Moodie Zoe, Huang Yunda, Gu Lin, Hural John, Self Steven G
Statistical Center for HIV/AIDS Research and Prevention Fred Hutchinson Cancer Research Center Seattle, Washington 98109, USA.
J Immunol Methods. 2006 Aug 31;315(1-2):121-32. doi: 10.1016/j.jim.2006.07.015. Epub 2006 Aug 15.
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.
酶联免疫斑点（ELISpot）测定法是用于在包括HIV疫苗临床试验在内的许多情况下测量细胞反应的主要技术之一。HIV-1特异性效应T淋巴细胞反应被认为是控制感染所必需的。细胞免疫反应的准确测量和总结对HIV研究至关重要。ELISpot测定法的读数通常根据一些预先指定的标准分为阳性/阴性反应。鉴于HIV疫苗试验网络（HVTN）实验室目前的测定配置中每次刺激使用的重复次数增加，现在有可能采用一种新方法。我们提出了一种基于假设驱动方法的客观标准，该方法在控制假阳性率的同时，保持对所研究的每种抗原特异性反应的敏感性。使用真实数据和模拟数据将新方法与其他常用标准进行了比较。
