Optimization and qualification of an Fc Array assay for assessments of antibodies against HIV-1/SIV.
Optimization and qualification of an Fc Array assay for assessments of antibodies against HIV-1/SIV.
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DOI：
10.1016/j.jim.2018.01.013
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发表时间：
2018-04
影响因子：
2.2
通讯作者：
Ackerman ME
中科院分区：
文献类型：
--
作者：
Brown EP;Weiner JA;Lin S;Natarajan H;Normandin E;Barouch DH;Alter G;Sarzotti-Kelsoe M;Ackerman ME
Fc Array是一种多重检测试剂盒，可评估抗原特异性抗体的Fc结构域特征，并有可能同时评价多达500种抗原特异性。抗原特异性抗体被捕获在抗原缀合珠上，并通过Fc结合蛋白阵列（包括抗体亚类试剂、Fcγ受体、补体蛋白和凝集素）探测其功能能力。在这里，我们提出了Fc阵列的优化和正式确认的结果，按照药物临床试验质量管理规范（GCLP）指导原则进行。优化了试验条件的性能和重现性，然后评价了试验的最终版本的专属性、准确度、精密度、检测限和定量限、线性、范围和耐用性。用于多克隆抗体的标准化基于阵列的表征平台抗体效应子功能的生物物理学代理的鉴定捕获抗原和Fc受体的抗体识别。能够对NHP和人抗体样本进行系统的血清学研究。
The Fc Array is a multiplexed assay that assesses the Fc domain characteristics of antigen-specific antibodies with the potential to evaluate up to 500 antigen specificities simultaneously. Antigen-specific antibodies are captured on antigen-conjugated beads and their functional capacity is probed via an array of Fc-binding proteins including antibody subclassing reagents, Fcγ receptors, complement proteins, and lectins. Here we present the results of the optimization and formal qualification of the Fc Array, performed in compliance with Good Clinical Laboratory Practice (GCLP) guidelines. Assay conditions were optimized for performance and reproducibility, and the final version of the assay was then evaluated for specificity, accuracy, precision, limits of detection and quantitation, linearity, range and robustness. Standardized array-based characterization platform for polyclonal antibodies Qualification of a biophysical proxy for antibody effector function Antibody recognition of antigen and by Fc receptors is captured. Enables systematic serologic studies of NHP and human antibody samples.
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影响因子：
5.7
作者：
Richards, John O.;Karki, Sher;Desjarlais, John R.
通讯作者：
Desjarlais, John R.
影响因子：
16.6
作者：
Bradley T;Pollara J;Santra S;Vandergrift N;Pittala S;Bailey-Kellogg C;Shen X;Parks R;Goodman D;Eaton A;Balachandran H;Mach LV;Saunders KO;Weiner JA;Scearce R;Sutherland LL;Phogat S;Tartaglia J;Reed SG;Hu SL;Theis JF;Pinter A;Montefiori DC;Kepler TB;Peachman KK;Rao M;Michael NL;Suscovich TJ;Alter G;Ackerman ME;Moody MA;Liao HX;Tomaras G;Ferrari G;Korber BT;Haynes BF
通讯作者：
Haynes BF
影响因子：
2.2
作者：
Gómez-Román, VR;Florese, RH;Robert-Guroff, M
通讯作者：
Robert-Guroff, M
影响因子：
2.2
作者：
Brown, Eric P.;Licht, Anna F.;Ackerman, Margaret E.
通讯作者：
Ackerman, Margaret E.
影响因子：
5.4
作者：
Lai, Jennifer I.;Licht, Anna F.;Ackerman, Margaret E.
通讯作者：
Ackerman, Margaret E.