Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays

Arch Pathol Lab Med. 2010 Jun;134(6):930-5. doi: 10.5858/134.6.930.


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.

Publication types

  • Validation Study

MeSH terms

  • Biomarkers, Tumor / metabolism
  • Breast Neoplasms / diagnosis
  • Breast Neoplasms / metabolism*
  • Carcinoma, Ductal, Breast / diagnosis
  • Carcinoma, Ductal, Breast / metabolism
  • False Negative Reactions
  • False Positive Reactions
  • Female
  • Health Planning Guidelines*
  • Humans
  • Immunohistochemistry / methods*
  • Neoplasm Recurrence, Local / diagnosis
  • Neoplasm Recurrence, Local / metabolism
  • Receptors, Estrogen / metabolism*
  • Receptors, Progesterone / metabolism*


  • Biomarkers, Tumor
  • Receptors, Estrogen
  • Receptors, Progesterone