Multiplexed enzyme-linked immunosorbent assay workstation for clinical research

项目概要/摘要。 临床和转化研究依赖于研究中生物样本中测量的替代标志物 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 受可从受试者获得的有限样本量以及与 一次测量一种不同的生物标志物。临床研究所的长期目标和 转化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品（血液，血清，血浆， 尿液、唾液、脑脊髓液）。卢旺达问题国际刑事法庭CRCL对发生在以下地点的临床研究进行了分析： 约翰霍普金斯大学医学院、护理学院和公共卫生学院，以及其他地区性的 马里兰州大学和国立卫生研究院临床中心等机构。 生物标志物已经从一个样品等分试样中的单一测量发展到一个样品中的许多测量 等分这些多重测定由生物标志物组组成，所述生物标志物组可以报告肿瘤的状态。 复杂系统和途径中的许多组分，如免疫反应（前- 与抗炎化合物）和血管/心血管系统（健康与急性或慢性 失调）。自2007年以来，临床研究核心实验室一直使用Mesoscale Discovery SI 2400 多重工作站为临床研究者提供多重免疫测定。这些测试是基于 酶联免疫吸附测定（ELISA）方法，使用具有离散微孔的96孔板 每个孔内的“区域”包被有特异性捕获抗体， 一个孔中的单个样品等分试样。多重ELISA具有更高的灵敏度和线性范围 因为检测是基于电致发光信号， 比色信号。SI 2400多路工作站为研究者提供了更多的选择， 确定生物标志物用作临床终点，并使更多的临床措施，以更少的时间， 以更少的成本和使用更小体积的研究受试者样品来节省时间。SI 2400多路工作站 2020年停止可靠工作，无法修复。在14年的服役中，这台机器 63种不同临床研究方案的约94，000个可报告结果。我们正在寻求资金， 更换多路复用工作站。MESO QuickScanner SQ 120 MM仪器是 SI 2400，使实验室能够继续为临床研究者提供使用 在降低成本、样品量要求和分析时间的情况下测量多种生物标志物。这 为临床研究者提供关于器官系统和信号传导状态的增强分子细节 促进其研究的健康相关目标的进步的途径。

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.