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Staphylococcus infection
Credit: Bill Branson
The US Food and Drug Administration (FDA) has approved the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illnesses in humans.
The system, called VITEK MS, can identify 193 different microorganisms and perform up to 192 different tests, each of which takes about 1 minute.
The VITEK MS can identify yeasts and bacteria associated with skin infections, pneumonia, meningitis, and bloodstream infections.
Patients whose immune systems are compromised or weakened by HIV/AIDS, cancer treatment, or antirejection therapy following transplants are particularly vulnerable to these infections.
“The ability for laboratories to use 1 device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health.
The VITEK MS incorporates a technology called matrix-assisted laser desorption/ionization–time of flight mass spectrometry. 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 system’s database to identify the microorganism.
Compared to 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 FDA reviewed the VITEK MS through its de novo classification process, a regulatory pathway for some novel, low-to-moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
The FDA based its decision on the results of a study of 7068 microorganisms. When compared to sequencing and biochemical testing, the VITEK MS correctly identified the scientific group or family 93.6% of the time (with 87.5% of microorganisms identified to species level).
The system provided a “no identification” result for 3.2% of the microorganisms in the study, 0.8% of the test results were incorrect, and 2.4% were low discrimination with no correct result.
The VITEK MS is manufactured by bioMerieux, Inc., located in Durham, North Carolina. 
Staphylococcus infection
Credit: Bill Branson
The US Food and Drug Administration (FDA) has approved the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illnesses in humans.
The system, called VITEK MS, can identify 193 different microorganisms and perform up to 192 different tests, each of which takes about 1 minute.
The VITEK MS can identify yeasts and bacteria associated with skin infections, pneumonia, meningitis, and bloodstream infections.
Patients whose immune systems are compromised or weakened by HIV/AIDS, cancer treatment, or antirejection therapy following transplants are particularly vulnerable to these infections.
“The ability for laboratories to use 1 device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health.
The VITEK MS incorporates a technology called matrix-assisted laser desorption/ionization–time of flight mass spectrometry. 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 system’s database to identify the microorganism.
Compared to 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 FDA reviewed the VITEK MS through its de novo classification process, a regulatory pathway for some novel, low-to-moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
The FDA based its decision on the results of a study of 7068 microorganisms. When compared to sequencing and biochemical testing, the VITEK MS correctly identified the scientific group or family 93.6% of the time (with 87.5% of microorganisms identified to species level).
The system provided a “no identification” result for 3.2% of the microorganisms in the study, 0.8% of the test results were incorrect, and 2.4% were low discrimination with no correct result.
The VITEK MS is manufactured by bioMerieux, Inc., located in Durham, North Carolina.
Staphylococcus infection
Credit: Bill Branson
The US Food and Drug Administration (FDA) has approved the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illnesses in humans.
The system, called VITEK MS, can identify 193 different microorganisms and perform up to 192 different tests, each of which takes about 1 minute.
The VITEK MS can identify yeasts and bacteria associated with skin infections, pneumonia, meningitis, and bloodstream infections.
Patients whose immune systems are compromised or weakened by HIV/AIDS, cancer treatment, or antirejection therapy following transplants are particularly vulnerable to these infections.
“The ability for laboratories to use 1 device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health.
The VITEK MS incorporates a technology called matrix-assisted laser desorption/ionization–time of flight mass spectrometry. 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 system’s database to identify the microorganism.
Compared to 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 FDA reviewed the VITEK MS through its de novo classification process, a regulatory pathway for some novel, low-to-moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
The FDA based its decision on the results of a study of 7068 microorganisms. When compared to sequencing and biochemical testing, the VITEK MS correctly identified the scientific group or family 93.6% of the time (with 87.5% of microorganisms identified to species level).
The system provided a “no identification” result for 3.2% of the microorganisms in the study, 0.8% of the test results were incorrect, and 2.4% were low discrimination with no correct result.
The VITEK MS is manufactured by bioMerieux, Inc., located in Durham, North Carolina.