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Evaluation of glutamic acid decarboxylase (GAD) 65 antibody detection methods for neurological and diabetic investigation in an Australian diagnostic laboratory. (评估澳大利亚诊断实验室神经学和糖尿病研究中谷氨酸脱羧酶(GAD)65抗体检测方法。)

Evaluation of glutamic acid decarboxylase (GAD) 65 antibody detection methods for neurological and diabetic investigation in an Australian diagnostic laboratory.

发表日期:2023 Mar 21
作者: Amelia Cecchin, Claire Reynolds, Syed Ali, Pravin Hissaria
来源: PATHOLOGY

摘要:

抗谷氨酸脱羧酶(GAD)65自身抗体在自身免疫性神经疾病中的作用正在发展,但在澳大利亚的检测建议仍然保持不变,只有GAD酶联免疫吸附试验(ELISA)和免疫印迹作为唯一两种治疗商品管理局批准的检测方法。通常我们诊断1型糖尿病(T1DM)使用ELISA,而诊断GAD65相关神经疾病则使用免疫印迹。我们观察到一组在GAD相关神经疾病情况下,在免疫印迹结果为阴性而ELISA结果为阳性的病人样本。在缺乏关于首选检测模式的强有力共识指导的情况下,我们试图确定ELISA在GAD相关神经疾病诊断中是否比免疫印迹更具优势。我们使用两种测试平台对55个患者样本进行了抗GAD65自身抗体检测,其中40个样本是为神经疾病而请求的,15个1型糖尿病样本具有检测到的抗GAD65。我们使用欧洲免疫抗GAD酶联免疫吸附试验(ELISA)和Euroimmun EuroLine免疫印迹对神经类肿瘤综合征进行检测。这些结果与临床情况进行了相关性分析。阳性的ELISA结果对于GAD65相关神经疾病的敏感性为100%,特异性为91%。免疫印迹显示GAD65相关神经疾病的敏感性为43%,特异性为76%。与免疫印迹相比,ELISA对于GAD65相关神经疾病更为敏感和特异,这引发了关于该检测方法在神经疾病中的作用的问题。我们建议在所有GAD65抗体相关的神经疾病中,ELISA应作为唯一的诊断方法,而免疫印迹中的抗GAD65抗体的存在具有可疑的临床意义。版权所有 ©2023年澳大利亚病理学家皇家学院。保留所有权利。
The role of anti-glutamic acid decarboxylase (GAD) 65 autoantibodies in autoimmune neurological conditions is evolving, but testing recommendations remain unchanged in Australia with GAD enzyme-linked immunosorbent assay (ELISA) and immunoblot as the only two Therapeutic Goods Administration approved testing methods available in Australia. Common practice is for use of ELISA in diagnosis of type 1 diabetes mellitus (T1DM) and use of immunoblot for diagnosis of GAD65-associated neurological disease. We observed a cohort of patients with negative immunoblot results and positive ELISA in the context of GAD-associated neurological disease without T1DM. In the absence of robust consensus guidelines on preferred testing modalities, we sought to determine if ELISA could have a superior role in the diagnosis of GAD-associated neurological disease when compared to immunoblot in this paper. We tested for anti-GAD65 autoantibodies on 55 patient samples, 40 samples requested for neurological disease and 15 type 1 diabetes samples with detectable anti-GAD65, using two testing platforms: Euroimmun anti-GAD enzyme-linked immunosorbent assay (ELISA) and. Euroimmun EuroLine immunoblot for paraneoplastic neurologic syndromes. These results were correlated against the clinical scenario. Positive ELISA results had a sensitivity of 100% and specificity of 91% for GAD65-related neurological disease. Immunoblot showed sensitivity of 43% and specificity of 76% for GAD65-related neurological disease. ELISA proved more sensitive and specific for GAD65-related neurological disease compared to immunoblot, raising questions about the role of this testing modality in neurological disease. We propose that ELISA should be used as a sole diagnostic method for all GAD65 antibody-related neurological disease over immunoblot. The presence of anti-GAD65 antibody on immunoblot is of doubtful clinical significance.Copyright © 2023 Royal College of Pathologists of Australasia. All rights reserved.