Core B

核心摘要/摘要 核心B，通常被本P01的调查人员认为是“实验室核心”，具有…并建议将其 继续提供三个独立但高度集成的功能，每个功能代表 S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、样本采集和获取对所有项目至关重要的研究对象样本。在这里，核心 将监督研究对象的确定，提供适当的患者同意，并安排样本 收集。2)规范样品处理，进行基因分型和临床实验室检测，分发 向调查人员提供样本，并提供可靠、安全、高质量的样本存储。在这里，核心B将确保 通过遵守良好的实验室操作规范(GLP)程序获得高质量的标本； 计算机化的样品跟踪、生物库最佳做法、存储以及应急规划，由 训练有素的员工。核心将例行存储作为计划的一部分收集的样本，包括血清、血浆、 外周血单个核细胞(PBMC)、DNA和RNA(根据特定需要而定 项目)。这些样本将使用基于Web的软件(Diabase和Sharepoint)进行安全管理 一起，跟踪并向调查人员提供关于研究对象人口统计、收集和 标本注释、标本处理方法、标本可获得性、储存、质量保证和 样本的分布。为此，核心B将向项目1、2和3提供统一处理的样品 以优化整个计划中数据的多变量分析。此核心的第二个活动 AIM涉及一系列基于免疫学、代谢和遗传的实验室分析。 具体地说，作为所有研究对象的常规分析，核心将提供：a)T1D的免疫学测试 自身抗体、1型干扰素水平的测量(HEK-Blue干扰素报告细胞)、CBC和广泛应用 人类免疫表型(HIP)流式细胞术；B)葡萄糖和HbA1C水平的代谢分析；以及 C)涉及高度创新的Axiom人类基因分型阵列(称为UFDIChip)分析的基因分型 这将包括人类白细胞抗原分型以及基于单核苷酸多态(SNPs)的相关信息 本P01中的各种项目。重要的是，这些化验将在临床实验室之后进行 标准；有效性将由参与国家/国际方案来确定，以确保 QA/QC。例如，CORE在国际糖尿病自身抗体标准化中的表现 程序(IASP)常规评分具有很高的敏感性/特异性。3)核心B还将提供数据库支持 用于收集和存储法规文档、患者人口统计和临床信息以及研究 数据，以方便调查员在所有项目内部和跨项目进行访问/数据分析。总而言之，我们认为核心B是 这是一个创新和极具价值的单位，只能通过P01核心机制提供。

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.