Development of an enzyme-linked immunosorbent assay for newborns dried blood spot thyroglobulin.

IF 3.5 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM
Camilo Fuentes Peña, María Cecilia Opazo, Luis Méndez, Claudia Riedel, Bernard Hauquier, Lionel Marcelis, Frederic Cotton, Rodrigo Moreno-Reyes
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Abstract

Background: Thyroglobulin (Tg) is a biomarker of iodine status. Newborn Tg is a more sensitive marker than neonatal TSH in detecting variations in iodine intake. This study aims to validate a Tg enzyme-linked immunosorbent assay (ELISA) for Tg determination on dried blood spots (DBS) in newborns. This study also set out to assess the stability of Tg and the influence of newborns' hematocrit on Tg determination.

Methods: A commercially available ELISA Tg assay was adapted for use on DBS. DBS-Tg in cord blood were measured in 209 newborns delivered from healthy euthyroid pregnant women. Sensitivity, linearity, repeatability, and intermediate fidelity were determined using the appropriate standards and quality control materials.

Results: The limit of detection (LoD) of the DBS-Tg assay was 2.4 µg/L, and the limit of quantification (LoQ) was 5.8 µg/L. Repeatability and intermediate fidelity were 7.7-8.3% and 11.0-11.2%, respectively. The median cord plasma Tg and DBS-Tg values in newborns were not significantly different, 30.2 (21.3-44.4) µg/L and 31.6 (19.3-48.7) µg/L (p=0.48) with the ELISA respectively, and 76.5 (40.0-101.5) µg/L with the Elecsys assay with an R=0.88. DBS-Tg concentrations decrease with increasing hematocrit values (p<0.05). DBS-Tg values were stable at a concentration of 25 µg/L for 12 months at -20ºC and 4ºC.

Conclusion: This DBS-Tg assay demonstrated good analytical performances over a wide range of Tg concentrations, suggesting it is well suited to detecting variations in Tg concentrations. Studies comparing populations with different prevalence of anemia should consider the effect of hematocrit on DBS-Tg determination. The availability of a DBS-Tg assay for newborns makes it possible to integrate iodine status monitoring with newborn screening for inherited metabolic diseases.

为新生儿干血斑甲状腺球蛋白开发酶联免疫吸附试验。
背景:甲状腺球蛋白(Tg甲状腺球蛋白(Tg)是碘状况的生物标志物。在检测碘摄入量变化方面,新生儿甲状腺球蛋白是比新生儿促甲状腺激素更灵敏的标志物。本研究旨在验证一种 Tg 酶联免疫吸附测定法(ELISA),以测定新生儿干血斑(DBS)中的 Tg。本研究还将评估 Tg 的稳定性以及新生儿血细胞比容对 Tg 测定的影响:方法:将市售的酶联免疫吸附 Tg 检测法用于 DBS。对 209 名健康甲状腺功能正常的孕妇所生的新生儿进行了脐带血中 DBS-Tg 的测定。使用适当的标准和质控材料测定了灵敏度、线性、可重复性和中间保真度:DBS-Tg测定的检测限(LoD)为2.4微克/升,定量限(LoQ)为5.8微克/升。重复性和中间可靠度分别为 7.7-8.3% 和 11.0-11.2%。新生儿脐带血浆 Tg 和 DBS-Tg 的中值差异不大,ELISA 法分别为 30.2 (21.3-44.4) µg/L 和 31.6 (19.3-48.7) µg/L (p=0.48),Elecsys 法为 76.5 (40.0-101.5) µg/L,R=0.88。DBS-Tg 浓度随着血细胞比容值的增加而降低(p 结论:该 DBS-Tg 检测方法证明了 DBS-Tg 检测的有效性:这种 DBS-Tg 检测法在 Tg 浓度的较大范围内都表现出良好的分析性能,表明它非常适合检测 Tg 浓度的变化。比较不同贫血患病率人群的研究应考虑血细胞比容对 DBS-Tg 测定的影响。有了新生儿 DBS-Tg 检测方法,就有可能将碘状态监测与新生儿遗传代谢疾病筛查结合起来。
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来源期刊
European Thyroid Journal
European Thyroid Journal Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
6.70
自引率
2.10%
发文量
156
期刊介绍: The ''European Thyroid Journal'' publishes papers reporting original research in basic, translational and clinical thyroidology. Original contributions cover all aspects of the field, from molecular and cellular biology to immunology and biochemistry, from physiology to pathology, and from pediatric to adult thyroid diseases with a special focus on thyroid cancer. Readers also benefit from reviews by noted experts, which highlight especially active areas of current research. The journal will further publish formal guidelines in the field, produced and endorsed by the European Thyroid Association.
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