Effective assay technologies fit for large-scale population screening of type 1 diabetes.
Effective assay technologies fit for large-scale population screening of type 1 diabetes.
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DOI：
10.3389/fcdhc.2022.1034698
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发表时间：
2022
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虽然世界范围内正在努力预防1型糖尿病(T1D)以消除或减缓糖尿病的进展，但迫切需要在普通人群中进行胰岛自身抗体(IAB)的大规模筛查。IAbs作为最可靠的生物标志物，在T1D的预测和临床诊断中起着至关重要的作用。通过实验室熟练程度计划和协调努力，放射性结合分析(RBA)已被确立为所有四种IAB的当前“金”标准分析。然而，考虑到在非糖尿病人群中进行大规模筛查的需要，澳洲央行始终面临两个基本挑战，即成本效益和疾病特异性。虽然所有四种IAB对于疾病预测都很重要，但拥有单独IAB测试格式的澳大利亚央行平台既费力又低效，而且成本高昂。此外，筛查中的大多数IAb阳性，特别是来自单个IAb的个体，被发现是低风险和低亲和力的。多项临床研究证明，低亲和力的IAB风险较低，与疾病的相关性较小或没有相关性。目前，德国和美国已成功地将两种非放射性多重检测方法--结合三种IAbs的三抗体夹心ELISA法和结合所有四种IAbs的多重ECL法成功地用作一般人群筛查的主要方法。最近，TrialNet预防路径研究组织了一次IAB研讨会，旨在分析IABS的5年T1D预测值。一种高效、低成本、样本量少的T1D特异性检测方法对于普通人群的筛查无疑是必要的。
While worldwide prevention efforts for type 1 diabetes (T1D) are underway to abrogate or slow progression to diabetes, mass screening of islet autoantibodies (IAbs) in the general population is urgently needed. IAbs, the most reliable biomarkers, play an essential role in prediction and clinical diagnosis of T1D. Through laboratory proficiency programs and harmonization efforts, a radio-binding assay (RBA) has been well established as the current ‘gold’ standard assay for all four IAbs. However, in view of the need for large-scale screening in the non-diabetic population, RBA consistently faces two fundamental challenges, cost-efficiency and disease specificity. While all four IAbs are important for disease prediction, the RBA platform, with a separate IAb test format is laborious, inefficient and expensive. Furthermore, the majority of IAb positivity in screening, especially from individuals with single IAb were found to be low risk with low affinity. It is well documented from multiple clinical studies that IAbs with low affinity are low risk with less or no disease relevance. At present, two non-radioactive multiplex assays, a 3-assay ELISA combining three IAbs and a multiplex ECL assay combining all four IAbs, have been successfully used as the primary methods for general population screenings in Germany and the US, respectively. Recently, the TrialNet Pathway to Prevention study has been organizing an IAb workshop which aims to analyze the 5-year T1D predictive values of IAbs. A T1D-specific assay with high efficiency, low cost and requiring low volume of sample will definitely be necessary to benefit general population screening.