APR 10, 2019 9:00 AM PDT

Validation and Implementation of Quantitative Molecular Assays

Sponsored by: DiaSorin Molecular LLC
C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Director, Clinical and Molecular Microbiology, Cook Children's Medical Center
    Biography
      Dr. Pence is the Director of Clinical and Molecular Microbiology at Cook Children's Medical Center in Fort Worth, Texas. Dr. Pence received her BS in Molecular and Cellular Biology from the University of Illinois at Urbana-Champaign in 2006 and her PhD in Biomedical Sciences from the University of California, San Diego in 2012. In 2014, she completed a fellowship in Clinical Microbiology at Washington University in St. Louis and joined Cook Children's Medical Center. Dr. Pence is a member of ASM, IDSA and PASCV and is the current president of the Southwestern Association of Clinical Microbiology (SWACM). Her interests include technologist and clinician education, regulatory requirements, rapid diagnostics and diagnostic stewardship.

    Abstract

    Regulatory requirements for verification and validation are complex and often cause confusion among clinical laboratorians, especially in regards to quantitative molecular assays. This presentation will discuss verification and validation requirements as defined by the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP). Calibrations and standards, including calibration, calibration verification, analytical measurement range (AMR) verification and the importance of quality standards, will also be discussed.

    Learning Objectives: 

    1. Define verification and validation
    2. Define the verification requirements for unmodified FDA-cleared/approved tests
    3. Discuss the validation requirements for modified FDA-cleared/approved tests and laboratory developed tests
    4. Describe calibration methods and standards for quantitative assays


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