New Functionalities Introduced for Microbial High-Throughput MALDI-TOF MS Platform

The MALDI Biotyper for microbial identification, based on MALDI-TOF mass spectrometry, is widely used in industrial and research-use-only (RUO) applications, and in its in vitro diagnostics (IVD) versions, CE- and FDA-cleared, is changing the paradigm in clinical microbial diagnostics and research. MALDI Biotyper covers a broad range of about 2,300 species with more than 5,600 well-characterized microbial isolates. It uses reliable and quick proteomic fingerprinting of unique species-specific patterns, requires minimal sample preparation, and offers low consumables cost.

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 identification functionality is now available in versions for clinical routine IVD laboratories, for industrial applications, and for RUO purposes. Industrial and research customers can additionally configure functionality by adding various new or expanded RUO software modules or hardware accessories.

The MBT STAR-BL (Beta Lactamase) module is part of the new MBT STAR assay family for selective testing of antibiotic resistance (STAR), and enables patented functional beta-lactamase testing for selected antibiotics, without the need of labeling by probes or antibodies. Although currently for RUO, Bruker is gathering feedback from infectious disease researchers on its performance and, due to strong demand for this type of resistance information, clinical IVD versions are being planned.

For industrial and RUO applications, 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 and integrated data generated with the MALDI Biotyper into laboratory information systems (LIS).

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 controlled 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.

The MBT Pilot supports the light-guided preparation of target plates. With the MBT Satellite software it allows for a paperless and barcode-tracked workflow with full traceability. Its ergonomic shape guides users during the preparation of plates, reducing the possibility of specimen transfer errors.

“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,” said Dr. Ulrich Eigner, Head of Study Department at Limbach Laboratory (Heidelberg, Germany).

Products of the MALDI Biotyper family are available in the US FDA-cleared MALDI Biotyper CA System version, in the IVD-CE version cleared according to EU directive EC/98/79, and in a research-use-only (RUO) version. The MALDI Biotyper also has medical device registrations in numerous other countries.

Related Links:
Bruker