人类表皮生长因子受体 2 免疫组织化学乳腺癌的定量图像分析：美国病理学家学院指南。
Quantitative Image Analysis of Human Epidermal Growth Factor Receptor 2 Immunohistochemistry for Breast Cancer: Guideline From the College of American Pathologists.
机构信息
From the Department of Anatomic Pathology, H. Lee Moffitt Cancer Center, Tampa, Florida (Dr Bui); the Department of Pathology, University of Texas MD Anderson Cancer Center, Houston (Dr Riben); the Department of Pathology, Stanford University Medical Center, Stanford, California (Dr Allison); Premier Laboratory, Longmont, Colorado (Ms Chlipala); Surveys (Mses Colasacco and Thomas), College of American Pathologists, Northfield, Illinois; the Department of Pathology, University of South Alabama, Mobile (Dr Kahn); Policy and Advocacy, American Society of Clinical Oncology, Alexandria, Virginia (Ms Lacchetti); the Department of Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio (Dr Madabhushi); the Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (Dr Pantanowitz); the Department of Pathology, University of Utah/ARUP Laboratories Inc, Salt Lake City (Dr Salama); the Department of Pathology, University of Kentucky, Lexington (Dr Stewart); the Department of Pathology and Anatomical Sciences, University at Buffalo, State University of New York, Buffalo (Dr Tomaszewski); and the Department of Pathology, University of Utah School of Medicine and Intermountain Healthcare, Salt Lake City (Dr Hammond).
出版信息
Arch Pathol Lab Med. 2019 Oct;143(10):1180-1195. doi: 10.5858/arpa.2018-0378-CP. Epub 2019 Jan 15.
CONTEXT.—: Advancements in genomic, computing, and imaging technology have spurred new opportunities to use quantitative image analysis (QIA) for diagnostic testing.
OBJECTIVE.—: 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.
DESIGN.—: The College of American Pathologists (CAP) convened a panel of pathologists, histotechnologists, and computer scientists with expertise in image analysis, immunohistochemistry, quality management, and breast pathology to develop recommendations for QIA of HER2 IHC in breast cancer. A systematic review of the literature was conducted to address 5 key questions. Final recommendations were derived from strength of evidence, open comment feedback, expert panel consensus, and advisory panel review.
RESULTS.—: Eleven recommendations were drafted: 7 based on CAP laboratory accreditation requirements and 4 based on expert consensus opinions. A 3-week open comment period received 180 comments from more than 150 participants.
CONCLUSIONS.—: To improve accurate, precise, and reproducible interpretation of HER2 IHC results for breast cancer, QIA and procedures must be validated before implementation, followed by regular maintenance and ongoing evaluation of quality control and quality assurance. HER2 QIA performance, interpretation, and reporting should be supervised by pathologists with expertise in QIA.
背景
基因组学、计算和成像技术的进步为使用定量图像分析（QIA）进行诊断测试提供了新的机会。
目的
制定基于证据的建议，以提高在使用 QIA 时对乳腺癌人表皮生长因子受体 2（HER2）免疫组织化学（IHC）进行解释的准确性、精密度和可重复性。
设计
美国病理学家学会（CAP）召集了一组病理学家、组织技术人员和计算机科学家，他们在图像分析、免疫组织化学、质量管理和乳腺病理学方面具有专业知识，以制定用于乳腺癌 HER2 IHC 的 QIA 建议。对文献进行了系统回顾，以解决 5 个关键问题。最终建议来自证据强度、公开意见反馈、专家小组共识和顾问小组审查。
结果
起草了 11 项建议：7 项基于 CAP 实验室认证要求，4 项基于专家共识意见。为期 3 周的公开意见征询期收到了来自 150 多名参与者的 180 条意见。
结论
为了提高乳腺癌 HER2 IHC 结果的准确、精确和可重复解释，在实施之前必须对 QIA 和程序进行验证，然后定期维护和持续评估质量控制和质量保证。HER2 QIA 的性能、解释和报告应由具有 QIA 专业知识的病理学家监督。
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