Standardization of Positive Controls in Diagnostic Immunohistochemistry

Diagnostic immunohistochemistry (dIHC) has been practiced for several decades, with an ongoing expansion of applications for diagnostic use, and more recently for detection of prognostic and predictive biomarkers. However, standardization of practice has yet to be achieved, despite significant advances in methodology. An Ad Hoc Expert Committee was formed to address the standardization of controls, which is a missing link in demonstrating and assuring standardization of the various components of dIHC. This committee has also developed a concept of immunohistochemistry critical assay performance controls that are intended to facilitate methodology transfer and harmonization in dIHC. Furthermore, the committee has clarified definitions of IHC assay sensitivity and specificity, with special emphasis on how these definitions apply to positive controls. Recommendations for “best laboratory practice” regarding positive controls for dIHC are specified. The first set of immunohistochemistry critical assay performance controls for several frequently used IHC stains or tests is also developed and presented.