Standardization of Clinical Immunohistochemistry

Standardization of clinical immunohistochemistry: why, how, and by whom?

The editorial by Fletcher and Fletcher1 in the August 2002 issue of AJCP in response to news that the Food and Drug Administration (FDA) is making plans to recommend a “standardized” immunohistochemical test for the KIT protein (CD117) highlighted the clash of cultures that is emerging in diagnostic surgical pathology. Largely based on the interpretation of histologic images, this profession ha...

Recommendations for improved standardization of immunohistochemistry.

Immunohistochemistry (IHC) continues to suffer from variable consistency, poor reproducibility, quality assurance disparities, and the lack of standardization resulting in poor concordance, validation, and verification. This document lists the recommendations made by the Ad-Hoc Committee on Immunohistochemistry Standardization to address these deficiencies. Contributing factors were established...

Computational Immunohistochemistry: Recipes for Standardization of Immunostaining

Cancer diagnosis and personalized cancer treatment are heavily based on the visual assessment of immunohistochemically-stained tissue specimens. The precision of this assessment depends critically on the quality of immunostaining, which is governed by a number of parameters used in the staining process. Tuning of the staining-process parameters is mostly based on pathologists’ qualitative asses...

Standardization of diagnostic immunohistochemistry: literature review and geisinger experience.

CONTEXT Immunohistochemistry has become an indispensable ancillary technique in anatomic pathology laboratories. Standardization of every step in preanalytic, analytic, and postanalytic phases is crucial to achieve reproducible and reliable immunohistochemistry test results. OBJECTIVE To standardize immunohistochemistry tests from preanalytic, analytic, to postanalytic phases. DATA SOURCES ...

Standardization of clinical trials