Recommendations for improved standardization of immunohistochemistry.

Immunohistochemistry (IHC) continues to suffer from variable consistency, poor reproducibility, quality assurance disparities, and the lack of standardization resulting in poor concordance, validation, and verification. This document lists the recommendations made by the Ad-Hoc Committee on Immunohistochemistry Standardization to address these deficiencies. Contributing factors were established to be underfixation and irregular fixation, use of nonformalin fixatives and ancillary fixation procedures divested from a deep and full understanding of the IHC assay parameters, minimal or absent IHC assay optimization and validation procedures, and lack of a standard system of interpretation and reporting. Definitions and detailed guidelines pertaining to these areas are provided.