WASHINGTON -- The U.S. Food and Drug Administration recently 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.
Known as the VITEK MS, the system 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 one minute.
People with immune systems that are compromised or weakened by HIV/AIDS, cancer treatment, or anti-rejection therapy following an organ transplant are particularly vulnerable to yeast and bacterial infections.
“The ability for laboratories to use one device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms,” said Dr. Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the Center for Devices and Radiological Health.
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 automatically compares the microorganism pattern to 193 known yeasts and bacteria in the test system’s database to identify the microorganism.
The VITEK MS 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.
The VITEK MS is manufactured by bioMerieux, Inc. in Durham, N.C.