MALDI BIOTYPER CA SYSTEM

The market-leading Bruker MALDI Biotyper system has quickly revolutionized the way microbial identification is performed. The speed, accuracy, ease of use and cost efficiency are so impressive that significant numbers of clinical laboratories all over the world already employ this system solution for microbial identification of clinically relevant microorganisms. 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. 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. The MALDI Biotyper CA System received in March a second, expanded claim adding 170 species and species groups, representing 180 clinically-relevant species of aerobic Gram positive, fastidious Gram negatives, Enterobacteriaceae, anaerobic bacteria and yeasts. In addition, customers will have additional specimen preparation options to further optimize workflows. As a result of the latest 510(k) clearance, the MALDI Biotyper CA System can now in total identify 210 species or species groups, covering 280 clinically relevant bacteria and yeast species, and representing more than 98% of the typical bacterial identification workflow of clinical microbiology laboratories. TECHNICAL DETAILS: 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.