Statistical positivity criteria for the analysis of ELISpot assay data in HIV-1 vaccine trials
Statistical positivity criteria for the analysis of ELISpot assay data in HIV-1 vaccine trials
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DOI：
10.1016/j.jim.2006.07.015
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发表时间：
2006-08-31
影响因子：
2.2
通讯作者：
Self, Steven G.
中科院分区：
文献类型：
--
作者：
Moodie, Zoe;Huang, Yunda;Self, Steven G.
酶联免疫斑点（ELISpot）检测是用于在许多环境（包括HIV疫苗临床试验）中测量细胞反应的领先技术之一。HIV-1特异性效应T淋巴细胞应答被认为是控制感染所必需的。准确测量和总结细胞免疫应答对HIV研究至关重要。ELISpot测定读数通常根据一些预先指定的标准被二分为阳性/阴性应答。鉴于HIV疫苗试验网络（HVTN）实验室中使用当前检测配置进行每次刺激的重复次数增加，现在可以采用新方法。我们提出了一个客观的标准，基于一个假设驱动的方法，控制假阳性率，同时保持敏感性的抗原特异性反应的研究。新的方法相比，其他常用的标准，使用真实的和模拟数据。由爱思唯尔公司出版
The enzyme-linked immunospot (ELISpot) assay is one of the leading technologies used to measure cellular responses in many settings including HIV vaccine clinical trials. HIV-1-specific effector T lymphocyte responses are considered necessary in the control of infection. Accurate measurement and summary of cellular immune responses are critical to HIV research. ELISpot assay readout is often dichotomized into positive/negative responses according to some pre-specified criteria. Given the increase in the number of replicates used for each stimulation with current assay configurations in the HIV Vaccine Trials Network (HVTN) laboratories, a new approach is now possible. We propose an objective criteria based on a hypothesis-driven method that controls the false positive rate while maintaining sensitivity to each of the antigen-specific responses under study. The new approach is compared to other commonly employed criteria using real and simulated data. Published by Elsevier B.V.