Diabetes antibody standardization program: First assay proficiency evaluation
Diabetes antibody standardization program: First assay proficiency evaluation
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DOI：
10.2337/diabetes.52.5.1128
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发表时间：
2003-05-01
期刊：
影响因子：
7.7
通讯作者：
Mueller, PW
中科院分区：
文献类型：
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作者：
Bingley, PJ;Bonifacio, E;Mueller, PW
糖尿病抗体标准化计划（DASP）首次能力评价的目的是评估测定方法的一般实施情况并评估新的世界卫生组织（WHO）参考试剂。用于 GAD 和 IA-2 自身抗体。 13个国家的46个实验室收到了来自50名新诊断的1型糖尿病患者和50名献血者对照受试者的编码血清，以及世界卫生组织参考试剂和稀释血清。使用受试者工作特征（ROC）曲线对结果进行分析。车间控制中的灵敏度调整为 90% 特异性。 GADA（45 个实验室）的中位调整敏感度为 84%（范围 62-96%），IA-2A（43 个实验室）为 58%（50-74%），胰岛素自身抗体（IAA；23 个实验室）为 36%（13-66%）。 ROC 曲线分析显示所有 GADA 和 IA-2A 检测以及 18/23 IAA 检测发现患者和对照受试者之间存在显着差异。实验室之间在按 GADA 和 IA-2A 水平对样品进行排序或结果是否相对于 WHO 参考试剂进行表达方面具有良好的一致性。 IAA 达到最高灵敏度的测定在排序样品中也是一致的，但 IAA 的总体一致性很差。必须解决实验室之间检测方案的差异，以便所有中心和试剂盒制造商都能达到相同的高标准。
The aims of the first proficiency evaluation of the Diabetes Antibody Standardization Program (DASP) were to assess general implementation of assay methods and to evaluate the new World Health Organization (WHO) reference reagent. for autoantibodies to GAD and IA-2. Forty-six laboratories in 13 countries received coded sera from 50 patients with newly diagnosed type 1 diabetes and 50 blood donor control subjects, together with the WHO reference reagent and diluent serum. Results were analyzed using receiver operator characteristic (ROC) curves. Sensitivity was adjusted to 90% specificity in workshop controls. The median adjusted sensitivity for GADA (45 laboratories) was 84% (range 62-96%), for IA-2A (43 laboratories) was 58% (50-74%), and for insulin autoantibody (IAA; 23 laboratories) was 36% (13-66%). ROC curve analysis showed all GADA and IA-2A assays, and 18/23 IAA assays found significant differences between patients and control subjects. There was good concordance between laboratories in ranking of samples by GADA and IA-2A levels or if results were expressed in relation to the WHO reference reagent. Assays that achieved the highest sensitivity for IAA were also concordant in ranking samples, but overall concordance for IAA -was poor. Differences in assay protocols between laboratories must be addressed so that all centers and kit manufacturers can perform to the same high standard.