Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays

  • Fitzgibbons P
  • Murphy D
  • Hammond M
 et al. 
  • 54

    Readers

    Mendeley users who have this article in their library.
  • 62

    Citations

    Citations of this article.

Abstract

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.

Get free article suggestions today

Mendeley saves you time finding and organizing research

Sign up here
Already have an account ?Sign in

Find this document

Authors

  • Patrick L. Fitzgibbons

  • Douglas A. Murphy

  • M. Elizabeth H Hammond

  • D. Craig Allred

  • Paul N. Valenstein

Cite this document

Choose a citation style from the tabs below

Save time finding and organizing research with Mendeley

Sign up for free