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HER2 testing in breast carcinoma: very low concordance rate between reference and local laboratories in Brazil.

Author(s): Wludarski SC, Lopes LF, Berto E Silva TR, Carvalho FM, Weiss LM, Bacchi CE

Publication: Appl Immunohistochem Mol Morphol, 2011, Vol. 19, Page 112-8

PubMed ID: 20930616 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to compare HER2 IHC and FISH results for breast carcinoma specimens and to determine factors leading to discordant IHC results between reference and local laboratories.

   Summary of Findings:

   Out of 2000 specimens examined, FISH results were inconclusive for 218 specimens predominantly due to inadequate preservation of tissue. Overall concordance was 98.4% for HER2 positive and negative cases by IHC and FISH. Specimens found to be HER2 equivocal by IHC staining were negative (nonamplified) for HER-2 by FISH 69.8% of the time and positive (amplified) by FISH 30.2% of the time. Between the reference laboratory and local laboratories, HER2 immunostaining results were concordant 6.2%, 14.0%, 84.9%, and 43.8% of the time for scores of 0, 1+, 2+, and 3+, respectively. 27 of the 247 cases (10.9%) scored as 0 or 1+ (negative) by the reference laboratory were scored as 3+ (positive) by local laboratories, and an additional 173 of these cases (70.0%) were scored as 2+ (equivocal) by local laboratories. Of note, information regarding the antibodies used for HER2 IHC analysis was not provided by 55.8% of the local laboratories, while all specimens were analyzed with the SP3 antibody at the reference laboratory. Further, information about fixative and fixation time was not provided by 62.6% of the local laboratories.

   Biospecimens

   • Tissue - Breast

   Preservative Types

   • Formalin

   Diagnoses:

   • Neoplastic - Carcinoma

   Platform:

   Analyte	Technology Platform
   Protein	Immunohistochemistry
   DNA	FISH
   Morphology	Light microscopy

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Immunohistochemistry Specific	Technology platform	FISH
   Immunohistochemistry Specific	Targeted peptide/protein	HER2
   Immunohistochemistry Specific	Type of antibody	SP3 Unspecified CB11 DAKO polyclonal 5A2 HercepTest A0485 Unspecified polyclonal TAB250 EP1045Y HER-24 CBE1 10A7
   FISH Specific	Targeted nucleic acid	HER2

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