The FDA has approved U.S. marketing of bioMerieux Inc.’s VITEK MS, the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans. It is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.
The VITEK MS can identify 193 different microorganisms and can perform up to 192 different tests in a single automated series of testing (about 1 minute per test). Yeasts such as those from the Candida, Cryptococcus and Malassezia groups, and bacteria from Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadaceae, and Bacteroidaceae families can be identified by the VITEK MS. These microorganisms are associated with skin infections, pneumonia, meningitis, and bloodstream infections.
The VITEK MS utilizes matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF-MS) technology that uses a laser to break yeast and bacteria into small particles that form its own unique pattern. The system then compares the microorganism pattern to 193 known yeasts and bacteria in the database to identify the microorganism. Testing can start as soon as growth is visible, which is generally within 18-24 hours. Traditional methods can take up to five days to produce the same identification results.
The FDA’s approval is based on the results of a study of 7,068 microorganisms. Compared to sequencing and biochemical testing methods, the VITEK MS identified the scientific group or family 93.6% of the time (with 87.5% identified at the species level). Overall, only 0.8% were incorrect and 2.4% were low discrimination with no correct result.
For more information call (800) 682-2666 or visit FDA.gov.