title: Standardization of positive controls in diagnostic immunohistochemistry: recommendations from the International Ad Hoc Expert Committee.
abstract: Diagnostic immunohistochemistry (dIHC) has been practiced for several decades, with an ongoing expansion of applications for diagnostic use, and more recently for detection of prognostic and predictive biomarkers. However, standardization of practice has yet to be achieved, despite significant advances in methodology. An Ad Hoc Expert Committee was formed to address the standardization of controls, which is a missing link in demonstrating and assuring standardization of the various components of dIHC. This committee has also developed a concept of immunohistochemistry critical assay performance controls that are intended to facilitate methodology transfer and harmonization in dIHC. Furthermore, the committee has clarified definitions of IHC assay sensitivity and specificity, with special emphasis on how these definitions apply to positive controls. Recommendations for "best laboratory practice" regarding positive controls for dIHC are specified. The first set of immunohistochemistry critical assay performance controls for several frequently used IHC stains or tests is also developed and presented.
authors.affiliation: *Department of Laboratory Hematology, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON **Vancouver Costal Health ††Vancouver General Hospital/University of British Columbia, Vancouver, BC ##Department of Pathology, University of Calgary, Calgary, AB, Canada †Canadian Immunohistochemistry Quality Control (CIQC), Vancouver, BC, Canada ‡Institute of Pathology, Aalborg University Hospital, Denmark §Nordic Immunohistochemistry Quality Control (NordiQC), Aalborg, Denmark ∥Griffith University School of Medicine, Gold Coast Campus ¶Australian Institute for Bioengineering and Nano-Technology, University of Queensland, Qld, Australia #Convenor Immunohistochemistry, Anatomical Pathology Program, RCPA QAP Pty Ltd., Sydney, Australia ‡‡Beth Israel Deaconess Medical Center §§Brigham and Women's Hospital, Harvard medical School, Boston, MA ∥∥UK National External Quality Assessment Scheme (UK NEQAS), University College London, London, UK ¶¶University of Washington, Seattle, WA ***Department of Pathology, Beijing Friendship Hospital, Capital Medical University, Beijing, China †††Chinese Committee for Pathology-Immunohistochemistry Quality Control (CCP-IHCQC) ‡‡‡Keck School of Medicine, University of Southern California, Los Angeles, CA.
authors.forename: Emina E
authors.initials: EE
authors.lastname: Torlakovic
authors.forename: Søren
authors.initials: S
authors.lastname: Nielsen
authors.forename: Glenn
authors.initials: G
authors.lastname: Francis
authors.forename: John
authors.initials: J
authors.lastname: Garratt
authors.forename: Blake
authors.initials: B
authors.lastname: Gilks
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Goldsmith
authors.forename: Jason L
authors.initials: JL
authors.lastname: Hornick
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Hyjek
authors.forename: Merdol
authors.initials: M
authors.lastname: Ibrahim
authors.forename: Keith
authors.initials: K
authors.lastname: Miller
authors.forename: Eugen
authors.initials: E
authors.lastname: Petcu
authors.forename: Paul E
authors.initials: PE
authors.lastname: Swanson
authors.forename: Xiaoge
authors.initials: X
authors.lastname: Zhou
authors.forename: Clive R
authors.initials: CR
authors.lastname: Taylor
authors.forename: Mogens
authors.initials: M
authors.lastname: Vyberg
mesh_terms: D026683:Advisory Committees; D005104:Expert Testimony; D006801:Humans; D007150:Immunohistochemistry / Q000379:methods / Q000592:standards*; D007391:International Cooperation; D017410:Practice Guidelines as Topic; D012015:Reference Standards; D012680:Sensitivity and Specificity