Core B. This Core will provide three separate but highly integrated functions, with each component representing a critical element to the P01's Projects. First is a biorepository function;a unit within the University of Florida's NIH funded CTSI Biorepository. Here, the Core will validate proper patient consenting, tissue procurement, sample processing, storage and distribution. Core B will ensure that high quality specimens are obtained through adherence to GLP procedures, computerized sample tracking, biobanking best practices, automated storage, as well as emergency response planning by trained staff. The Core will routinely store samples collected as part of the Program, including serum, plasma, PBMCs, DNA, RNA and urine (if ever deemed necessary). The samples will be securely managed using web-based software including the OnCore Biospecimen Management System that tracks patient consent, patient visits, collection and annotation of specimens, specimen processing, storage, quality assurance and distribution of samples. With this, the Core should provide Projects 1 and 2 with a uniformly processed aliquot of a sample in order to optimize multivariate analysis of data across the Program. A second activity for this Core involves service by the Immunology/Pathology Laboratory. Here, as a routine analysis for subjects enrolled in this study, the Core will provide autoantibody (i.e., GADA, IA-2A, and ZnT8A) analysis using commercially available kits, and mlAA by standard assay. The Core's performance in the Diabetes Autoantibody Standardization Program routinely scores with high sensitivity/specificity. Additional services will include HLA typing and overseeing the highly innovative immunochip analysis. Finally, the Core will provide Molecular Pathology services. This laboratory serves as a key element to the JDRF Network for Pancreatic Organ donors with Diabetes (nPOD) effort. Core B will provide paraffin and frozen section preparation, histology, quantitative morphology, immunolocalization (IHC, IF, ISH) and e-storage of microscopic images. We see Core B as both an innovative and highly valuable unit only available through a PPG Core mechanism.
Core B will provide quality samples, as well as a comprehensive laboratory data storage/analysis function;both deemed essential to high quality research. In addition, the Core has established standard operating procedures (GLP grade) and trained personnel to ensure high quality performance. Core activities will also help integrate Projects within the POI;increasing its value and potential to deliver on its goals.
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