Related Experiment Video

Updated: Apr 1, 2026

Synthetic Antigen Controls for Immunohistochemistry
09:30

Synthetic Antigen Controls for Immunohistochemistry

Published on: August 23, 2021

3.1K

Principles of Analytic Validation of Clinical Immunohistochemistry Assays

Jeffrey D Goldsmith1, Patrick L Fitzgibbons, Paul E Swanson

  • 1*Department of Pathology, Beth Israel Deaconess Medical Center, Children's Hospital Boston, and Harvard Medical School, Boston, MA †Department of Pathology, St. Jude Medical Center, Fullerton, CA ‡Department of Pathology and Laboratory Medicine, University of Calgary and Foothills Medical Centre, Calgary, AB, Canada.

Advances in Anatomic Pathology
|October 10, 2015
PubMed

Insights

Clinical pathology laboratories must validate all assays before use. This review outlines validation strategies for immunohistochemistry assays, guided by the College of American Pathologists.

Area of Science:

  • Anatomic and clinical pathology
  • Laboratory medicine

Background:

  • Assay validation is a mandatory prerequisite for clinical implementation in pathology laboratories.
  • Ensuring the reliability and accuracy of diagnostic tests is paramount for patient care.

Purpose of the Study:

  • To summarize validation strategies for clinical immunohistochemistry assays.
  • To provide practical guidance based on the College of American Pathologists' recent guideline.

Main Methods:

  • Review of existing literature and guidelines.
  • Focus on the College of American Pathologists' recommendations for immunohistochemistry assay validation.

Main Results:

  • Key validation steps and considerations for immunohistochemistry assays are detailed.
  • The review emphasizes a systematic approach to ensure assay performance.

Conclusions:

  • Adherence to standardized validation protocols is crucial for reliable immunohistochemistry testing.
  • The College of American Pathologists' guideline offers a robust framework for assay validation in clinical practice.

More Related Videos

Automated Multiplex Immunofluorescence Panel for Immuno-oncology Studies on Formalin-fixed Carcinoma Tissue Specimens10:49

Automated Multiplex Immunofluorescence Panel for Immuno-oncology Studies on Formalin-fixed Carcinoma Tissue Specimens

Published on: January 21, 2019

21.8K
High-Throughput Automated Multiplex Immunofluorescence Assays for Translational Research09:12

High-Throughput Automated Multiplex Immunofluorescence Assays for Translational Research

Published on: June 10, 2025

1.4K

Related Concept Videos

Immunocytochemistry and Immunohistochemistry01:22

Immunocytochemistry and Immunohistochemistry

Immunocytochemistry (ICC) and immunohistochemistry (IHC) are techniques that use antibodies to check for specific proteins or antigens in a sample. The technique was first published by Albert Coons in 1941 to detect the presence of pneumococcal antigen in tissue sections from mice infected with Pneumococcus. Immunocytochemistry helps localization of proteins or antigens in individual cells like blood cells, stem cells, etc., while immunohistochemistry does the same for tissue samples.
These...
14.9K
Data Validation01:15

Data Validation

Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
3.6K