Artículo
Clinical performance evaluation of the Idylla (TM) EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cáncer
Autor/es | Delgado-García, Mercedes
Weynand, Birgit Gómez-Izquierdo, Lourdes Hernández, María José Blanco, Ángela María Varela, Mar Álava Casado, Enrique de Biscuola, Michele |
Departamento | Universidad de Sevilla. Departamento de Citología e Histología Normal y Patológica |
Fecha de publicación | 2020 |
Fecha de depósito | 2023-05-05 |
Publicado en |
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Resumen | 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 ... 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. |
Cita | Delgado-García, M., Weynand, B., Gómez-Izquierdo, L., Hernández, M.J., Blanco, Á.M., Varela, M.,...,Biscuola, M. (2020). Clinical performance evaluation of the Idylla (TM) EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cáncer. BMC Cancer, 20 (1), 275. https://doi.org/10.1186/s12885-020-6697-7. |
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