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

G. Lithwick-Yanai, N. Dromi, A. Shtabsky, S. Morgenstern, Y. Strenov, M. Feinmesser, V. Kravtsov, ME. Leon, M. Hajdúch, SZ. Ali, CJ. VandenBussche, X. Zhang, L. Leider-Trejo, A. Zubkov, S. Vorobyov, M. Kushnir, Y. Goren, S. Tabak, E. Kadosh, H....

. 2017 ; 70 (6) : 500-507. [pub] 20161026

Language English Country England, Great Britain

Document type Journal Article, Multicenter Study, Validation Study

Persistent link   https://www.medvik.cz/link/bmc17031325
E-resources Online Full text

NLK ProQuest Central from 2000-01-01 to 6 months ago
Health & Medicine (ProQuest) from 2000-01-01 to 6 months ago

Links

PubMed 27798083
DOI 10.1136/jclinpath-2016-204089
Knihovny.cz E-resources

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.

References provided by Crossref.org

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$a AIMS: The distinction between benign and malignant thyroid nodules has important therapeutic implications. Our objective was to develop an assay that could classify indeterminate thyroid nodules as benign or suspicious, using routinely prepared fine needle aspirate (FNA) cytology smears. METHODS: A training set of 375 FNA smears was used to develop the microRNA-based assay, which was validated using a blinded, multicentre, retrospective cohort of 201 smears. Final diagnosis of the validation samples was determined based on corresponding surgical specimens, reviewed by the contributing institute pathologist and two independent pathologists. Validation samples were from adult patients (≥18 years) with nodule size >0.5 cm, and a final diagnosis confirmed by at least one of the two blinded, independent pathologists. The developed assay, RosettaGX Reveal, differentiates benign from malignant thyroid nodules, using quantitative RT-PCR. RESULTS: Test performance on the 189 samples that passed quality control: negative predictive value: 91% (95% CI 84% to 96%); sensitivity: 85% (CI 74% to 93%); specificity: 72% (CI 63% to 79%). Performance for cases in which all three reviewing pathologists were in agreement regarding the final diagnosis (n=150): negative predictive value: 99% (CI 94% to 100%); sensitivity: 98% (CI 87% to 100%); specificity: 78% (CI 69% to 85%). CONCLUSIONS: A novel assay utilising microRNA expression in cytology smears was developed. The assay distinguishes benign from malignant thyroid nodules using a single FNA stained smear, and does not require fresh tissue or special collection and shipment conditions. This assay offers a valuable tool for the preoperative classification of thyroid samples with indeterminate cytology.
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$a Shtabsky, Alexander $u Pathology Institute, Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel. The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
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$a Morgenstern, Sara $u The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Pathology Institute, Rabin Medical Center, Petach Tikva, Israel.
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$a Strenov, Yulia $u The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Pathology Institute, Rabin Medical Center, Petach Tikva, Israel.
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$a Feinmesser, Meora $u The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Pathology Institute, Rabin Medical Center, Petach Tikva, Israel.
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$a Kravtsov, Vladimir $u The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Pathology Institute, Meir Medical Center, Kfar Saba, Israel.
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$a Zubkov, Asia $u Pathology Institute, Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel.
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$a Kushnir, Michal $u Rosetta Genomics Ltd, Rehovot, Israel.
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$a Goren, Yaron $u Rosetta Genomics Ltd, Rehovot, Israel. Geha Mental Health Center, Petach Tikva, Israel.
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$a Dattner, Olivia $u Rosetta Genomics Inc, Philadelphia, Pennsylvania, USA.
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