Establishment of an H3Africa Biorepository at Contract Laboratory Services

描述(由申请人提供)：该H3非洲生物储存库项目包括扩展和改进威特沃特斯兰德大学附属的合同实验室服务处的生物储存库能力。CLS成立于2000年，是一家专注于提供诊断实验室服务的组织，包括临床试验和研究研究的样本存储设施。它已经代表一些合作的临床试验网络管理着一个庞大的人体样本储存库(700,000个样本)，这些网络包括NIH资助的CIPRA项目“保护家庭”(2002-2008年)、中央艾滋病毒艾滋病疫苗免疫学(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)、杀微生物剂试验网络(MTN)，并充当南非癌症流行病学研究小组的中央资料库。由于我们在非洲的临床试验和实验室支持工作方面的经验，我们重视在这种环境中进行能力建设，以满足和支持卫生需求。为了成为H3非洲项目的主要利益相关者，项目资金将用于扩大和优化CLS的样品存储基础设施，以便在专门的最先进设施中容纳来自H3非洲的样品。该项目还将协助实施CLS的几项重要活动，以便更好地满足H3非洲倡议的需要，包括升级其实验室和样品管理软件，使用射频识别标签以减少人为错误和样品退化，以及进一步培训其工作人员质量保证以及储存库管理工具和标准。在该项目的第一阶段(UH2)，CLS将对生物储存库技术的趋势和H3非洲的需求进行更详细的评估和可行性分析，特别是在样品跟踪、分析、储存、检索和分配方面。它还将利用这段时间与所有H3非洲/基因组研究中心建立进一步的联系，以便使CLS生物库能力建设与我们的合作者的需求保持一致，并为第二阶段(UH3)活动准备详细的规范。在第二阶段(UH3)，CLS将启动一个专门的H3非洲生物储存库，按照UH2范围研究中的规定，从非洲各地收集、储存和分发样本。它 还将实施几种最先进的保管库做法，以确保对H3Africa样本的最高关爱和管理。在所有阶段，将按照CLS临床试验合作伙伴的要求，特别注意保持高标准的样本保护。我们注意到，CLS在这方面已经取得了以下成就：自1999年以来，通过南非国家认可系统(SANA)对其所有实验室进行了ISO 15189认证(以及优秀的检验报告)；通过英国质量小组对CLS实验室进行了认证；通过PPD和FHI监测批准了DAIDS；对其储存库进行了IATA和LDMS认证。CLS在过去10年中以高成本效益的方式管理和增长其生物资源库，这是一个经过验证的跟踪历史；该项目将进一步支持这些服务的扩展和持续改进。

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.