Biological sample storage in biomedical research.

IF 2.9 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Clinica Chimica Acta Pub Date : 2026-01-01 Epub Date: 2025-08-06 DOI:10.1016/j.cca.2025.120538
Claudia Carranza, Esmeralda Juárez, Laura E Carreto-Binaghi, Rodolfo L Chávez-Domínguez, Montserrat A García-Ramos, Mercedes Viettri, I A Corona-Galvan, Horacio Zamudio-Meza, Edgar Reyna-Rosas, Milton Nieto-Ponce, Andrea Palencia-Reyes, Carlos Blancas-Ruíz, Martha Torres
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引用次数: 0

Abstract

Despite the central role of biological samples in biomedical discovery, many research laboratories operate without robust sample storage systems. This compromises sample integrity, reproducibility, biosafety, and the long-term utility of the data. Implementing structured sample storage policies and infrastructure is crucial for maintaining scientific quality, ensuring regulatory compliance, and promoting responsible research conduct. It would be highly beneficial for any research laboratory to transition from sample storage to the implementation of a formal biobank. Biobanks constitute a critical infrastructure for biomedical research, as they systematically store biological specimens and databases, which are essential for maximizing utility in clinical investigations and facilitating international collaborative efforts. Most countries lack biobank-specific regulatory frameworks, which limits the ability to implement concurrent initiatives in line with international standards. Integrating quality management systems is essential for ensuring specimen quality and security. In this study, we analyzed the importance of the sample storage conditions and the steps required to transition to a formal biobank. We proposed a guide for doing so in the absence of a regulatory framework, based on the ISO 20387:2018 model, and included an example of successful implementation. We integrated environmental sustainability considerations and inter-institutional networking as a strategy for enhancing operational efficiency. Transforming an internal sample storage system into a formal biobank is a strategic and scientific advancement. It ensures that biological materials are managed with the rigor, transparency, and ethical responsibility required by contemporary biomedical research. By doing so, research institutions strengthen their capacity for innovation and collaboration.

生物医学研究中生物样品的保存。
尽管生物样本在生物医学发现中发挥着核心作用,但许多研究实验室的运作没有强大的样本存储系统。这损害了样品的完整性、可重复性、生物安全性和数据的长期效用。实施结构化的样本存储政策和基础设施对于维持科学质量、确保法规遵从性和促进负责任的研究行为至关重要。这将是非常有益的任何研究实验室从样本存储过渡到实施正式的生物库。生物银行是生物医学研究的关键基础设施,因为它们系统地存储生物标本和数据库,这对于最大限度地发挥临床研究的效用和促进国际合作努力至关重要。大多数国家缺乏针对生物库的监管框架,这限制了按照国际标准实施同步行动的能力。整合质量管理体系对确保标本质量和安全至关重要。在本研究中,我们分析了样品储存条件的重要性以及过渡到正式生物库所需的步骤。我们根据ISO 20387:2018模型提出了在缺乏监管框架的情况下这样做的指南,并包括一个成功实施的例子。我们将环境可持续性考虑和机构间网络作为提高运营效率的策略。将内部样本存储系统转变为正式的生物库是一项战略和科学进步。它确保生物材料的管理具有当代生物医学研究所需的严谨性、透明度和道德责任。通过这样做,研究机构加强了创新和合作的能力。
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来源期刊
Clinica Chimica Acta
Clinica Chimica Acta 医学-医学实验技术
CiteScore
10.10
自引率
2.00%
发文量
1268
审稿时长
23 days
期刊介绍: The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.
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