Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
J Immunol Methods. 2014 Jul;409:1-5. doi: 10.1016/j.jim.2014.05.016. Epub 2014 Jun 6.
This Special Issue of the Journal of Immunological Methods includes 16 manuscripts describing quality assurance activities related to virologic and immunologic monitoring of six global laboratory resource programs that support international HIV/AIDS clinical trial studies: Collaboration for AIDS Vaccine Discovery (CAVD); Center for HIV/AIDS Vaccine Immunology (CHAVI); External Quality Assurance Program Oversight Laboratory (EQAPOL); HIV Vaccine Trial Network (HVTN); International AIDS Vaccine Initiative (IAVI); and Immunology Quality Assessment (IQA). The reports from these programs address the many components required to develop comprehensive quality control activities and subsequent quality assurance programs for immune monitoring in global clinical trials including: all aspects of processing, storing, and quality assessment of PBMC preparations used ubiquitously in HIV clinical trials, the development and optimization of assays for CD8 HIV responses and HIV neutralization, a comprehensive global HIV virus repository, and reports on the development and execution of novel external proficiency testing programs for immunophenotyping, intracellular cytokine staining, ELISPOT and luminex based cytokine measurements. In addition, there are articles describing the implementation of Good Clinical Laboratory Practices (GCLP) in a large quality assurance laboratory, the development of statistical methods specific for external proficiency testing assessment, a discussion on the ability to set objective thresholds for measuring rare events by flow cytometry, and finally, a manuscript which addresses a framework for the structured reporting of T cell immune function based assays. It is anticipated that this series of manuscripts covering a wide range of quality assurance activities associated with the conduct of global clinical trials will provide a resource for individuals and programs involved in improving the harmonization, standardization, accuracy, and sensitivity of virologic and immunologic testing.
本期《免疫学方法杂志》特刊包括 16 篇论文，描述了支持国际 HIV/AIDS 临床试验研究的六个全球实验室资源计划的病毒学和免疫学监测相关的质量保证活动：艾滋病疫苗发现合作组织（CAVD）；艾滋病毒/艾滋病疫苗免疫学中心（CHAVI）；外部质量保证计划监督实验室（EQAPOL）；艾滋病毒疫苗试验网络（HVTN）；国际艾滋病疫苗倡议（IAVI）；和免疫学质量评估（IQA）。这些计划的报告涉及为全球临床试验中的免疫监测制定全面质量控制活动和后续质量保证计划所需的许多组成部分，包括：广泛用于 HIV 临床试验的 PBMC 制剂处理、储存和质量评估的所有方面，CD8 HIV 反应和 HIV 中和测定的开发和优化，一个全面的全球 HIV 病毒库，以及关于免疫表型、细胞内细胞因子染色、ELISPOT 和基于 Luminex 的细胞因子测量的新型外部能力验证测试计划的开发和执行的报告。此外，还有一些文章描述了在大型质量保证实验室中实施良好临床实验室规范（GCLP）的情况，开发了专门用于外部能力验证评估的统计方法，讨论了通过流式细胞术测量稀有事件的能力设定客观阈值的问题，最后，一篇文章介绍了基于 T 细胞免疫功能测定的结构化报告框架。预计涵盖与全球临床试验进行相关的广泛质量保证活动的这一系列论文将为参与提高病毒学和免疫学检测的协调、标准化、准确性和敏感性的个人和计划提供资源。
