Quantitative Image Analysis of Human Epidermal Growth Factor Receptor 2 Immunohistochemistry for Breast Cancer
Publication Date: October 1, 2019
Last Updated: March 14, 2022
Guideline Statements
1. Laboratories that choose to implement quantitative image analysis (QIA) for human epidermal growth factor receptor 2 (HER2) immunohistochemistry interpretation for clinical testing should select a QIA system that is validated for diagnostic interpretation. The final reporting schema should be consistent with the American Society of Clinical Oncology and the College of American Pathologists guideline ‘‘Recommendations for Human Epidermal Growth Factor 2 Testing in Breast Cancer.’’ (Expert Consensus Opinion)
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2. Laboratories should validate their QIA results for clinical use by comparing them to an alternative, validated method(s) such as HER2 fluorescence in situ hybridization or consensus images for HER2 immunohistochemistry. (Recommendation)
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3. Laboratories should ensure that the results produced by a QIA system are reproducible within and between different batch analyses. (Recommendation)
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4. Laboratories should ensure that the results produced by a QIA system are reproducible between operators when they select regions of interest (ROIs) for analysis and/or perform annotation. (Recommendation)
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5. Laboratories should monitor and document the performance of their QIA system. (Recommendation)
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6. Laboratories should have procedures in place to address changes to the QIA system that could impact clinical results. (Recommendation)
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7. The pathologist should document that results were obtained by using QIA in the pathology report. (Expert Consensus Opinion)
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8. Personnel involved in the QIA process should be trained specifically in the use of the technology. (Recommendation)
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9. Laboratories should retain QIA results and the algorithm metadata in accordance with local requirements and applicable regulations. (Expert Consensus Opinion)
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10. The pathologist who oversees the entire HER2 QIA process used for clinical practice should have appropriate expertise in this area. (Recommendation)
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11. The pathologist finalizing the case should be knowledgeable in the use of the HER2 QIA system and visually verify that the correct ROI was analyzed, the algorithm annotated image produced, and the image analysis results. (Expert Consensus Opinion)
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Title
Quantitative Image Analysis of Human Epidermal Growth Factor Receptor 2 Immunohistochemistry for Breast Cancer
Authoring Organization
College of American Pathologists
Publication Month/Year
October 1, 2019
Last Updated Month/Year
January 31, 2024
External Publication Status
Published
Country of Publication
US
Document Objectives
To develop evidence-based recommendations to improve accuracy, precision, and reproducibility in the interpretation of human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) for breast cancer where QIA is used.
Inclusion Criteria
Female, Male, Adolescent, Adult
Health Care Settings
Hospital, Laboratory services, Outpatient
Intended Users
Nurse, nurse practitioner, physician, physician assistant
Scope
Assessment and screening, Prevention, Management
Diseases/Conditions (MeSH)
D001943 - Breast Neoplasms
Keywords
breast cancer, human epidermal growth factor receptor 2 (HER2), immunohistochemistry, Human Epidermal Growth Factor Receptor 2, Breast Cancer
Methodology
Number of Source Documents
55
Literature Search Start Date
January 1, 2006
Literature Search End Date
January 1, 2017