BMC cancer, 2020-04, Vol.20 (1), p.275-275, Article 275
2020
Details
- Autor(en) / Beteiligte
- Titel
- Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer
- Ist Teil von
- BMC cancer, 2020-04, Vol.20 (1), p.275-275, Article 275
- Ort / Verlag
- England: BioMed Central Ltd
- Erscheinungsjahr
- 2020
- Link zum Volltext
- Quelle
- Free E-Journal (出版社公開部分のみ）
- Beschreibungen/Notizen
- 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. 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). 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%. The Idylla™ EGFR Mutation Test passed its clinical validity performance characteristics for accuracy.
- Sprache
- Englisch
- Identifikatoren
- ISSN: 1471-2407eISSN: 1471-2407DOI: 10.1186/s12885-020-6697-7Titel-ID: cdi_doaj_primary_oai_doaj_org_article_931a3412f3ce49e3a946c98467c818ef
- Format
- –
- Schlagworte
- Adult, Aged, Aged, 80 and over, Automation, Biopsy - methods, Carcinoma, Non-Small-Cell Lung - diagnosis, Carcinoma, Non-Small-Cell Lung - genetics, Carcinoma, Non-Small-Cell Lung - pathology, Care and treatment, DNA Mutational Analysis - methods, EGFR, Epidermal growth factor, Epidermal growth factor receptors, Epidermal growth factors, ErbB Receptors - genetics, Exons, Female, Formaldehyde, Formaldehyde - chemistry, Humans, Kinases, Lung cancer, Non-small cell, Lung carcinoma, Lung Neoplasms - diagnosis, Lung Neoplasms - genetics, Lung Neoplasms - pathology, Male, Middle Aged, Molecular Diagnostic Techniques - methods, Mutation, Mutations, Non-small cell lung cancer, Non-small cell lung carcinoma, Osimertinib, Paraffin, Paraffin Embedding - methods, Patients, Performance evaluation, Protein-tyrosine kinase, Small cell lung carcinoma, Tyrosine