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Emina Torlakovic

International standardization of positive and negative controls for IHC

Handout (pdf 62 p)

Handout (pdf16 p)


Diagnostic immunohistochemistry (dIHC) has been in practice for several decades and it is currently one of the most powerful tools in the hands of pathologists. Controls, both positive and negative controls are essential for all medical laboratory testing. Despite many attempts to standardize dIHC, it is only recently that standardization of controls for dIHC has started to be addressed. Standardization of controls for dIHC is directly linked to “fit-for-use” principle since the standard controls need to serve the purpose for which they are used. Therefore, the same test may need or may have different controls if it is used differently. Standardization of controls in IHC will also enable methodology transfer, which is one of the most challenging issues that dIHC has. Standardized controls enable transfer of IHC protocols from published literature to clinical IHC laboratories, from one clinical laboratory to another, from industry to clinical laboratory, from clinical trials to clinical laboratory, etc. An International Ad Hoc Expert Panel has recently published recommendations on standard terminology and classification of controls, recommendations for “best laboratory practice” regarding the use of controls, and has also developed a concept of Immunohistochemistry Critical Assay Performance Controls (iCAPCs) as well as tree-tier classification for IHC sensitivity and specificity.


Dr. Emina Emilia Torlakovic obtained her M.D. at the University of Zagreb Medical School and her Ph.D. at the University of Oslo Medical School. She is board certified by The American Board of Pathology in Anatomic and Clinical Pathology with subspecialty boards in Hematopathology. She is an associate professor at the Department of Laboratory Medicine and Pathobiology, Faculty of Medicine, University of Toronto and practices as a staff hematopathologist in the Department of Laboratory Hematology at the University Health Network. She was a founding member of the NordiQC and also co-founded CIQC, which she is currently co-directing. Dr. Torlakovic is the Chair of the National Standards Committee for High Complexity Testing of the Canadian Association of Pathologists. This committee prepared and published several Canadian guidelines for standardization of IHC testing. Dr. Torlakovic chairs the International Council for Standardization in Hematology Working Party for Standardization of Bone Marrow Immunohistochemistry, which developed international guidelines for bone marrow IHC. She was also a member of the ASCO/CAP expert panel that published guidelines for hormone receptor testing in breast cancer. She is also currently leading projects related to global standardization of controls in diagnostic IHC.

Dr. Torlakovic is also known for a discovery of a sessile serrated adenoma and her classification of serrated polyps of the colon is recently adopted for WHO classification.

Dr. Torlakovic has published over 80 peer reviewed manuscripts, authored a book on Bone Marrow Immunohistochemistry, and has lectured widely nationally and internationally on immunohistochemistry, quality assurance, and hematopathology.

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