Biomarker Core

生物标志物核心：综述/摘要 Biomarker Core在两个主要领域支持ADNI的研究。第一个是生物流体样本管理： (A)保持高度注解的生物流体等分样本，这些样本是按照以下标准收集、处理和储存的 美国宾夕法尼亚大学ADNI生物库专用冰柜中的ADNI样品制备和存储方案 全天候持续监测；(B)帮助组织和参与致力于标准化的持续研究 分析前样品采集方案(特别是最近的血浆)和测量方法 AD生物流体生物标记物；以及(C)整理和转移ADNI生物流体样本给其生物标记物的调查人员 资源分配检讨委员会(RARC)批准进行一项研究，以测量 使用先进的分析平台采集ADNI生物流体样本，从而丰富ADNI生物流体生物标记物 简介第二个主要职责领域是推荐最坚固和有效的 在Biomarker Core中用于进行血浆生物标记物测试的方法。该建议将是 与ADNI PI协商，并在学术和PPSB工业生物标记科学家的投入下完成， 化验供应商，并进一步从“面对面”比较研究的结果中了解情况。一旦做出关于 平台搭建完成后，将在Biomarker Core实验室进行血浆生物标志物检测 在所有4,000名非临床抽血者中检测Aβ、PTAU和其他候选生物标记物 由Quest Diagnostics和所有门诊ADNI参与者以及11,720多名传统ADNI组织 来自2582个人的血浆样本。所有这些工作都将提供高度标准化的数据，用于 用于AD疾病检测和预测的多模式生物标志物关系的评估 进度，如项目中计划和描述的。 总而言之，BiomMarker的核心目标是：1.从ADNI现场获取生物流体样本，全天候处理、存储 并将样本移交给经RARC批准的调查人员。2.在测试方法标准化方面开展合作 测试-性能-多中心研究。这包括“面对面”评估的实验室间研究。 β正电子发射计算机断层扫描测量候选斑块负荷的分析性能和预测精度 用于血浆A、β和PTAU测量的分析平台和试剂。3.分析方法的选择 和平台(S)以及在Biomarker Core中的实施。4.与项目和生物统计合作 以建模和分析为核心。

Biomarker Core: Summary/Abstract The Biomarker Core supports the ADNI study in two main areas. The first is biofluid sample management: (a) maintains highly annotated biofluid aliquot samples that are collected, processed and stored in accord with ADNI sample preparation and storage protocols in dedicated freezers in the ADNI Biobank at UPenn and continuously monitored 24/7; (b)helps to organize and participate in ongoing studies devoted to standardization of pre-analytical sample collection protocols (especially plasma most recently) and methods for measurement of AD biofluid biomarkers; and (c) organizes and transfers ADNI biofluid samples to investigators whose biomarker study was approved by the Resource Allocation Review Committee (RARC) to measure new biomarkers in ADNI biofluid samples using advanced analytical platforms and thereby enrich the ADNI biofluid biomarker profiles The second major area of responsibility is to make a recommendation for the most rugged and effective methodology for use in the Biomarker Core to perform plasma biomarker testing. The recommendation will be done in consultation with the ADNI PI, and with input by academic and PPSB industrial biomarker scientists, assay vendors, and further informed by results from “head to head” comparison studies. Once the decision on platform is made it will be implemented in the Biomarker Core laboratory to perform plasma biomarker testing for Aβ and ptau and other candidate biomarkers in all of the non-clinical 4,000 individuals with blood draws organized by Quest Diagnostics and all the in-clinic ADNI participants and more than 11,720 “legacy” ADNI plasma samples from 2,582 individuals. All of these efforts will provide highly standardized data for use in the assessments of multimodal biomarker relationships for AD disease detection and prediction of disease progression, as planned and described in the Project. In summary, the Biomarker Core Aims are to: 1. Obtain biofluid samples from ADNI sites, process, store 24/7 and transfer the samples to investigators approved by RARC. 2. Collaborate on test methods standardization in test-performance-multicenter-studies. This includes interlaboratory studies of “head-to-head” assessments of analytical performance and prediction accuracy for Aβ PET measured amyloid plaque burden for candidate analytical platforms and reagents for plasma Aβ and ptau measurements. 3. Selection of analytical methods and platform(s) and implementation in the Biomarker Core. 4. Collaboration with the Project and Biostatistics Core on modeling and analyses.