Schranz D B, Bekris L, Landin-Olsson M, Törn C, Niläng A, Toll A, Grönlund H, Toivola B, Lernmark A
Department of Medicine, University of Washington, Seattle 98195-7710, USA.
J Immunol Methods. 1998 Apr 1;213(1):87-97. doi: 10.1016/s0022-1759(98)00025-8.
GAD65Ab and ICA512Ab are strongly associated with insulin-dependent (Type 1) diabetes mellitus. A novel, simple radio-antigen binding assay with microSepharose conjugated with monoclonal antibodies specific for human immunoglobulin light chains was developed to provide diagnostic sensitivity and specificity of GAD65Ab and ICA512Ab for Type 1 diabetes. The Receiver Operating Characteristic (ROC) curve was used to determine the upper level of Normal in 583 new onset Type 1 diabetic patients and in 829 matched controls. The sensitivity of GAD65Ab and ICA512Ab was 66% (384/583) and 41% (211/520), respectively, and the diagnostic specificity was 96% for both autoantibodies. Levels, but not frequency, of GAD65Ab were higher among female Type 1 diabetes patients, whereas ICA512Ab levels did not differ between males and females. Positivity for GAD65Ab. ICA512Ab or both showed a sensitivity of 74% and a specificity of 92% for Type 1 diabetes. This simple, one-step centrifugation, high-capacity radio-antigen binding assay has a high precision and reproducibility to accurately detect both GAD65Ab and ICA512Ab. This assay should also prove useful in other autoantibody assays against conformation-sensitive autoantigens.
谷氨酸脱羧酶65自身抗体（GAD65Ab）和胰岛细胞抗体512（ICA512Ab）与胰岛素依赖型（1型）糖尿病密切相关。我们开发了一种新型的简单放射抗原结合试验，该试验采用与针对人免疫球蛋白轻链的单克隆抗体偶联的微琼脂糖，以提供GAD65Ab和ICA512Ab对1型糖尿病的诊断敏感性和特异性。采用受试者工作特征（ROC）曲线来确定583例新诊断的1型糖尿病患者和829例匹配对照的正常上限。GAD65Ab和ICA512Ab的敏感性分别为66%（384/583）和41%（211/520），两种自身抗体的诊断特异性均为96%。1型糖尿病女性患者中GAD65Ab的水平较高，但频率无差异，而ICA512Ab水平在男性和女性之间无差异。GAD65Ab、ICA512Ab或两者均呈阳性对1型糖尿病的敏感性为74%，特异性为92%。这种简单的一步离心、高容量放射抗原结合试验具有高精度和可重复性，能够准确检测GAD65Ab和ICA512Ab。该试验在针对构象敏感自身抗原的其他自身抗体检测中也应具有实用性。
