October 30, 2025: (1) Direct Establishment of pediatric reference intervals on the Roche cobas® pro in the CALIPER cohort of healthy children; (2) A Novel Xylazine Rapid Test Strip for Clinical Urine Screening

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Price

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SPEAKERS:

(1) Dr. Lusia Sepiashvili is a board-certified Clinical Biochemist in the Department of Paediatric Laboratory Medicine at The Hospital for Sick Children where she provides scientific oversight in the Clinical Biochemistry Division including the core laboratory, immunology, and special chemistry laboratories. She has co-authored over 25 peer-reviewed manuscripts and presented over 30 abstracts internationally and nationally. She serves as a member of the College of American Pathologists Diagnostic Immunology and Flow Cytometry committee and teaches at the undergraduate, graduate and post-graduate levels. She is also involved in numerous collaborative research studies as an Associate Professor in the Department of Laboratory Medicine and Pathobiology at the University of Toronto and Project Investigator at the Sickkids Research Institute.

(2) Dr. Ping Wang PhD, D(ABCC), FADLM is Professor of Pathology and Laboratory Medicine at University of Pennsylvania and is Chief of Clinical Chemistry and Director of Core Laboratory at Hospital of the University of Pennsylvania. She has 20 years of experience practicing in the clinical diagnostics field. Dr. Wang is also a translational researcher focusing on developing highly innovative diagnostic technologies. Her research has been continuously funded by federal agencies and Industry. She is the author/co-author of many peer-reviewed articles, reviews, and book chapters, and inventor of diagnostics patents. She has served as chartered member of NIH study sections and member of the FDA Medical Devices Advisory Committee.

overviews:

(1) This lecture will provide an overview of the CLSI-based approach used for direct pediatric reference interval establishment and describe the established pediatric reference intervals derived from the CALIPER cohort of healthy children for several common biochemical markers on the Roche cobas pro® integrated system. This overview will fill an important gap in pediatric reference interval availability for this system for numerous key tests such as electrolytes, metabolites, enzymes, proteins and lipids, while highlighting analytes requiring age- or sex-specific reference intervals.

(2) This lecture will describe the research, development and validation of a novel rapid test strip for detection of xylazine in clinical urine samples. The goals, methods and results for this novel diagnostic method will be presented. Clinical implications and future directions will also be discussed.

learning objectives:

(1) At the conclusion of this session, participants will be able to:
-Define the CALIPER program
-Describe a CLSI-based approach used for direct establishment of pediatric reference intervals
-Recognize pediatric reference intervals for key chemistry tests on the Roche cobas® pro

(2) At the conclusion of this session, participants will be able to:
-Describe the clinical need for xylazine testing
-Describe the mechanism of the novel xylazine test strip
-Describe the clinical sensitivity and specificity of the novel xylazine test strip