NSF I-Corps: Wide Working Range Test for the Diagnosis of Immune Mediated Disease in Animals

Delaware State University, Dover DE

Investigators

Abstract

The broader impact/commercial potential of this I-Corps project will be accomplished through helping more than 85 million US pet owners and their pets, as owning a companion animal is associated with improved well-being. The provisional-patent-protected innovation, a single-test immunoassay for pet disease diagnosis, is expected to lead to significant outcomes in the animal healthcare commercial market, with an option of expanding to other markets. This project is based on technology that combines in a single test (such as a paper strip test) the high sensitivity, selectivity and wide working range of the particle immunoassay for diagnosing pets' diseases at various stages. The unique feature of our test is high sensitivity with the incorporated protection against false-negative analytical bias caused by the high dose effect, which is important for the diagnostic accuracy of late- and early-stage disease. The selectivity of the test has been demonstrated to detect about 0.01 Units per milliliter of ovarian cancer biomarker 125 in human blood plasma, with near single-molecule assay selectivity. In the proof-of-concept experiment, the proposed approach was modified based on the heterogeneous-media encapsulation of gold nanoparticles modified with biotin and iron oxide microparticles modified with streptavidin. This test offers significant competitive advantages over existing technologies: it can be used for early- and late-stages of disease; manufacturing and operational costs are low, based on a cheap point-of-care application; and it offers the possibility of detecting multiple modalities of disease in one test. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.