Microbial Identification for Clinical Laboratories (US-IVD)

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.

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系统措施高度丰富的蛋白质re 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 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.

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.

• 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
  

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