Quality assurance and quality control of biospecimen

With the fast growth and increasing demands for translational research, collection of clinical research resources in biobanks around the world has brought us a big concern about sample quality and its usability. Quality assurance(QA) and quality control (QC) of biospecimen are the key factors of biobank quality and usability. The main factors influencing the quality of biospecimen are pre-analytical and analytical variables, including the donor′s biological and environmental factors, biospecimen collection, processing, transportation, storage, distribution, analysis and so on. Those factors such as personnel, equipment, material, method and environment, which could interact with pre-analytical and analytical variables, directly influence the quality of biospecimen, so it is difficult to guarantee quality samples in clinical translational research if only single factor is applied to sample quality management. We should develop a quality management system specific to quality control of biobank. The goal is to gradually develop international standardization and accreditation. Taking together, it would facilitate quality samples for quality research as clinical research resources in term of biomarker and drug discovery for both translational and personal medicine. Key words: Clinical bio-bank; Quality control; Quality assurance; Translational medicine