Abstract:
Background: The Institute of Human Virology Nigeria (IHVN) – Human Heredity and Health
in Africa (H3Africa) Biorepository (I-HAB) seeks to provide high-quality biospecimens
for research. This depends on the ability of clinical research sites (CRS) – who provide
biospecimens – to operate according to well-established industry standards. Yet, standards are
often neglected at CRSs located in Africa. Here, I-HAB reports on its four-pronged approach
to empower CRSs to prepare high-quality biospecimens for research.
Objectives: I-HAB sought (1) to assess a four-pronged approach to improve biobanking
practices and sample quality among CRSs, and (2) to build human capacity.
Methods: I-HAB partnered with two H3Africa principal investigators located in Nigeria and
Ghana from August 2013 through to May 2017 to debut its four-pronged approach (needs
assessment, training and mentorship, pilot, and continuous quality improvement) to empower
CRSs to attain high-quality biospecimens.
Results: Close collaborations were instrumental in establishing mutually beneficial and lasting
relationships. Improvements during the 12 months of engagement with CRSs involved
personnel, procedural, and supply upgrades. In total, 51 staff were trained in over 20 topics.
During the pilot, CRSs extracted 50 DNA biospecimens from whole blood and performed
quality control. The CRSs shipped extracted DNA to I-HAB and I-HAB that comparatively
analysed the DNA. Remediation was achieved via recommendations, training, and mentorship.
Preanalytical, analytical and post-analytical processes, standard operating procedures, and
workflows were systematically developed.
Conclusion: Partnerships between I-HAB and H3Africa CRSs enabled research sites to
produce high-quality biospecimens through needs assessment, training and mentorship, pilot,
and continuous monitoring and improvement.
