NOV 11, 2015 01:30 PM PST

Why to validate diagnostic tests?

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  • Associate Professor, University of Texas Health Science Center at San Antonio
      I graduated from the Collegium Medicum at Jagiellonski University in Poland, and subsequently completed residency program in anatomic, clinical pathology and clinical chemistry. I have been practicing pathology in the University of Texas Health Science Center at San Antonio, Texas as a staff pathologist and medical director of clinical chemistry and molecular laboratory.
      I have been serving the Instrumental Resource Committee of the College of American Pathologist (CAP) since 2008. Since 2009 I have served for the Pharmacogenomics Committee, Educational subcommittee working on Pharmacogenomics Educational Course. I was actively involved in the CLSI on a project "Method Validation by using patient's sample". The main scientific interest is in biomarkers for aggressive prostate cancer as well as biomarkers for monitoring the trauma patients with hemorrhagic shock.


    This lecture will provide attendees with the knowledge and skills to bring on new clinical laboratory tests in clinical chemistry and molecular diagnostics. The lecture will provide a general overview of the CLIA and CAP regulatory requirements for the implementation of new tests, including conducting test validation, discussing the analytical measurement range (as appropriate for quantitative assays), cut offs for qualitative tests and carry over identification. The lecture will discuss some examples from the areas of clinical chemistry and molecular diagnostics which are related the general principles of validation.

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