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)

doi:10.1097/PAI.0000000000000451

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 journal › Review article › peer-review

36 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 language	English
Journal	Applied Immunohistochemistry & Molecular Morphology
Volume	25
Issue number	1
Pages (from-to)	4-11
Number of pages	8
ISSN	1541-2016
DOIs	https://doi.org/10.1097/PAI.0000000000000451
Publication status	Published - 2017

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Cheung, C. C., D'Arrigo, C., Dietel, M., Francis, G. D., Gilks, C. B., Hall, J. A., Hornick, J. L., Ibrahim, M., Marchetti, A., Miller, K., van Krieken, J. H., Nielsen, S., Swanson, P. E., Taylor, C. R., Vyberg, M., Zhou, X., Torlakovic, E. E., & From the International Society for Immunohistochemistry and Molecular Morphology (ISIMM) and International Quality Network for Pathology (IQN Path) (2017). 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. Applied Immunohistochemistry & Molecular Morphology, 25(1), 4-11. https://doi.org/10.1097/PAI.0000000000000451

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title = "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",

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.{"}",

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

year = "2017",

doi = "10.1097/PAI.0000000000000451",

language = "English",

volume = "25",

pages = "4--11",

journal = "Applied Immunohistochemistry & Molecular Morphology",

issn = "1541-2016",

publisher = "Lippincott Williams & Wilkins",

number = "1",

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Cheung, CC, D'Arrigo, C, Dietel, M, Francis, GD, Gilks, CB, Hall, JA, Hornick, JL, Ibrahim, M, Marchetti, A, Miller, K, van Krieken, JH, Nielsen, S, Swanson, PE, Taylor, CR, Vyberg, M, Zhou, X, Torlakovic, EE & From the International Society for Immunohistochemistry and Molecular Morphology (ISIMM) and International Quality Network for Pathology (IQN Path) 2017, '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', Applied Immunohistochemistry & Molecular Morphology, vol. 25, no. 1, pp. 4-11. https://doi.org/10.1097/PAI.0000000000000451

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. / Cheung, Carol C; D'Arrigo, Corrado; Dietel, Manfred et al.
In: Applied Immunohistochemistry & Molecular Morphology, Vol. 25, No. 1, 2017, p. 4-11.

Research output: Contribution to journal › Review article › peer-review

TY - JOUR

T1 - Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine

T2 - Part 1: Fit-for-Purpose Approach to Classification of Clinical Immunohistochemistry Biomarkers

AU - Cheung, Carol C

AU - D'Arrigo, Corrado

AU - Dietel, Manfred

AU - Francis, Glenn D

AU - Gilks, C Blake

AU - Hall, Jacqueline A

AU - Hornick, Jason L

AU - Ibrahim, Merdol

AU - Marchetti, Antonio

AU - Miller, Keith

AU - van Krieken, J Han

AU - Nielsen, Søren

AU - Swanson, Paul E

AU - Taylor, Clive R

AU - Vyberg, Mogens

AU - Zhou, Xiaoge

AU - Torlakovic, Emina E

AU - From the International Society for Immunohistochemistry and Molecular Morphology (ISIMM) and International Quality Network for Pathology (IQN Path)

PY - 2017

Y1 - 2017

N2 - 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."

AB - 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."

U2 - 10.1097/PAI.0000000000000451

DO - 10.1097/PAI.0000000000000451

M3 - Review article

SN - 1541-2016

VL - 25

SP - 4

EP - 11

JO - Applied Immunohistochemistry & Molecular Morphology

JF - Applied Immunohistochemistry & Molecular Morphology

IS - 1

ER -

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

Abstract

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