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.
H3Africa is an important Africa-wide initiative to build capacity in genomics-based research in order to address the problems of African health and disease. Although focused primarily on benefitting the people of Africa, such research will also be relevant to the health of individuals in the United States and other countries worldwide, particularly those of African descent. The initiative has three objectives, namely to increase the human resources for conducting cutting-edge genomics-based research in Africa; secondly to support state of the art genomics/genetics research that will generate important findings and build research capacity of African laboratories; and thirdly to support the improvement of specific types of infrastructure required for genomics-based research, including biorepository capacity. This proposal relates to the third objective and covers the extension and improvement of the biorepository capacity at the Contract Laboratory Services (CLS), which is a division of the Wits Health Consortium, University of the Witwatersrand. Established in 2000, CLS is a focused organization providing diagnostic and research laboratory services, including sample storage facilities for clinical trials and research studies. It already manages a large repository f human samples (>700,000 samples) on behalf of a number of collaborating clinical trial networks including for the NIH funded CIPRA study (Secure the Household), 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. CLS is strategically well placed in Johannesburg, South Africa, and linked to both university and clinical research centers. We have current capacity to be a 'hub-site' for repository services for the African continent. Our expertise of building laboratory capacity in Africa is proven and we believe that the relationships we have already built will be crucial in establishing further networks for other biorepository H3Africa projects. The project funding will be used to expand CLS' sample storage infrastructure in order to accommodate samples from H3Africa in a dedicated facility. Furthermore, the project will assist with the implementation of several important activities in order to better serve the needs of the H3Africa initiative, including the upgrading of CLS' 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 laboratory accreditation standards. CLS will also collaborate and network with African sites to ensure efficient and effective functioning of the repository. CLS is dedicated to supporting the research of the medical research community in Africa through the analysis, storage, retrieval and distribution of clinical samples; this project will deepen its ability to prvide such support and enable H3Africa to reach its broader goals.
