Clin Chem:胰岛自身抗体标准化项目---实验室间比较谷氨酸脱羧酶自身抗体检测性能

2019-10-19 gladiator MedSci原创

胰岛自身抗体标准化项目(IASP)旨在提高检测1型糖尿病(T1D)相关自身抗体的免疫测定的性能和实验室间结果的一致性。

胰岛自身抗体标准化项目(IASP)旨在提高检测1糖尿病(T1D)相关自身抗体的免疫测定的性能和实验室间结果的一致性。IASP组织国际实验室间分析比较研究,将盲样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,我们描述了在IASP 2018研讨会上介绍的谷氨酸脱羧酶自身抗体(GADA)检测结果。

20185月,IASP43例新发T1D患者、7例自身抗体阳性非糖尿病患者和90例献血者的独特编码血清分发给参与者。结果分析了以下指标:敏感性、特异性、准确性、ROC曲线下面积(ROC- auc)ROC- auc部分95%特异性(pAUC95)、定性与定量结果的一致性。

研究显示,本研究采用了9种不同的格式,37个实验室提交了总共48个不同的GADA检测结果。ROC-AUCpAUC95中位数分别为0.87[四分位间距(IQR) 0.83-0.89]0.036 (IQR, 0.032-0.039)pAUC95(范围为0.001-0.0411)在各项检测中存在较大差异。在广泛采用的格式中,bridge ELISAs的中位数pAUC95最好(0.039;范围内,0.036 - -0.041)

本研究采用的几种新型分析方法具有异质性。2018年,大多数表现最好的GADA免疫测定法由新的或已建立的非放射性试验组成,这些试验被证明与先前的金标准GADA测定法(radiobinding assay)相当或优于后者。

原始出处:

Vito Lampasona, David L. Pittman,Islet Autoantibody Standardization Program 2018 Workshop: Interlaboratory Comparison of Glutamic Acid Decarboxylase Autoantibody Assay Performance

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    2020-05-19 baoya
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    2019-10-21 marongnuan
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