New M/S System IDs Dangerous Bacteria, Yeasts

FDA announced it has allowed the marketing of the VITEK MS, which can identify 193 different microorganisms and perform up to 192 different tests in a single automated series of testing.

The U.S. Food and Drug Administration on Aug. 21 allowed the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans to be marketed, the agency announced. The VITEK MS can identify 193 different microorganisms and perform as many as 192 different tests in a single automated series of testing. Each test takes about a minute.

VITEK MS, manufactured by bioMerieux, Inc. in Durham, N.C., "can identify yeasts such as those from the Candida, Cryptococcus, and Malassezia groups, and bacteria from the Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadaceae, and Bacteroidaceaefamilies, which are associated with skin infections, pneumonia, meningitis, and bloodstream infections. 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 these infections," according to its announcement.

"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 Alberto Gutierrez,Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at FDA's Center for Devices and Radiological Health. "Rapid identification of harmful microorganisms can improve the care of critically ill patients."

The M/S uses a technology called matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS), according to the agency. "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." Traditional identification methods require up to five days for the same results.

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    January 2019

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