Product News: Bruker Introduces Beta-Lactamase Testing, New Productivity Software Modules, as well as MBT Pilot and MBT Galaxy Accessories for MALDI Biotyper

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.

At the 24th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Bruker introduces new and expanded research-use only (RUO) capabilities for the MALDI Biotyper™ platform.

The MALDI 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. The MALDI Biotyper RUO 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 the MALDI Biotyper is done using proteomic fingerprinting, where unique species-specific patterns are automatically compared with reference spectra in the MALDI Biotyper library.

Due to the modular design of the MALDI Biotyper software, 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 their MALDI Biotyper systems with further functionality by adding various new or expanded RUO software modules or hardware accessories:

• The MBT Explorer module 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.
• The MBT Satellite module allows for an efficient paperless setup. Multiple MBT Satellite modules can be used for laboratories with multiple microbiology work-benches.
• The MBT Sepsityper module supports the analyses of data generated from positive blood culture samples. This software complements the MALDI Sepsityper kit with streamlined data interpretation for this workflow.
• The MBT STAR-BL (Beta Lactamase) module is part of the new MBT STAR assay family for Selective Testing of Antibiotic Resistance, and enables patented functional beta-lactamase testing for selected antibiotics. The MBT STAR-BL software monitors the mass shifts introduced by enzymatic degradation of betalactam antibiotics, like some penicillins, 3rd generation cephalosporins and carbapenems. These changes are monitored by direct measurements of molecular weights without the need of any labelling by probes or antibodies. Bruker is 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 the MALDI Biotyper continues 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, Bruker now offers the new MBT Compliance Assistance Module to support 21 CFR Part 11 requirements.
• MBT Translator and MBT Integrator modules provide functionality to connect data generated with the MALDI Biotyper to laboratory information systems (LIS). MALDI Biotyper results are translated into the language of the LIS and are integrated with information available in the LIS.
• The MBT Pilot™ is a hardware accessory to support the light-guided preparation of target plates. In combination with the MBT Satellite software it allows for a paperless and barcode-tracked workflow with full traceability. The ergonomically-shaped MBT Pilot guides users during the preparation of plates, reducing the possibility of specimen transfer errors.
• The MBT 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. The MBT Galaxy eliminates the need for manual reagent pipetting, reducing repetitive motions and labor costs required for target preparation. The MBT Galaxy is equipped with on-board barcode reading to connect directly to the MALDI Biotyper server.

Dr. Ulrich Eigner, Head of Study Department at Limbach Laboratory in Heidelberg, Germany, commented: “We have been working with Bruker´s MALDI Biotyper system in our network of microbiology laboratories for several years and we are very pleased with the analytical performance. With the MBT Pilot and MBT Galaxy Bruker now introduces further smart and convincing workflow improvement tools.”

Dr. Wolfgang Pusch, Executive Vice President - Microbiology Business at Bruker Daltonics, explained: “We believe that our MALDI Biotyper can 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 the MALDI Biotyper platform.”

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.