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Microbiology & Diagnostics

Microbial Identification for Clinical Laboratories (US-IVD)

Unbiased and fast identification of microorganisms down to the species level

Identification of microorganisms

Significant advances in clinical microbiology have been achieved thanks to continuous innovations in mass spectrometry (MS) over the past decade. Now the standard in microorganism identification, Matrix-Assisted Laser Desorption/Ionization Time-Of-Flight (MALDI-TOF) MS enables clinical microbiology laboratories to reliably and rapidly identify microbes, for diagnosing patient infections in a cost-effective manner.

A revolution in microbiology

Microorganisms identification to the species level is a key task of clinical microbiology. Traditionally this has been achieved by carrying out labour-intensive and time-consuming biochemical assays. Though current sequencing technologies may provide very precise insights, they are still far too slow and expensive. Bruker has successfully introduced an innovative, molecular-based mass spectrometric identification method that enables faster and more efficient analysis than conventional assays or sequencing.

By using our experience and expertise as a worldwide leading provider of MALDI-TOF mass spectrometry, Bruker developed the MALDI Biotyper® - a revolutionary approach for the analysis of microorganisms, which can be easily integrated into any clinical laboratory environment. Within just a few years, the MALDI Biotyper® has become the worldwide leading solution for clinical microbiology.

MALDI Biotyper® CA System - Identifying microorganisms by their fingerprint

The MALDI Biotyper® CA System has been granted USA FDA clearance under Section 510(k) for the identification of gram-­negative and gram-positive bacteria, anaerobic bacteria and yeast, cultured from human specimens. The MALDI Biotyper® CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid the diagnosis of bacterial and yeast infections.
Bruker has conducted a multi-site clinical trial comparing the performance of the MALDI Biotyper® CA System to 16S ribosomal RNA gene sequencing. The overall accuracy of the MALDI Biotyper® CA System was comparable to that of nucleic acid sequencing.

The Bruker MALDI Biotyper® CA System identifies microorganisms using MALDI-TOF Mass Spectrometry to determine the unique protein fingerprint of an organism. Specifically, the MALDI Biotyper® CA System measures highly abundant proteins that are found in all microorganisms. The characteristic patterns of these proteins are used to reliably and accurately identify a particular microorganism by matching it against the FDA-cleared library of reference spectra.

The microorganism reference library

The MALDI Biotyper® CA System covers 488 clinically relevant bacteria and yeast species, representing more than 98% of the typical microbial identification workflow of clinical microbiology laboratories.

A complete system solution

The MALDI Biotyper® CA System includes Bruker's benchtop MALDI-TOF MALDI Biotyper® sirius one CA System or the high-end MALDI Biotyper® sirius CA System, software, US IVD labeled reagents, a disposable MBT Biotarget 96 or a reusable 48-spot MALDI target plate and the FDA-cleared microorganism reference library. 

Your benefits

  • Accuracy comparable to Nucleic Acid Sequencing
  • Applicable to a wide range of microorganisms
  • Much faster than traditional identification methods
  • Robust and easy to use
  • True benchtop system
  • Cost-effective
  • With optional additional workflow tools to improve productivity and standardization 

Hospital cost savings

  • Proven length of stay reduction
  • Proven pharmacy expenses reduction
  • Impactful return on investment

 

Only for sale in the USA and Puerto Rico.