IRCCS Istituto Ortopedico Galeazzi, Laboratory of Experimental Biochemistry & Molecular Biology, Milan, Italy.
Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway.
Clin Chem Lab Med. 2021 Feb 9;60(4):523-532. doi: 10.1515/cclm-2020-1885. Print 2022 Mar 28.
Thyroid biomarkers are fundamental for the diagnosis of thyroid disorders and for the monitoring and treatment of patients with these diseases. The knowledge of biological variation (BV) is important to define analytical performance specifications (APS) and reference change values (RCV). The aim of this study was to deliver BV estimates for thyroid stimulating hormone (TSH), free thyroxine (FT4), free triiodothyronine (FT3), thyroglobulin (TG), and calcitonin (CT).
Analyses were performed on serum samples obtained from the European Biological Variation Study population (91 healthy individuals from six European laboratories; 21-69 years) on the Roche Cobas e801 at the San Raffaele Hospital (Milan, Italy). All samples from each individual were evaluated in duplicate within a single run. The BV estimates with 95% CIs were obtained by CV-ANOVA, after analysis of variance homogeneity and outliers.
The within-subject (CV ) BV estimates were for TSH 17.7%, FT3 5.0%, FT4 4.8%, TG 10.3, and CT 13.0%, all significantly lower than those reported in the literature. No significant differences were observed for BV estimates between men and women.
The availability of updated, in the case of CT not previously published, BV estimates for thyroid markers based on the large scale EuBIVAS study allows for refined APS and associated RCV applicable in the diagnosis and management of thyroid and related diseases.
甲状腺生物标志物对于甲状腺疾病的诊断以及这些疾病患者的监测和治疗至关重要。了解生物学变异（BV）对于定义分析性能规格（APS）和参考变化值（RCV）非常重要。本研究旨在提供甲状腺刺激激素（TSH）、游离甲状腺素（FT4）、游离三碘甲状腺原氨酸（FT3）、甲状腺球蛋白（TG）和降钙素（CT）的 BV 估计值。
在意大利米兰圣拉斐尔医院的罗氏 Cobas e801 上对来自六个欧洲实验室的 91 名健康个体（21-69 岁）的欧洲生物学变异研究人群的血清样本进行分析。每个个体的所有样本均在单个运行中重复评估两次。通过方差分析同质性和异常值分析，获得 CV-ANOVA 后 95%CI 的 BV 估计值。
个体内（CV ）BV 估计值分别为 TSH 17.7%、FT3 5.0%、FT4 4.8%、TG 10.3%和 CT 13.0%，均显著低于文献报道值。未观察到 BV 估计值在男性和女性之间存在显著差异。
基于大规模 EuBIVAS 研究的更新的、在 CT 情况下未发表的甲状腺标志物 BV 估计值的可用性，为甲状腺和相关疾病的诊断和管理提供了更精细的 APS 和相关 RCV。
