SEP 18, 2018 09:00 AM PDT

Validation of clinical LC-MS/MS methods: What you need to know

C.E. CREDITS: P.A.C.E. CE | Florida CE
  • Assistant Director of Chemistry, University of California San Francisco Clinical Laboratories
      Deborah French received her Ph.D. in biochemistry from the University of Strathclyde in Glasgow, Scotland. She completed a pharmacogenomics postdoctoral fellowship at St. Jude Children's Research Hospital in Memphis, TN from and then completed a Clinical Chemistry postdoctoral fellowship at the University of California San Francisco with Alan Wu. Currently, Deborah is the Assistant Director of Chemistry and Director of Mass Spectrometry at UCSF Clinical Laboratories. In these positions she develops and validates mass spectrometry assays for steroid hormones, therapeutic drug monitoring and toxicology, teaches clinical laboratory scientists and residents about clinical chemistry and mass spectrometry, and oversees the running of the Chemistry Section with the Director of Chemistry. Deborah also holds a faculty appointment as an Associate Clinical Professor in the Department of Laboratory Medicine at UCSF.


    DATE: September 18, 2018
    TIME: 9:00AM PDT

    LC-MS/MS has been increasingly adopted by clinical laboratories due to the potential it has for increased sensitivity and specificity over more commonly used analytical techniques.  However, implementation can be daunting due to the complex nature of the instrumentation and the added burden of development and validation of methods that must be undertaken by the laboratory if they are laboratory developed tests (LDTs).  This presentation will discuss best practices for validating clinical LC-MS/MS methods including writing a validation plan, pre-validation recommendations and post-validation monitoring.

    Learning Objectives:

    • Write a validation plan and pre-validation recommendations
    • Discuss best practices and solutions for determining common validation parameters such as precision, linearity, matrix effects, extraction recovery and accuracy
    • Write a validation summary and establish LC-MS/MS data review and reporting criteria

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