Thyroglobulin antibody in differentiated thyroid cancer: international laboratory practice survey and the case for a dual-threshold model.

IF 4.4 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry and laboratory medicine Pub Date : 2026-09-21 DOI:10.1515/cclm-2026-1063

Eliane F E Wenstedt, Marco Migliardi, Ruggero Dittadi, Sjoerd A A Van Den Berg, Mario Plebani, Luca Giovanella

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引用次数: 0

Abstract

Objectives: Anti-thyroglobulin antibodies (TgAb) have a dual role during the follow-up of differentiated thyroid cancer (DTC): they may interfere with thyroglobulin (Tg) immunoassays and also serve as surrogate biomarkers of disease status. However, laboratory practices for TgAb measurement and reporting remain poorly standardised. We conducted an international survey to characterize current laboratory approaches and identify opportunities for harmonization.

Methods: A structured questionnaire was distributed to 120 laboratory medicine centres performing Tg and TgAb testing. The survey collected information on analytical platforms, TgAb reporting practices, positivity and interference thresholds, interference assessment strategies, and the interpretation of longitudinal TgAb changes. Results were analysed descriptively.

Results: Fifty-one centres from six European countries participated (response rate, 42 %). Most laboratories (88 %) measured Tg and TgAb using assays from the same manufacturer. Marked heterogeneity was observed in quantitative TgAb reporting, definition of pathological TgAb concentrations, and thresholds considered indicative of potential Tg assay interference. Although more than half of the laboratories reported having defined an interference threshold, only two (4 %) implemented and explicitly reported separate thresholds for thyroid autoimmunity and Tg assay interference. Structured interference investigations were uncommon (26 %) and relied mainly on recovery testing, whereas predefined delta-check criteria for longitudinal TgAb interpretation were used by only 8 % of centres.

Conclusions: Current laboratory practice for TgAb testing in DTC is highly heterogeneous and may contribute to inconsistent interpretation of Tg results. A dual-threshold reporting model that clearly distinguishes the diagnostic threshold for thyroid autoimmunity from the analytical threshold indicating potential Tg assay interference promote harmonization. Routine support for longitudinal TgAb interpretation, including serial trend reporting, represents an additional opportunity for laboratory specialists to enhance the management of patients with DTC.

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分化型甲状腺癌的甲状腺球蛋白抗体：国际实验室实践调查和双阈值模型的案例。

目的：抗甲状腺球蛋白抗体（TgAb）在分化型甲状腺癌（DTC）的随访中具有双重作用：它们可能干扰甲状腺球蛋白（Tg）免疫测定，也可作为疾病状态的替代生物标志物。然而，TgAb测量和报告的实验室实践仍然缺乏标准化。我们进行了一项国际调查，以描述当前的实验室方法并确定协调的机会。方法：采用结构化问卷对120家检验医学中心进行Tg和TgAb检测。调查收集了分析平台、TgAb报告实践、积极性和干扰阈值、干扰评估策略以及纵向TgAb变化的解释等信息。对结果进行描述性分析。结果：来自6个欧洲国家的51个中心参与了调查（回复率为42% %）。大多数实验室（88 %）使用来自同一制造商的分析方法测量Tg和TgAb。在定量TgAb报告、病理TgAb浓度的定义和被认为指示潜在Tg测定干扰的阈值方面观察到明显的异质性。虽然超过一半的实验室报告定义了干扰阈值，但只有两个（4 %）实施并明确报告了甲状腺自身免疫和Tg测定干扰的单独阈值。结构化干扰调查并不常见（26% %），主要依赖于采收率测试，而纵向TgAb解释的预定义三角洲检查标准仅被8% %的中心使用。结论：目前DTC中TgAb检测的实验室实践是高度异质性的，可能导致Tg结果的解释不一致。双阈值报告模型明确区分甲状腺自身免疫的诊断阈值和表明潜在Tg测定干扰的分析阈值，促进了统一。对纵向TgAb解释的常规支持，包括连续趋势报告，为实验室专家提供了加强对DTC患者管理的额外机会。

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来源期刊

Clinical chemistry and laboratory medicine 医学-医学实验技术

CiteScore

11.30

自引率

16.20%

发文量

306

审稿时长

3 months

期刊介绍： Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!