FDA has granted clearance for Bruker Corp to market its MALDI Biotyper CA system in the United States for identifying gram-negative bacterial colonies cultured from human specimens. The debut reflects the company’s ongoing efforts to build matrix-assisted laser desorption ionization time-of-flight (MALDI-TOF) mass spectrometry as an effective platform for clinical microbiology identification.
Bruker launched the previous generation of the system in 2009, making the IVD-MALDI Biotyper system the first MALDI-TOF product to receive the CE mark for use in European clinical microbiology laboratories. Initial clinical trials have shown the new system’s accuracy to be comparable to that of nucleic acid sequencing. Features of the MALDI Biotyper CA system include a matrix-assisted laser desorption ionization time-of-flight (MALDI-TOF) mass spectrometer, software, IVD labeled reagents, a 48-spot MALDI target, and a microorganism reference spectra library.
Robert Jerris, PhD, D (ABMM), director of clinical microbiology at the Children´s Healthcare of Atlanta pediatric hospital, said, “MALDI-TOF has had a dramatic impact on patient care at Children’s Healthcare of Atlanta. The ability to identify organisms directly from plates—saving at minimum a day over conventional phenotypic tests for many organisms—has impacted therapy, timely infection control and contributed to decrease in healthcare expenditures.”
For more information, visit Bruker.