The purpose of the present work is to underline the importance of obtaining a standardized procedure to ensure and evaluate both clinical and research usability of human tissue samples. The study, which was carried out by the Biospecimen Science Working Group of the Spanish Biobank Network, is based on a general overview of the current situation about quality assurance in human tissue biospecimens. It was conducted an exhaustive review of the analytical techniques used to evaluate the quality of human tissue samples over the past 30 years, as well as their reference values if they were published, and classified them according to the biomolecules evaluated: (i) DNA, (ii) RNA, and (iii) soluble or/and fixed proteins for immunochemistry. More than 130 publications released between 1989 and 2019 were analysed, most of them reporting results focused on the analysis of tumour and biopsy samples. A quality assessment proposal with an algorithm has been developed for both frozen tissue samples and formalin-fixed paraffin-embedded (FFPE) samples, according to the expected quality of sample based on the available pre-analytical information and the experience of the participants in the Working Group. The high heterogeneity of human tissue samples and the wide number of pre-analytic factors associated to quality of samples makes it very difficult to harmonize the quality criteria. However, the proposed method to assess human tissue sample integrity and antigenicity will not only help to evaluate whether stored human tissue samples fit for the purpose of biomarker development, but will also allow to perform further studies, such as assessing the impact of different pre-analytical factors on very well characterized samples or evaluating the readjustment of tissue sample collection, processing and storing procedures. By ensuring the quality of the samples used on research, the reproducibility of scientific results will be guaranteed.

译文

本工作的目的是强调获得标准化程序以确保和评估人体组织样本的临床和研究可用性的重要性。这项研究是由西班牙生物银行网络的生物样本科学工作组进行的,该研究基于对人体组织生物样本质量保证现状的总体概述。对过去30年来用于评估人体组织样品质量的分析技术以及其参考值 (如果已发表) 进行了详尽的审查,并根据评估的生物分子对其进行了分类 :( i) DNA,(ii) RNA,和 (iii) 用于免疫化学的可溶性或/和固定蛋白。对1989年发布的130多种出版物和2019进行了分析,其中大多数报告的结果集中在肿瘤和活检样本的分析上。根据可用的分析前信息和参与者的经验,根据样品的预期质量,已针对冷冻组织样品和福尔马林固定石蜡包埋 (FFPE) 样品开发了带有算法的质量评估建议在工作组中。人体组织样本的高度异质性以及与样本质量相关的大量预分析因素使得很难统一质量标准。然而,所提出的评估人体组织样品完整性和抗原性的方法不仅有助于评估储存的人体组织样品是否适合生物标志物开发的目的,而且还将允许进行进一步的研究,例如评估不同的预先分析因素对特征非常好的样品的影响,或评估组织样品收集,处理和存储程序的重新调整。通过确保用于研究的样品的质量,将保证科学结果的可重复性。

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