Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine – Part 2: Immunohistochemistry Test Performance Characteristics : Applied Immunohistochemistry & Molecular Morphology

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Review Article

Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine – Part 2: Immunohistochemistry Test Performance Characteristics

Torlakovic, Emina E. MD, PhD*†‡; Cheung, Carol C. MD, PhD, JD; D’Arrigo, Corrado MB, ChB, PhD, FRCPath∥¶#; Dietel, Manfred MD, PhD**; Francis, Glenn D. MBBS, FRCPA, MBA, FFSc (RCPA)††,‡‡,§§; Gilks, C. Blake MD∥∥; Hall, Jacqueline A. PhD¶¶; Hornick, Jason L. MD, PhD##; Ibrahim, Merdol PhD***; Marchetti, Antonio MD, PhD†††; Miller, Keith FIBMS***; van Krieken, J. Han MD, PhD‡‡‡; Nielsen, Soren BMS§§§,∥∥∥; Swanson, Paul E. MD¶¶¶; Vyberg, Mogens MD§§§,∥∥∥; Zhou, Xiaoge MD###,****; Taylor, Clive R. MD††††

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Applied Immunohistochemistry & Molecular Morphology 25(2):p 79-85, February 2017. | DOI: 10.1097/PAI.0000000000000444

Abstract

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.”

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