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Rigshospitalet - en del af Københavns Universitetshospital
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High concordance between two companion diagnostics tests: a concordance study between the HercepTest and the HER2 FISH pharmDx kit

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  • Jan Trøst Jørgensen
  • Susanne Møller
  • Birgitte B Rasmussen
  • Ole Henrik Winther
  • Andreas Schønau
  • Ann Knoop
Vis graf over relationer
The present study was done to investigate the concordance between the HER2 status measured by immunohistochemical analysis (HercepTest, DAKO, Carpinteria, CA) and fluorescence in situ hybridization (FISH; HER2 FISH pharmDx, DAKO) in a large study cohort (n = 681) of patients with high-risk breast cancer. A high agreement between immunohistochemical and FISH results was demonstrated. For the whole study population, the agreement between the 2 assays was 93.1% with a corresponding κ coefficient of 0.85. When the equivocal immunohistochemical 2+ cases were excluded from the analysis (n = 79), the agreement increased to 95.0% with a κ coefficient of 0.90. When the cutoff value for amplified/nonamplified cases in the HER2 FISH assay was increased from 2.0 to 2.2 as recommended in the American Society of Clinical Oncology/College of American Pathologists guidelines, the concordance between the 2 assays was 94.3% with a κ coefficient of 0.87 in the whole study population. When the equivocal immunohistochemical 2+ cases were excluded from this analysis, the concordance is similar (95.7% with a κ coefficient of 0.91).
OriginalsprogEngelsk
TidsskriftAmerican Journal of Clinical Pathology
Vol/bind136
Udgave nummer1
Sider (fra-til)145-51
Antal sider7
ISSN0002-9173
DOI
StatusUdgivet - jul. 2011

ID: 33284266