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Validation and Proficiency Testing of Biomarker Immunohistochemistry: Diagnostic Accuracy “Fit for Purpose” in a 3D World

Validation and Proficiency Testing of Biomarker Immunohistochemistry: Diagnostic Accuracy “Fit... EDITORIAL Validation and Proficiency Testing of Biomarker Immunohistochemistry: Diagnostic Accuracy “Fit for Purpose” in a 3D World Paul E. Swanson, MD he analytic validation of clinical tests in the diagnostic immunohistochemistry Tlaboratory, and the ongoing demonstration of laboratory proficiency in the per- formance of those tests, depends on the ability of a candidate test (optimized against well-defined controls and tested against an accepted limit of detection standard )to perform at an acceptable level of analytic sensitivity and specificity against a com- 2 3,4 parator test or data set that reflects the intended purpose of the assay. Ideally, the comparator test would be a well-defined reference methodology or an assay that performs optimally against an appropriately designed proficiency testing challenge. However, for most practical purposes, these comparators are not readily available for diagnostic markers used in clinical practice. Hence, despite recommendations de- 2–4 signed to enhance this process, I suspect that, in most laboratory settings, new immunohistochemical tests intended to identify targets of diagnostic value are often compared against an existing assay for the same general purpose or against archived cases with expected patterns of immunoreactivity. But inferring the presence of a specific immunohistochemical target through reproducible patterns of immunoreactivity http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Applied Immunohistochemistry & Molecular Morphology Wolters Kluwer Health

Validation and Proficiency Testing of Biomarker Immunohistochemistry: Diagnostic Accuracy “Fit for Purpose” in a 3D World

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Publisher
Wolters Kluwer Health
Copyright
Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
ISSN
1541-2016
eISSN
1533-4058
DOI
10.1097/PAI.0000000000000746
Publisher site
See Article on Publisher Site

Abstract

EDITORIAL Validation and Proficiency Testing of Biomarker Immunohistochemistry: Diagnostic Accuracy “Fit for Purpose” in a 3D World Paul E. Swanson, MD he analytic validation of clinical tests in the diagnostic immunohistochemistry Tlaboratory, and the ongoing demonstration of laboratory proficiency in the per- formance of those tests, depends on the ability of a candidate test (optimized against well-defined controls and tested against an accepted limit of detection standard )to perform at an acceptable level of analytic sensitivity and specificity against a com- 2 3,4 parator test or data set that reflects the intended purpose of the assay. Ideally, the comparator test would be a well-defined reference methodology or an assay that performs optimally against an appropriately designed proficiency testing challenge. However, for most practical purposes, these comparators are not readily available for diagnostic markers used in clinical practice. Hence, despite recommendations de- 2–4 signed to enhance this process, I suspect that, in most laboratory settings, new immunohistochemical tests intended to identify targets of diagnostic value are often compared against an existing assay for the same general purpose or against archived cases with expected patterns of immunoreactivity. But inferring the presence of a specific immunohistochemical target through reproducible patterns of immunoreactivity

Journal

Applied Immunohistochemistry & Molecular MorphologyWolters Kluwer Health

Published: Apr 1, 2019

References