Biomarker Core

生物标志物核心：摘要/摘要 生物标志物核心在两个主要领域支持ADNI研究。首先是生物流体样本管理： (a)保存高度注释的生物流体等分试样样本，这些样本的收集、处理和储存符合雅阁， ADNI样品制备和在宾夕法尼亚大学ADNI生物库的专用冰柜中储存方案， 24/7持续监测;（B）帮助组织和参与正在进行的标准化研究 分析前样品采集方案（尤其是最近的血浆）和测量方法 AD生物流体生物标志物;以及（c）组织ADNI生物流体样品并将其转移给其生物标志物 资源分配审查委员会（RARC）批准了一项研究， ADNI生物流体样品使用先进的分析平台，从而丰富ADNI生物流体生物标志物 简介第二个主要的责任领域是为最坚固和有效的 用于生物标志物核心中进行血浆生物标志物检测的方法学。推荐建议将 与ADNI PI协商完成，并由学术和PPSB工业生物标志物科学家提供投入， 分析供应商，并通过“头对头”比较研究的结果进一步通知。一旦决定 该平台将在生物标志物核心实验室实施，以进行血浆生物标志物检测 所有非临床4,000例抽血个体中的Aβ和ptau以及其他候选生物标志物 由Quest Diagnostics和所有诊所内ADNI参与者以及超过11，720名“传统”ADNI组织 2,582人的血浆样本。所有这些努力将提供高度标准化的数据， 用于AD疾病检测和疾病预测的多模式生物标志物关系的评估 按照项目中计划和描述的进度。 总之，生物标志物的核心目标是：1。从ADNI研究中心获取生物流体样本，全天候处理和储存 并将样本转交给RARC批准的调查人员2.在测试方法标准化方面进行合作 测试性能多中心研究。这包括实验室间的“头对头”评估研究， Aβ PET测量的候选人淀粉样斑块负荷的分析性能和预测准确性 用于血浆Aβ和ptau测量的分析平台和试剂。3.分析方法的选择 和平台以及在生物标志物核心中的实施。4.与项目和生物统计学的合作 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.