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Background: Biospecimen shipping and handling challenges in Africa include climates that can potentially jeopardize sample integrity, and infrastructure and regulation limitations that affect courier reliability, access, and costs. There is a lack of investigations reporting on validation of standardized processes for biospecimen exchange among African countries and regions. The Human Heredity and Health in Africa (H3Africa) Initiative funded four African biorepositories (BR) to pilot test operations, and assess effectiveness of trans-African shipment of high-quality DNA, and other biospecimens for genomics research. Pilot studies tested the following: workflows and forms related to biospecimen exchange, transport logistics, and comparability and confirmation of quality control (QC) methods. Methods: Ethical and legal requirements for biospecimen, and data transfer were acquired before shipment. Biospecimens were collected and subjected to QC by the BR of origin before shipment, and by the recipient BR on arrival. Minimal QC requirements included concentration and purity for DNA. Paired Student's t-tests were used to determine significant differences in DNA concentrations, DNA purity, and urine pH pre- and postshipment. Results: The turnaround time for import/export permits was 21-90 days and material transfer agreements 1-10 months. There were nine shipments. Shipping duration averaged 5 days. Shipments sent at uncontrolled ambient temperature fluctuated between 5.6°C and 32.7°C. Seventy-seven percent of source DNA had purity ratios within the acceptable range before shipment. Eighty-nine percent of the DNA results did not differ significantly before and after shipment. Ninety-five percent of DNA extracted from shipped whole blood had acceptable purity. Conclusion: African BRs can collect, process, store, and ship biospecimens of good quality. This study shows it is possible to ship biospecimens between different regions of Africa in a reasonable time frame, without compromise to the cold chain and biospecimen integrity. It is also possible to harmonize ethical documents, guidelines, and processes among African BRs to facilitate collaboration. [ABSTRACT FROM AUTHOR]

A laboratory information management system (LIMS) is central to the informatics infrastructure that underlies biobanking activities. To date, a wide range of commercial and open-source LIMSs are available and the decision to opt for one LIMS over another is often influenced by the needs of the biobank clients and researchers, as well as available financial resources. The Baobab LIMS was developed by customizing the Bika LIMS software () to meet the requirements of biobanking best practices. The need to implement biobank standard operation procedures as well as stimulate the use of standards for biobank data representation motivated the implementation of Baobab LIMS, an open-source LIMS for Biobanking. Baobab LIMS comprises modules for biospecimen kit assembly, shipping of biospecimen kits, storage management, analysis requests, reporting, and invoicing. The Baobab LIMS is based on the Plone web-content management framework. All the system requirements for Plone are applicable to Baobab LIMS, including the need for a server with at least 8 GB RAM and 120 GB hard disk space. Baobab LIMS is a server-client-based system, whereby the end user is able to access the system securely through the internet on a standard web browser, thereby eliminating the need for standalone installations on all machines. [ABSTRACT FROM AUTHOR]

The high burden of infectious diseases and the growing problem of noncommunicable and metabolic disease syndromes in South Africa (SA) forces a more focused research approach to facilitate cutting-edge scientific growth and public health development. Increased SA research on these diseases and syndromes and the collection of associated biospecimens has ensured a plethora of biobanks created by individuals, albeit without the foresight of prospective and collective use by other local and international researchers. As the need for access to high-quality specimens in statistically relevant numbers has increased, so has the necessity for the development of national human biobanks in SA and across the Continent. The prospects of achieving sustainable centralized biobanks are still an emerging and evolving concept, primarily and recently driven by the launch of the H3Africa consortium, which includes the development of harmonized and standardized biobanking operating procedures. This process is hindered by a myriad of complex societal considerations and ethico-legal challenges. Efforts to consolidate and standardize biological sample collections are further compromised by the lack of full appreciation by national stakeholders of the biological value inherent in these collections, and the availability of high quality human samples with well-annotated data for future scientific research and development. Inadequate or nonexistent legislative structures that specifically regulate the storage, use, dispersal, and disposal of human biological samples are common phenomena and pose further challenges. Furthermore, concerns relating to consent for unspecified future uses, as well as access to information and data protection, are all new paradigms that require further consideration and public engagement. This article reviews important fundamental issues such as governance, ethics, infrastructure, and bioinformatics that are important foundational prerequisites for the establishment and evolution of successful human biobanking in South Africa. [ABSTRACT FROM AUTHOR]