Lessons Learned from Biospecimen Shipping Among the Human Heredity and Health in Africa Biorepositories
Lessons Learned from Biospecimen Shipping Among the Human Heredity and Health in Africa Biorepositories
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DOI：
10.1089/bio.2017.0009
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发表时间：
2017-04-01
影响因子：
1.6
通讯作者：
Penno, Sue
中科院分区：
文献类型：
--
作者：
Croxton, Talishiea;Swanepoel, Carmen;Penno, Sue
背景：生物菌素在非洲的运输和处理挑战包括可能危及样本完整性的气候，以及影响快递可靠性、获取途径和成本的基础设施和监管限制。缺乏关于非洲国家和区域之间生物检疫剂交换标准化程序的验证情况的调查报告。非洲人类遗传与健康(H3Africa)倡议资助了四个非洲生物储存库(BR)，以试验测试操作，并评估跨非洲运输高质量DNA和其他用于基因组学研究的生物检验剂的有效性。初步研究测试了与生物制剂交换、运输物流、质量控制(QC)方法的可比性和确认相关的工作流程和表格。方法：在发货前获取生物制剂的伦理和法律要求以及数据传输。生物检疫剂在装运前由原产国BR收集并接受QC，到达时由接收方BR收集和接受QC。最低的质量控制要求包括DNA的浓度和纯度。用配对学生t检验确定发货前后DNA浓度、DNA纯度和尿液pH值的差异。结果：进出口许可证的周转时间为21-90天，物资转移协议为1-10个月。一共有九批货。运输持续时间平均为5天。在不受控制的环境温度下发送的货物在5.6摄氏度到32.7摄氏度之间波动。77%的源DNA在发货前的纯度比率在可接受的范围内。89%的DNA结果在发货前后没有明显差异。从运输的全血中提取的95%的DNA纯度可接受。结论：非洲BRS可以收集、加工、储存和运输质量良好的生物检疫品。这项研究表明，在不损害冷链和生物检疫完整性的情况下，在合理的时间框架内在非洲不同地区之间运输生物检疫是可能的。还可以协调非洲业务代表之间的伦理文件、准则和程序，以促进合作。
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 degrees C and 32.7 degrees 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.