Immunohistochemistry Validations

Course overview

Immunohistochemistry assays are highly critical to the care and treatment of our patients, aiding in the diagnosis of many different conditions as well as helping to determine the best course of treatment. Due to the many different considerations, mainly pre-analytical factors, there has not been a large adoption of "cleared" protocols throughout the industry. This has led to most labs using "Laboratory Developed Tests" in their practice. Over time many labs have created varying processes to validate their assays. The purpose of this workshop is to demonstrate why analytical validation is so important. We will do this by reviewing the intent behind the validation process and reviewing the regulatory requirements as delineated by CAP. We will conclude the discussion by reviewing current best practices in validations to help better standardize your lab's validation process.