Abstract
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.
Highlights
Human tissue samples obtained from biopsies, surgical specimens, organ transplants and autopsies are a great resource to find potential targets to aid clinical decisions such as diagnosis and treatment of diseases
We propose to carry out a first staining process with Vimentin and CD31 antibodies without antigenic reconstitution
In the case of rare diseases, only collaborative approaches make it possible to collect a relevant number of samples with high quality associated clinical data [97, 98], while it is essential for any collection that the quality of samples remains homogenous
Summary
Human tissue samples obtained from biopsies, surgical specimens, organ transplants and autopsies are a great resource to find potential targets to aid clinical decisions such as diagnosis and treatment of diseases. Research on disease biomarkers is one of the main requirements for the progress of personalized medicine and its use for targeted therapies [2,3,4,5] This clinical approach, in Oncology, allows a great number of patients to access more efficient and safer therapeutic protocols, which have been selected according to molecular findings in tissue samples obtained from patients for diagnostic or therapeutic purposes. Most of them cannot be applied to clinical practice due to a lack of high sensitivity or/and specificity, compromising its reproducibility and its successful clinical implementation [7] In this context, the recruitment of subjects, as well as the selection and management of tissues, is critical in biomarker research [8, 9]
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