bioMérieux, Durham, NC, has been granted FDA 510(k) de novo clearance for its VITEK MS—the first clinical mass spectrometry MALDI-TOF-based system available in the United States for rapid identification of disease-causing bacteria and yeast, according to the company.
VITEK MS detects microorganisms in minutes.
The Cleveland Clinic recently named the technique one of the top breakthrough medical technologies of 2013.
For microbiologists who choose mass spectrometry for microbial identification, bioMérieux offers integrated workflow solutions with its VITEK® 2 system to ensure optimal user convenience, full sample traceability, and quality of results. All of the company’s systems will be managed with the Myla® web-based lab informatics solution. The fully integrated system will provide connectivity between identification with VITEK MS and antibiotic sensitivity testing with VITEK 2, enhanced information and workflow management.
How it Works
The system uses a novel method for identifying microorganism from clinical cultures, enabling fast results. The Matrix-Assisted Laser Desorption Ionization Time of Flight mass spectrometer (MALDI-TOF-MS) analzes material from microbial cultures to provide organism identification.
Samples are submitted to multiple laser shots inside the system. 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.
By comparing the spectra to a library owned by bioMérieux, the precise microorganism can be easily identified.
The VITEK MS database represents the vast majority of bacterial and fungal infections that afflict humans.