2026-05-31T16:52:51Zhttps://repisalud.isciii.es/rest/oai/request
oai:repisalud.isciii.es:20.500.12105/252852024-10-23T13:07:25Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16958col_20.500.12105_16962col_20.500.12105_16986
Repisalud author Delgado-García, Mercedes author Weynand, Birgit author Gómez-Izquierdo, Lourdes author Hernández, María José author Blanco, Ángela María author Varela, Mar author Matias-Guiu, Xavier author Nadal, Ernest author Márquez-Lobo, Bélgica author Alarcão, Ana author de Álava, Enrique author Biscuola, Michele 2024-10-23T13:07:25Z 2024-10-23T13:07:25Z 2020-04-03 10.1186/s12885-020-6697-7 1471-2407 BMC cancer http://hdl.handle.net/10668/15321 32245434 https://hdl.handle.net/20.500.12105/25285 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. eng EGFR Mutations Non-small-cell lung carcinoma Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer research article