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Updated: May 1, 2026
Synthetic Antigen Controls for Immunohistochemistry
Published on: August 23, 2021
Standardization of negative controls in diagnostic immunohistochemistry: recommendations from the international ad
Emina E Torlakovic1, Glenn Francis, John Garratt
1*Laboratory Medicine Program, University Health Network/University of Toronto, Toronto, ON #Department of Pathology, Lions Gate Hospital **Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada †Canadian Immunohistochemistry Quality Control ‡CAP-ACP National Standards Committee for High Complexity Testing/Immunohistochemistry §Griffith University School of Medicine, Gold Coast ¶Australian Institute for Bioengineering and Nanotechnology, University of Queensland, Qld, Australia ∥Convenor Immunohistochemistry, Anatomical Pathology Program, RCPA QAP Pty Ltd. ††University College London, UK NEQAS ICC&ISH, London, UK ‡‡ProPath, Dallas, TX §§Institute of Pathology, Aalborg University Hospital, Aalborg, Denmark ∥∥Nordic Immunohistochemical Quality Control (NordiQC) ¶¶Department of Pathology, University of Washington, Seattle, WA ##Department of Pathology, Keck School of medicine, University of Southern California, Los Angeles, CA.
Insights
Standardizing diagnostic immunohistochemistry (dIHC) controls is crucial for accuracy. This study proposes best practice recommendations for negative controls in dIHC to improve reliability and cost-effectiveness.
Area of Science:
- Pathology
- Laboratory Medicine
- Biotechnology
Background:
- Standardization of positive and negative controls is essential for diagnostic immunohistochemistry (dIHC).
- Current use of IHC-negative controls lacks standardization, posing challenges for pathologists and laboratory budgets.
- Accurate IHC testing is increasingly vital, particularly for predictive markers in personalized medicine.
Purpose of the Study:
- To review the classification of negative controls relevant to clinical practice.
- To propose standard terminology for negative controls in dIHC.
- To develop evidence-based recommendations for the use of negative controls in dIHC.
Main Methods:
- An international ad hoc expert panel convened to review existing practices.
- Classification of negative controls was assessed for clinical relevance.
- Evidence for IHC specificity was evaluated.
- Recommendations were developed based on 'fit-for-use' principles.
Main Results:
- A review of negative control classifications relevant to clinical practice was conducted.
- Standard terminology for negative controls was proposed.
- Recommendations for the use of negative controls in dIHC were developed.
Conclusions:
- Standardized use of negative controls in dIHC is necessary for reliable diagnostic testing.
- The proposed recommendations aim to enhance the accuracy and efficiency of dIHC.
- Adoption of these 'fit-for-use' principles will support best practices in clinical IHC.
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.
