Interlaboratory comparison of immunohistochemical testing for HER2: results of the 2004 and 2005 College of American Pathologists HER2 Immunohistochemistry Tissue Microarray Survey.

Author(s): Fitzgibbons PL, Murphy DA, Dorfman DM, Roche PC, Tubbs RR

Publication: Arch Pathol Lab Med, 2006, Vol. 130, Page 1440-5

PubMed ID: 17090184 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to compare HER2 IHC staining of tissue microarrays containing invasive breast carcinoma tissue with FISH results using the same tissue specimens. IHC was performed using different antibody types and different antigen retrieval methods.

   Summary of Findings:

   Results were obtained from 102 and 141 different institutions in 2004 and 2005 respectively. Each institution performed IHC, using their own techniques, on the same tissue microarrays containing 80 different tissue specimens. FISH testing was used as the standard for determining HER2 positive or HER2 negative status. In each year, approximately half of the institutions used CB11 antibody while the other half used the HercepTest. Cores were graded as HER2 positive or HER2 negative when there was at least a 90% consensus among the staining results from the institutions. While the authors report no significant differences in staining between the different antigen retrieval methods, the two major antibody types used did appear to make a difference. 37 cores were graded as HER2 negative by FISH analysis but did not achieve a grade with IHC. Laboratories using the HercepTest were twice as likely to report a false positive IHC result than those laboratories using CB11 antibody. On the other hand, 12 cores were graded as HER2 positive by FISH analysis but did not achieve a grade with IHC. Laboratories using the CB11 antibody were much more likely to score a false negative IHC result than those laboratories using the HercepTest.

   Biospecimens

   • Tissue - Breast

   Preservative Types

   • Formalin

   Diagnoses:

   • Neoplastic - Carcinoma

   Platform:

   Analyte	Technology Platform
   Protein	Immunohistochemistry
   Protein	Tissue microarray
   DNA	FISH

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Immunohistochemistry Specific	Targeted peptide/protein	HER2
   Immunohistochemistry Specific	Type of antibody	Rabbit polyclonal HercepTest Mouse monoclonal CB11
   FISH Specific	Targeted nucleic acid	HER2
   FISH Specific	Technology platform	FISH Immunohistochemistry

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