Department of Medicine, Jackson Memorial Hospital, Miami, Florida, USA.
Division of Endocrinology, Jackson Memorial Hospital, University of Miami, Miami, Florida, USA.
Thyroid. 2020 Nov;30(11):1613-1619. doi: 10.1089/thy.2019.0673. Epub 2020 May 26.
The Afirma gene expression classifier (GEC) has been used to aid in the diagnosis and management of thyroid nodules having Bethesda category III fine-needle aspiration cytologic diagnosis (B3 nodules). The American Thyroid Association sonographic risk stratification system for thyroid nodules (ATA-US) may stratify B3 nodules and aid in the decision to order a molecular test. The aim of this study was to assess the association between ATA-US and GEC as well as to determine their individual and combined diagnostic performances when applied to B3 nodules. A retrospective single-center study included B3 nodules that had undergone evaluation by GEC. Each ultrasound was reviewed by three radiologists, and nodules were classified using the 2015 ATA sonographic risk categories. Nodules were determined to be benign or malignant based on surgical pathology or minimum 11 months of follow-up. Positive predictive values (PPV) and negative predictive values (NPV) were calculated for GEC, ATA-US, and GEC across all ATA-US categories. One hundred twenty-six B3 nodules with GEC results were included and deemed benign or malignant based on final pathology or follow-up. Prevalence of malignancy was 32%. The rate of malignancy was similar in the ATA-US high suspicion (HS) and intermediate suspicion (IS) categories at 42% and 38%, respectively; and lower in nodules with low suspicion sonography (LS) and very low suspicion sonography (VLS) at 23% and 11%, respectively. The PPV and NPV of ATA-US was calculated by designating HS or IS sonography as a "positive" test and the lower risk categories as "negative." ATA-US had a PPV of 40% and NPV of 79%. The GEC PPV was 40% and NPV was 83%. The PPV of GEC was 50% in nodules with HS or IS ATA-US and lower at 28% and 20%, respectively, in LS and VLS nodules. The NPV of GEC was 80% in HS, 77% in IS, 84% in LS, and 100% in VLS sonography categories. In B3 nodules, ATA-US and GEC have similar diagnostic performance. The PPV of GEC varies across ATA-US categories, while the NPV remains similar. These data support the need for future prospective studies.
Affirma 基因表达分类器（GEC）已被用于辅助诊断和管理具有 Bethesda 细针抽吸细胞学诊断类别 III（B3 结节）的甲状腺结节。美国甲状腺协会（ATA）的甲状腺结节超声风险分层系统（ATA-US）可对 B3 结节进行分层，并有助于决定是否进行分子检测。本研究旨在评估 ATA-US 和 GEC 之间的相关性，并确定当应用于 B3 结节时它们各自和联合的诊断性能。这是一项回顾性单中心研究，纳入了接受 GEC 评估的 B3 结节。每位放射科医生对每个超声进行了审查，并使用 2015 年 ATA 超声风险类别对结节进行了分类。根据手术病理或至少 11 个月的随访，确定结节为良性或恶性。计算了 GEC、ATA-US 以及在所有 ATA-US 类别中的 GEC 的阳性预测值（PPV）和阴性预测值（NPV）。纳入了 126 个具有 GEC 结果的 B3 结节，并根据最终病理或随访确定为良性或恶性。恶性肿瘤的患病率为 32%。ATA-US 高度可疑（HS）和中间可疑（IS）类别的恶性肿瘤发生率分别为 42%和 38%，相似；而在超声低度可疑（LS）和极低度可疑（VLS）的结节中分别为 23%和 11%，较低。ATA-US 的 PPV 和 NPV 是通过将 HS 或 IS 超声指定为“阳性”试验和较低的风险类别指定为“阴性”试验来计算的。ATA-US 的 PPV 为 40%，NPV 为 79%。GEC 的 PPV 为 40%，NPV 为 83%。在 HS 或 IS ATA-US 结节中，GEC 的 PPV 为 50%，在 LS 和 VLS 结节中分别为 28%和 20%。GEC 的 NPV 在 HS 为 80%，IS 为 77%，LS 为 84%，VLS 为 100%。在 B3 结节中，ATA-US 和 GEC 的诊断性能相似。GEC 的 PPV 随 ATA-US 类别而变化，而 NPV 则保持相似。这些数据支持未来进行前瞻性研究的必要性。
