A false sense of security? Can tiered approach be trusted to accurately classify immunogenicity samples?
A false sense of security? Can tiered approach be trusted to accurately classify immunogenicity samples?
复制标题
虚假的安全感？
DOI：
10.1016/j.jpba.2016.05.031
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发表时间：
2016
影响因子：
3.4
通讯作者：
Jaki T
中科院分区：
文献类型：
--
作者：
Jaki T
针对蛋白质疗法的抗药抗体(ADA)的检测和表征对于监测有害的免疫反应至关重要。通常采用多层方法对患者样本进行ADA活性检测，这种方法最初快速筛选阳性样本，随后在单独的检测中确认阳性样本。在这份手稿中，我们用筛选和基于竞争的验证性测试来评估不同方法用于分类主题的能力。我们发现，对于多阶段过程的整体绩效，用于确认的方法是最重要的，当差异从中到大时，at-test最好。此外，我们发现，当正样本和负样本之间的差异不够大时，使用基于竞争的确认步骤确实会产生对正样本的不良分类。
Detecting and characterizing of anti-drug antibodies (ADA) against a protein therapeutic are crucially important to monitor the unwanted immune response. Usually a multi-tiered approach that initially rapidly screens for positive samples that are subsequently confirmed in a separate assay is employed for testing of patient samples for ADA activity. In this manuscript we evaluate the ability of different methods used to classify subject with screening and competition based confirmatory assays. We find that for the overall performance of the multi-stage process the method used for confirmation is most important where at-test is best when differences are moderate to large. Moreover we find that, when differences between positive and negative samples are not sufficiently large, using a competition based confirmation step does yield poor classification of positive samples.
影响因子：
20.3
作者：
Whelan, Shawn F. J.;Hofbauer, Christoph J.;Reipert, Birgit M.
通讯作者：
Reipert, Birgit M.
将样品分类为真正特异性的方法与验证性免疫测定的比较。
影响因子：
3.4
作者：
T. Jaki;J. Lawo;M. Wolfsegger;P. Allacher;F. Horling
通讯作者：
F. Horling