Preferential localization of c-kit product in tissue mast cells, basal cells of skin, epithelial cells of breast, small cell lung carcinoma and seminoma/dysgerminoma in human: immunohistochemical study on formalin-fixed, paraffin-embedded tissues

1994 ◽  
Vol 424 (2) ◽  
Author(s):  
Y. Tsuura ◽  
H. Hiraki ◽  
K. Watanabe ◽  
T. Suzuki ◽  
S. Igarashi ◽  
...  
Keyword(s):  
Immunohistochemical Study ◽  
Small Cell Lung Carcinoma ◽  
Small Cell ◽  
Basal Cells ◽  
Small Cell Lung ◽  
Cell Lung Carcinoma ◽  
Formalin Fixed Paraffin ◽  
Preferential Localization ◽  
Formalin Fixed Paraffin Embedded ◽  
Formalin Fixed

scholarly journals Clinical Performance Evaluation of the Idylla™ Egfr Mutation Test on Formalin-Fixed Paraffin-Embedded Tissue of Non-Small Cell Lung Cancer

2020 ◽  
Author(s):  
Mercedes Delgado-Garcia ◽  
Birgit Weynand ◽  
Lourdes Gómez Izquierdo ◽  
María José Hernández Barrera ◽  
Ángela María Blanco Lobo ◽  
...  
Keyword(s):  
Egfr Mutation ◽  
Small Cell ◽  
Test Method ◽  
Small Cell Lung ◽  
Diagnostic Agreement ◽  
Cell Lung Carcinoma ◽  
Mutational Status ◽  
Formalin Fixed Paraffin ◽  
Formalin Fixed Paraffin Embedded ◽  
Formalin Fixed

Abstract Background: detection of epidermal growth factor receptor (EGFR) mutations in exons 18-21 is recommended in all patients with advanced Non-small-cell lung carcinoma due to the demonstrated efficiency of the standard therapy with tyrosine kinase inhibitors in EGFR-mutated patients. Therefore, choosing a suitable technique to test EGFR mutational status is crucial to warrant a valid result in a short turnaround time using the lowest possible amount of tissue material.The Idylla™ EGFR Mutation Test is a simple, fast and reliable method designed for the detection of EGFR mutations from formalin-fixed paraffin-embedded samples. The aim of this study was the Clinical Performace Evaluation of the Idylla™ EGFR Mutation Test on the Idylla™ System.Methods: EGFR mutational status was determined on 132 archived formalin-fixed paraffin-embedded tissue sections with Idylla™ technology. Results were compared with the results previously obtained by routine method in the reference lab (Therascreen® EGFR RGQ PCR v2, Qiagen in Molecular Pathology lab, Hospital Universitario Virgen del Rocío de Sevilla).Results: the overall agreement between results obtained with the Idylla™ EGFR Mutation Test and the Comparator test method was 95.38% (with 1-sided 95% lower limit of 91.7%) showing Positive Diagnostic Agreement of 93.22% and Negative Diagnostic Agreement of 97.18%, with a Limit Of Detection ≤5%. Conclusions: the Idylla™ EGFR Mutation Test passed its clinical validity performance characteristics for accuracy.

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