title: Principles of Analytic Validation of Clinical Immunohistochemistry Assays.
abstract: All assays performed in anatomic and clinical pathology laboratories must be validated before they are placed into clinical service. This review summarizes strategies for validation of clinical immunohistochemistry assays, and is chiefly based on the recently released guideline released by The College of American Pathologists.
authors.affiliation: *Department of Pathology, Beth Israel Deaconess Medical Center, Children's Hospital Boston, and Harvard Medical School, Boston, MA †Department of Pathology, St. Jude Medical Center, Fullerton, CA ‡Department of Pathology and Laboratory Medicine, University of Calgary and Foothills Medical Centre, Calgary, AB, Canada.
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Goldsmith
authors.forename: Patrick L
authors.initials: PL
authors.lastname: Fitzgibbons
authors.forename: Paul E
authors.initials: PE
authors.lastname: Swanson
mesh_terms: D006801:Humans; D007150:Immunohistochemistry / Q000379:methods* / Q000592:standards*; D010338:Pathology, Clinical / Q000592:standards*; D054928:Validation Studies as Topic