Guidelines for Management and Quality Assurance of Biobanks
There are many guidelines for the management of biobanks, such as the International Society for Biological and Environmental Repositories (ISBER) guideline and Organization for Economic Cooperation and Development (OECD) [15] guideline [16]. ISBER is the largest international forum that addresses the technical, legal, ethical, and managerial issues relevant to repositories of biological and environmental specimens. ISBER has the "Best Practices for Repositories/Collection, Storage and Retrieval of Human Biological Materials for Research." Also, ISBER has introduced standard PREanalytical Coding (SPREC) and can be used in the biobank [17]. In October 2009, the OECD council adapted a recommendation for Human Biobanks and Genetic Research Databases (HBGRDs). The purpose of this recommendation suggests guidelines for the establishment, management, governance, operation, access, use, and discontinuation of HBGRDs, which are structured resources that can be used for the purpose of genetic research. The OECD Best Practice Guidelines for Biological Resource Centers set out further complementary quality assurance and technical aspects for the acquisition, maintenance, and provision of high-quality biological materials in a secure manner.
The standard operating protocols (SOPs), regulations, and management for human biospecimens are important. DNA stability and DNA purity in clinical samples are essential for correct performance and interpretation for diagnosis and research. Generally, quality assurance of human biospecimens consists of a DNA stability test, DNA purity test, microorganism contamination test, and cross-contamination test. All biospecimens collected from the Korea Genome and Epidemiology Study (KoGES) in the case of the NBK underwent a DNA degradation test and purity test. Ten percent of biospecimens stored in NBK were randomly chosen and tested for the quality assurance test to ensure the high quality of DNA extracted from the biospecimens and to check contamination by microorganisms. The quality of DNA is important for genetic research, such as genome-wide association studies (GWASs) and whole-genome sequencing (WGS). In general, pure preparations of DNA and RNA have an OD260/OD280 of 1.8 and 2.0 respectively. LCL quality assurance was also conducted, and 10% of the stocked LCL was randomly selected to undergo survival rate investigation and cross-contamination test in the NBK [13].