Multiplexed enzyme-linked immunosorbent assay workstation for clinical research

项目总结/抽象。

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.