Introduction The BRAF V600E mutation is the most common genetic event in papillary thyroid carcinoma (PTC). The BRAF V600E mutational status has a significant diagnostic and prognostic role in PTC since it can be detected in 32%–87% of PTC by various molecular methods.
Aim(s) A novel, fully automated real-time PCR-based Idylla test is assessed to detect the BRAF mutation in formalin-fixed paraffin-embedded (FFPE) thyroid samples.
Methods 99 PTC and 11 nodular hyperplasia FFPE thyroid tissues are evaluated for the BRAF V600E mutation by the Idylla tests and compared with peptide nucleic acid-clamping PCR, real-time PCR and pyrosequencing.
Results The sensitivity and specificity of the Idylla test to detect BRAF V600E are 98.8% and 100%, which is superior to real-time PCR and pyrosequencing. The concordance between Idylla and true positive is highest at 0.974.
Conclusions This study validates that the Idylla test is a sensitive and specific method to detect BRAF V600E in FFPE thyroid tissues. A simple, quick and easy to handle Idylla test is a useful and reliable molecular technique to evaluate BRAF mutations.
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Handling editor Runjan Chetty
Contributors M-KY: planning, principal worker and primary author. M-KJ and Y-ML: coworker and coauthor. S-YL: principal worker and coauthor. GMH: guide and corresponding author. J-MK: conceptualisation, planning and corresponding author.
Funding This work was supported by a grant of the Korean Health Technology R&D Project, Ministry of Health and Welfare (HI15C0789) and Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Science, ICT and Future Planning (No 2014R1A2A1A01004363).
Competing interests None declared.
Ethics approval Institutional Review Board of Chungnam National University Hospital (CNUH 2016-04-040).
Provenance and peer review Not commissioned; externally peer reviewed.
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