Lessons Learned from Biospecimen Shipping Among the Human Heredity and Health in Africa Biorepositories

Abstract

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.

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Blueprint for building a biorepository in a resource-limited setting that follows international best practices

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“…A number of collaborative manuscripts from the H3Africa Biorepository Working Group have highlighted several relevant concepts, including the role of genomics in African health, how biorepositories in Africa directly support African genomics research, the value of piloting biorepository operations across national boundaries and the complex governance of ‘sharing’ biospecimens for secondary research. 28,29,30,31…”

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