SBIR Phase I: A Novel Immunoassay Platform for Faster and More Accurate Protein Detection

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) proposal will be the development of a simplified testing method for measuring the concentration of specific proteins within a sample for diagnostic testing. In recent years, protein quantification has begun to play an increasingly important role in medical diagnostics, academic research, and pharmaceutical development, industries that together represent a $13.8 billion global market. In each of these areas, additional steps directly contribute to 5 of the top 8 factors driving the transition to new methods including: increased error, longer testing time, higher technician costs, decreased throughput, and added complexity. The proposed technology addresses each of these areas in a broadly applicable fashion by reducing the overall number of steps by up to 50% using materials that are estimated to contribute to a mere 1% increase in the cost of each test. This is particularly relevant to the medical diagnostic industry, where speed and accuracy have an immense effect on patient treatment and therapy success. Further, the reduction in test complexity represents a key factor enabling the development of portable devices with the potential to allow for new domestic applications as well as increased access to medical testing in third world countries. This SBIR Phase I project proposes to develop a broadly applicable label-based immunoassay platform with fewer steps than conventional immunoassays. It is a well-established problem in the field that label-based immunoassays require independent antigen and detection antibody binding steps, and that single step label-free immunoassays provide significantly lower sensitivity. The proposed project aims to develop an alternative to the conventional sandwich immunoassay, which uses intramolecular binding kinetics to combine antigen and detection antibody binding steps in a fashion which allows for label based target detection following a single incubation of typical duration. This method will be initially studied using streptavidin-biotin binding as a model system to optimize complex formation and demonstrate fluorescent-based detection following a single incubation. This platform will then be applied to antibody mediated detection of the myocardial infarction indicator cardiac troponin I. This system will then be evaluated in comparison with the conventional sandwich immunoassay. At the conclusion of this research, the goal is to provide proof-of-concept data for a simplified immunoassay platform with the potential to combine immunoassay steps to provide up to two-fold improvements in speed, technician time, accuracy, throughput, and complexity.