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Establishment of an H3Africa Biorepository at Contract Laboratory Services

Elizabeth Mayne

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Funding source

National Institutes of Health (NIH)
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. Itwill 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.