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Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays
Patrick L Fitzgibbons1, Douglas A Murphy, M Elizabeth H Hammond
1Department of Pathology, St Jude Medical Center, Fullerton, California 92835, USA. pfitz@stjoe.org
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 false-positive and false-negative results. Required ongoing assay assessment procedures are also described.
