RT Journal Article T1 In search of an evidence-based strategy for quality assessment of human tissue samples: report of the tissue Biospecimen Research Working Group of the Spanish Biobank Network A1 Esteva-Socias, Margalida A1 Artiga, María-Jesús A1 Bahamonde, Olga A1 Belar, Oihana A1 Bermudo, Raquel A1 Castro, Erika A1 Escámez, Teresa A1 Máximo, Fraga A1 Jauregui-Mosquera, Laura A1 Novoa, Isabel A1 Peiró-Chova, Lorena A1 Rejón, Juan-David A1 Ruiz-Miró, María A1 Vieiro-Balo, Paula A1 Villar-Campo, Virginia A1 Zazo, Sandra A1 Rábano, Alberto A1 Villena, Cristina K1 Quality K1 Pre-analytical variables K1 Biobank K1 Tissue K1 Biospecimen science K1 Quality control K1 Control de calidad K1 Technology assessment, biomedical K1 Evaluación de la tecnología biomédica K1 Banco de tejidos K1 Tissue preservation K1 Conservación de tejido K1 Tejidos AB 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. PB BioMed Central Ltd. YR 2019 FD 2019-11-12 LK http://hdl.handle.net/10668/3195 UL http://hdl.handle.net/10668/3195 LA en NO Esteva-Socias M, Artiga MJ, Bahamonde O, Belar O, Bermudo R, Castro E, et al. In search of an evidence-based strategy for quality assessment of human tissue samples: report of the tissue Biospecimen Research Working Group of the Spanish Biobank Network. J Transl Med. 2019 Nov 12;17(1):370. DS RISalud RD Apr 5, 2025