A deep dive into four thyroglobulin immunoassays from analytical perspective.

IF 1.4 4区医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Scandinavian Journal of Clinical & Laboratory Investigation Pub Date : 2025-04-01 Epub Date: 2025-03-17 DOI:10.1080/00365513.2025.2479037

Tuba Saadet Deveci Bulut, Muhittin Abdulkadir Serdar, Mehmet Muhittin Yalçın, Meriç Coşkun, Aylar Poyraz, Seda Gökgöz Acar, Gizem Yaz Aydın, Özlem Gülbahar

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Abstract

Backgrounds: Serum thyroglobulin immunometric assays (sTg) are crucial for monitoring differentiated thyroid cancer (DTC) treatment. However, challenges such as anti-thyroglobulin autoantibodies (TgAb) and assay variability hinder evaluations. This study assessed four sTg methods-three second-generation (Architect, Access, Elecsys) and one first-generation (Immulite)-following Clinical and Laboratory Standards Institute (CLSI) and American Thyroid Association (ATA) guidelines.

Methods: The study compared sTg_(Architect), sTg_(Access), sTg_(Elecsys), and sTg_(Immulite). Precision was evaluated per CLSI EP05-A3, while the lower limits of detection (LLD) were assessed using EP17-A2. Passing-Bablok and Bland-Altman analyses were conducted as per EP09c, and semi-quantitative comparisons used Kappa statistics.

Results: The second-generation sTgs (Architect, Access, Elecsys) exhibited satisfactory precision (<7% coefficient of variation, CV%), unlike sTg_(Immulite), which showed significant deviations and inadequate sensitivity for DTC recurrence (Limit of quantitation, LoQ = 4.59 μg/L). Second-generation sTgs had strong correlations (r > 0.884) across all concentration ranges (≤1, 1-10, >10 μg/L), with biases (slope: 1.131-2.027). sTg_(Immulite) correlated well with second-generation methods for concentrations >10 μg/L (r > 0.945) but less so for <10 μg/L (r < 0.642). TgAb significantly impacted sTg_(Immulite). Kappa statistics revealed strong agreement among second-generation methods (κ > 0.800) but lower concordance with sTg_(Immulite), especially in TgAb(+) samples (κ: 0.562-0.653). Agreement ratios were high for second-generation methods (0.667-1.000) but variable for sTg_(Immulite), particularly at lower concentrations and in TgAb(+) cases (0.097-0.727).

Conclusions: sTg_(Immulite) did not meet LLD and precision criteria for DTC monitoring, facing issues with TgAb interference. Second-generation sTgs demonstrated consistent performance across all concentrations.

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从分析角度深入探讨四种甲状腺球蛋白免疫测定法。

背景：血清甲状腺球蛋白免疫测定（sTg）是监测分化型甲状腺癌（DTC）治疗的关键。然而，诸如抗甲状腺球蛋白自身抗体（TgAb）和测定变异性等挑战阻碍了评估。本研究评估了四种sTg方法——三种第二代（Architect, Access, Elecsys）和一种第一代（Immulite）——遵循临床和实验室标准协会（CLSI）和美国甲状腺协会（ATA）的指南。方法：比较sTg（Architect）、sTg（Access）、sTg（Elecsys）和sTg（Immulite）。采用CLSI EP05-A3评价精密度，采用EP17-A2评价检测下限。Passing-Bablok和Bland-Altman分析采用EP09c，半定量比较采用Kappa统计。结果：第二代sTgs （Architect、Access、Elecsys）具有较好的精度（Immulite），但对DTC复发的检测偏差较大，灵敏度不足（定量限，LoQ = 4.59 μg/L）。第二代sTgs在各浓度范围（≤1,1 ~ 10,>10 μg/L）具有较强的相关性（r > 0.884），存在偏倚（斜率为1.131 ~ 2.027）。sTg（免疫莫来石）与第二代方法在浓度>0 μg/L （r > 0.945）时相关性良好，而r（免疫莫来石）相关性较差。Kappa统计结果显示，第二代方法之间的一致性较强（κ > 0.800），但与sTg（Immulite）的一致性较低，特别是在TgAb（+）样品中（κ: 0.562-0.653）。第二代方法的符合率很高（0.667-1.000），但sTg（免疫莫来石）的符合率不同，特别是在低浓度和TgAb（+）病例中（0.097-0.727）。结论：sTg（Immulite）不符合DTC监测的LLD和精密度标准，存在TgAb干扰问题。第二代sTgs在所有浓度下都表现出一致的性能。

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来源期刊

Scandinavian Journal of Clinical & Laboratory Investigation 医学-医学：研究与实验

CiteScore

3.50

自引率

4.80%

发文量

审稿时长

4-8 weeks

期刊介绍： The Scandinavian Journal of Clinical and Laboratory Investigation is an international scientific journal covering clinically oriented biochemical and physiological research. Since the launch of the journal in 1949, it has been a forum for international laboratory medicine, closely related to, and edited by, The Scandinavian Society for Clinical Chemistry. The journal contains peer-reviewed articles, editorials, invited reviews, and short technical notes, as well as several supplements each year. Supplements consist of monographs, and symposium and congress reports covering subjects within clinical chemistry and clinical physiology.