The Total Test Approach to IHC Standardization (OLC)

Course overview

Standardization is a continual challenge in immunohistochemical testing. When considering the various parameters involved (i.e. tissue acquisition, fixation, protocol steps, reagents, instrumentation), this is not surprising; however, consistency and reproducibility are more important than ever. The prominence of personalized medicine, particularly companion diagnostics, has increased clinical accessibility to antibodies capable of identifying mutated or abnormally expressed proteins which are then targeted by therapeutic drugs. Consistency and reproducibility are also important in research in order to validate antibodies and their results. Aside from understanding the significance, the process and approach to standardization can be overwhelming. In the 1990s, a more rigorous Total Test approach was recommended for IHC assays. This approach offers a comprehensive, methodical review by categorizing the factors that affect consistency and reproducibility. This session will explore the challenges to standardization factored into the approach, and how it can be utilized to improve standardization in any laboratory setting.