Standardization of negative controls in diagnostic immunohistochemistry: recommendations from the international Ad Hoc expert panel

Torlakovic, Emina E., Francis, Glenn, Garratt, John, Gilks, Blake, Hyjek, Elizabeth, Ibrahim, Merdol, Miller, Rodney, Nielsen, Søren, Petcu, Eugen B., Swanson, Paul E., Taylor, Clive R. and Vyberg, Mogens (2014) Standardization of negative controls in diagnostic immunohistochemistry: recommendations from the international Ad Hoc expert panel. Applied Immunohistochemistry and Molecular Morphology, 22 4: 241-252. doi:10.1097/PAI.0000000000000069


Author Torlakovic, Emina E.
Francis, Glenn
Garratt, John
Gilks, Blake
Hyjek, Elizabeth
Ibrahim, Merdol
Miller, Rodney
Nielsen, Søren
Petcu, Eugen B.
Swanson, Paul E.
Taylor, Clive R.
Vyberg, Mogens
Title Standardization of negative controls in diagnostic immunohistochemistry: recommendations from the international Ad Hoc expert panel
Journal name Applied Immunohistochemistry and Molecular Morphology
ISSN 1541-2016
1533-4058
Publication date 2014-04-01
Year available 2014
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1097/PAI.0000000000000069
Open Access Status Not Open Access
Volume 22
Issue 4
Start page 241
End page 252
Total pages 12
Place of publication Philadelphia, United States
Publisher Lippincott Williams and Wilkins
Language eng
Subject 2734 Pathology and Forensic Medicine
3607 Medical Laboratory Technology
2722 Histology
Abstract 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.
Keyword Canadian Immunohistochemistry Quality Control (CIQC)
College of American Pathologists-External Quality Assurance/Proficiency Testing (CAP-EQA/PT)
FDA classification of immunohistochemistry devices
Immunohistochemistry
Negative controls
Nordic immunohistochemical Quality Control (NordiQC)
Positive controls
Quality assurance
Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP)
Standardization
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collections: Official 2015 Collection
Australian Institute for Bioengineering and Nanotechnology Publications
 
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