Standardization of HER2 immunohistochemistry in breast cancer by automated quantitative analysis.

摘要: Abstract Context.—There is critical need for standardization of HER2 immunohistochemistry testing in the clinical laboratory setting. Recently, American Society Clinical Oncology and College Pathologists have submitted guidelines recommending that laboratories achieve 95% concordance between assays observers testing. Objective.—As a potential aid to pathologists achieving these new guidelines, we conducted an examination using automated quantitative analysis (AQUA analysis) provide standardized expression score across instruments (sites), operators, staining runs. Design.—We analyzed by cohort (n = 669) invasive breast cancers tissue microarray format different 3), operators runs 3). Using light source, instrument calibration techniques, generation image software, produced normalized AQUA scores each ...