The latest addition to the MALDI Biotyper product portfolio is the MALDI Biotyper CA System, which has been granted USA FDA clearance under Section 510(k) for the identification of Gram negative bacterial colonies cultured from human specimens. The MALDI Biotyper CA System is intended for use in conjunction with other clinical and laboratory findings to aid the diagnosis of Gram-negative bacterial infections.
The MALDI Biotyper CA System includes Bruker’s benchtop microflex™ MALDI-TOF (Matrix Assisted Laser Desorption Ionization-Time of Flight) mass spectrometer, software, IVD labeled reagents, a 48-spot MALDI target and a microorganism reference database.
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 (Matrix Assisted Laser Desorption Ionization-Time of Flight) Mass Spectrometry to determine the unique molecular fingerprint of an organism. The characteristic spectrum pattern of this molecular fingerprint is used to reliably and accurately identify a particular microorganism by matching it against the FDA-cleared library.
Accuracy comparable to Nucleic Acid Sequencing
Much faster than traditional methods
Cost effective
Robust and easy to use
A true benchtop system
MALDI Biotyper CA System
FDA-cleared in the United States for identification of Gram negative bacterial colonies cultured from human specimens
The MALDI Biotyper CA System is the only bench-top microbiology Mass Spectrometry solution for quick, reliable identification of Gram negative microorganisms. The system utilizes MALDI-TOF mass spectrometry to measure highly abundant proteins to determine an organism’s molecular fingerprint. In conjunction with other clinical and laboratory findings, the MALDI Biotyper CA System helps diagnose infections caused by Gram negative bacteria, including E.coli, Haemophilus influenzae, and Klebsiella pneumoniae.
High Accuracy: Greater than 98 percent accuracy compared to reference method 16S RNA sequencing in multi-site clinical trial
High Sensitivity: With the most sensitive detector technology available (FlashDetector™) you can benefit from having the same high performance technology as large research grade instruments
High Throughput: At approximately 200 identifications per hour, MALDI Biotyper offers the highest throughput for MALDI-TOF microbiology testing
Fast and gentle: Data generation is accelerated by minimizing the number of shots per sample needed to generate a signal
Easy to use: Intuitive software, WhisperMode™ for silent and pleasant operation
Significantly reduces costs: Studies show MALDI Biotyper costs are as much as 80 percent lower than conventional microbiology methods
Space saving: True bench-top solution with less than 3 feet of counter space and under 185 pounds offers flexibility in meeting lab needs
Open Microbiology Concept: Open system with proven connectivity to widest variety of lab devices
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