Implementation of American Society of Clinical Oncology/College of American Pathologists HER2 Guideline Recommendations in a tertiary care facility increases HER2 immunohistochemistry and fluorescence in situ hybridization concordance and decreases the number of inconclusive cases.
Author(s): Middleton LP, Price KM, Puig P, Heydon LJ, Tarco E, Sneige N, Barr K, Deavers MT
Publication: Arch Pathol Lab Med, 2009, Vol. 133, Page 775-80
PubMed ID: 19415952 PubMed Review Paper? No
Purpose of Paper
Conclusion of Paper
Studies
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Study Purpose
The purpose of this study was to assess concordance among HER-2 results by FISH and immunohistochemistry before and after implementation of the American Society of Clinical Oncology/College of American Pathologists guideline recommendations. Formalin-fixed, paraffin-embedded core breast needle biopsies were used for analysis.
Summary of Findings:
A retrospective analysis of specimens procured and assessed for HER-2 prior to the publication of the guidelines revealed a 98% concordance among results of FISH and immunohistochemistry, and an additional 10.8% of cases that produced inconclusive FISH results. The majority of cases which yielded inconclusive results were retrospectively correlated to the time of day specimens were submitted to pathology (after 2 pm) and the duration of formalin fixation (an average of 4 h). Standardization of fixation time to a minimum of 6 h via improved annotation and use of an automated processor resulted in a significant decrease in the number of FISH inconclusive cases from 10.8% to 3.4% as well as an increase among FISH and immunohistochemistry concordance from 98% to 98.5%.
Biospecimens
Preservative Types
- Formalin
Diagnoses:
- Neoplastic - Carcinoma
Platform:
Analyte Technology Platform Protein Immunohistochemistry DNA FISH Pre-analytical Factors:
Classification Pre-analytical Factor Value(s) Biospecimen Preservation Time in fixative 4 h
6 h