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Principles of Analytic Validation of Immunohistochemical Assays


The 2014 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. Updates to this guideline are important as IHC testing is an essential component of the pathologic evaluation of many specimens, and the results increasingly provide key information that helps determine how patients are treated.

Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to grading quality (or certainty) of evidence and strength of recommendations, the draft update reaffirms original recommendations but now categorizes 11 of the original 14 statements as “Good Practice Statements,” which indicates a high level of certainty, but a lack of direct, published evidence.

Guideline Information

  • Status: Complete Recommendations
  • Published online ahead of print: March 19, 2014
  • Originally published: November 2014
  • Open comment period: August 4-25, 2021

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