RT Journal Article
SR Electronic
T1 Multicentre validation of a microRNA-based assay for diagnosing indeterminate thyroid nodules utilising fine needle aspirate smears
JF Journal of Clinical Pathology
JO J Clin Pathol
FD BMJ Publishing Group Ltd and Association of Clinical Pathologists
SP 500
OP 507
DO 10.1136/jclinpath-2016-204089
VO 70
IS 6
A1 Lithwick-Yanai, Gila
A1 Dromi, Nir
A1 Shtabsky, Alexander
A1 Morgenstern, Sara
A1 Strenov, Yulia
A1 Feinmesser, Meora
A1 Kravtsov, Vladimir
A1 Leon, Marino E
A1 Hajdúch, Marián
A1 Ali, Syed Z
A1 VandenBussche, Christopher J
A1 Zhang, Xinmin
A1 Leider-Trejo, Leonor
A1 Zubkov, Asia
A1 Vorobyov, Sergey
A1 Kushnir, Michal
A1 Goren, Yaron
A1 Tabak, Sarit
A1 Kadosh, Etti
A1 Benjamin, Hila
A1 Schnitzer-Perlman, Temima
A1 Marmor, Hagai
A1 Motin, Maria
A1 Lebanony, Danit
A1 Kredo-Russo, Sharon
A1 Mitchell, Heather
A1 Noller, Melissa
A1 Smith, Alexis
A1 Dattner, Olivia
A1 Ashkenazi, Karin
A1 Sanden, Mats
A1 Berlin, Kenneth A
A1 Bar, Dganit
A1 Meiri, Eti
YR 2017
UL http://jcp.bmj.com/content/70/6/500.abstract
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.