Islet Autoantibody Standardization Program 2018 Workshop: Interlaboratory Comparison of Glutamic Acid Decarboxylase Autoantibody Assay Performance
Islet Autoantibody Standardization Program 2018 Workshop: Interlaboratory Comparison of Glutamic Acid Decarboxylase Autoantibody Assay Performance
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DOI：
10.1373/clinchem.2019.304196
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发表时间：
2019-09-01
影响因子：
9.3
通讯作者：
Hagopian, W. A.
中科院分区：
文献类型：
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作者：
Lampasona, Vito;Pittman, David L.;Hagopian, W. A.
背景技术背景：胰岛自身抗体标准化计划（IASP）旨在提高测量1型糖尿病（T1 D）相关自身抗体的免疫测定的性能以及实验室之间结果的一致性。IASP组织国际实验室间检测比较研究，将设盲的血清样本分发给参与实验室，然后集中收集和分析结果，为参与者提供公正的比较评估。在这份报告中，我们描述了谷氨酸脱羧酶自身抗体（GADA）检测的结果在IASP 2018 workshop.METHODS：在2018年5月，IASP分发给参与者唯一编码的血清从43新发T1 D患者，7个多个自身抗体阳性的非糖尿病个体，和90名献血员。结果进行了分析，以下指标：灵敏度，特异性，准确性，ROC曲线下面积（ROC-AUC），部分ROC-AUC在95%的特异性（pAUC 95），和一致性的定性和定量results.RESULTS：三十七个实验室提交的结果，共48个不同的GADA检测采用9种不同的格式。所有试验的中位ROC-AUC和pAUC 95分别为0.87 [四分位距（IQR），0.83-0.89]和0.036（IQR，0.032-0.039）。在各试验中观察到pAUC 95的较大差异（范围，0.001-0.0411）。在广泛采用的形式中，桥式ELISA显示出最佳的中位数pAUC 95（0.039;范围，0.036-0.041）。结论：提交给本研究的几种新型检测形式显示出异质性性能。在2018年，大多数表现最好的GADA免疫测定包括新的或已建立的非放射性检测，这些检测被证明与放射性结合测定相当或上级放射性结合测定，放射性结合测定是GADA测量的先前金标准测定形式。(C)2019年美国临床化学协会
BACKGROUND: The Islet Autoantibody Standardization Program (IASP) aims to improve the performance of immunoassays measuring type 1 diabetes (T1D)-associated autoantibodies and the concordance of results among laboratories. IASP organizes international interlaboratory assay comparison studies in which blinded serum samples are distributed to participating laboratories, followed by centralized collection and analysis of results, providing participants with an unbiased comparative assessment. In this report, we describe the results of glutamic acid decarboxylase autoantibody (GADA) assays presented in the IASP 2018 workshop.METHODS: In May 2018, IASP distributed to participants uniquely coded sera from 43 new-onset T1D patients, 7 multiple autoantibody-positive nondiabetic individuals, and 90 blood donors. Results were analyzed for the following metrics: sensitivity, specificity, accuracy, area under the ROC curve (ROC-AUC), partial ROC-AUC at 95% specificity (pAUC95), and concordance of qualitative and quantitative results.RESULTS: Thirty-seven laboratories submitted results from a total of 48 different GADA assays adopting 9 different formats. The median ROC-AUC and pAUC95 of all assays were 0.87 [interquartile range (IQR), 0.83-0.89] and 0.036 (IQR, 0.032-0.039), respectively. Large differences in pAUC95 (range, 0.001-0.0411) were observed across assays. Of formats widely adopted, bridge ELISAs showed the best median pAUC95 (0.039; range, 0.036-0.041).CONCLUSIONS: Several novel assay formats submitted to this study showed heterogeneous performance. In 2018, the majority of the best performing GADA immunoassays consisted of novel or established nonradioactive tests that proved on a par or superior to the radiobinding assay, the previous gold standard assay format for GADA measurement. (C) 2019 American Association for Clinical Chemistry