Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline
|Publication Date:||1 January 2011|
The purpose of this document is to provide guidance to all of the stakeholders involved with design and implementation of immunohistochemistry
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.