Department od Laboratory Diagnostics, Diagnostic Laboratory for Teaching and Research, Faculty of Pharmacy, Wroclaw Medical University, Wroclaw, Poland.
Department of Laboratory Diagnostics, University Clinical Hospital, Wroclaw Medical University, Wroclaw, Poland.
PLoS One. 2022 Jan 7;17(1):e0261715. doi: 10.1371/journal.pone.0261715. eCollection 2022.
The results of examinations of laboratory parameters are the basis of appropriate medical decisions. The availability of reliable and accurate reference intervals (RIs) for each laboratory parameter is an integral part of its appropriate interpretation. Each medical laboratory should confirm their RIs. Up-to-date reference intervals for thyroid function hormones are still a matter of ongoing controversy. The aim of the study was the application of the indirect Hoffman method to determine RIs for TSH and fT4 based on the large data pools stored in laboratory information systems and the comparison of these RIs to generally used RIs.
The TSH and fT4 routine examination results of hospitalized and outpatient populations were collected over five years (2015-2019), and reference limits were established by the improved Hoffmann method after the exclusion of outliers. Comparative verification of established RIs was conducted with the RIs values provided by test manufacturers and literature data.
Various RIs were observed in different age groups in the examined populations. For TSH, RIs varied between different age groups, with a narrower range of RIs in the studied adult population and a shift of both reference boundaries toward higher values in comparison to manufacturers' data among children. RIs estimated for fT4 were very similar to the manufacturer and literature data.
Thyroid hormone levels change during a person's lifetime and vary between sexes, but this difference does not always influence the clinical interpretation of laboratory results in the context of RIs. The use of indirect methods is justified due to the ease and low cost of their application.
实验室参数检查结果是做出适当医疗决策的基础。每个实验室参数都有可靠且准确的参考区间（RI），这是其正确解释的一个组成部分。每个医学实验室都应确认其 RI。目前，甲状腺功能激素的参考区间仍然存在争议。本研究的目的是应用间接 Hoffman 方法，基于存储在实验室信息系统中的大量数据池来确定 TSH 和 fT4 的 RI，并将这些 RI 与通常使用的 RI 进行比较。
在五年（2015-2019 年）内收集了住院和门诊人群的 TSH 和 fT4 常规检查结果，并通过排除异常值后采用改良 Hoffmann 方法确定参考限值。通过与检测制造商提供的 RI 值和文献数据对建立的 RI 进行比较验证。
在被检查人群中，不同年龄组观察到不同的 RI。对于 TSH，RI 在不同年龄组之间存在差异，研究中的成年人群 RI 范围较窄，与制造商数据相比，儿童的参考界限向更高值移动。fT4 的 RI 与制造商和文献数据非常相似。
甲状腺激素水平在人的一生中会发生变化，并且在性别之间存在差异，但这种差异并不总是会影响 RI 背景下对实验室结果的临床解释。由于间接方法的简便性和低成本，因此使用间接方法是合理的。
