Emina Torlakovic

cIQc Non-Small Cell Lung Cancer EQA for PD-L1
Presentation (PDF)

CIQC conducted pilot/educational run for proficiency testing for PD-L1. Although the number of participants was small, the review of the results revealed number of pitfalls related to the design of the proficiency testing materials and the analysis of the achieved results. This presentation reviews lessons learned from the experience.___
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Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine (also see Carol Cheung)
Part II: Immunohistochemistry Test Performance Characteristics
 
All laboratory tests have test performance characteristics (TPCs), whether or not they are explicitly known to the laboratorian or the pathologist. TPCs are thus also an integral characteristic of immunohistochemistry (IHC) tests and other in situ, cell-based molecular assays such as DNA or RNA in situ hybridization or aptamer-based testing. Because of their descriptive, in situ, cell-based nature, IHC tests have a limited repertoire of appropriate TPCs. Although only a few TPCs are relevant to IHC, proper selection of informative TPCs is nonetheless essential for the development of and adherence to appropriate quality assurance measures in the IHC laboratory. This paper describes the TPCs that are relevant to IHC testing and emphasizes the role of TPCs in the validation of IHC tests. This is part 2 of the 4-part series “Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine.”
 
Part III: Technical Validation of IHC Assays in Clinical IHC Laboratories
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Validation of immunohistochemistry (IHC) assays is a subject that is of great importance to clinical practice as well as basic research and clinical trials. When applied to clinical practice and focused on patient safety, validation of IHC assays creates objective evidence that IHC assays used for patient care are “fit-for-purpose.” Validation of IHC assays needs to be properly informed by and modeled to assess the purpose of the IHC assay, which will further determine what sphere of validation is required, as well as the scope, type, and tier of technical validation. These concepts will be defined in this review, part 3 of the 4-part series “Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine.”____
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Emina Emilia Torlakovic, MD, PhD, FCAP
Adjunct Professor, Department of Laboratory Medicine and Pathobiology, University of Toronto.
Staff Hematopathologist, William Osler Health System, Toronto, Ontario.

Dr. Torlakovic received her MD at the University of Zagreb, completed her residency in Anatomical and Clinical Pathology and fellowships in Hematopathology and Surgical Pathology at the University of Minnesota, MN, USA. She is a Diplomate of the American Board of Pathology in Anatomical and Clinical Pathology and Hematopathology. She has authored over 100 peer-reviewed manuscripts and also published author of book/book chapters. She led several national and international published guidelines in the field of immunohistochemistry and is also a co-author of ASCO/CAP guidelines for ER/PR testing in breast cancer. Dr. Torlakovic is a founding member of NordiQC, Canadian Immunohistochemistry Quality Control (cIQc), as well as International Society for Immunohistochemistry and Molecular Morphology (ISIMM).  She is the Chair of the Canadian Association of Pathologists’ National Standards Committee for High Complexity Laboratory Testing and also co-directs cIQc. She has widely lectured in the field of quality assurance as well as in hematopathology. She is also internationally recognized for her seminal work in and discovery of sessile serrated adenoma.