Improving diagnostic accuracy of 3 Screen ICA ELISA kit in the identification of Japanese type 1 diabetes

IF 3.2 3区医学

Journal of Diabetes Investigation Pub Date : 2023-06-08 DOI:10.1111/jdi.14038

Eiji Kawasaki, Hideaki Jinnouchi, Yasutaka Maeda, Akira Okada, Yoshihisa Ito, Koichi Kawai

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引用次数: 1

Abstract

Aim/Introduction

This study aimed to investigate the clinical utility of 3 Screen ICA ELISA in identifying immune-mediated type 1 diabetes in Japanese subjects.

Methods

We compared the positivity of 3 Screen ICA were compared with autoantibodies against GAD, IA-2, and ZnT8 in 638 patients with type 1 diabetes and 159 healthy control subjects.

Results

With a cut-off value of 20.0 index, 67.4% of acute-onset type 1 diabetic patients, 71.8% of slowly progressive type 1 diabetic (SPIDDM) patients, and none of the fulminant type 1 diabetic patients showed 3 Screen ICA levels above this threshold. The prevalence of 3 Screen ICA was 14.2% higher in acute-onset type 1 diabetes and 1.6% higher in SPIDDM than in GADA. 3 Screen ICA-positive cases were found in 4.8% of cases of individual autoantibody-negative acute-onset type 1 diabetes and 3.8% of SPIDDM, indicating improved diagnostic sensitivity with the 3 Screen ICA. Among individual autoantibody-negative patients, the sum of each autoantibody level was significantly lower in fulminant type 1 diabetes than in acute onset type 1 diabetes and in SPIDDM (P < 0.0001). Additionally, 84.2% of patients negative for individual autoantibodies but positive for 3 Screen ICA had a sum of individual autoantibody levels of ≥4.7 U/mL. Furthermore, 3 Screen ICA levels were significantly higher in patients with type 1 diabetes with other autoimmune diseases than in those without (P < 0.0001).

Conclusion

Our findings suggest that the 3 Screen ICA ELISA may be a valuable screening tool for Japanese patients with type 1 diabetes, potentially increasing the diagnostic sensitivity and accuracy beyond the existing GADA, IA-2A, and ZnT8A tests.

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提高3 Screen ICA ELISA试剂盒对日本1型糖尿病的诊断准确性

目的/简介本研究旨在探讨3 Screen ICA ELISA在日本受试者中识别免疫介导型1型糖尿病的临床应用。方法对638例1型糖尿病患者和159例健康对照者进行GAD、IA-2和ZnT8自身抗体的检测。结果以20.0指数为临界值，67.4%的急性发作型1型糖尿病患者、71.8%的缓慢进展型1型糖尿病(SPIDDM)患者、无暴发性1型糖尿病患者的3 Screen ICA水平高于该阈值。3 Screen ICA在急性发作型1型糖尿病中的患病率比GADA高14.2%，在SPIDDM中比GADA高1.6%。在个体自身抗体阴性的急性发作型1型糖尿病病例中，有4.8%和3.8%的SPIDDM病例中发现了3 Screen ICA阳性病例，这表明使用3 Screen ICA可提高诊断敏感性。在个体自身抗体阴性的患者中，暴发性1型糖尿病患者各自身抗体水平的总和明显低于急性发作型1型糖尿病患者和SPIDDM患者(P < 0.0001)。此外，84.2%个体自身抗体阴性但3 Screen ICA阳性的患者个体自身抗体水平总和≥4.7 U/mL。此外，合并其他自身免疫性疾病的1型糖尿病患者3 Screen ICA水平显著高于未合并其他自身免疫性疾病的1型糖尿病患者(P < 0.0001)。结论3 Screen ICA ELISA可能是日本1型糖尿病患者的一种有价值的筛查工具，可能比现有的GADA、IA-2A和ZnT8A检测提高诊断的敏感性和准确性。

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来源期刊

Journal of Diabetes Investigation Medicine-Internal Medicine

自引率

9.40%

发文量

218

期刊介绍： Journal of Diabetes Investigation is your core diabetes journal from Asia; the official journal of the Asian Association for the Study of Diabetes (AASD). The journal publishes original research, country reports, commentaries, reviews, mini-reviews, case reports, letters, as well as editorials and news. Embracing clinical and experimental research in diabetes and related areas, the Journal of Diabetes Investigation includes aspects of prevention, treatment, as well as molecular aspects and pathophysiology. Translational research focused on the exchange of ideas between clinicians and researchers is also welcome. Journal of Diabetes Investigation is indexed by Science Citation Index Expanded (SCIE).