Establishment of an H3Africa Biorepository at Contract Laboratory Services

在合同实验室服务处建立 H3Africa 生物样本库

• 批准号: 8908098
• 负责人: Ute Jentsch
• 金额: $ 69.9万
• 依托单位: WITS HEALTH CONSORTIUM (PTY), LTD
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-25 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8908098
• 关键词: AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Accreditation; Achievement; Address; Adopted; Adult; Africa; African; Air; Bioinformatics; British; Caring; Certification; Clinical Distribution; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Communicable Diseases; Communities; Computer Hardware; Computer software; Contracts; Country; Database Management Systems; Developing Countries; Development; Diagnostic; Diagnostic Services; Diagnostics Research; Disease; Ensure; Environment; Epidemiology; Evaluation; Feasibility Studies; Frequencies; Funding; Genetic Research; Genomics; Goals; HIV; Health; Household; Human; Human Resources; IMPAACT; Immunology; Individual; International; Knowledge; Label; Laboratories; Link; Liquid substance; Malignant Neoplasms; Medical Research; Microbicide Trials Network; Mission; Monitor; Nitrogen; Phase; Prevalence Study; Prevention; Process; Proteomics; Radio; Recording of previous events; Reporting; Research; Research Infrastructure; Research Project Grants; Research Support; Retrieval; Robotics; Safety; Sampling; Sampling Errors; Scientist; Secure; Services; Site; South Africa; Specific qualifier value; Staging; System; Technology; Training; Training Support; United States; United States National Institutes of Health; Universities; Vaccine Clinical Trial; Vaccines; Wit; Work; base; biobank; clinical practice; cost; data management; data sharing; experience; high standard; improved; operation; pediatric AIDS; quality assurance; repository; research study; tool; trend

DESCRIPTION (provided by applicant): This H3Africa biorepository project covers the extension and improvement of the biorepository capacity at the Contract Laboratory Services (CLS), which is subsidiary of the University of the Witwatersrand. Established in 2000, CLS is a focused organization providing diagnostic laboratory services, including sample storage facilities for clinical trials and research studies. It already manages a large repository (>700,000 samples) of human samples on behalf of a number of collaborating clinical trial networks including NIH funded CIPRA project "Safeguard the household" (2002-2008), Central HIV Aids Vaccine Immunology (CHAVI), the International HIV/AIDS Vaccine Initiative (IAVI), the Adult and Pediatric AIDS Clinical Trials Group (ACTG/PACTG/IMPAACT), Partners in Prevention (PIP and PreP), Microbicide Trial Network (MTN), and acts as the central repository for the South African Cancer Epidemiological Research Group. Due to our experience in clinical trials and laboratory support work in Africa, we value capacity building in this environment to address and support health needs as critical. In order to be a key stakeholder in the H3Africa mission, the project funding will be used to expand and optimize CLS' sample storage infrastructure in order to accommodate samples from H3Africa in a dedicated state of the art facility. The project will also assist with the implementation of several important CLS activities in order to better serve the needs of the H3Africa initiative, including the upgrading of its laboratory and sample management software, the use of radio frequency identification tags to reduce human error and sample degradation, and the further training of its staff in quality assurance, and repository management tools and standards. In the first phase of the project (UH2), CLS will undertake a more detailed assessment and feasibility analysis of trends in biorepository technology and the needs of H3Africa, particularly in respect of sample tracking, analysis, storage, retrieval and distribution. It will also use this period to build further links with all the H3Africa /genomic research centers in order to align CLS biorepository capacity building with the needs of our collaborators and prepare detailed specifications for the second phase (UH3) activities. In the second phase (UH3), CLS will activate a dedicated H3Africa biorepository, collecting, storing and distributing samples from and to all over Africa as specified in the scoping studies of UH2. It will also implement several state-of-the-art repository practices in order to ensure the highest care and management of H3Africa samples. In all stages specific care will be taken to maintain the high standards of sample protection, as required by CLS' clinical trial partners. We note that CLS already has the following achievements in this regard: "ISO 15189 accreditation for all its laboratories (and excellent inspection reports) through the South African National Accreditation System (SANAS) since 1999" accreditation for the CLS laboratory through the British Quality Group "DAIDS approved through PPD and FHI monitoring" IATA and LDMS certification of its repository. CLS has a proven track history of managing and growing its biorepository over the last 10 years in a highly cost-efficient manner; this project will further support expansion and continuous improvement of these services.

描述（由申请人提供）：该 H3Africa 生物样本库项目涵盖了合同实验室服务 (CLS) 生物样本库容量的扩展和改进，该实验室是威特沃特斯兰德大学的子公司。 CLS 成立于 2000 年，是一家专注于提供诊断实验室服务的组织，包括用于临床试验和研究的样本存储设施。它已经代表许多合作临床试验网络管理着大型人类样本存储库（>700,000 个样本），包括 NIH 资助的 CIPRA 项目“保护家庭”（2002-2008 年）、中央 HIV 艾滋病疫苗免疫学 (CHAVI)、国际艾滋病毒/艾滋病疫苗倡议 (IAVI)、成人和儿童艾滋病临床试验小组 (ACTG/PACTG/IMPAACT)、预防合作伙伴（PIP 和 PreP）、杀菌剂试验网络 (MTN)，并充当南非癌症流行病学研究小组的中央存储库。由于我们在非洲进行临床试验和实验室支持工作的经验，我们重视在这种环境下的能力建设，以解决和支持健康需求至关重要。为了成为 H3Africa 任务的关键利益相关者，项目资金将用于扩展和优化 CLS 的样本存储基础设施，以便在专用的最先进设施中容纳来自 H3Africa 的样本。该项目还将协助实施几项重要的 CLS 活动，以更好地满足 H3Africa 倡议的需求，包括升级其实验室和样本管理软件、使用射频识别标签来减少人为错误和样本降解，以及对其工作人员进行质量保证、存储库管理工具和标准方面的进一步培训。 在该项目的第一阶段（UH2），CLS将对生物样本库技术的趋势和H3Africa的需求进行更详细的评估和可行性分析，特别是在样本跟踪、分析、存储、检索和分发方面。它还将利用这段时间与所有 H3Africa/基因组研究中心建立进一步的联系，以使 CLS 生物样本库能力建设与我们合作者的需求保持一致，并为第二阶段 (UH3) 活动准备详细规范。在第二阶段 (UH3)，CLS 将启动一个专用的 H3Africa 生物储存库，按照 UH2 范围研究的规定，收集、存储和分发来自非洲各地的样本。它 还将实施多种最先进的存储库实践，以确保对 H3Africa 样本进行最高程度的护理和管理。按照 CLS 临床试验合作伙伴的要求，在所有阶段都将采取特别措施，以维持样本保护的高标准。我们注意到，CLS 在这方面已经取得了以下成就： “自 1999 年以来，其所有实验室均通过南非国家认可系统 (SANAS) 的 ISO 15189 认可（以及优秀的检验报告）” CLS 实验室通过英国质量集团的认可“DAIDS 通过 PPD 和 FHI 监控获得批准” IATA 和 LDMS 对其存储库进行认证。过去 10 年来，CLS 在以极具成本效益的方式管理和发展其生物样本库方面拥有良好的记录；该项目将进一步支持这些服务的扩展和持续改进。