title: Quality Assurance of Samples and Processes in the Spanish Renal Research Network (REDinREN) Biobank.
abstract: BACKGROUND
  Biobanks are useful platforms to build bridges between basic, translational, and clinical research and clinical care. They are repositories of high-quality human biological samples ideal for evaluating their histological characteristics and also their genome, transcriptome, and proteome. The Spanish Renal Research Network Biobank contains more than 76,500 well-preserved frozen samples of a wide variety of kidney diseases, collected from 5450 patients seen by over 70 nephrology services throughout the Spanish territory.
  
  
  OBJECTIVE
  To determine and to report the results of the quality control of samples and processes conducted in our biobank, implemented in accordance with the requirements of the ISO 9001:2008 international standard.
  
  
  METHODS
  Two types of quality controls were performed: (1) systematic, that is, measurement of viable peripheral blood mononuclear cells (PBMCs) obtained and purity of nucleic acids and (2) ad-hoc, that is, viability of thawed PBMC, DNA extraction process reproducibility, and the integrity and functionality of nucleic acids, implemented on a routine basis.
  
  
  RESULTS
  PBMC isolation by Ficoll yielded reproducible results and its cryopreserved viability was >90%. Acceptable A260/A280 ratios were obtained for the vast majority of the DNA (n = 2328) and RNA (n = 78) samples analyzed. DNA integrity was demonstrated by agarose gels and by β-globulin gene polymerase chain reaction (PCR) amplification of 1327 and 989 bp fragments. DNA of acceptable quality had at least three bands of β-globulin amplified obtained (n = 26/30). RNA integrity number (RIN) determinations obtained RIN numbers ≥7 (n = 87/96). The amplifiability of nucleic acids was confirmed by qPCR and RT-qPCR of β-actin and GAPDH genes. Long storage or delayed processing time did not affect the quality of the samples analyzed. The processes of DNA extraction also yielded reproducible results.
  
  
  CONCLUSIONS
  These results clearly indicate that our PBMC, DNA, and RNA stored samples meet the required quality standards to be used for biomedical research, ensuring their long-term preservation.
authors.affiliation: 1 Physiology Unit, Department of Systems Biology, Medicine School, Alcala University , Madrid, Spain .|2 IRSIN and REDinREN (Instituto de Salud Carlos III), Madrid, Spain .
authors.forename: Laura
authors.initials: L
authors.lastname: Calleros-Basilio
authors.affiliation: 3 CONICET (Consejo Nacional de Investigaciones Científicas y Técnicas), Medicine School, Universidad Nacional del Nordeste , Corrientes, Argentina .
authors.forename: María Alicia
authors.initials: MA
authors.lastname: Cortés
authors.affiliation: 1 Physiology Unit, Department of Systems Biology, Medicine School, Alcala University , Madrid, Spain .|2 IRSIN and REDinREN (Instituto de Salud Carlos III), Madrid, Spain .
authors.forename: Andrea
authors.initials: A
authors.lastname: García-Jerez
authors.affiliation: 1 Physiology Unit, Department of Systems Biology, Medicine School, Alcala University , Madrid, Spain .|2 IRSIN and REDinREN (Instituto de Salud Carlos III), Madrid, Spain .
authors.forename: Alicia
authors.initials: A
authors.lastname: Luengo-Rodríguez
authors.affiliation: 1 Physiology Unit, Department of Systems Biology, Medicine School, Alcala University , Madrid, Spain .|2 IRSIN and REDinREN (Instituto de Salud Carlos III), Madrid, Spain .
authors.forename: Ana
authors.initials: A
authors.lastname: Orozco-Agudo
authors.affiliation: 2 IRSIN and REDinREN (Instituto de Salud Carlos III), Madrid, Spain .|4 Department of Experimental Nephrology, Institut de Recerca Biomédica de Lleida, Universitat de Lleida , Lleida, Spain .
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Valdivielso
authors.affiliation: 2 IRSIN and REDinREN (Instituto de Salud Carlos III), Madrid, Spain .|5 Nephrology Section and Research Unit, Hospital Universitario Príncipe de Asturias , Alcalá de Henares, Madrid, Spain .
authors.forename: Diego
authors.initials: D
authors.lastname: Rodríguez-Puyol
authors.affiliation: 1 Physiology Unit, Department of Systems Biology, Medicine School, Alcala University , Madrid, Spain .|2 IRSIN and REDinREN (Instituto de Salud Carlos III), Madrid, Spain .
authors.forename: Manuel
authors.initials: M
authors.lastname: Rodríguez-Puyol
mesh_terms: D018070:Biological Specimen Banks / Q000458:organization & administration* / Q000592:standards; D035843:Biomedical Research / Q000592:standards; D002470:Cell Survival; D015925:Cryopreservation / Q000379:methods; D006801:Humans; D007962:Leukocytes / Q000166:cytology*; D009398:Nephrology; D009696:Nucleic Acids / Q000302:isolation & purification* / Q000592:standards; D013030:Spain; D013048:Specimen Handling / Q000592:standards*
chemical_list: D009696:Nucleic Acids
keywords: ISO 9001:2008; biobank; chronic kidney disease; sample quality control