Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA; Departments of Surgery, Duke University Medical Center, Durham, NC, USA; Duke Global Health Institute, Duke University Medical Center, Durham, NC, USA.
J Immunol Methods. 2014 Jul;409:99-106. doi: 10.1016/j.jim.2014.05.019. Epub 2014 Jun 10.
External proficiency testing programs designed to evaluate the performance of end-point laboratories involved in vaccine and therapeutic clinical trials form an important part of clinical trial quality assurance. Good clinical laboratory practice (GCLP) guidelines recommend both assay validation and proficiency testing for assays being used in clinical trials, and such testing is facilitated by the availability of large numbers of well-characterized test samples. These samples can be distributed to laboratories participating in these programs and allow monitoring of laboratory performance over time and among participating sites when results are obtained with samples derived from a large master set. The leukapheresis procedure provides an ideal way to collect samples from participants that can meet the required number of cells to support these activities. The collection and processing of leukapheresis samples require tight coordination between the clinical and laboratory teams to collect, process, and cryopreserve large number of samples within the established ideal time of ≤8 hours. Here, we describe our experience with a leukapheresis cryopreseration program that has been able to preserve the functionality of cellular subsets and that provides the sample numbers necessary to run an external proficiency testing program.
旨在评估参与疫苗和治疗性临床试验的终点实验室表现的外部能力测试计划是临床试验质量保证的重要组成部分。良好的临床实验室规范（GCLP）指南建议对临床试验中使用的检测方法进行检测验证和能力测试，并且可以通过提供大量特征良好的测试样本来促进这种测试。这些样本可以分发给参与这些计划的实验室，并允许在使用来自大型主集的样本获得结果时，对实验室的性能进行随时间和参与站点的监测。白细胞分离术提供了一种从参与者中收集样本的理想方法，这些样本可以满足支持这些活动所需的细胞数量。白细胞分离术样本的采集和处理需要临床和实验室团队之间的紧密协调，以便在规定的理想时间内（≤8 小时）采集、处理和冷冻保存大量样本。在这里，我们描述了我们在白细胞分离冷冻保存计划方面的经验，该计划能够保持细胞亚群的功能，并提供运行外部能力测试计划所需的样本数量。
