Advances in Celiac Disease Testing: From method validation to serological diagnosis

Presented By:
Lusia Sepiashvili
Jane Dickerson

Speaker Biography:
Dr. Lusia Sepiashvili is a board-certified Clinical Biochemist in the Department of Paediatric Laboratory Medicine at The Hospital for Sick Children. She is involved in numerous collaborative research studies as an Assistant Professor in the Department of Laboratory Medicine and Pathobiology at the University of Toronto. She co-authored 12 peer-reviewed manuscripts, 3 book chapters, and presented over 20 abstracts internationally and nationally. She serves as the Associate Editor for the AACC NEJM+ Clinical Immunology adaptive learning courses and recently served as a member of the AACC’s COVID 19 Serology Task Force where she contributed to the guidelines for clinical implementation and interpretation of SARS-CoV-2 serologic tests.
Jane Dickerson, PhD, DABCC is Director of Chemistry, Director of Reference Lab Services, and the Medical Director at the North Clinic at Seattle Children’s Hospital. She completed her graduate work in analytical chemistry at the University of Washington, where she stayed for clinical chemistry fellowship in the Department of Lab Medicine and Pathology. As a clinical associate professor, Dr. Dickerson focuses her research on the science of the delivery of care—improving processes to get the right test ordered (laboratory stewardship), performed (analysis of alternative matrices), and resulted (failure to retrieve) for the best patient care. She is a co-founder and Director of Clinical Services for PLUGS (Patient-centered Laboratory Utilization Guidance Services), a national collaboration whose mission is to improve test ordering, retrieval, interpretation, and reimbursement. Dr. Dickerson is board certified by the American Board of Clinical Chemistry.
Advances in Celiac Disease Testing: From method validation to serological diagnosis

Webinar Abstract:
Celiac disease (CD) serology plays an important role in CD screening, diagnosis and monitoring of dietary adherence and ongoing mucosal inflammation. Numerous societies have universally recommended CD screening in gluten-exposed individuals through serologic testing for IgA autoantibodies to tissue transglutaminase (tTG IgA), as the most sensitive screening test. The North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHN) has recommended a biopsy in symptomatic children with positive tTG IgA or asymptomatic at-risk children with positive tTG IgA or tTG IgG. The European Society Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) has proposed a no-biopsy option for children with tTG IgA result of ≥10 times the upper limit of normal (10XULN), if endomysial IgA antibody (EMA IgA) is positive in a second blood sample Since the analytical performance of serology assays has not been standardized, large inter-assay variability and variable concordance with confirmatory methods can be found. Therefore, assays and testing algorithms should be carefully evaluated for clinical and analytical performance by testing laboratories. In particular, the dose-response relationships amongst tTG IgA assays are often non-linear and therefore, implementation of the 10X ULN cut-off should be carefully evaluated. This presentation will provide an overview of analytical methods used for serologic evaluation of celiac disease, their strengths and limitations, as well as important analytical considerations of clinical impact when one is validating a new method.

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