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确定干血斑采样用于筛查胰岛特异性自身抗体的性能和可接受性。

Establishing the performance and acceptability of dried blood spot sampling to screen for islet-specific autoantibodies.

作者信息

Faustini Siân E, Quinn Lauren M, Hoque Madeeha, Young Siobhan, Bentley Christopher, Kwok Hin-Fai, Plant Timothy, Litchfield Ian, Boardman Felicity, Greenfield Sheila M, Narendran Parth, Richter Alex G

机构信息

Clinical Immunology Services, University of Birmingham, Birmingham, UK.

College of Medicine and Health, University of Birmingham, Birmingham, UK.

出版信息

Diabet Med. 2025 Aug;42(8):e70071. doi: 10.1111/dme.70071. Epub 2025 May 19.

Abstract

BACKGROUND

Islet-specific autoantibodies predate and predict the onset of type 1 diabetes and can be used to screen for presymptomatic disease. Dried blood spots (DBS) offer a convenient and reliable method for community-based capillary sampling requiring low blood volumes compared to venous collection. We aimed to verify the use of DBS for detecting autoantibodies by the ElisaRSR (3-screen) multiplex assay compared to venous sampling and also explore the acceptability of DBS sampling.

METHODS

Paired serum and DBS samples were collected from healthy controls (HC) and individuals with type 1 diabetes on insulin. Validation and verification of a 3-screen Islet cell autoantibody (IA-2A, GADA and ZnT8A) ELISA assay was undertaken for both matrices and compared. Perceived acceptability of DBS testing was explored via semi-structured interviews with parents and professional stakeholders.

RESULTS

Temporally paired serum and DBS samples were collected for 101 individuals with type 1 diabetes (aged 7-73 years) and 22 HC (aged 18-60 years). Performance characteristics were similar for serum and DBS; sensitivity for serum was 86% compared to 89% for DBS and a specificity of 97% for serum compared to 100% for DBS. Parents (n = 38) and stakeholders (n = 25) thought DBS testing offered a minimally invasive, convenient screening test. Parents emphasised choice of screening location, including home and community settings.

CONCLUSIONS

DBS sampling can be used as an alternative to serum for use with the 3-screen assay for general population type 1 diabetes autoantibody screening. DBS sampling appears acceptable to parents and stakeholders.

摘要

背景

胰岛特异性自身抗体先于1型糖尿病发病并可预测其发病,可用于筛查症状前疾病。与静脉采血相比,干血斑(DBS)为基于社区的毛细血管采样提供了一种方便可靠的方法,所需血量较少。我们旨在验证与静脉采样相比,通过ElisaRSR(3项筛查)多重检测法使用DBS检测自身抗体的情况,并探讨DBS采样的可接受性。

方法

从健康对照(HC)和接受胰岛素治疗的1型糖尿病患者中收集配对的血清和DBS样本。对两种基质进行了3项筛查胰岛细胞自身抗体(IA-2A、GADA和ZnT8A)ELISA检测的验证和比较。通过与家长和专业利益相关者进行半结构化访谈,探讨了DBS检测的可接受性。

结果

收集了101例1型糖尿病患者(年龄7 - 73岁)和22例HC(年龄18 - 60岁)的时间配对血清和DBS样本。血清和DBS的性能特征相似;血清的敏感性为86%,而DBS为89%,血清的特异性为97%,而DBS为100%。家长(n = 38)和利益相关者(n = 25)认为DBS检测提供了一种微创、方便的筛查测试。家长强调了筛查地点的选择,包括家庭和社区环境。

结论

DBS采样可作为血清的替代方法用于一般人群1型糖尿病自身抗体筛查的3项筛查检测。DBS采样似乎为家长和利益相关者所接受。

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