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Recommendations for Improved Standardization of Immunohistochemistry

Recommendations for Improved Standardization of Immunohistochemistry REVIEW ARTICLE Recommendations for Improved Standardization of Immunohistochemistry Neal S. Goldstein, MD, Stephen M. Hewitt, MD, PhD, Clive R. Taylor, MD, DPhil, Hadi Yaziji, MD, David G. Hicks, MD, and Members of Ad-Hoc Committee On Immunohistochemistry Standardization IHC assay standardization was vital for reproducible and Abstract: Immunohistochemistry (IHC) continues to suffer from reliable results. Agencies, including the Biologic Stain variable consistency, poor reproducibility, quality assurance Commission, CLSI (previously NACCLS), FDA, and the disparities, and the lack of standardization resulting in poor manufacturing sector established guidelines, standards, concordance, validation, and verification. This document lists and recommendations for reagents and package inserts. the recommendations made by the Ad-Hoc Committee on These efforts have resulted in consistent, high-quality Immunohistochemistry Standardization to address these defi- assay components and instruments on which contempor- 1–4 ciencies. Contributing factors were established to be under- ary IHC is performed. It has also allowed the fixation and irregular fixation, use of nonformalin fixatives and development and use of so-called black box IHC stainers ancillary fixation procedures divested from a deep and full in which IHC assays have preset parameters set by the understanding of the IHC assay parameters, minimal or absent manufacturer. IHC assay optimization and validation procedures, http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Applied Immunohistochemistry & Molecular Morphology Wolters Kluwer Health

Recommendations for Improved Standardization of Immunohistochemistry

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ISSN
1541-2016
DOI
10.1097/PAI.0b013e31804c7283
pmid
17525622
Publisher site
See Article on Publisher Site

Abstract

REVIEW ARTICLE Recommendations for Improved Standardization of Immunohistochemistry Neal S. Goldstein, MD, Stephen M. Hewitt, MD, PhD, Clive R. Taylor, MD, DPhil, Hadi Yaziji, MD, David G. Hicks, MD, and Members of Ad-Hoc Committee On Immunohistochemistry Standardization IHC assay standardization was vital for reproducible and Abstract: Immunohistochemistry (IHC) continues to suffer from reliable results. Agencies, including the Biologic Stain variable consistency, poor reproducibility, quality assurance Commission, CLSI (previously NACCLS), FDA, and the disparities, and the lack of standardization resulting in poor manufacturing sector established guidelines, standards, concordance, validation, and verification. This document lists and recommendations for reagents and package inserts. the recommendations made by the Ad-Hoc Committee on These efforts have resulted in consistent, high-quality Immunohistochemistry Standardization to address these defi- assay components and instruments on which contempor- 1–4 ciencies. Contributing factors were established to be under- ary IHC is performed. It has also allowed the fixation and irregular fixation, use of nonformalin fixatives and development and use of so-called black box IHC stainers ancillary fixation procedures divested from a deep and full in which IHC assays have preset parameters set by the understanding of the IHC assay parameters, minimal or absent manufacturer. IHC assay optimization and validation procedures,

Journal

Applied Immunohistochemistry & Molecular MorphologyWolters Kluwer Health

Published: Jun 1, 2007

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