bioMérieux has been granted FDA 510(k) de novo clearance for VITEK MS, a clinical mass spectrometry MALDI-TOF-based system for rapid identification of disease-causing bacteria and yeast. To gain FDA clearance, bioMérieux submitted data from a multi-center study consisting of 7,068 clinical isolates. VITEK MS accuracy was compared to 16S ribosomal RNA gene sequencing for the following categories of microbial pathogens: anaerobic bacteria, Enterobacteriaceae, gram-positive aerobes, fastidious gram-negative bacteria, gram-negative non-Enterobacteriaceae, and yeast. The overall accuracy of VITEK MS compared to nucleic acid sequencing for these organisms was 93.6%.
The VITEK MS is a Matrix-Assisted Laser Desorption Ionization Time of Flight mass spectrometer (MALDI-TOF-MS). The device analyzes material from microbial cultures to provide organism identification. Samples are submitted to multiple laser shots inside VITEK MS. The matrix absorbs the laser light and vaporizes, along with the sample, in the process gaining an electrical charge (ionization).
Electric fields then guide the ions into a vacuum tube which separates them according to their weight, with the smaller molecules rising up the column faster than the larger molecules. This “time of flight” creates a series of peaks, which correspond with the different molecules contained in the organism from the sample. All of these peaks create spectra unique to that microorganism. The spectra are then compared to a library owned by bioMérieux to identify the precise microorganism. According to bioMerieux spokespersons, the VITEK MS database represents the vast majority of bacterial and fungal infections that afflict humans. Learn more about the VITEK MS microbial identification system.
