ReviewDevelopments in biobanking workflow standardization providing sample integrity and stability☆
Graphical abstract
Introduction
The healthcare sector and the research community are in great need of diagnostic biomarkers that provide accurate indices of health status that can be used to assist clinical decision-making. The measurement of these biomarkers in accurate and reproducible quantitative indices further requires measures of standardization guaranteeing the quality control of the clinical samples providing these biomarkers.
It is also essential at this stage to insure that the technology platforms used to provide such biomarker measurements also are consistent in sensitivity and specificity irrespective of their global location. The measurement performed on an instrument in India should provide the same level of accuracy as an instrument in Sweden, United Kingdom or the United States.
Samples collected for clinical analysis are either used immediately or discarded or they are stored in biobanks for future use. The current methods of storage of samples are often different in different laboratories, hospital institutions, and government agencies. Consequently, one of the challenges encountered in biobanking activities has been the difficulty in inter-laboratory studies. Differences in experimental designs, protocols, as well as reagents and disposables used will impact on data quality and reproducibility. Standardization and best practice protocols have been proposed to address this problem [1]. Consequently, the strategic roles in biobanking are a matter at heart, where new directives and best practice with clear standardizations and procedures need to be applied.
Currently we have a situation where clinical samples are managed in biobanks spread throughout the world for biomedical research, both in the public and in the private sectors. A general concept is that each biobank follows its own protocols and in general implements its own quality criteria. This leads to a large variation on the way that the quality, integrity and performance of individual samples can vary extensively. A consequence of the current status is that experimental studies using these resources therefore lose statistical power and significance. An evaluation of the current tools at hand in biobanking and the resulting recommendations for improving this status quo is a very important first step in providing a best-case analysis that can be used as a model for improving current practice. It is likely that such evaluations will point out local recommendation linked to those local environments. Irrespective whether the enterprise of biobanking is being conducted on a small scale or on a large scale, the area of best practice in biobanking has many common elements that are universal to all biobanking activities. We envision that in the future, even the physical structure of sample storage will have common standard and integration with other areas of patient care [2]. Central to this thinking will be the development of consensus of standardized procedures and policy to guide future questions of the how, and where, and why samples will be utilized in providing benefit to the patient. Previously, Time magazine published an article on Ten Ideas Changing the World Right Now, where biobanking was highlighted as an important activity with important potential consequence for mankind [3].
The challenge at hand is to have the potential to build large standardized and high quality patient sample collections that offer information that can contribute as a critical factor for successfully developing new drug, and diagnostics developments. Biobanks will fill an important gap here that is strategic and key for future healthcare developments.
Section snippets
Economics and biobanking development
One should not underestimate the funding needed to build and preserve biorepositories [4]. Consequently, there is a need to further develop the value and treasure that biobanking holds. It is still a challenge for our healthcare society to develop, approve on the quality, standardize and organize modern units being built for future use. The demands on successful usage of biobank materials are many, especially in the area of novel drugs developed and introduced into the hospitals. The timeline
Ethical and legal aspects of biobanks
It is a given prerequisite that patient integrity needs to be protected in all circumstances of sample acquisition and eventual use. Most countries have such ethical laws in place that provide this protection. For biobanks in general, protecting the donor against research risks is a key responsibility. In Europe there is the biobank law that has a common basis in European countries and where each European Union member state has established their own national biobank law. There are global
Guidelines and standardization
As of today, we are as yet still developing our understanding of how to best manage the collection, processing and storage of samples within biobanks. Each country based activity in biobanking seeks to establish its own ordered structure but in more or less an independent manner. As of today, there are no cross-border, internationally recognized guidelines from our governmental agencies on biobanking. There are many initiatives underway in Europe, North America and Asia that strive to find
Standards — human blood plasma and cerebrospinal fluid
Recently we reported on the development of a blood plasma reference material that is available as a global resource for proteomic and clinical research [7]. One of the objectives with providing a high quality global plasma reference is to standardize experimental laboratory studies that include quality aspects and continuity in biobanks. Large-scale science initiatives like C-HPP will for instance benefit as one scientific program when the entire human proteome is mapped and linked to human
Standardization of biobanks
The biobank archive with the sample collection therein must have a qualitative level that can meet a demand from the scientific community and the expert research teams, in order to be able to obtain the highest level of output data. It is mandatory to introduce standardization criteria that are documented in protocols and directives. These procedures can be implemented by a standard operation procedure (SOP), that guarantees the reproducible handling of clinical material. There are several
Electronic systems for sample integrity
The electronic registry of the sample is a central part of biobank developments in order to safely preserve patient data. This registry can, or is usually integrated within the national healthcare system, which makes the value of the samples, and the resulting analysis data so much valuable. It allows for future follow-ups and evaluation of disease presentation, in addition to experience building on best practice in treatments of common diseases [15], [16], [17], [18].
