Multicentre validation of a microRNA-based assay for diagnosing indeterminate thyroid nodules utilising fine needle aspirate smears

作者：G. Lithwick-Yanai, N. Dromi, A. Shtabsky, S. Morgenstern, Y. Strenov, M. Feinmesser, V. Kravtsov, M. Leon, M. Hajdůch, Syed Z. Ali, C. VandenBussche, Xinmin Zhang, L. Leider-Trejo, A. Zubkov, S. Vorobyov, M. Kushnir, Y. Goren, S. Tabak, E. Kadosh, H. Benjamin, Temima Schnitzer-Perlman, Hagai Marmor, M. Motin, D. Lebanony, S. Kredo-Russo, Heather Mitchell, M. Noller, Alexis Smith, Olivia Dattner, K. Ashkenazi, Mats O. Sanden, Kenneth Berlin, Dganit Bar, E. Meiri · 发表于：Journal of Clinical Pathology · 年份：2016 · DOI：10.1136/jclinpath-2016-204089 · 被引用次数：119 · 研究领域：Medicine

Aims The distinction between benign and malignant thyroid nodules has important therapeutic implications. Our objective was to develop an assay that could classify indeterminate thyroid nodules as benign or suspicious, using routinely prepared fine needle aspirate (FNA) cytology smears. Methods A training set of 375 FNA smears was used to develop the microRNA-based assay, which was validated using a blinded, multicentre, retrospective cohort of 201 smears. Final diagnosis of the validation samples was determined based on corresponding surgical specimens, reviewed by the contributing institute pathologist and two independent pathologists. Validation samples were from adult patients (≥18 years) with nodule size >0.5 cm, and a final diagnosis confirmed by at least one of the two blinded, independent pathologists. The developed assay, RosettaGX Reveal, differentiates benign from malignant thyroid nodules, using quantitative RT-PCR. Results Test performance on the 189 samples that passed quality control: negative predictive value: 91% (95% CI 84% to 96%); sensitivity: 85% (CI 74% to 93%); specificity: 72% (CI 63% to 79%). Performance for cases in which all three reviewing pathologists were in agreement regarding the final diagnosis (n=150): negative predictive value: 99% (CI 94% to 100%); sensitivity: 98% (CI 87% to 100%); specificity: 78% (CI 69% to 85%). Conclusions A novel assay utilising microRNA expression in cytology smears was developed. The assay distinguishes benign from ...