Diabetes, Thyroid, and Endocrine Center, Shin-Koga Hospital, Kurume 830-8577, Japan.
Department of Internal Medicine, Jinnouchi Hospital Diabetes Care Center, Kumamoto 862-0976, Japan.
Int J Mol Sci. 2024 Jul 11;25(14):7618. doi: 10.3390/ijms25147618.
The 3 Screen ICA ELISA is a novel assay capable of simultaneously measuring autoantibodies to glutamic acid decarboxylase (GADA), insulinoma-associated antigen-2 (IA-2A), and zinc transporter 8 (ZnT8A), making it a valuable tool for screening type 1 diabetes. Despite its advantages, it cannot specify which individual autoantibodies are positive or negative. This study aimed to estimate individual positive autoantibodies based on the 3 Screen ICA titer. Six hundred seventeen patients with type 1 diabetes, simultaneously measured for 3 Screen ICA and three individual autoantibodies, were divided into five groups based on their 3 Screen ICA titer. The sensitivities and contribution rates of the individual autoantibodies were then examined. The study had a cross-sectional design. Sixty-nine percent (424 of 617) of patients with type 1 diabetes had 3 Screen ICA titers exceeding the 99th percentile cut-off level (20 index). The prevalence of GADA ranged from 80% to 100% in patients with a 3 Screen ICA over 30 index and 97% of patients with a 3 Screen ICA ≥300 index. Furthermore, the prevalence of all individual autoantibodies being positive was 0% for ≤80 index and as high as 92% for ≥300 index. Significant associations were observed in specific titer groups: the 20-29.9 index group when all the individual autoantibodies were negative, the 30-79.9 index group when positive for GADA alone or IA-2A alone, the 30-299.9 index group when positive for ZnT8A alone, the 80-299.9 index group when positive for both IA-2A and ZnT8A, the 300-499.9 index group when positive for both GADA and ZnT8A, and the ≥300 index group when positive for all individual autoantibodies. These results suggest that the 3 Screen ICA titer may be helpful in estimating individual positive autoantibodies.
3 窗型 ICA ELISA 是一种新型的检测方法，能够同时测量谷氨酸脱羧酶（GADA）、胰岛素瘤相关抗原 2（IA-2A）和锌转运蛋白 8（ZnT8A）自身抗体，是筛查 1 型糖尿病的有价值的工具。尽管它有很多优点，但它不能确定哪些个体自身抗体是阳性或阴性。本研究旨在根据 3 窗型 ICA 滴度来估计个体阳性自身抗体。同时测量了 617 例 1 型糖尿病患者的 3 窗型 ICA 和三种个体自身抗体，根据 3 窗型 ICA 滴度将他们分为五组。然后检查了个体自身抗体的敏感性和贡献率。本研究采用了横断面设计。69%（617 例中的 424 例）的 1 型糖尿病患者的 3 窗型 ICA 滴度超过第 99 百分位截断值（20 索引）。3 窗型 ICA 超过 30 索引的患者中 GADA 的患病率为 80%至 100%，而 3 窗型 ICA≥300 索引的患者中 GADA 的患病率为 97%。此外，所有个体自身抗体均为阳性的患病率在≤80 索引时为 0%，而在≥300 索引时高达 92%。在特定滴度组中观察到显著的相关性：当所有个体自身抗体均为阴性时，20-29.9 索引组；当仅 GADA 或 IA-2A 阳性时，30-79.9 索引组；当仅 ZnT8A 阳性时，30-299.9 索引组；当 IA-2A 和 ZnT8A 均阳性时，80-299.9 索引组；当 GADA 和 ZnT8A 均阳性时，300-499.9 索引组；当所有个体自身抗体均为阳性时，≥300 索引组。这些结果表明，3 窗型 ICA 滴度可能有助于估计个体阳性自身抗体。
