Or, tuberculosis identification system using high performance liquid chromatography gains US Food and Drug Administration approval
Agilent Technologies and Midi have announced FDA 510(k) clearance for the Midi Sherlock mycobacteria identification system, used to identify Mycobacterium tuberculosis (TB).
According to the World Health Organisation, TB causes more than two million deaths annually, and one in every three people has a latent form of the disease.
A critical element in preventing the spread of the disease is to accurately identify and treat new active cases as soon as possible.
"Rapid and accurate laboratory identification of Mycobacterium tuberculosis isolates from patient specimens is crucial for proper patient management and is essential in order to break the chain of person-to-person transmission of the disease" said Kenneth Jost, supervisor with the Texas Department of Health Mycobacteriology Laboratory. "The Sherlock Mycobacteria identification system has proven to be an effective diagnostic for accomplishing this goal." The Sherlock system uses the Agilent 1100 series high performance liquid chromatograph (HPLC) to analyse mycolic acids derived from cultured bacterial samples.
HPLC is a technology used to separate, identify, purify and quantify compounds.
In one simple step, Sherlock analyses the mycolic acids in the bacterial sample, then searches its library of reference mycobacteria using pattern recognition software.
The Sherlock software automates liquid chromatography with the Agilent 1100 series HPLC, making the system easy to use and maintain.
A low cost per sample allows for more routine screening of TB in those regions of the world that have the highest incidences of this disease.
