Multiplexed enzyme-linked immunosorbent assay workstation for clinical research

用于临床研究的多重酶联免疫吸附测定工作站

• 批准号: 10413539
• 负责人: NEAL S FEDARKO
• 金额: $ 6.5万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-15 至 2023-08-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10413539
• 关键词: Acute; Address; Aliquot; Anti-Inflammatory Agents; Antibodies; Biological; Biological Markers; Blood Vessels; Cardiovascular system; Cerebrospinal Fluid; Chronic; Clinical; Clinical Investigator; Clinical Research; Clinical Research Protocols; Complex; Detection; Discipline of Nursing; Enzyme-Linked Immunosorbent Assay; Equilibrium; Funding; Goals; Health; Immune response; Immunoassay; Institutes; Institution; Laboratories; Maryland; Measures; Methodology; Molecular; Participant; Pathway interactions; Plasma; Protocols documentation; Public Health; Reporting; Research; Research Personnel; Research Support; Saliva; Sampling; Sampling Studies; Serum; Services; Signal Pathway; Signal Transduction; Study Subject; Surrogate Markers; System; Testing; Time; Translational Research; United States National Institutes of Health; Universities; Update; Urine; base; biomarker panel; body system; clinical center; cost; instrument; medical schools; multiplex assay; repaired

Project Summary/Abstract. Clinical and translational research relies on surrogate markers measured in biological samples from study subjects and used to address the underlying research questions. The choice of surrogate biomarkers is often limited by the limited sample volume obtainable from subjects and by the increased costs associated with measuring many different biomarkers one at a time. The long-standing goal of the Institute for Clinical and Translational Research Clinical Research Core Laboratory (ICTR CRCL) has been to support research protocols through measuring levels of surrogate markers in study participant samples (blood, serum, plasma, urine, saliva, cerebrospinal fluid). The ICTR CRCL has performed analyses for clinical research occurring at the Johns Hopkins University Schools of Medicine, Nursing, and Public Health, as well as at other regional institutions such as the University of Maryland and the Clinical Center at the National Institutes of Health. Biomarkers have evolved from single measure in a sample aliquot to many measures in a single sample aliquot. These multiplexed assays are comprised of panels of biomarkers that can report on the status of numerous components in complex systems and pathways such as immune responses (the balance of pro- versus anti-inflammatory compounds) and vascular/cardiovascular systems (health versus acute or chronic dysregulation). Since 2007, the Clinical Research Core Laboratory has used a Mesoscale Discovery SI2400 Multiplex Workstation to offer multiplexed immunoassays to clinical investigators. These tests are based on enzyme-linked immunosorbent assay (ELISA) methodology using 96 well plates that have discrete ‘micro-well regions’ within each well coated with specific capture antibodies enabling the capture of multiple analytes from a single sample aliquot in one well. The multiplexed ELISAs have a greater sensitivity and linear range compared to traditional ELISAs because detection is based on an electrochemiluminescent signal as opposed to a colorimetric signal. The SI2400 Multiplex Workstation gave investigators greater options in terms of the identifying biomarkers to utilize as clinical endpoints and enabled more clinical measures to be made in less time for less cost and using smaller volumes of study subject samples. The SI2400 Multiplex Workstation ceased working reliably in 2020 and cannot be repaired. During its 14 years of service the machine yielded ~94,000 reportable results for 63 different clinical research protocols. We are seeking funding for a replacement multiplex workstation. The MESO QuickPlex SQ120MM instrument is an updated version of the SI2400 that will enable the laboratory to continue to provide clinical investigators with the ability to use measures of multiple biomarkers at reducing costs, sample volume requirements and analysis times. This provides clinical investigators with enhanced molecular detail on the status of organ systems and signaling pathways that facilitates advancement of the health-related goals of their research.

项目摘要/摘要。 临床和转译研究依赖于从研究中测量的生物样本中的替代标志物 主题，并用于解决潜在的研究问题。替代生物标志物的选择通常是 受限于可从受试者那里获得的样本数量有限，以及与此相关的成本增加 一次测量一个不同的生物标志物。临床和医学研究所的长期目标是 翻译研究临床研究核心实验室(ICTR CRCL)一直在支持研究 通过测量研究参与者样本(血液、血清、血浆、 尿液、唾液、脑脊液)。卢旺达问题国际法庭CRCL对#年发生的临床研究进行了分析 约翰霍普金斯大学医学院、护理和公共卫生学院以及其他地区 马里兰大学和国立卫生研究院的临床中心等机构。 生物标志物已经从一份样品中的单一测量演变为一份样品中的多个测量 等分。这些多路化验由生物标志物面板组成，这些生物标志物可以报告 复杂系统和途径中的许多组件，如免疫反应(前体脂平衡) 与抗炎化合物相比)和血管/心血管系统(健康与急性或慢性 监管失调)。自2007年以来，临床研究核心实验室使用了中尺度发现SI2400 多路工作站为临床研究人员提供多路免疫分析。这些测试基于 酶联免疫吸附试验(EL ISA)方法使用96个含有离散‘微孔’的孔板 每个孔内的区域都涂有特定的捕获抗体，从而能够捕获来自 一口井中的单一样品等分。多路复用的ELISA具有更高的灵敏度和线性范围 与传统的ELISA相比，因为检测是基于电化学发光信号，而不是 转换成色度信号。SI2400多路复用工作站在以下方面为调查人员提供了更多选择 识别可用作临床终点的生物标记物，从而以更少的成本进行更多的临床措施 时间更短，成本更低，使用的研究对象样本数量更少。SI2400多路传输工作站 2020年停止可靠工作，无法修复。在其14年的使用期间，这台机器产生了 63项不同临床研究方案的约94,000项可报告结果。我们正在为一项 更换多路复用工作站。Meso QuickPlex SQ120 MM仪器是 SI2400，将使实验室能够继续为临床研究人员提供使用 在降低成本、样本量要求和分析时间方面采用多种生物标志物的措施。这 为临床研究人员提供关于器官系统和信号状态的增强的分子细节 促进其研究中与健康有关的目标取得进展的途径。