A NANOeSPRi-based IVD Assay for Multiple Organ Injury

D. Patel, J. Obliosca, G. Zhang, Z. Zhou
Luna Innovations Inc.,
United States

Keywords: surface plasmon resonance imaging, biomarker, organ injury, in vitro diagnostic


Major organ injuries such as liver, kidney, heart and lung injuries can lead to high morbidity and mortality in critically ill patients. An advanced noninvasive testing with high sensitivity and specificity is needed to detect specific organ injury particularly at early stages. Office of the Principal Assistant for Acquisition – USAMRMC requires a multiplex assay to detect a multitude of highly prioritized organ-specific early, predictive, noninvasive biomarkers present in a diverse set of clinical specimens using a single detection platform with high sensitivity and specificity, fast turnaround time, and cost-effectiveness. Current techniques such as PCR, MS, absorption-based assays, ELISA and microfluidic-Luminex, cannot meet such requirements. To address this issue, Luna is developing a multiplex biomarker assay based on nanoenhanced SPRi (NANOeSPRi) technique that is specific and sensitive to a diversity of organ injuries. In this in vitro diagnostic assay, an array of antibody pairs or aptamer pairs that form a sandwich type complex with proteins or microRNAs is used to detect multiple biomarkers simultaneously within a short period of time with significantly improved specificity and limit of detection compared to existing or clinically used tools including ELISA. An assay kit including a biochip and pertinent reagents and buffers will be developed for use in the filed or clinical labs. In Phase I study, Luna has demonstrated the proposed assay with high sensitivity down to 10s pg/mL scale and its multiplexity by the detection of two organ biomarkers simultaneously. The success of this project will result in a diagnostic product that helps both military and civilian hospitals determine whether a patient has organ injury, thereby allowing the possibility to take early curative intervention. This work is supported by the US Army Medical Research and Materiel Command under Contract No W81XWH-14-C-0146.