Core B

核心摘要/摘要 核心B，通常被本P01的研究者视为"实验室核心"，已. 继续提供三个独立但高度一体化的职能，每个职能都是 P01的项目，最终，他们的集体成功。这些要素包括：1）提供患者 同意、样本采集和获得研究受试者样本对所有项目至关重要。在这里，核心 将监督研究受试者识别，提供适当的患者知情同意书，并安排样本 收藏. 2)标准化样本处理，进行基因分型和临床实验室检测，分发 为研究人员提供样本，并提供可靠、安全、高质量的样本存储。在此，核心B将确保 通过遵守良好实验室规范（GLP）程序获得高质量样本， 计算机化样本跟踪、生物库最佳实践、存储以及应急响应规划， 训练有素的工作人员。核心将定期储存作为项目一部分采集的样本，包括血清、血浆， 外周血单核细胞（PBMC）、DNA和RNA（根据特定的需要）。 项目）。样本将使用基于网络的软件（Diplomat和Sharepoint）进行安全管理， 一起跟踪并向研究者提供关于研究受试者人口统计学、收集和 标本注释、标本处理方法、标本可用性、储存、质量保证和 样品的分布。据此，核心B将向项目1、2和3提供统一处理的样品， 以优化整个程序中数据的多变量分析。本核心的第二项活动是 目的是进行一系列基于免疫学、代谢和遗传学的实验室测定。 具体而言，作为所有研究受试者的常规分析，核心将提供：A）T1D的免疫学检测 自身抗体，1型干扰素水平（HEK-Blue IFN报告细胞）的测量，CBC，以及广泛的 通过流式细胞术进行的人免疫表型分析（HIP）; B）葡萄糖和HbA1C水平的代谢分析;和 C）基因分型，涉及高度创新的Axiom人类基因分型阵列（称为UFDIchip）分析 这将包括HLA分型以及基于单核苷酸多态性（SNP）的相关信息， P01中的各种项目。重要的是，这些试验将在临床实验室检查后进行。 标准;有效性将通过参与国家/国际计划来确定，以确保 QA/QC。例如，核心在国际糖尿病自身抗体标准化中的表现 程序（IASP）常规评分具有高灵敏度/特异性。3)核心B还将提供数据库支持 用于收集和存储监管文件、患者人口统计学和临床信息以及研究 数据，以便于研究者在所有项目内和项目间访问/数据分析。总之，我们将核心B视为 这是一个创新的和非常有价值的单位，只有通过P01核心机制。

CORE SUMMARY/ABSTRACT 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.