PMID- 12088449 OWN - NLM STAT- MEDLINE DCOM- 20020730 LR - 20210527 IS - 0003-9985 (Print) IS - 0003-9985 (Linking) VI - 126 IP - 7 DP - 2002 Jul TI - Clinical laboratory assays for HER-2/neu amplification and overexpression: quality assurance, standardization, and proficiency testing. PG - 803-8 AB - 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. CN - Cell Markers And Cytogenetics Committees College Of American Pathologists LA - eng PT - Journal Article PT - Review PL - United States TA - Arch Pathol Lab Med JT - Archives of pathology & laboratory medicine JID - 7607091 RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Breast Neoplasms/genetics/metabolism/pathology MH - Carcinoma/genetics/metabolism/pathology MH - Clinical Laboratory Techniques/*methods/standards MH - Gene Amplification/*genetics MH - *Genes, erbB-2 MH - Humans MH - Immunohistochemistry MH - In Situ Hybridization, Fluorescence MH - Quality Assurance, Health Care MH - Receptor, ErbB-2/*genetics/*metabolism MH - Reproducibility of Results MH - Societies, Medical RF - 53 EDAT- 2002/06/29 10:00 MHDA- 2002/07/31 10:01 CRDT- 2002/06/29 10:00 PHST- 2002/06/29 10:00 [pubmed] PHST- 2002/07/31 10:01 [medline] PHST- 2002/06/29 10:00 [entrez] AID - 10.5858/2002-126-0803-CLAFHN [doi] PST - ppublish SO - Arch Pathol Lab Med. 2002 Jul;126(7):803-8. doi: 10.5858/2002-126-0803-CLAFHN.