Context.-Estrogen receptor and progesterone receptor status is assessed on all newly diagnosed, invasive breast carcinomas and in recurrences to determine patient eligibility for hormonal therapy, but 10% to 20% of estrogen receptor and progesterone receptor test results are discordant when tested in multiple laboratories. Objective.-To define the analytic (technical) validation requirements for estrogen receptor and progesterone receptor immunohistochemistry assays used to select patients for hormonal therapy. Data Sources.-Literature review and expert consensus. Conclusions.-A standardized process for initial test validation is described. We believe adoption of this process will improve the accuracy of hormone-receptor testing, reduce interlaboratory variation, and minimize falsepositive and false-negative results. Required ongoing assay assessment procedures are also described.
CITATION STYLE
Fitzgibbons, P. L., Murphy, D. A., Hammond, M. E. H., Allred, D. C., & Valenstein, P. N. (2010). Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays. Archives of Pathology and Laboratory Medicine, 134(6), 930–935. https://doi.org/10.5858/134.6.930
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