Agreement between routinely used immunoassays for thyroid function testing in non-pregnant and pregnant adults

IF 3 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM
Ida Marie Nørum Wigh, Lærke Andersen, Maja Hjelm Lundgaard, Nanna Maria Uldall Torp, Jesper Karmisholt, Stig Andersen, Stine Linding Andersen
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引用次数: 0

Abstract

Objective

Thyroid function tests are common biochemical analyses, and agreement between the routinely used immunoassays is important for diagnosis and monitoring of thyroid disease. Efforts are continuously made to align the biochemical assays, and we aimed to evaluate the agreement between immunoassays used in a clinical laboratory setting among non-pregnant and pregnant adults.

Design

Cross-sectional study.

Participants

Serum samples were obtained from 192 blood donors (non-pregnant adults) and from 86 pregnant women in the North Denmark Region with no known thyroid disease.

Measurements

Each sample was used for measurement of thyroid-stimulating hormone (TSH) with the routinely used automatic immunoassays in the regional Departments of Clinical Biochemistry (Alinity, Abbott Laboratories, Cobas, Roche Diagnostics, and Atellica, Siemens Healthineers) and reported as the median with 95% confidence interval (95% CI).

Results

In nonpregnant adults, the level of TSH was higher with Cobas and Atellica than with Alinity as reflected by median (Alinity: 1.39 mIU/L (95% CI: 1.30–1.51 mIU/L); Cobas: 1.57 mIU/L (95% CI: 1.48–1.75 mIU/L); Atellica: 1.74 mIU/L (95% CI: 1.61–1.83 mIU/L)). Similarly, a trend was seen towards higher median TSH with Cobas than with Alinity among pregnant women (Alinity: 1.90 mIU/L (95% CI: 1.37–2.82 mIU/L); Cobas: 2.33 mIU/L (95% CI: 1.69–3.62 mIU/L)).

Conclusion

Results of thyroid function tests obtained with different immunoassays were not interchangeable when evaluated among pregnant and non-pregnant adults. The distinct differences are relevant for clinical decision making and emphasize the necessity of clinical laboratory information when different assays are used for diagnosis and monitoring of patients with thyroid disease.

Abstract Image

非孕妇和孕妇甲状腺功能检测中常规使用的免疫测定之间的一致性
目的甲状腺功能检测是一种常见的生化分析,常规使用的免疫测定之间的一致性对于诊断和监测甲状腺疾病非常重要。我们的目的是评估临床实验室中使用的免疫测定方法在非孕妇和孕妇中的一致性。测量方法每个样本均用于测量促甲状腺激素(TSH),测量方法为地区临床生化部门常规使用的自动免疫测定法(雅培实验室的 Alinity、罗氏诊断公司的 Cobas 和西门子健康公司的 Atellica),并以中位数和 95% 置信区间 (95% CI) 的形式进行报告。结果在非怀孕成人中,Cobas 和 Atellica 的 TSH 水平高于 Alinity,中位数分别为:Alinity:1.39 mIU/L (95% CI: 1.30-1.51 mIU/L);Cobas:1.57 mIU/L (95% CI: 1.48-1.75 mIU/L);Atellica:1.74 mIU/L (95% CI: 1.75 mIU/L):1.74 mIU/L (95% CI: 1.61-1.83 mIU/L))。同样,在孕妇中,Cobas 的 TSH 中位数有高于 Alinity 的趋势(Alinity:1.90 mIU/L (95% CI: 1.37-2.82 mIU/L);Cobas:2.33 mIU/L (95% CI: 1.69-3.62 mIU/L))。这些明显的差异与临床决策相关,并强调了在使用不同检测方法诊断和监测甲状腺疾病患者时临床实验室信息的必要性。
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来源期刊
Clinical Endocrinology
Clinical Endocrinology 医学-内分泌学与代谢
CiteScore
6.40
自引率
3.10%
发文量
192
审稿时长
1 months
期刊介绍: Clinical Endocrinology publishes papers and reviews which focus on the clinical aspects of endocrinology, including the clinical application of molecular endocrinology. It does not publish papers relating directly to diabetes care and clinical management. It features reviews, original papers, commentaries, correspondence and Clinical Questions. Clinical Endocrinology is essential reading not only for those engaged in endocrinological research but also for those involved primarily in clinical practice.
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