Multicentre validation of a microRNA-based assay for diagnosing indeterminate thyroid nodules utilising fine needle aspirate smears
| Autor: | Yaron Goren, Xinmin Zhang, Marino E. Leon, Melissa Noller, Marian Hajduch, Kenneth A Berlin, Hila Benjamin, Mats Sanden, Yulia Strenov, Michal Kushnir, Hagai Marmor, Danit Lebanony, Sergey Vorobyov, Gila Lithwick-Yanai, Heather Mitchell, Eti Meiri, Syed Z. Ali, Nir Dromi, Vladimir Kravtsov, Olivia Dattner, Alexander Shtabsky, Leonor Leider-Trejo, Sara Morgenstern, Temima Schnitzer-Perlman, Karin Ashkenazi, Etti Kadosh, Alexis Smith, Dganit Bar, Sarit Tabak, Sharon Kredo-Russo, Christopher J. VandenBussche, Asia Zubkov, Meora Feinmesser, Maria Motin |
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| Rok vydání: | 2016 |
| Předmět: |
Male
0301 basic medicine Thyroid nodules medicine.medical_specialty MOLECULAR ONCOLOGY Biopsy Fine-Needle THYROID CANCER DIAGNOSTICS Pathology and Forensic Medicine 03 medical and health sciences 0302 clinical medicine THYROID Predictive Value of Tests Cytology Biopsy medicine Humans Thyroid Neoplasms Thyroid Nodule Thyroid cancer Observer Variation medicine.diagnostic_test business.industry Thyroid disease Thyroid Nodule (medicine) General Medicine Middle Aged medicine.disease LABORATORY TESTS MicroRNAs 030104 developmental biology medicine.anatomical_structure 030220 oncology & carcinogenesis Predictive value of tests Original Article Female Radiology medicine.symptom business |
| Zdroj: | Journal of Clinical Pathology |
| ISSN: | 1472-4146 0021-9746 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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