Core B, commonly considered by investigators of this P01 as the ?Laboratory Core?, has?and is proposed to continue to provide three separate but highly integrated functions, each representing a critical element to the P01's Projects and ultimately, their collective success. These constituents include: 1) Provide patient consenting, sample collection and access to study subject samples essential for all Projects. Here, the Core will oversee study subject identification, provide appropriate patient consenting, and arrange for sample collection. 2) Standardize sample processing, perform genotyping and clinical laboratory testing, distribute samples to investigators, and offer reliable, secure, high quality specimen storage. Here, Core B will ensure that high quality specimens are obtained through adherence to good laboratory practice (GLP) procedures, computerized sample tracking, biobanking best practices, 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, peripheral blood mononuclear cells (PBMC), DNA, and RNA (as necessary for the needs of the specific Projects). The samples will be securely managed using web-based software (Diabase and Sharepoint) that together, tracks and provides investigators knowledge regarding study subject demographics, collection and annotation of specimens, specimen processing methods, specimen availability, storage, quality assurance and distribution of samples. With this, Core B will provide Projects 1, 2, & 3 with uniformly processed samples in order to optimize multivariate analysis of data across the Program. A second activity for this Core within this aim involves performance of a series of immunologic, metabolic, and genetic based laboratory assays. Specifically, as a routine analysis for all study subjects, the Core will provide: A) immunologic testing for T1D autoantibodies, measurement of type 1 interferon levels (HEK-Blue IFN reporter cells), CBC, and extensive human immunophenotyping (HIP) by flow cytometry; B) metabolic analysis of glucose and HbA1C levels; and C) genetic typing involving the highly innovative Axiom human genotyping array (termed, UFDIchip) analysis that will include HLA typing as well as single nucleotide polymorphism (SNPs) based information relevant to the various Projects in this P01. Importantly, these assays will be performed following clinical laboratory standards; an effectiveness that will be determined by participation in national/international programs to assure QA/QC. For example, the Core's performance in the International Diabetes Autoantibody Standardization Program (IASP) routinely scores with high sensitivity/specificity. 3) Core B will also provide database support for collection and storage of regulatory documents, patient demographic and clinical information, and research data to facilitate investigator access/data analysis within and across all Projects. In sum, we see Core B as both an innovative and highly valuable unit only available through a P01 Core mechanism.
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