Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine: Part 1: Fit-for-Purpose Approach to Classification of Clinical Immunohistochemistry Biomarkers

Carol C Cheung, Corrado D'Arrigo, Manfred Dietel, Glenn D Francis, C Blake Gilks, Jacqueline A Hall, Jason L Hornick, Merdol Ibrahim, Antonio Marchetti, Keith Miller, J Han van Krieken, Søren Nielsen, Paul E Swanson, Clive R Taylor, Mogens Vyberg, Xiaoge Zhou, Emina E Torlakovic, From the International Society for Immunohistochemistry and Molecular Morphology (ISIMM) and International Quality Network for Pathology (IQN Path)

Research output: Contribution to journalReview articleResearchpeer-review

20 Citations (Scopus)

Abstract

The numbers of diagnostic, prognostic, and predictive immunohistochemistry (IHC) tests are increasing; the implementation and validation of new IHC tests, revalidation of existing tests, as well as the on-going need for daily quality assurance monitoring present significant challenges to clinical laboratories. There is a need for proper quality tools, specifically tissue tools that will enable laboratories to successfully carry out these processes. This paper clarifies, through the lens of laboratory tissue tools, how validation, verification, and revalidation of IHC tests can be performed in order to develop and maintain high quality "fit-for-purpose" IHC testing in the era of precision medicine. This is the final part of the 4-part series "Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine."

Original languageEnglish
JournalApplied Immunohistochemistry & Molecular Morphology
Volume25
Issue number1
Pages (from-to)4-11
Number of pages8
ISSN1541-2016
DOIs
Publication statusPublished - 2017

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