2019CAP指南：乳腺癌人表皮生长因子受体2免疫组化定量分析.pdfVIP

CAP Laboratory Improvement Programs Quantitative Image Analysis of Human Epidermal Growth Factor Receptor 2 Immunohistochemistry for Breast Cancer Guideline From the College of American Pathologists Marilyn M. Bui, MD, PhD; Michael W. Riben, MD; Kimberly H. Allison, MD; Elizabeth Chlipala, BS, HTL(ASCP)QIHC; Carol Colasacco, MLIS, SCT(ASCP); Andrea G. Kahn, MD; Christina Lacchetti, MHSc; Anant Madabhushi, PhD; Liron Pantanowitz, MD; Mohamed E. Salama, MD; Rachel L. Stewart, DO, PhD; Nicole E. Thomas, MPH, CT(ASCP)cm; John E. Tomaszewski, MD; M. Elizabeth Hammond, MD  Context.—Advancements in genomic, computing, and was conducted to address 5 key questions. Final recom- imaging technology have spurred new opportunities to use mendations were derived from strength of evidence, open quantitative image analysis (QIA) for diagnostic testing. comment feedback, expert panel consensus, and advisory Objective.—To develop evidence-based recommenda- panel review. tions to improve accuracy, precision, and reproducibility Results.— Eleven recommendations were drafted: 7 in the interpretation of human epidermal growth factor based on CAP laboratory accreditation requirements and receptor 2 (HER2) immunohistochemistry (IHC) for breast 4 based on expert consensus opinions. A 3-week open cancer where QIA is used. comment period received 180 comments from more than Design.—The College of American Pathologists (CAP) 150 participants. convened a panel of pathologists, histotechnologists, and Conclusions.—To i