CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
The College of American Pathologists Pathology and Laboratory Quality Center (the Center) develops and maintains evidence-based guidelines and consensus statements.
The CAP welcomes participation in the open comment period through July 29, on the Center guideline recommendations for Immunohistochemical (IHC) Assays: Principles of Analytic Validation.
IHCÂ testing is an essential component of the pathologic evaluation of many specimens and increasingly provides key information that helps determine how patients are treated. As with any laboratory test, laboratories must validate all IHC assays before they are used to test patient specimens. Unfortunately, recent studies have found significant interlaboratory variation in validation practices and revealed that many laboratories do not follow consistent procedures.
The expert and advisory panels, chaired by Patrick L. Fitzgibbons, MD, addressed the overarching question:
What is needed for initial analytic assay validation before placing any immunohistochemical test into clinical service and what are the revalidation requirements?
In addition, the panel is exploring the following questions: