Addressing the quality challenge of a human biospecimen biobank through the creation of a quality management system.
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2022
2022
Historique:
received:
04
05
2022
accepted:
22
11
2022
entrez:
30
12
2022
pubmed:
31
12
2022
medline:
4
1
2023
Statut:
epublish
Résumé
The objective of the COMET (COllection of MEtabolic Tissues) biobank project is to create a high-quality collection of insulin-sensitive tissues (liver, muscle, adipose tissues, and epiploic artery) and blood sample derivatives (plasma, serum, DNA and RNA), collected from 270 grade 2-3 obese patients undergoing bariatric surgery. Relevant data on patient such as clinical/biological characteristics and sample handling are also collected. For this, our aim was to establish a Quality Management System (QMS) to meet the reliability and quality requirements necessary for its scientific exploitation. The COMET QMS includes: (1) Quality Assurance to standardize all stages of the biobanking process, (2) Quality Controls on samples from the first patients included in order to validate the sample management process and ensure reproducible quality; and 3) "in process" Quality Controls to ensure the reliability of the storage procedures and the stability of the samples over time. For serum and plasma, several corrective actions, such as temperature handling and centrifugation conditions, were made to the protocol and led to improvement of the volume and quality of samples. Regarding DNA, all samples evaluated achieved a satisfactory level of purity and integrity and most of them yielded the required DNA quantity. All frozen tissue samples had RNAs of good purity. RNA quality was confirmed by RIN, achieving values in most cases over 7 and efficient amplification of housekeeping genes by RT-qPCR, with no significant differences among samples from the same tissue type. In the "in process" Quality Controls, DNA, RNA, and histological integrity of tissues showed no differences among samples after different preservation times. Quality Control results have made it possible to validate the entire biobank process and confirm the utility of implementing QMS to guarantee the quality of a biospecimen collection.
Sections du résumé
BACKGROUND
The objective of the COMET (COllection of MEtabolic Tissues) biobank project is to create a high-quality collection of insulin-sensitive tissues (liver, muscle, adipose tissues, and epiploic artery) and blood sample derivatives (plasma, serum, DNA and RNA), collected from 270 grade 2-3 obese patients undergoing bariatric surgery. Relevant data on patient such as clinical/biological characteristics and sample handling are also collected. For this, our aim was to establish a Quality Management System (QMS) to meet the reliability and quality requirements necessary for its scientific exploitation.
MATERIALS AND METHODS
The COMET QMS includes: (1) Quality Assurance to standardize all stages of the biobanking process, (2) Quality Controls on samples from the first patients included in order to validate the sample management process and ensure reproducible quality; and 3) "in process" Quality Controls to ensure the reliability of the storage procedures and the stability of the samples over time.
RESULTS
For serum and plasma, several corrective actions, such as temperature handling and centrifugation conditions, were made to the protocol and led to improvement of the volume and quality of samples. Regarding DNA, all samples evaluated achieved a satisfactory level of purity and integrity and most of them yielded the required DNA quantity. All frozen tissue samples had RNAs of good purity. RNA quality was confirmed by RIN, achieving values in most cases over 7 and efficient amplification of housekeeping genes by RT-qPCR, with no significant differences among samples from the same tissue type. In the "in process" Quality Controls, DNA, RNA, and histological integrity of tissues showed no differences among samples after different preservation times.
CONCLUSION
Quality Control results have made it possible to validate the entire biobank process and confirm the utility of implementing QMS to guarantee the quality of a biospecimen collection.
Identifiants
pubmed: 36584180
doi: 10.1371/journal.pone.0278780
pii: PONE-D-22-13034
pmc: PMC9803146
doi:
Substances chimiques
RNA
63231-63-0
DNA
9007-49-2
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0278780Informations de copyright
Copyright: © 2022 Servais et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
Références
Eur J Cancer. 2006 Nov;42(16):2684-91
pubmed: 17027255
Biopreserv Biobank. 2014 Oct;12(5):351-7
pubmed: 25289566
Biopreserv Biobank. 2016 Aug;14(4):264-70
pubmed: 27158753
FASEB J. 2005 Aug;19(10):1356-8
pubmed: 15955843
Nucleic Acids Res. 2005 Mar 30;33(6):e56
pubmed: 15800207
J Clin Pathol. 1965 May;18:383-4
pubmed: 14304262
Cell Tissue Bank. 2017 Sep;18(3):425-431
pubmed: 28258397
PLoS One. 2015 Jan 30;10(1):e0115960
pubmed: 25635817
J Biotechnol. 2007 Jan 20;127(4):549-59
pubmed: 16945445
Biopreserv Biobank. 2018 Apr;16(2):106-113
pubmed: 29298092
Diabetes Care. 2010 Jan;33 Suppl 1:S62-9
pubmed: 20042775
Sci Rep. 2021 Oct 25;11(1):20975
pubmed: 34697345
Biomed Res Int. 2020 Feb 25;2020:9349132
pubmed: 32185225
Biopreserv Biobank. 2017 Aug;15(4):344-349
pubmed: 28541714
EPMA J. 2016 Feb 22;7:4
pubmed: 26904153
Biopreserv Biobank. 2013 Dec;11(6):366-70
pubmed: 24475321
PLoS One. 2013 Nov 20;8(11):e79826
pubmed: 24278187
J Thorac Oncol. 2010 Jul;5(7):956-63
pubmed: 20512072
Biopreserv Biobank. 2019 Oct;17(5):425-432
pubmed: 31025876
J Surg Res. 2001 Aug;99(2):222-7
pubmed: 11469890
Diabetes Metab. 2022 Jul;48(4):101345
pubmed: 35339664
Appl Transl Genom. 2016 Jul 01;10:2-9
pubmed: 27668169
Ann Surg Oncol. 2010 Aug;17(8):2229-36
pubmed: 20162455
Lab Invest. 2006 Feb;86(2):202-11
pubmed: 16402036
N Biotechnol. 2022 Dec 25;72:29-37
pubmed: 36049650
Biopreserv Biobank. 2015 Jun;13(3):200-6
pubmed: 26035010
J Clin Pathol. 2016 Mar;69(3):260-5
pubmed: 26598626
Biopreserv Biobank. 2016 Feb;14(1):29-38
pubmed: 26812548
BMC Mol Biol. 2006 Jan 31;7:3
pubmed: 16448564
Anal Biochem. 2012 Apr 15;423(2):229-35
pubmed: 22343191