甲状腺激素检测系统之间的一致性评估：基于外部质量评估数据的比较研究。
Evaluation of harmonization among thyroid hormone testing systems: A comparative study based on external quality assessment data.
作者信息
Kong Lirui, Liu Yanqun, Zhou Chaoqiong, He Dahai, Wu Xiaoheng, Huang Ying, Xie Yehong, Xu Xiaohua, Wang Lin, Wu Feng, Zhang Yan
机构信息
Department of Clinical Laboratory, Chengdu Pidu District Hospital of Traditional Chinese Medicine, China.
Department of Clinical Laboratory, No.3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), China.
出版信息
Pract Lab Med. 2025 Jul 9;46:e00491. doi: 10.1016/j.plabm.2025.e00491. eCollection 2025 Sep.
OBJECTIVE
To evaluate thyroid hormone test harmonization using external quality assessment (EQA) data, guiding laboratory quality enhancement and big data interoperability.
METHODS
EQA data for T3, T4, FT3, FT4, and TSH from January 2022 to December 2024 were collected. We calculated the total allowable error for both our laboratory (TEa-Lab) and peer groups (TEa-peer) using bias and coefficient of variation data. We derived harmonization indices (HI) by comparing TEa values against three biological variation thresholds (minimum, desirable, and optimal). An HI value ≤ 1 indicated satisfactory harmonization.
RESULTS
The TSH test in our laboratory showed desirable harmonization; however, the HI for T3, T4, FT3, and FT4 ranged from 1.1 to 1.9, failing to reach the minimum harmonization level. Among the peer group tests, the level of coordination of each analysis system varies, and the harmonization levels ranging from below the minimum to the optimal harmonization level, even failing to reach the minimum level. The harmonization level of thyroid hormones between our laboratory and peer groups showed strong consistency.
CONCLUSION
The HI values quantitatively calculated from EQA data accurately reflect the harmonization level between thyroid hormone testing systems in the laboratory and peer groups. This helps identify laboratory issues and implement corrective actions, providing a reference for laboratory big data interoperability and clinical decision-making.
目的
利用外部质量评估（EQA）数据评估甲状腺激素检测的一致性，指导实验室质量提升和大数据互操作性。
方法
收集2022年1月至2024年12月期间T3、T4、FT3、FT4和TSH的EQA数据。我们使用偏差和变异系数数据计算了我们实验室（TEa-Lab）和同行组（TEa-peer）的总允许误差。通过将TEa值与三个生物学变异阈值（最小、理想和最佳）进行比较，得出一致性指数（HI）。HI值≤1表示一致性良好。
结果
我们实验室的TSH检测显示出理想的一致性；然而，T3、T4、FT3和FT4的HI值在1.1至1.9之间，未达到最低一致性水平。在同行组检测中，各分析系统的协调程度各不相同，一致性水平从低于最低水平到最佳水平不等，甚至未达到最低水平。我们实验室与同行组之间甲状腺激素的一致性水平显示出很强的一致性。
结论
从EQA数据定量计算得出的HI值准确反映了实验室与同行组甲状腺激素检测系统之间的一致性水平。这有助于识别实验室问题并采取纠正措施，为实验室大数据互操作性和临床决策提供参考。
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