Clinical laboratory assays for HER-2/neu amplification and overexpression: quality assurance, standardization, and proficiency testing

Arch Pathol Lab Med. 2002 Jul;126(7):803-8. doi: 10.5858/2002-126-0803-CLAFHN.


Objective: To present and contrast the results of immunohistochemistry and fluorescence in situ hybridization (FISH) proficiency testing surveys for HER-2/neu, as conducted by the Cell Markers and Cytogenetics Committees of the College of American Pathologists.

Design: During the past 2 years, unstained sections from invasive breast carcinomas have been used for both immunohistochemistry and interphase FISH proficiency surveys. In most instances, the same cases were used for both the Cell Markers and Cytogenetics surveys. Additional data regarding interpretative variability for immunohistochemistry surveys have also been captured.

Results: The number of laboratories performing FISH for HER-2/neu testing doubled during the 2-year period. The results of FISH testing have been remarkably concordant for laboratories submitting results. In contrast, the results of immunohistochemistry testing continue to highlight substantial variability among laboratories evaluating the same cases. The data show that this variability is at least in part due to variability in interpretation among observers, as well as inherent differences between immunohistochemistry and FISH techniques.

Conclusions: College of American Pathologists proficiency survey programs provide useful information about clinical testing for HER-2/neu amplification/overexpression.

Publication types

  • Review

MeSH terms

  • Breast Neoplasms / genetics
  • Breast Neoplasms / metabolism
  • Breast Neoplasms / pathology
  • Carcinoma / genetics
  • Carcinoma / metabolism
  • Carcinoma / pathology
  • Clinical Laboratory Techniques / methods*
  • Clinical Laboratory Techniques / standards
  • Gene Amplification / genetics*
  • Genes, erbB-2*
  • Humans
  • Immunohistochemistry
  • In Situ Hybridization, Fluorescence
  • Quality Assurance, Health Care
  • Receptor, ErbB-2 / genetics*
  • Receptor, ErbB-2 / metabolism*
  • Reproducibility of Results
  • Societies, Medical


  • Receptor, ErbB-2