Division of Diabetes, Metabolism and Endocrinology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
Division of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Anti-glycation Research Section, Showa University School of Medicine, Tokyo, Japan.
J Diabetes Investig. 2023 Jul;14(7):856-863. doi: 10.1111/jdi.14016. Epub 2023 Apr 20.
AIMS/INTRODUCTION: This study aimed to compare the positivity rates of glutamic acid decarboxylase autoantibodies (GADA) and ElisaRSR™ 3 Screen ICA™ (3 Screen ICA), a newly developed assay for the simultaneous measurement of GADA, insulinoma-associated antigen-2 autoantibodies (IA-2A), and zinc transporter 8 autoantibodies (ZnT8A), in recently obtained sera from patients who had been previously diagnosed with slowly progressive type 1 diabetes (SPIDDM). MATERIALS AND METHODS: We enrolled 53 patients with SPIDDM who were positive for GADA at the diagnosis and 98 non-diabetic individuals, and investigated the diagnostic accuracy of the 3 Screen ICA (cutoff index ≥30 units) compared with that of GADA. In addition, we compared the clinical characteristics of patients with SPIDDM who were negative or positive on 3 Screen ICA. RESULTS: The positivity rates of 3 Screen ICA, GADA, IA-2A, and ZnT8A were 88.7, 86.8, 24.5, and 13.2%, respectively. The respective sensitivity, specificity, and positive and negative predictive values for SPIDDM were 88.7, 100, 100, and 94.2% by 3 Screen ICA and 86.8, 100, 100.0, and 93.3% by GADA. There were no significant differences in age at onset, duration of diabetes, body mass index, glycated hemoglobin and C-peptide levels, and the prevalence of autoimmune thyroiditis between patients with SPIDDM who were positive or negative on 3 Screen ICA. However, the prevalence of insulin users was significantly higher in those who were positive than in those who were negative on 3 Screen ICA. CONCLUSIONS: Similar to GADA, 3 Screen ICA may be a useful diagnostic tool for detecting patients with SPIDDM.
目的/引言:本研究旨在比较谷氨酸脱羧酶自身抗体(GADA)和 ElisaRSR™3 Screen ICA(3 Screen ICA)的阳性率,后者是一种新开发的同时测量谷氨酸脱羧酶、胰岛细胞抗原-2 自身抗体(IA-2A)和锌转运体 8 自身抗体(ZnT8A)的检测方法,用于检测先前诊断为缓慢进展 1 型糖尿病(SPIDDM)的患者近期获得的血清。
材料和方法:我们纳入了 53 名在诊断时 GADA 阳性的 SPIDDM 患者和 98 名非糖尿病个体,并研究了 3 Screen ICA(cutoff index≥30 units)的诊断准确性与 GADA 的比较。此外,我们比较了 3 Screen ICA 阴性或阳性的 SPIDDM 患者的临床特征。
结果:3 Screen ICA、GADA、IA-2A 和 ZnT8A 的阳性率分别为 88.7%、86.8%、24.5%和 13.2%。3 Screen ICA 对 SPIDDM 的灵敏度、特异性、阳性预测值和阴性预测值分别为 88.7%、100%、100%和 94.2%,GADA 分别为 86.8%、100%、100.0%和 93.3%。3 Screen ICA 阳性和阴性的 SPIDDM 患者在发病年龄、糖尿病病程、体重指数、糖化血红蛋白和 C 肽水平以及自身免疫性甲状腺炎的患病率方面无显著差异。然而,3 Screen ICA 阳性患者中胰岛素使用者的比例明显高于阴性患者。
结论:与 GADA 相似,3 Screen ICA 可能是检测 SPIDDM 患者的有用诊断工具。
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