Speaker:
Dr. Qian (Katie) Sun, Corewell Health William Beaumont University Hospital, Michigan
Dr. Sun is a board-certified Clinical Chemist at Corewell Health William Beaumont University Hospital in Michigan and Assistant Professor at Oakland University William Beaumont School of Medicine. She serves as the Technical Director of the Automated Chemistry and Urinalysis Laboratories. She has been highly productive in clinical service, scientific research, and in the professional community as evidenced by her publications and presentations nationally and internationally. Dr. Sun has published more than 30 book chapters and peer-reviewed articles in journals including Clinical Chemistry, Blood, and JAMA Cardiology. The many awards she has received include the Paul E. Strandjord Young Investigator Award from the Academy of Clinical Laboratory Physicians and Scientists and Outstanding Speaker Award from the American Association for Clinical Chemistry. Her research interests include endocrine and autoimmune biomarkers, as well as quality improvement in the clinical laboratory.
Overview:
This session delves into the complexities of designing validation plan for detecting PSA (Prostate-specific antigen) in a patient population beyond intended use specified by manufacturers. Real world examples will be presented for analytical and clinical validation of PSA tests for patients under 50 years old, as well as for comparison of validation results from different institutions using various PSA methods. Professionals attending this session will be better equipped to implement testing methodologies beyond the intended use, ensuring that needs for diverse patient populations are met.
Learning Objectives:
At the conclusion of this session, participants will be able to:
- Appreciate the need to offer PSA tests to patients under 50 years of age.
- Design validation strategies for off-label use of PSA in specific patient populations.