The unique code that each
Conclusions
Biobank repositories must be planned, managed and administered at a high level of professional organization. Operating a professional biobank requires not only the necessary equipment for storage but also a planned infrastructure. Biobank sustainability is dependent upon adequate staffing of managers and technicians for sample handling, clinical expertise in patient classification and clinical metadata associations, and administrators overseeing the legal, ethical, and consent questions that
Acknowledgment
This work was supported by grants from the Swedish Academy of Pharmaceutical Sciences, C-HPP (HUPO), Swedish Research Council, the Swedish Foundation for Strategic Research (SSF, TOTAL AMI), Vinnova, Ingabritt & Arne Lundbergs forskningsstiftelse, and by the Crafoord Foundation.
References (20)
- et al.
Molecular microheterogeneity of prostate specific antigen in seminal fluid by mass spectrometry
Clin Biochem
(2012) - et al.
Developments for a growing Japanese patient population: facilitating new technologies for future health care
J Proteomics
(2011) - et al.
Human biospecimen research: experimental protocol and quality control tools
Cancer Epidemiol Biomarkers Prev
(2009) - Park A. Ten ideas changing the world right now: biobanks. TIME;...
- et al.
State of the art in preservation of fluid biospecimens
Biopreserv Biobank
(2011) The ethics of research biobanking
JAMA
(2010)Improving international research with clinical specimens: 5 achievable objectives
J Proteome Res
(2012)- et al.
Blood plasma reference material — a global resource for proteomic research
J Proteome Res
(2013) - et al.
Consensus guidelines for CSF and blood biobanking for CNS biomarker studies
(2011) Biorepositories: building better biobanks
Nature
(2012)
Cited by (48)
Microsampling with cotton thread: Storage and ultra-sensitive analysis by thread spray mass Spectrometry
2019, Analytica Chimica ActaCitation Excerpt :Another key challenge in microsampling, which involves the uneven analyte distribution in the collected sample, is a significant issue in dried blood spots (DBS) prepared on paper substrates [8–11]. Safeguarding homogeneity in microvolumes of liquid samples (<20 μL) is also not trivial due to (i) sample loss via potential adsorption of the analyte to the wall of the container and the fact that (ii) cold storage often leads to unfavorable volume/surface ratios which results in evaporation (free-drying) after prolong storage [12]. Currently, there are multiple microsampling techniques utilized to circumvent these challenges.
Quality assurance procedures for mass spectrometry untargeted metabolomics. a review
2018, Journal of Pharmaceutical and Biomedical AnalysisCitation Excerpt :Malm et al. have highlighted the need for increased awareness regarding biobank samples collection, storage and utilization. The authors give a global view of the field where best practice, the standardization aspects and conventional acceptances of biobanking are presented [73]. Up to date several initiatives that disseminate best practice for biobanking have been established such as Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) (www.bbmri-eric.eu), The European, Middle Eastern & African Society for Biopreservation & Biobanking (ESBB) (www.esbb.org) or EuPA Biobank Initiative (www.eupa-biobank.eu) [74].
Multicentric study of the effect of pre-analytical variables in the quality of plasma samples stored in biobanks using different complementary proteomic methods
2017, Journal of ProteomicsCitation Excerpt :Many proteomic studies for biomarker discovery have been developed based on access to these collections [35]. However, standardization of sample quality is a critically important requirement for valid use of the full potential of the collected samples [36]. The need for improved biomarker research has focused attention on the effects of pre-analytical variable on collected samples as key parameters determining the obtained results [37].
A new insight updates in diagnosis and management of acute lymphoblastic leukemia, cytogenetics, immunophenotyping, and proteomic profile
2023, Electronic Journal of General MedicineConvolutional Neural Network Application to Automate the Process of Aliquoting Biosamples †
2023, Engineering Proceedings
- ☆
This article is part of a Special Issue entitled: Standardization and Quality Control in Proteomics.