High concordance between two companion diagnostics tests: a concordance study between the HercepTest and the HER2 FISH pharmDx kit.
Am J Clin Pathol
; 136(1): 145-51, 2011 Jul.
Article
em En
| MEDLINE
| ID: mdl-21685042
ABSTRACT
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).
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Mama
/
Imuno-Histoquímica
/
Hibridização in Situ Fluorescente
/
Receptor ErbB-2
Tipo de estudo:
Diagnostic_studies
/
Guideline
Limite:
Female
/
Humans
Idioma:
En
Revista:
Am J Clin Pathol
Ano de publicação:
2011
Tipo de documento:
Article
País de afiliação:
Dinamarca