NOV 02, 2016 7:30 AM PDT

FDA and Mass Spec Tests for Clinical Labs

Speaker
  • Director, Endocrine Laboratory, Mayo Clinic
    Biography
      Ravinder J. Singh, Ph.D., is the director of the Mayo Clinic Endocrine Laboratory. He has a focused area of investigation that has broad applicability to the field. Dr. Singh studies the application of liquid chromatography-tandem mass spectrometry (LC-MS/MS) to clinical laboratory analysis. Many of the methods that Dr. Singh developed are now considered reference methods. They have subsequently been utilized for method standardization efforts as well as to establish clinical disease correlates, which he has published with his collaborators.

      Dr. Singh's work has directly contributed to improving methods for the clinical diagnosis of Cushing's disease, pheochromocytoma and congenital adrenal hyperplasia. He continues to work to discover innovative ways to better understand the uses of LC-MS/MS in providing patients with faster and more accurate diagnoses.

    Abstract

    Most of the tests performed for patient care use automated colorimetric and immunoassay methods in the clinical laboratories. Clinical labs are regulated by CLIA and are routinely inspected by the College of American Pathologists. In local hospital clinical labs, all the machines and methods used are FDA cleared. There are numerous tests used in clinical practice which are not FDA cleared and have been developed by large reference laboratories. The methods used for these tests rely on technologies used for genomics, metabolomics, and proteomics areas of research. Mass Spectrometry is a powerful tool that is now commonly used in clinical laboratories and helps in making diagnosis of various diseases. Very few mass spec methods have been cleared by the FDA. The presenter recently attended a workshop held by the FDA and will present his experience and interactions in the workshop.


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