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Author: us4cure

Biological, Medical, and Other Tissue Variables Affecting Biospecimen Utilization Abstract

This review discusses the technical characteristics of biospecimens that can cause morphological and molecular variability and/or limit the usefulness of biospecimens in research.

This article also describes current challenges related to biospecimen characteristics that may affect biospecimen utilization. These include inadequate awareness of investigators about the availability of biospecimens with specific morphologic and molecular features, donor variability, preanalytical variables, technical problems inherent with an investigator’s request for biospecimens, limited tissue availability from a biorepository based on requested sizes and/or numbers of available biospecimens, effects of times of warm and cold ischemia, damage of tissues during surgery, and molecular changes during storage. To ensure maximal biospecimen utilization of all types of biospecimens requires continual education of investigators from diverse fields, particularly on factors that cause variability in the morphological and molecular characteristics of tissues.

The investigators’ requests for biospecimens and associated data should be reviewed carefully, including by a bioresource-associated pathologist. Queries arising from the request/application form should be resolved by bioresource personnel directly with the investigator.

The Importance of Human Tissue Bioresources in Advancing Biomedical Research

“… the provision to investigators of high-quality human tissues by biobanks/bioresources has been critical to advancing biomedical research and science as well as improving medical care, especially of patients with cancer. Bioresources have been central to biomarker discovery and precision medicine, including diagnostics and targeted therapies. Investigators need access to bioresources that can provide high-quality and consistent biospecimens linked to reliable clinical and pathological information. Because research directions are constantly evolving, bioresources must adjust to provide biospecimens necessary to generate preliminary data for novel grants, as well as to establish reproducible results for key articles; also, the biomedical research data should lead to improvements in patient care. Thus, biorepositories are a critical component of the research infrastructure.”

Diffalha et al., 2019 The Importance of Human Tissue Bioresources in Advancing Biomedical Research.

Quality Assurance in Tissue Resources Supporting Biomedical Research

 “…Monitoring the quality and diagnoses of the actual tissues provided for research (i.e., quality control) is a very important component of the QA program. Tissue facilities have used various forms of QC to aid investigators with their studies in order to ensure that the tissues and associated information provided meet the needs of the investigator (13). Many tissues, especially tumors, are heterogeneous; thus, specimens from tumors vary as to the extent of neoplastic cells, mucin production, inflammatory cells and/or necrosis. Fibrosis in and adjacent to tumors may be intermixed with or mistaken for tumor and some tumors may diffusely infiltrate normal tissues making areas of tumor difficult to identify grossly. Therefore, in general, just knowing the diagnosis of a patient from whom tissues are obtained is not adequate quality control for tissues provided for research… Typically in the QC examination, the proportion (percent) of the specimen that is diseased is specified along with the percent necrosis/fibrosis of the diseased areas as well as the percent of other factors such as mucin formation…

2. Cell Preserv Technol. 2008 Jul 30; 6(2): 113–118.  doi: 10.1089/cpt.2008.9993.

 “The quality control examination also can be in part based on “molecular quality control” in which mRNA, DNA and protein are extracted from small aliquots followed by molecular characterization of the molecules using various analytical methods ranging from mass spectrometry or gene arrays to examination of ribosomal bands of RNA using gels (5) or other systems such as the Agilent 2100 System”

 “The QA of bodily fluids primarily involves selecting the parameter of collection, processing and storage, and incorporating these into SOPs. It is also important to avoid bias in the selection of patients and in the collection, processing and storage of the specimens (6).