PDF(Pubmed)
Abstract：
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.
摘要：
3筛选ICAELISA是一种能够同时测量谷氨酸脱羧酶（GADA）自身抗体的新型测定法，胰岛素瘤相关抗原-2（IA-2A），和锌转运蛋白8（ZnT8A），使其成为筛查1型糖尿病的有价值的工具。尽管有其优势,它不能指定哪些个体自身抗体是阳性或阴性。本研究旨在基于3筛选ICA滴度估计个体阳性自身抗体。六百十七个1型糖尿病患者，同时测量3个筛选ICA和3个单独的自身抗体，根据他们的3筛选ICA滴度分为五组。然后检查个体自身抗体的敏感性和贡献率。该研究具有横截面设计。69%（617人中的424人）的1型糖尿病患者的3ScreenICA滴度超过第99百分位数截止水平（20指数）。GADA的患病率在30指数以上的3屏幕ICA患者中为80％至100％，在3屏幕ICA≥300指数的患者中为97％。此外，所有个体自身抗体阳性的患病率≤80指数为0%,≥300指数为92%.在特定滴度组中观察到显着关联：当所有个体自身抗体均为阴性时，20-29.9指数组，30-79.9指数组在GADA单独或IA-2A单独阳性时，30-299.9指数组，单独的ZnT8A阳性时，当IA-2A和ZnT8A均为阳性时，80-299.9指数组，当GADA和ZnT8A均为阳性时，300-499.9指数组，和≥300指数组，当所有个体自身抗体呈阳性时。这些结果表明，3筛选ICA滴度可能有助于估计个体阳性自身抗体。
