US FDA Approves Infectious Disease Identifier
August 22, 2013
GREAT NECK, NY – Christine Ginocchio, PhD , North Shore-LIJ Health System Senior Medical Director and Chief of Infectious Disease Diagnostics, was one of the lead investigators into a rapid and accurate method of identifying infectious disease pathogens that was approved recently by the US Food and Drug Administration, the health system announced today.
The FDA said Wednesday it has approved matrix-assisted, laser desorption-ionization time of flight mass spectrometry (MALDI-TOF MS), which allows for faster treatment thanks to a quicker diagnosis.
“In the battle with infectious diseases, time is a luxury we don’t have,” said Dr. Ginocchio. “MALDI-TOF will have one of the greatest impacts on clinical microbiology in that it will revolutionize how we approach traditional microbial identification. With this technology, combined with rapid antimicrobial susceptibility testing, we can now provide diagnosis and treatment options within a time frame that will reduce morbidity and mortality.”
Mass spectrometry is a technique used to identify a molecule and determine its chemical structure by analyzing the mass and the charge of its ions. MALDI-TOF MS determines the elemental composition of a sample and can identify a microorganism’s genus and species in just a few minutes. Prior to the technology of MALDI-TOF MS, identification of a microorganism to the species level typically required several steps and it could take up to 24 hours or more for results. By diagnosing an infection faster, clinicians can treat it faster and select the best possible anti-microbial drug.
“The rapid identification of microorganisms or germs will have a positive impact on patient management, promote the appropriate use of antimicrobial therapy, compliment antimicrobial stewardship programs, and assure the prompt initiation of infection control measures,” said Dr. Ginocchio, a Brightweaters, .
More about MALDI-TOF MS
According to bioMérieux, the company that was give FDA clearance for this ground-breaking new diagnostic device, called the VITEK ®MS, Matrix-assisted laser desorption-ionization time of flight mass spectrometry (MALDI-TOF MS) technology examines the patterns of proteins detected directly from intact bacteria. The sample to be analyzed is mixed with another compound, called a matrix. The mixture is applied to a metal plate target slide and irradiated ionized with a laser. The matrix absorbs the laser light and vaporizes, along with the sample, and in the process gaining gains an electrical charge (ionization). Electrical fields then guide the ions into the time of flight mass spectrometer, ions are separated according to their mass to charge (m/z) ratio, and ultimately the quantity of each ion is measured. Detection is achieved at the end of the flight tube. bioMérieux, a world-leader in microbiology and in-vitro diagnostics, is headquartered in Marcy L’Etoile, France, with its U.S. headquarters in Durham, NC
About North Shore-LIJ Health System
The nation's third-largest, non-profit, secular healthcare system, North Shore-LIJ delivers world-class clinical care throughout the New York metropolitan area, pioneering research at The Feinstein Institute for Medical Research and a visionary approach to medical education, highlighted by the Hofstra North Shore-LIJ School of Medicine. North Shore-LIJ cares for people at every stage of life at 16 hospitals, long-term care facilities and nearly 400 outpatient physician practices throughout the region. North Shore-LIJ’s owned hospitals and long-term care facilities house more than 6,000 beds, employ more than 10,000 nurses and have affiliations with more than 9,400 physicians. With a workforce of more than 46,000, North Shore-LIJ is the largest employer on Long Island and the third-largest private employer in New York City. For more information, go to www.northshorelij.com.
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