Abstract
Quality assurance (QA) in immunohistochemistry (IHC) underwent a major overhaul as a result of the pressures and demands of precision medicine. As this trend continues, IHC laboratories as well as pathologists will continue to face increasing external expectations with respect to the validity of results from IHC testing, especially when such testing is employed for predictive and prognostic biomarker assays. Even seemingly simplistic “existential” questions such as “what is IHC?”, “what is an assay?”, or “what is an antibody?”, has to be reconsidered and addressed through the lens of precision diagnostics. This chapter is an attempt to provide guidance on recently published concepts related to defining quality in IHC. It also aims to provide clarification for why we must i) gain a clear understanding of the test performance characteristics that are applicable to IHC, ii) adopt more precise terminology, and iii) embrace the age of evidence in which the term “validation” is only meaningful if further qualified by its sphere, type, scope, and tier. As IHC and other in situ cell-based biomarker testing methodologies continue to evolve technologically as well as in their applicability, it is to be expected that the terminology, concepts, and overall framework of QA in IHC will also be subject to additional refinements.
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