Core C: Clinical Resarch Laboratory

项目摘要/摘要 该项目采取了一种全面的方法来调查登革病毒(DENV) 家庭环境中的传播(项目1)，确定对DENV的早期免疫反应及其相关性 到结果(项目2)，以及调查DENV疫苗接受者的免疫反应(项目3)。这些 项目包括具有不同实验设计的研究，其中两个大型前瞻性队列在两个 国家(泰国和菲律宾)。这项复杂和综合的研究工作将得到一个 实验室核心(核心C)，将为标本处理、管理、 以及常规的临床和登革热诊断实验室检测。临床研究实验室核心(核心C) 由3个设施组成：a)AFRIMS-泰国曼谷的病毒学实验室(C-BKK核心)，b)AFRIMS-病毒学 泰国Kamphaeng Phet(核心C-KPP)的实验室和c)宿务的AFRIMS-病毒学实验室 菲律宾(核心C-宿务)。Core C-BKK一直在东南亚和附近地区进行研究 50多年来一直是黄病毒诊断的参考实验室；它将成为 实验室活动的行政和后勤中心，并将成为血清学诊断的主要实验室 以及针对特定研究的专门测试。核心C-KPP将是项目样品处理的主要设施 1和2；它还将作为分子诊断实验室，并进行研究实验室测试，包括 用流式细胞术和抗原抗体评价病毒载量和分析免疫应答 化验。C-Cebu核心实验室是目前处理登革热样本的主要机构。 项目3中的疫苗研究主题。核心实验室将成为样本存储、库存和 分发。核心实验室有一个安全和负责的库存系统，该系统促进了样本 分发给诊断和研究实验室。自计划项目开始以来，核心 实验室已处理和管理样本，包括血浆/血清、冷冻保存的PBMC和RNA 来自PBMC。这些样品已被用于功能性抗体检测、生物介体检测、 以及已经发表的分子和蛋白质组分析，有助于目前对 登革热的许多方面。已经制定了针对研究的质量管理计划，实验室的 每季度对样品链保管、样品处理和样品责任的操作进行审计。

Project Summary/Abstract This Program Project takes a comprehensive approach to investigating dengue virus (DENV) transmission within a family setting (Project 1), defining the early immune response to DENV and its correlations to outcomes (Project 2), and investigating immune responses in DENV vaccine recipients (Project 3). These projects include studies with distinct experimental designs with two large prospective cohorts conducted in two countries (Thailand and the Philippines). This complex and integrative research effort will be supported by a laboratory core (Core C) which will provide high quality laboratory support for specimen processing, management, and routine clinical and dengue diagnostic laboratory testing. The Clinical Research Laboratory Core (Core C) consists of 3 facilities: a) AFRIMS-Virology laboratory in Bangkok, Thailand (Core C-BKK), b) AFRIMS-Virology laboratory in Kamphaeng Phet (Core C-KPP), Thailand, and c) AFRIMS-Virology laboratory in Cebu, the Philippines (Core C-Cebu). Core C-BKK has been conducting research in Southeast Asia and nearby regions for over 50 years and has served as a reference laboratory for flavivirus diagnosis; it will serve as the administrative and logistics center for laboratory activities and will be the main laboratory for serologic diagnosis and for study-specific specialized tests. Core C-KPP will be the main facility for specimen processing for Projects 1 and 2; it will also serve as a molecular diagnostic laboratory and perform research laboratory testing including assessment of viral burden and analysis of immune responses by flow cytometry and antigen and antibody assays. Core C-Cebu is currently the main specimen processing facility for samples collected from dengue vaccine study subjects in Project 3. The Core Laboratory will be the center for specimen storage, inventory, and distribution. The Core Laboratory has a secure and accountable inventory system that has facilitated sample distribution to diagnostic and research laboratories. Since the beginning of the Program Project, the Core Laboratory has processed and managed specimens including plasma/serum, cryopreserved PBMC, and RNA from PBMC. These samples have been used for functional antibody assays, assays for biological mediators, and molecular and proteomic analyses that have been published and contributed to current understanding on many aspects of dengue. Study-specific quality management plans have been established and the laboratory’s operation is audited quarterly for specimen chain custody, specimen handling, and sample accountability.