dc.creator | Delgado-García, Mercedes | es |
dc.creator | Weynand, Birgit | es |
dc.creator | Gómez-Izquierdo, Lourdes | es |
dc.creator | Hernández, María José | es |
dc.creator | Blanco, Ángela María | es |
dc.creator | Varela, Mar | es |
dc.creator | Álava Casado, Enrique de | es |
dc.creator | Biscuola, Michele | es |
dc.date.accessioned | 2023-05-05T11:30:56Z | |
dc.date.available | 2023-05-05T11:30:56Z | |
dc.date.issued | 2020 | |
dc.identifier.citation | 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. | |
dc.identifier.issn | 1471-2407(electrónico) | es |
dc.identifier.uri | https://hdl.handle.net/11441/145480 | |
dc.description.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. | es |
dc.format | application/pdf | es |
dc.format.extent | 10 p. | es |
dc.language.iso | eng | es |
dc.publisher | BMC | es |
dc.relation.ispartof | BMC Cancer, 20 (1), 275. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | EGFR | es |
dc.subject | Mutations | es |
dc.subject | Non-small-cell lung carcinoma | es |
dc.title | Clinical performance evaluation of the Idylla (TM) EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cáncer | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Citología e Histología Normal y Patológica | es |
dc.relation.publisherversion | https://bmccancer.biomedcentral.com/articles/10.1186/s12885-020-6697-7 | es |
dc.identifier.doi | 10.1186/s12885-020-6697-7 | es |
dc.journaltitle | BMC Cancer | es |
dc.publication.volumen | 20 | es |
dc.publication.issue | 1 | es |
dc.publication.initialPage | 275 | es |