Regulatory Validation of Standardized Clinical Immunohistochemistry Controls

DESCRIPTION (provided by applicant): The broad, long-term goal of this project is consistent, standardized diagnostic testing of surgical biopsies by immunohistochemistry (IHC). The methods to achieve this goal are well understood in the field of clinicallaboratory testing: (1) standardization of reagents and protocols, (2) automation to reduce human errors, and (3) the use of standardized controls to provide test performance feedback. Over the last two decades, the first two of these three methods were implemented for IHC testing. This grant project focuses on the third - standardized controls. Current practice teaches non-standardized controls. Each histopathology lab typically procures test controls from leftover tissue samples in its own paraffin blockarchives. This is a strikingly different practice from clinical blood laboratories, where standardized and validated controls are produced in large quantities and sold through commercial vendors. Since each human tissue is a limited resource, present