ARTICLE;
BREAST TUMOR;
FEMALE;
HUMAN;
IMMUNOHISTOCHEMISTRY;
MEDICAL SOCIETY;
METABOLISM;
PATHOLOGY;
PRACTICE GUIDELINE;
QUESTIONNAIRE;
STANDARD;
STATISTICS;
UNITED STATES;
VALIDATION STUDY;
BREAST NEOPLASMS;
FEMALE;
HUMANS;
IMMUNOHISTOCHEMISTRY;
PATHOLOGY, SURGICAL;
PRACTICE GUIDELINES AS TOPIC;
QUESTIONNAIRES;
RECEPTOR, ERBB-2;
SOCIETIES, MEDICAL;
TUMOR MARKERS, BIOLOGICAL;
UNITED STATES;
FDA issues final rule for classification and reclassification of immunohistochemistry reagents and kits
Taylor CR. FDA issues final rule for classification and reclassification of immunohistochemistry reagents and kits. Am J Clin Pathol. 1999;111(4):443-444.
American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal grown factor receptor 2 testing in breast cancer
Wolf AC, Hammond EH, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal grown factor receptor 2 testing in breast cancer. Arch Pathol Lab Med 2007;131(1):18-43.
Real-world performance of HER2 testing-National Surgical Adjuvant Breast and Bowel Project experience
Paik S, Bryant J, Tan-Chiu E, et al. Real-world performance of HER2 testing-National Surgical Adjuvant Breast and Bowel Project experience. J Natl Cancer Inst. 2002;94(11):853-854.
Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831
Roche PC, Suman VJ, Jenkins RB, et al. Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831. J Natl Cancer Inst. 2002;94(11):855-857.
Laboratory compliance with the American Society of Oncology/College of American Pathologists guidelines for human epidermal growth factor receptor 2 testing: A College of American Pathologists survey of 757 laboratories
Nakhleh RE, Grimm EE, Idowu MO, et al. Laboratory compliance with the American Society of Oncology/College of American Pathologists guidelines for human epidermal growth factor receptor 2 testing: A College of American Pathologists survey of 757 laboratories. Arch Pathol Lab Med. 2010;134(5):728-734.
American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer
Hammond EH, Hayes DF, Dowsett M, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. Arch Pathol Lab Med. 2010;131(6):907-922.
12 CFR Part 820.3(z). 9. Clinical Laboratory Standards Institute. Quality assurance for design control and implementation of immunohistochemistry assays: Approved guideline, second edition. In: CLSI Document I/LA28-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2011
Rules and regulations. Part VII, Dept of Health and Human Services, FDA Fed Regist. 1996;61(195):52222-52601. 12 CFR Part 820.3(z). 9. Clinical Laboratory Standards Institute. Quality assurance for design control and implementation of immunohistochemistry assays: Approved guideline, second edition. In: CLSI Document I/LA28-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2011.
