Máximo Fraga, Raquel Bermudo, Alberto Rábano, Paula Vieiro-Balo, Laura Jauregui-Mosquera, Sandra Zazo, Cristina Villena, Virginia Villar-Campo, Isabel Novoa, Maria Ruiz-Miró, Oihana Belar, Margalida Esteva-Socias, Olga Bahamonde, María-Jesús Artiga, Erika Castro, Teresa Escámez, Lorena Peiró-Chova, Juan-David Rejón, Ministerio de Ciencia, Innovación y Universidades (España), Instituto de Salud Carlos III, Red Nacional de Biobancos (España), Unión Europea. Fondo Europeo de Desarrollo Regional (FEDER/ERDF), Govern de les Illes Balears (España), Universidade de Santiago de Compostela. Departamento de Ciencias Forenses, Anatomía Patolóxica, Xinecoloxía e Obstetricia, e Pediatría, [Esteva-Socias, Villena,C] Centro de Investigación Biomédica en Red Respiratory Diseases (CIBERES), Plataforma Biobanco Pulmonar CIBERES, Hospital Universitari Son Espases, Palma, Spain. [Esteva-Socias, Villena,C] Grupo de Inflamación, reparación y cáncer en enfermedades respiratorias, Institut d’Investigació Sanitària de les Illes Balears (IdISBa), Hospital Universitari Son Espases, Palma, Spain. [Artiga,MJ] CNIO Biobank, Spanish National Cancer Centre (CNIO), Madrid, Spain. [Bahamonde,O, Peiró-Chova,L] INCLIVA Biobank, Valencia, Spain. [Belar,O, Castro,E] Basque Foundation for Health Innovation and Research, Basque Biobank, Barakaldo, Spain. [Bermudo,R] Hospital Clínic-IDIBAPS Biobank, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. [Escámez,T] IMIB Biobank, Instituto Murciano de Investigación Biosanitaria, Murcia, Spain. [Fraga,M] Depto. de Ciencias Forenses, Anatomía Patolóxica, Xinecología e Obstetricia, e Pediatría, Facultade de Medicina, Universidade de Santiago de Compostela (USC), Santiago, Spain. [Fraga,M, Vieiro-Balo,P] Biobanco Complejo Hospitalario Universitario de Santiago de Compostela (CHUS), SERGAS, Santiago, Spain. [Jauregui-Mosquera,L, Villar-Campo,V] University of Navarra’s Biobank-IdiSNA, Pamplona, Spain. [Novoa,I] Vall d’Hebron University Hospital Biobank, Vall d’Hebron Hospital Research Institute, Barcelona, Spain. [Rejón,JD] Biobanco del Sistema Sanitario Público de Andalucía, Granada, Spain. [Ruiz-Miró,M] IRBLleida Biobank, Instituto de Investigaciones Biomédica de Lleida-Fundación Dr. Pifarre, Lérida, Spain. [Zazo,S] Department of Pathology, IIS-Fundación Jiménez Díaz, Madrid, Spain. [Rábano,A] Banco de Tejidos, Fundación CIEN, Instituto de Salud Carlos III, Madrid, Spain., and This work was funded by the Ministerio de Ciencia, Innovación y Universidades of Spain and Instituto de Salud Carlos III (PI16/00528, PI16/00946, PI16/01207 and PI16/01276), co-funded by the Spanish Biobank Network (PT13/0010/0030, PT17/0015/0001, PT17/0015/0021, PT17/0015/0049, PT17/0015/0018, PT17/0015/0002, PT17/0015/0016, PT17/0015/0038, PT17/0015/0027, PT17/0015/0004, PT17/0015/0047, PT17/0015/0014, PT17/0015/0041, and PT17/0015/0006), European Regional Development Fund (FEDER) 'A way to make Europe' and granted by Conselleria d’Innovació, Recerca i Turisme del Govern de les Illes Balears (TEC/002/2017). more...
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., This work was funded by the Ministerio de Ciencia, Innovacion y Universidades of Spain and Instituto de Salud Carlos III (PI16/00528, PI16/00946, PI16/01207 and PI16/01276), co-funded by the Spanish Biobank Network (PT13/0010/0030, PT17/0015/0001, PT17/0015/0021, PT17/0015/0049, PT17/0015/0018, PT17/0015/0002, PT17/0015/0016, PT17/0015/0038, PT17/0015/0027, PT17/0015/0004, PT17/0015/0047, PT17/0015/0014, PT17/0015/0041, and PT17/0015/0006), European Regional Development Fund (FEDER) A way to make Europe and granted by Conselleria d'Innovacio, Recerca i Turisme del Govern de les Illes Balears (TEC/002/2017). more...