Getting controls under control: The time is now for immunohistochemistry

Abstract

For several decades, immunohistochemistry (IHC), more specifically diagnostic IHC (dIHC), has been considered an art rather than a laboratory test. There was no clarity about what test performance characteristics are relevant to dIHC, test performance characteristics were not fully defined for dIHC and partly as a consequence of that, there were no standardised controls or reference standards. Herein, we discuss the role of standardisation of external controls for test performance characteristics and the role of standardised controls and reference standards for overall standardisation of IHC.