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Applied Immunohistochemistry & Molecular Morphology:
Standardization of Negative Controls in Diagnostic Immunohistochemistry: Recommendations From the International Ad Hoc Expert Panel
Torlakovic, Emina E. MD, PhD*,†,‡; Francis, Glenn MBBS, FRCPA, MBA, FFSc (RCPA)§,∥,¶; Garratt, John RT†,‡,#; Gilks, Blake MD, FRCPC†,‡,**; Hyjek, Elizabeth MD, PhD*; Ibrahim, Merdol PhD††; Miller, Rodney MD‡‡; Nielsen, Søren HT, CT§§,∥∥; Petcu, Eugen B. MD, PhD§; Swanson, Paul E. MD¶¶; Taylor, Clive R. MD, PhD##; Vyberg, Mogens MD§§,∥∥
Standardization of controls, both positive and negative controls, is needed for diagnostic immunohistochemistry (dIHC). The use of IHC-negative controls, irrespective of type, although well established, is not standardized. As such, the relevance and applicability of negative controls continues to challenge both pathologists and laboratory budgets. Despite the clear theoretical notion that appropriate controls serve to demonstrate the sensitivity and specificity of the dIHC test, it remains unclear which types of positive and negative controls are applicable and/or useful in day-to-day clinical practice. There is a perceived need to provide “best practice recommendations” for the use of negative controls. This perception is driven not only by logistics and cost issues, but also by increased pressure for accurate IHC testing, especially when IHC is performed for predictive markers, the number of which is rising as personalized medicine continues to develop. Herein, an international ad hoc expert panel reviews classification of negative controls relevant to clinical practice, proposes standard terminology for negative controls, considers the total evidence of IHC specificity that is available to pathologists, and develops a set of recommendations for the use of negative controls in dIHC based on “fit-for-use” principles.
© 2014 Lippincott Williams & Wilkins, Inc.
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immunohistochemistry, positive controls, negative controls, standardization, quality assurance, Nordic immunohistochemical Quality Control (NordiQC), College of American Pathologists-External Quality Assurance/Proficiency Testing (CAP-EQA/PT), Canadian Immunohistochemistry Quality Control (CIQC), Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP), FDA classification of immunohistochemistry devices
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