Wolfgang Pusch, Executive Vice President - Microbiology Business at Bruker Daltonics, explained: “We believe that ourMALDI Biotypercan now provide even more than best-in-class identification to microbiology laboratories. That’s why we are continuously working on adding additional high-value functional assays, new software tools, library extensions and productivity tools to theMALDI Biotyperplatform.”

About the Bruker MALDI Biotyper

The MALDI Biotyper family of systems enables molecular identification, and taxonomical classification or dereplication of microorganisms like bacteria, yeasts and fungi. 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 and published studies have highlighted the greater accuracy and lower cost offered, as well as the typically much faster time-to-result (TTR).

Applications of the various MALDI Biotyper solutions include clinical routine 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 five years due to the accuracy, speed, extensive species coverage, ease of use and cost effectiveness of the system. Classical biochemical techniques detect different metabolic properties of microorganisms, can take many hours or even days for completion, and they often lack specificity.

The robust MALDI Biotyper method 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 numerous other countries. RUO versions of the MALDI Biotyper even allow selected high-value antimicrobial resistance tests in translational research.

ABOUT BRUKER CORPORATION(NASDAQ: BRKR)
Brukeris a leading provider of high-performance scientific instruments and solutions for molecular and materials research, as well as for industrial, diagnostics and applied analysis. For more information:www.energie2point0.com.

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Source: Bruker Corporation