Comparison of Enzyme-Linked Immunosorbent Assay and Lateral Flow Assay to Measure Thyroid-Stimulating Hormone and Free T4 in Human Serum

IF 2.6 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Journal of Clinical Laboratory Analysis Pub Date : 2025-04-17 DOI:10.1002/jcla.70032

Rolando Advíncula-Espino, Jair Li, Jaime Rosales-Rimache

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引用次数: 0

Abstract

Background

Thyroid disorders affect millions of people around the world, mainly women. Measurement of hormones is critical in their identification, treatment, and monitoring; Therefore, the methods must be as reliable and valid as possible.

Methods

We designed a cross-sectional study to compare thyroid-stimulating hormone (TSH) and free tetraiodothyronine (fT4) concentrations using ELISA (Enzyme-Linked Immunosorbent Assay) and LFA (Lateral Flow Assay) in human serum samples. We obtained 96 serum samples that were evaluated with a commercial kit for ELISA (Accubind Monobite, Lake Forest, California, US) and LFA (Micropofit Fluorecare, Guangdong, Shenzhen, China). We used the Wilcoxon nonparametric test, Bland–Altman, and Passing-Bablok regression to compare TSH and fT4 concentrations obtained by ELISA and LFA.

Results

The median TSH concentrations obtained by ELISA and LFA were 1.92 and 2.11 μIU/mL, and for fT4 were 1.14 and 1.10 ng/dL. On the other hand, the Spearman's rho between ELISA and LFA for TSH was 0.845. The TSH concentrations between ELISA and LFA had significant differences (p < 0.05). About fT4, the Spearman's rho between methods was 0.348. The bias for TSH was −0.315, and for fT4 was −0.013. The Deming regression for TSH (p = 0.309) and fT4 (=0.938) shows that the levels obtained by both methods do not present significant differences, and the Passing-Bablok regression identifies significant bias between both methods, especially for fT4, in the range of concentrations studied.

Conclusion

TSH measurement by LFA may be a viable alternative to evaluate thyroid diseases, but fT4 by LFA is not precise and presents a high bias.

Abstract Image

查看原文本刊更多论文

酶联免疫吸附法和侧流法测定人血清促甲状腺激素和游离T4的比较。

背景：甲状腺疾病影响着全世界数百万人，主要是女性。激素的测量对其识别、治疗和监测至关重要；因此，这些方法必须尽可能的可靠和有效。方法：我们设计了一项横断面研究，采用ELISA（酶联免疫吸附法）和LFA（横向流动法）比较人血清样本中促甲状腺激素（TSH）和游离四碘甲状腺原氨酸（fT4）的浓度。我们获得96份血清样本，用ELISA商用试剂盒（Accubind Monobite, Lake Forest, California，美国）和LFA （Micropofit Fluorecare，广东，深圳，中国）进行评估。我们使用Wilcoxon非参数检验、Bland-Altman和Passing-Bablok回归来比较ELISA和LFA获得的TSH和fT4浓度。结果：ELISA法和LFA法测得的TSH中位浓度分别为1.92和2.11 μIU/mL， fT4中位浓度分别为1.14和1.10 ng/dL。另一方面，ELISA与LFA测定TSH的Spearman’s rho为0.845。结论：LFA测定TSH可能是评估甲状腺疾病的一种可行的替代方法，但LFA测定fT4不准确且存在高偏倚。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Laboratory Analysis 医学-医学实验技术

CiteScore

5.60

自引率

7.40%

发文量

584

审稿时长

6-12 weeks

期刊介绍： Journal of Clinical Laboratory Analysis publishes original articles on newly developing modes of technology and laboratory assays, with emphasis on their application in current and future clinical laboratory testing. This includes reports from the following fields: immunochemistry and toxicology, hematology and hematopathology, immunopathology, molecular diagnostics, microbiology, genetic testing, immunohematology, and clinical chemistry.