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Zinc transporter 8 autoantibody testing requires age-related cut-offs
BMJ Open Diabetes Research & Care ( IF 3.7 ) Pub Date : 2021-08-01 , DOI: 10.1136/bmjdrc-2021-002296
Sian Louise Grace 1 , Angela Cooper 2 , Angus G Jones 1, 3 , Timothy James McDonald 2, 4
Affiliation  

Introduction Zinc transporter 8 autoantibodies (ZnT8A) are biomarkers of beta cell autoimmunity in type 1 diabetes that have become more widely available to clinicians in recent years. Robust control population-defined thresholds are essential to ensure high clinical specificity in islet autoantibody testing. We aimed to determine the optimal cut-offs for ZnT8A testing. Research design and methods 97.5th and 99th centile cut-offs were determined using residual clinical sera from 1559 controls aged between 0 and 83 years with no history of diabetes and a hemoglobin A1c level of less than 6.0% (<42 mmol/mol). ZnT8A were measured by ELISA (RSR, Cardiff, UK) on a Dynex DS2 ELISA robot (Dynex, Preston, UK). We assessed the impact of age-related cut-offs in comparison with the manufacturer’s recommended threshold in a mixed cohort of young-onset (

中文翻译:

锌转运蛋白 8 自身抗体测试需要与年龄相关的截止值

引言 锌转运蛋白 8 自身抗体 (ZnT8A) 是 1 型糖尿病中 β 细胞自身免疫的生物标志物,近年来临床医生越来越广泛地使用它。稳健的对照人群定义的阈值对于确保胰岛自身抗体检测的高临床特异性至关重要。我们旨在确定 ZnT8A 测试的最佳临界值。研究设计和方法 使用 1559 名年龄在 0 至 83 岁之间、无糖尿病史且血红蛋白 A1c 水平低于 6.0% (<42 mmol/mol) 的对照的残留临床血清确定第 97.5 和第 99 个百分位数截断值。在 Dynex DS2 ELISA 机器人(Dynex,Preston,UK)上通过 ELISA(RSR,Cardiff,UK)测量 ZnT8A。我们评估了年龄相关临界值与制造商推荐阈值在年轻发病混合队列中的影响。
更新日期:2021-08-04
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