Immunoassay platform for single-step detection of analytes in biological fluids for rapid monitoring of antigens, antibodies, and therapeutic drugs.

Anti-TNF (tumor necrosis factor) therapeutics are top-grossing drugs that are a major treatment advancement for inflammatory diseases such as rheumatoid arthritis, inflammatory bowel disease, and Crohn’s disease. Patient blood levels of TNF blockers need routine monitoring to ensure effective therapeutic response and patient safety. The current clinical test for TNF blockers is expensive and time-consuming, requiring cell culturing.

University of Utah researchers have developed an immunoassay platform with customized antibody detection reagents that enables one-step anti-TNF drug monitoring. The immunoassay provides a fluorimetric readout in less than an hour.

Pre-Clinical Validation

• Offers high detection limits of 0.05 to 35,000 ng/ml.
• Provides small sample size requirements and can use low-cost reagents.
• Low-cost plate readers.
• Offers high-throughput capabilities.
• Customizable for detection of any protein-peptide analyte.

Dixon, A. S., Kim, S. J., Baumgartner, B. K., Krippner, S., & Owen, S. C. (2017). A Tri-part Protein Complementation System Using Antibody-Small Peptide Fusions Enables Homogeneous Immunoassays. Scientific Reports, 7(1). doi: 10.1038/s41598-017-07569-y

Kim, S. J., Dixon, A. S., Adamovich, P. C., Robinson, P. D., & Owen, S. C. (2021). Homogeneous Immunoassay Using a Tri-Part Split-Luciferase for Rapid Quantification of Anti-TNF Therapeutic Antibodies. ACS sensors, 6(5), 1807–1814. https://doi.org/10.1021/acssensors.0c02642

Publication Number: US-2018-0172692-A1
Patent Title: Target-Binding Activated Split Reporter Systems for Analyte Detection and Related Components and Methods
Jurisdiction/Country: United States
Application Type: Non-Provisional

Aaron Duffy
(801) 585-1377
aaron.duffy@utah.edu