PT  - JOURNAL ARTICLE
AU  - Lithwick-Yanai, Gila
AU  - Dromi, Nir
AU  - Shtabsky, Alexander
AU  - Morgenstern, Sara
AU  - Strenov, Yulia
AU  - Feinmesser, Meora
AU  - Kravtsov, Vladimir
AU  - Leon, Marino E
AU  - Hajdúch, Marián
AU  - Ali, Syed Z
AU  - VandenBussche, Christopher J
AU  - Zhang, Xinmin
AU  - Leider-Trejo, Leonor
AU  - Zubkov, Asia
AU  - Vorobyov, Sergey
AU  - Kushnir, Michal
AU  - Goren, Yaron
AU  - Tabak, Sarit
AU  - Kadosh, Etti
AU  - Benjamin, Hila
AU  - Schnitzer-Perlman, Temima
AU  - Marmor, Hagai
AU  - Motin, Maria
AU  - Lebanony, Danit
AU  - Kredo-Russo, Sharon
AU  - Mitchell, Heather
AU  - Noller, Melissa
AU  - Smith, Alexis
AU  - Dattner, Olivia
AU  - Ashkenazi, Karin
AU  - Sanden, Mats
AU  - Berlin, Kenneth A
AU  - Bar, Dganit
AU  - Meiri, Eti
TI  - Multicentre validation of a microRNA-based assay for diagnosing indeterminate thyroid nodules utilising fine needle aspirate smears
AID  - 10.1136/jclinpath-2016-204089
DP  - 2017 Jun 01
TA  - Journal of Clinical Pathology
PG  - 500--507
VI  - 70
IP  - 6
4099  - http://jcp.bmj.com/content/70/6/500.short
4100  - http://jcp.bmj.com/content/70/6/500.full
SO  - J Clin Pathol2017 Jun 01; 70
AB  - 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 malignant thyroid nodules using a single FNA stained smear, and does not require fresh tissue or special collection and shipment conditions. This assay offers a valuable tool for the preoperative classification of thyroid samples with indeterminate cytology.