性能评估和Abbott Alinity甲状腺刺激激素受体抗体 (TRAb) 试验的参考间隔建立,用于诊断格雷夫斯病
Hao Xue1, Bowen Li1, Xiaowei Wang2
1Department of Laboratory Medicine, Peking University Shenzhen Hospital, Shenzhen, China.
PloS one
|February 4, 2026
概括
阿博特Alinity TRAb测定显示了强大的分析和临床性能,用于检测甲状腺疾病. 这项研究为健康的中国人口确定了其参考区间.
科学领域:
- 临床化学 临床化学
- 免疫测试开发 免疫测试的发展
- 甲状腺诊断 甲状腺诊断
背景情况:
- 甲状腺刺激激素受体抗体 (TRAb) 是诊断格雷夫斯病的关键生物标志物.
- 准确可靠的TRAb测定对于有效的患者管理至关重要.
- 建立特定人群的参考间隔对于准确解释测试结果至关重要.
研究的目的:
- 评估Abbott Alinity TRAb化学发光微粒子免疫试验 (CMIA) 的分析和临床性能.
- 在健康的中国人群中使用阿博特试验确定TRAb的参考间隔.
主要方法:
- 分析性能 (精度,灵敏度,线性) 根据临床和实验室标准研究所的指导方针进行验证.
- 方法比较和临床性能使用300名患者样本 (格雷夫斯病和其他甲状腺疾病) 进行评估.
- 使用接收器操作特征 (ROC) 分析来确定诊断准确性,并从366名健康个体中建立了参考间隔.
主要成果:
- 艾伯特Alinity TRAb测定显示出极好的精度 (CV%1.04-5.92%) 和线性 (1.14-47.72 IU/L).
- 与罗氏TRAb试验相比,观察到高相关性 (斯皮尔曼r=0.972) 和一致性 (97.7%).
- 该试验显示了高诊断准确度的格雷夫斯病 (AUC=0.999,灵敏度=98.4%,特异性=99.4%) 的最佳切线为2.89 IU/L. 中国人口的上限参考值为1.56 IU/L (95 个百分点) 和1.95 IU/L (97.5 个百分点).
结论:
- 阿博特Alinity TRAb CMIA表现出强大的分析和临床性能,适合临床应用.
- 这项研究成功地在健康的中国人群中确定了Abbott TRAb试验的参考间隔.
- 这些发现支持使用Abbott Alinity TRAb测试来诊断和监测中国人的甲状腺相关疾病.
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