Sipos Jennifer A, Aloi Joseph, Gianoukakis Andrew, Lee Stephanie L, Klopper Joshua P, Kung Jacqueline T, Lupo Mark A, Morgenstern David, Prat-Knoll Cristina, Schuetzenmeister Andre, Goldner Whitney S
Division of Endocrinology, Diabetes and Metabolism, The Ohio State University, Columbus, OH 43210, USA.
Division of Endocrinology, Diabetes and Metabolism, Atrium Health Wake Forest Baptist, Winston-Salem, NC 27101, USA.
J Endocr Soc. 2023 Aug 3;7(9):bvad102. doi: 10.1210/jendso/bvad102. eCollection 2023 Aug 1.
Serum thyroglobulin (Tg) is a biochemical marker for detecting persistent or recurrent differentiated thyroid carcinoma (DTC) post-thyroidectomy. Tg can indicate DTC before structural disease (SD) is visible with imaging procedures.
This work aimed to evaluate the clinical performance of the Elecsys Tg II assay at a Tg cutoff of 0.2 ng/mL for ruling out SD in adults with DTC after total/near-total thyroidectomy, with or without radioiodine ablation (RAI).
Patients were enrolled into 2 cohorts: longitudinal (Tg assessed every 6 months over 2 years under thyroid-stimulating hormone [TSH] suppression therapy following thyroidectomy with or without RAI) and cross-sectional with confirmed SD (Tg assessed once >12 weeks after thyroidectomy). Analyses were performed for both cohorts combined and in the longitudinal cohort.
The study included 530 clinically evaluable samples, the majority (n = 424 samples) from patients who had not received RAI treatment. Following correction for SD prevalence (4.97% in the longitudinal cohort), an Elecsys Tg II cutoff of 0.2 ng/mL ruled out SD with a negative predictive value of 99.9% (95% CI, 99.5%-100%). The assay had excellent sensitivity (98.5%-100%) and acceptable specificity (53.4%-53.5%) for detecting SD (Tg ≥ 0.2 ng/mL) for both cohorts combined and in the longitudinal cohort, with similar findings in RAI-treated and non-RAI-treated subgroups.
In this cohort of DTC patients post-thyroidectomy, a Tg cutoff of 0.2 ng/mL was highly effective for ruling out the presence of SD under TSH-suppressed conditions, including in patients who had not received RAI treatment.
血清甲状腺球蛋白（Tg）是甲状腺切除术后检测持续性或复发性分化型甲状腺癌（DTC）的生化标志物。在影像学检查可见结构性疾病（SD）之前，Tg可提示DTC。
本研究旨在评估Elecsys Tg II检测在Tg临界值为0.2 ng/mL时，对全甲状腺切除/近全甲状腺切除术后接受或未接受放射性碘消融（RAI）的成年DTC患者排除SD的临床性能。
患者被纳入2个队列：纵向队列（甲状腺切除术后接受或未接受RAI，在促甲状腺激素[TSH]抑制治疗下每6个月评估Tg，持续2年）和确诊SD的横断面队列（甲状腺切除术后>12周评估一次Tg）。对两个队列合并及纵向队列进行分析。
该研究纳入了530份可进行临床评估的样本，其中大多数（n = 424份样本）来自未接受RAI治疗的患者。在校正SD患病率（纵向队列中为4.97%）后，Elecsys Tg II临界值为0.2 ng/mL排除SD的阴性预测值为99.9%（95%CI，99.5%-100%）。对于两个队列合并及纵向队列，该检测在检测SD（Tg≥0.2 ng/mL）方面具有出色的敏感性（98.5%-100%）和可接受的特异性（53.4%-53.5%），在接受RAI治疗和未接受RAI治疗的亚组中结果相似。
在该队列甲状腺切除术后的DTC患者中，0.2 ng/mL的Tg临界值在TSH抑制状态下排除SD非常有效，包括未接受RAI治疗的患者。
