HPTN CENTRAL LABORATORY

约翰霍普金斯大学（JHU）请求为艾滋病毒预防试验网络（HPTN）建立一个中心实验室（CL）提供资金。JHU CL将与位于北卡罗来纳州达勒姆的国际家庭健康组织的协调和运营中心（CORE）以及位于华盛顿州西雅图的弗雷德哈钦森癌症研究中心的统计和数据管理中心（SDMC）建立联系。具体目标如下：1. 提供基于实验室的科学领导和咨询， HPTN合作组织和协议团队。2. 参与HPTN方案的制定和评审过程。3. 参与网络的管理和建立 HPTN科学议程。4. 提供处理、储存和检索国内和 国际HPTN试验标本。5. 为样本处理、分析提供质量保证 性能，以及在以下位置执行的样本相关数据传输 艾滋病毒预防试验单位（HPTU）。6. 在实验室QA、分析方面提供培训和基础设施支持 性能和样本运输程序 现场实验室。 7. 进行免疫学、药理学和病毒学/细菌学 测试HPTN协议8. 开发和评估用于HPTN试验的新检测方法。9. 协调程序并及时传输准确的实验室数据， HPTN SDMC。10. 发布新检测试剂盒开发/评估的结果 和基于发病机制的研究。为了优化所需的科学专业知识和实验室能力，HPTN CL将基于涉及JHU、匹兹堡大学和加州公共卫生部（VRDL）的中心辐射概念。

Johns Hopkins University (JHU) requests funding for the establishment of a Central Laboratory (CL) for the HIV Prevention Trials Network (HPTN). The JHU CL will be affiliating with the Coordinating and Operations Center (CORE) at Family Health International in Durham, NC and the Statistical and Data Management Center SDMC) at the Fred Hutchinson Cancer Research Center in Seattle, WA. Specific aims are the following: 1. Provide laboratory based scientific leadership and consultation to the HPTN collaborating organization and protocol teams. 2. Participate in the HPTN protocol development and review process. 3. Participate in the network management and establishment of the HPTN scientific agenda. 4. Provide processing, storage, and retrieval of domestic and international HPTN trial specimens. 5. Provide quality assurance for specimen processing, assay performance, and specimen related data transmission performed at the HIV Prevention Trial Unit (HPTU) sites. 6. Provide training and infrastructure support in laboratory QA, assay performance, and specimen shipping procedures at the HPTU clinical site laboratories. 7. Perform immunologic, pharmacologic, and virologic/bacteriologic testing for the HPTN protocols. 8. Develop and evaluate new assays for use in HPTN trials. 9. Coordinate procedures and timely transmission of accurate lab data to the HPTN SDMC. 10. Publish findings of new assay development/evaluation and pathogenesis based studies. To optimize the amount of scientific expertise and lab capabilities needed, the HPTN CL will be based on a hub and spoke concept involving JHU, University of Pittsburgh, and the California Public Health Dept (VRDL).