The validation of a novel method combining both HER2 immunohistochemistry and HER2 dual-colour silver in situ hybridization on one slide for gastric carcinoma testing.

摘要: HER2 status assessment is a prerequisite for the establishment of an appropriate treatment strategy in gastric cancer. Gastric cancers are very heterogeneous and separate evaluations gene amplification protein expression lead to uncertainties localizing distinct clones time consuming. This study evaluates equivalence novel method combining both platforms on one slide. Immunohistochemistry (IHC) dual-colour silver situ hybridization (SISH) as single methods (IHC/SISH) gene-protein platform slide (gene/protein) were performed randomly collected 100 cases adenocarcinoma. Results IHC/SISH compared with gene/protein staining. 96 samples assessable. In staining, pathologists able assess consequent at cell level. comparison trials, was observed 14.6% by both, conventional SISH (agreement 100%; Kappa-coefficient κ = 1.0). Protein scores IHC 70.8% (0), 10.4% (1+), 9.4% (2+), (3+). were: 11.5% 7.3% (2+) (3+) patients. There complete concordances score 0 (100.0%; κ = 1). High shown 1+ (98.96%; κ = 0.947) 3+ (96.88%; κ = 0.825) good 2+ (95.83%; κ = 0.728). combined has advantage being evaluate same cancer may be particular interest research patient’s care. Disease Biomarker.