Molecular Testing Using ThyGeNEXT/ThyraMIR in Thyroid Nodules With Indeterminate Cytology: A Single Medical Institute Experience.

IF 1 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY

Diagnostic Cytopathology Pub Date : 2025-04-06 DOI:10.1002/dc.25474

Zhongbo Yang, Komal Ijaz, Magda Esebua

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引用次数: 0

Abstract

Background: Up to 30% of thyroid nodules, by fine needle aspiration (FNA), have indeterminate cytology, including Bethesda III (atypia of undetermined significance [AUS]), IV (follicular neoplasm/suspicious for follicular neoplasm [FN/SFN]), and V (suspicious for malignancy). Molecular testing is utilized for further risk stratification of these indeterminate thyroid nodules. A multiplatform test (MPTX), one of the commercially offered molecular tests, combines next-generation sequencing panel (ThyGeNEXT) with microRNA expression classifier (ThyraMIR) to help with risk stratification. This study aimed to evaluate the performance of MPTX in cytologically indeterminate thyroid nodules in real-world experience.

Methods: All cases with indeterminate thyroid FNA results and corresponding MPTX test results in a period of 5 years were searched and retrieved. Subsequent clinical or surgical follow-up information was obtained. Molecular test results were compared to the histologic diagnoses. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated accordingly.

Results: A total of 106 cases were identified in the search, including 89 Bethesda III and 17 Bethesda IV. Overall MPTX results were negative in 59 cases, positive in 36 cases, and nondiagnostic in 11 cases. Only 17% of cases with negative molecular results had surgery, whereas 86% of those with positive molecular results had surgical follow-up. The false negative rate and false positive rate based on cytologic-histologic correlation (CHC) alone were 70% and 29%, respectively. In addition, based on both surgical and clinical follow-up data, the MPTX tests had an overall sensitivity of 76%, specificity of 75%, NPV of 83%, and PPV of 67%.

Conclusions: This study showed that more than half (56%) of the thyroid nodules with indeterminate cytology had benign molecular results by MPTX testing. The MPTX test showed moderate to high NPV and moderate PPV, suggesting that the MPTX test can be useful as an ancillary study to further risk-stratify cytologically indeterminate thyroid nodules. It is critical, however, to know the limitations of this assay, and the molecular results should be considered in correlation with clinical and radiologic findings.

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背景：多达 30% 的甲状腺结节通过细针穿刺 (FNA) 获得了不确定的细胞学结果，包括贝塞斯达 III（意义未定的不典型性 [AUS]）、IV（滤泡性肿瘤/滤泡性肿瘤可疑 [FN/SFN]）和 V（恶性肿瘤可疑）。分子检测用于对这些不确定的甲状腺结节进行进一步的风险分层。多平台检测（MPTX）是市场上提供的分子检测之一，它结合了新一代测序面板（ThyGeNEXT）和微RNA表达分类器（ThyraMIR），有助于进行风险分层。本研究旨在根据实际经验评估MPTX在细胞学不确定甲状腺结节中的表现：搜索并检索5年内所有甲状腺FNA结果不确定的病例以及相应的MPTX检测结果。获取随后的临床或手术随访信息。将分子检测结果与组织学诊断结果进行比较。计算出相应的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）：搜索共发现 106 个病例，包括 89 个 Bethesda III 型和 17 个 Bethesda IV 型病例。总体而言，MPTX 结果阴性的有 59 例，阳性的有 36 例，无诊断结果的有 11 例。分子检测结果为阴性的病例中只有 17% 进行了手术，而分子检测结果为阳性的病例中有 86% 进行了手术随访。仅根据细胞学-组织学相关性（CHC）得出的假阴性率和假阳性率分别为 70% 和 29%。此外，根据手术和临床随访数据，MPTX 检测的总体敏感性为 76%，特异性为 75%，NPV 为 83%，PPV 为 67%：本研究表明，半数以上（56%）细胞学结果不确定的甲状腺结节通过MPTX检测获得了良性分子结果。MPTX检测显示出中等到较高的NPV和中等的PPV，这表明MPTX检测可作为一项辅助检查，用于进一步对细胞学不确定的甲状腺结节进行风险分级。但是，了解这种检测方法的局限性至关重要，而且分子检测结果应与临床和放射学检查结果结合起来考虑。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diagnostic Cytopathology 医学-病理学

CiteScore

2.60

自引率

7.70%

发文量

163

审稿时长

3-6 weeks

期刊介绍： Diagnostic Cytopathology is intended to provide a forum for the exchange of information in the field of cytopathology, with special emphasis on the practical, clinical aspects of the discipline. The editors invite original scientific articles, as well as special review articles, feature articles, and letters to the editor, from laboratory professionals engaged in the practice of cytopathology. Manuscripts are accepted for publication on the basis of scientific merit, practical significance, and suitability for publication in a journal dedicated to this discipline. Original articles can be considered only with the understanding that they have never been published before and that they have not been submitted for simultaneous review to another publication.