New Test System Identifies 193 Yeasts and Bacteria Known to Cause Illness
FDA allows marketing in U.S. (August 21)
The FDA has allowed marketing in the U.S. of the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans. The VITEK MS system (bioMerieux, Inc.) can identify 193 different microorganisms and can perform up to 192 different tests in a single automated series of testing, with each test taking about 1 minute.
The test system can identify yeasts, such as those from the Candida, Cryptococcus, and Malassezia groups, and bacteria from the Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadaceae, and Bacteroidaceae families, which are associated with skin infections, pneumonia, meningitis, and bloodstream infections.
People with immune systems that are compromised or weakened by human immunodeficiency virus (HIV) infection, by acquired immune deficiency syndrome (AIDS), by cancer treatment, or by anti-rejection therapy following an organ transplant are particularly vulnerable to these infections.
The VITEK MS system incorporates a technology called matrix-assisted laser desorption/ionization–time of flight mass spectrometry (MALDI-TOF MS). The technology uses a laser to break yeast and bacteria specimens into small particles that form a pattern unique to the microorganism. The VITEK MS system automatically compares the microorganism pattern with that of 193 known yeasts and bacteria in the test system’s database to identify the microorganism.
Compared with other identification methods that require abundant organism growth for testing, mass spectrometry requires only a small amount of yeast or bacterial growth, so testing can start as soon as growth is visible, generally within 18 to 24 hours. Traditional methods can take up to 5 days to produce the same identification results.
The VITEK MS system is for clinical use for the identification of microorganisms cultured from human specimens. It is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.
Source: FDA; August 21, 2013.