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Principles of Analytic Validation of Immunohistochemical Assays


We are committed to keeping this guideline up to date. The guideline is currently being updated with expected completion in 2020.


Our evidence-based guideline, "Principles of Analytic Validation of Immunohistochemical Assays," serves as a practical guide to help ensure accuracy and reduce variation in laboratory practices for immunohistochemical (IHC) test results for all patient specimens.

The panel addressed the key question of "What is needed for initial analytic assay validation before placing any immunohistochemical test into clinical service and what are the revalidation requirements?" They conducted a systematic review of more than 1,500 references and developed 14 recommendations in the context of feedback received during the open comment period, quality of evidence, and their own expert judgments in the field of immunohistochemistry.

The guideline recommendations help ensure that an IHC test accurately measures the analyte of interest and that validation is appropriate for the test's intended use. Recommendations are also provided for verifying that an existing validated assay continues to perform as expected when there has been a change in laboratory location, test methods, or equipment. The guideline may also provide a framework for validating molecular and genomic-based assays.

Guideline Information

  • Status: In Review
  • Published online ahead of print: March 19, 2014
  • Originally published: November 2014

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