PFI-TT: A Rapid Multiplexed Diagnostic Tool for Serology of Tick-Borne Diseases

This Partnerships for Innovation - Technology Translation (PFI-TT) project seeks to improve blood-based detection of tick-borne diseases (TBDs) through an innovative, multiplexed, serological point-of-care (POC) assay. Addressing a critical gap in current TBD diagnostic methods, this project will develop a comprehensive platform for Lyme disease, Babesia, Anaplasma, and relapsing fever. By encompassing different TBDs co-located in similar geographical areas, the platform provides a single test solution to determine exposure to multiple TBDs, thus capturing a significant segment of the available market. The simplicity and affordability of the tool make it beneficial for resource-limited and rural areas, most impacted by TBDs. Furthermore, the platform is expected to have significant societal and healthcare benefits, allowing patients and physicians to conduct timely testing to measure immune response against multiple TBDs, which is critical in determining patient care and treatment regimens. The commercial potential of this project lies in filling a substantial market need for comprehensive and cost-effective TBD diagnostics, promising widespread adoption in various healthcare settings, including clinics and field-stations. By enhancing scientific understanding and technology in the medical diagnostics field, this project aligns with the broader goal of improving global health. This project focuses on the development of a POC, multiplexed, serological assay capable of detecting multiple TBDs simultaneously. The technology addresses the challenge of cross-reactivity, co-infection of different TBDs in endemic regions and limited sensitivity and specificity in current serological tests. By integrating specific antigen epitopes for various TBDs into a single multiplexed assay and employing advanced machine learning algorithms, this solution aims to significantly enhance serodiagnostic accuracy. The research involves iterative epitope selection and optimization of the paper-based immunoreaction platform comprising the multiplexed panel. The technology also involves developing a robust, machine learning-based diagnostic algorithm to analyze different biomarker-specific signals into interpretable and actionable diagnoses that can be used by physicians to treat patients. This project addresses the current lack of a point-of-care (POC) multiplexed test for TBDs, where patients typically require multiple tests at different centralized labs. The project's anticipated outcomes include improved serodiagnostic capabilities for various TBDs, contributing significantly to the fields of medical diagnostics and public health, particularly in areas with a high prevalence of tick-borne infections. 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.