Development of a Novel Approach for Immunohistochemical Assay Validation

摘要

Immunohistochemical (IHC) assays are increasingly used to detect protein biomarkers. For an IHC biomarker assay to be used to its maximal utility, assay development and validation are of paramount importance. Assay development and validation typically follows the guidelines set out in Validation of Analytical Procedures: Text and Methodology Q2(R1) and Q2B Validation of Analytical Procedures: Methodology. Assay validation can include quantitation and while quantitative immunohistochemistry is performed, relative measures (relative optical density, and others) are frequently used.