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.
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 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 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.
Only for sale in the USA and Puerto Rico.
As of May 2021, Bruker Daltonik GmbH is now Bruker Daltonics GmbH & Co. KG.