A Consortium for Analytic Standardization in Immunohistochemistry

Author:

Bogen Steven A.1,Dabbs David J.2,Miller Keith D.3,Nielsen Søren4,Parry Suzanne C.5,Szabolcs Matthias J.6,t'Hart Nils7,Taylor Clive R.8,Torlakovic Emina E.910

Affiliation:

1. From Boston Cell Standards Inc, Boston, Massachusetts (Bogen).

2. From PreludeDx, Laguna Hills, California (Dabbs).

3. From the Research Department of Pathology, University College London, London, United Kingdom (Miller).

4. From NordiQC, Aalborg, Denmark (Nielsen).

5. From UKNEQAS-ICC ISH, London, United Kingdom (Parry).

6. From the Department of Pathology & Laboratory Medicine, New York Presbyterian/Columbia University Irving Medical Center, New York, New York (Szabolcs).

7. From the Department of Pathology, Isala, Zwolle, Netherlands (t'Hart).

8. From the Department of Pathology, Keck School of Medicine, University of Southern California, Los Angeles (Taylor).

9. From the Department of Pathology, University of Saskatchewan and Saskatoon Health Authority, Saskatoon, Canada (Torlakovic).

10. From Canadian Biomarker Quality Assurance, Saskatoon, Saskatchewan, Canada (Torlakovic).

Abstract

Context.— The authors announce the launch of the Consortium for Analytic Standardization in Immunohistochemistry, funded with a grant from the National Cancer Institute. As with other laboratory testing, analytic standards are important for many different stakeholders: commercial vendors of instruments and reagents, biopharmaceutical firms, pathologists, scientists, clinical laboratories, external quality assurance organizations, and regulatory bodies. Analytic standards are customarily central to assay development, validation, and method transfer into routine assays and are critical quality assurance tools. Objective.— To improve immunohistochemistry (IHC) test accuracy and reproducibility by integrating analytic standards into routine practice. To accomplish this mission, the consortium has 2 mandates: (1) to experimentally determine analytic sensitivity thresholds (lower and upper limits of detection) for selected IHC assays, and (2) to inform IHC stakeholders of what analytic standards are, why they are important, and how and for what purpose they are used. The consortium will then publish the data and offer analytic sensitivity recommendations where appropriate. These mandates will be conducted in collaboration and coordination with clinical laboratories, external quality assurance programs, and pathology organizations. Data Sources.— Literature review and published external quality assurance data. Conclusions.— Integration of analytic standards is expected to (1) harmonize and standardize IHC assays; (2) improve IHC test accuracy and reproducibility, both within and between laboratories; and (3) dramatically simplify and improve methodology transfer for new IHC protocols from published literature or clinical trials to clinical IHC laboratories.

Publisher

Archives of Pathology and Laboratory Medicine

Subject

Medical Laboratory Technology,General Medicine,Pathology and Forensic Medicine

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