The market-leading Bruker MALDI Biotyper system has quickly revolutionized the way microbial identification is performed
MALDI Biotyper CA System FDA-cleared for USA only
The speed, accuracy, ease of use and cost efficiency are so impressive that an ever increasing number of clinical laboratories all over the world already employ this system solution for the identification of microorganisms.
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 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.
Identifying microorganisms by their molecular fingerprint
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.