The purpose of this document is to provide guidance to all of the stakeholders involved with design and implementation of immunohistochemistry (IHC) assays. It is intended for use by all clinical and reference laboratories performing immunocytochemical assays on cytological preparations or immunohistochemical assays on surgical pathology specimens, for the manufacturers of commercial reagents and test kits, and for individuals and organizations involved in the development and implementation of laboratory quality assurance (QA) programs for these assays.
This guideline presents information on the total product life cycle of the discovery, design, development, verification, and analytical and clinical validation of IHC and immunocytochemistry (ICC) reagents, kits, and systems. Its emphasis is that accurate and reliable IHC and ICC results require attention to the total test system of the assay.