TY - JOUR
T1 - Quantitative image analysis of human epidermal growth factor receptor 2 immunohistochemistry for breast cancer
T2 - Guideline from the college of American pathologists
AU - Bui, Marilyn M.
AU - Riben, Michael W.
AU - Allison, Kimberly H.
AU - Chlipala, Elizabeth
AU - Colasacco, Carol
AU - Kahn, Andrea G.
AU - Lacchetti, Christina
AU - Madabhushi, Anant
AU - Pantanowitz, Liron
AU - Salama, Mohamed E.
AU - Stewart, Rachel L.
AU - Thomas, Nicole E.
AU - Tomaszewski, John E.
AU - Hammond, M. Elizabeth
N1 - Publisher Copyright:
© 2019 College of American Pathologists. All rights reserved.
PY - 2019
Y1 - 2019
N2 - 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.
AB - 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.
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U2 - 10.5858/arpa.2018-0378-CP
DO - 10.5858/arpa.2018-0378-CP
M3 - Article
C2 - 30645156
AN - SCOPUS:85063917500
SN - 0003-9985
VL - 143
SP - 1180
EP - 1195
JO - Archives of Pathology and Laboratory Medicine
JF - Archives of Pathology and Laboratory Medicine
IS - 10
ER -