Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

Immunohistochemistry Critical Assay Performance Controls (ICAPC) Reduce Interobserver Variability in the Interpretation of BRAFV600E Immunohistochemistry

Immunohistochemistry Critical Assay Performance Controls (ICAPC) Reduce Interobserver Variability... The utility of prognostic and predictive immunohistochemistry biomarkers in the context of cancer is plagued by inconsistent interpretation of results which can lead to poor rates of adoption or inappropriate use of novel therapeutic strategies. To monitor immunohistochemistry assay performance, a new on-slide control motif, Immunohistochemistry Critical Assay Performance Controls (ICAPC) was developed. We hypothesized that the use of these controls by the diagnosing pathologist to interpret BRAFV600E would result in reduced interobserver and intraobserver interpretation errors. A cross-sectional, sequentially obtained sample of surgical pathology cases stained for BRAFV600E was assembled from a single hospital in Vancouver, British Columbia. Half of the cases had normal on-slide controls and the remainder with ICAPC. Results from 6 independent and blinded readers were compared with each other and to the gold-standard pathologic diagnosis with the goal of demonstrating superior interrater agreement with ICAPC relative to standard on-slide controls. Cohen’s κ was used to compute pair-wise reader agreements, whereas Fleiss’ κ was used to compare to the gold standard. The implementation of ICAPC resulted in statistically significant improvements in the interobserver agreement of BRAF mutation status ascertained by BRAFV600E immunohistochemistry. Half of the readers demonstrated significant improvements in agreement with the gold-standard diagnosis with the addition of ICAPC. Across all readers, the mean increase in κ was 0.14 with a 95% confidence interval of 0.01-0.28 (P=0.04). This study demonstrates that the addition of ICAPC serves to significantly reduce interobserver variability in the assessment of BRAFV600E immunohistochemistry. As such, we recommend that this approach should be used as part of a comprehensive quality management strategy in the setting of histopathology. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Applied Immunohistochemistry & Molecular Morphology Wolters Kluwer Health

Immunohistochemistry Critical Assay Performance Controls (ICAPC) Reduce Interobserver Variability in the Interpretation of BRAFV600E Immunohistochemistry

Download PDF
6 pages

Loading next page...
 
/lp/wolters-kluwer-health/immunohistochemistry-critical-assay-performance-controls-icapc-reduce-0hIYZuOfOb

References

References for this paper are not available at this time. We will be adding them shortly, thank you for your patience.

Publisher
Wolters Kluwer Health
Copyright
Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
ISSN
1541-2016
DOI
10.1097/PAI.0000000000000784
Publisher site
See Article on Publisher Site

Abstract

The utility of prognostic and predictive immunohistochemistry biomarkers in the context of cancer is plagued by inconsistent interpretation of results which can lead to poor rates of adoption or inappropriate use of novel therapeutic strategies. To monitor immunohistochemistry assay performance, a new on-slide control motif, Immunohistochemistry Critical Assay Performance Controls (ICAPC) was developed. We hypothesized that the use of these controls by the diagnosing pathologist to interpret BRAFV600E would result in reduced interobserver and intraobserver interpretation errors. A cross-sectional, sequentially obtained sample of surgical pathology cases stained for BRAFV600E was assembled from a single hospital in Vancouver, British Columbia. Half of the cases had normal on-slide controls and the remainder with ICAPC. Results from 6 independent and blinded readers were compared with each other and to the gold-standard pathologic diagnosis with the goal of demonstrating superior interrater agreement with ICAPC relative to standard on-slide controls. Cohen’s κ was used to compute pair-wise reader agreements, whereas Fleiss’ κ was used to compare to the gold standard. The implementation of ICAPC resulted in statistically significant improvements in the interobserver agreement of BRAF mutation status ascertained by BRAFV600E immunohistochemistry. Half of the readers demonstrated significant improvements in agreement with the gold-standard diagnosis with the addition of ICAPC. Across all readers, the mean increase in κ was 0.14 with a 95% confidence interval of 0.01-0.28 (P=0.04). This study demonstrates that the addition of ICAPC serves to significantly reduce interobserver variability in the assessment of BRAFV600E immunohistochemistry. As such, we recommend that this approach should be used as part of a comprehensive quality management strategy in the setting of histopathology.

Journal

Applied Immunohistochemistry & Molecular Morphology – Wolters Kluwer Health

Published: Jul 24, 2020

References

  • Diagnostic immunohistochemistry: what can go wrong and how to prevent it
  • BRAF V600E mutation-specific antibody: a review
  • BRAF mutation in sporadic colorectal cancer and Lynch syndrome
  • Improved survival with vemurafenib in melanoma with BRAF V600E mutation
  • Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial
  • Poor survival associated with the BRAF V600E mutation in microsatellite-stable colon cancers
  • Association between BRAF V600E mutation and mortality in patients with papillary thyroid cancer
  • Clinical features and outcome of patients with non–small-cell lung cancer harboring BRAF mutations
  • BRAF V600E mutation is a negative prognosticator in pediatric ganglioglioma
  • BRAF mutations in hairy-cell leukemia
  • Evaluation of BRAF mutation testing methodologies in formalin-fixed, paraffin-embedded cutaneous melanomas
  • Immunohistochemistry with the anti-BRAF V600E (VE1) antibody: impact of pre-analytical conditions and concordance with DNA sequencing in colorectal and papillary thyroid carcinoma
  • Discordance between Cobas BRAF V600 testing and VE1 immunohistochemistry in a melanoma patient with bone marrow metastases
  • Evaluation of allele-specific PCR and immunohistochemistry for the detection of BRAF V600E mutations in hairy cell leukemia
  • Accurate detection of BRAF p.V600E mutations in challenging melanoma specimens requires stringent immunohistochemistry scoring criteria or sensitive molecular assays
  • Value of immunohistochemistry in the detection of BRAF(V600E) mutations in fine-needle aspiration biopsies of papillary thyroid carcinoma
  • Detection of the BRAF V600E mutation in colon carcinoma: critical evaluation of the imunohistochemical approach
  • Standardization of positive controls in diagnostic immunohistochemistry: recommendations from the International Ad Hoc Expert Committee
  • SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process
  • Case-control and two-gate designs in diagnostic accuracy studies
  • Immunohistochemical detection of the BRAF V600E mutant protein in colorectal cancers in Taiwan is highly concordant with the molecular test