I-Corps: Multiplexed paper-based test for rapid diagnosis of early-stage Lyme Disease

The broader impact/commercialization potential of this I-Corps project is the development of a low-cost rapid diagnostic tool with the ability to measure multiple health markers in a single test. Development of this platform may benefit the healthcare system by improving the accessibility of diagnostic and prognostic testing that requires a panel of measurements.

Specifically, there is potential for an early-stage Lyme disease (LD) diagnostic. Approximately 300,000 people contract LD each year, incurring a $1.3 billion cost to the medical system. Unfortunately, much of the societal and economic costs of LD stem from misdiagnosis due to the low sensitivity of the current Centers for Disease Control (CDC)-recommended testing protocol, which is typically <50% for the early-stage of disease, a time when many patients seek care.

Therefore, the commercialization of an accurate and rapid test may provide a low-cost yet effective tool for identifying early-stage infection at the point-of-care, leading to faster and more effective treatment. The results from this potential I-Corps project also may benefit the diagnostics and medical community by demonstrating the value of a data-driven approach to multiplexed rapid testing.

This I-Corps project is based on the development of a point-of-care diagnostic assay for early-stage Lyme disease (LD). Previously, the design and validation of a low-cost, paper-based vertical flow assay (VFA) was completed. Unlike standard rapid testing formats, the proposed VFA technology enables the point-of-care measurement (from patient blood) of a large panel of antibodies specific to the early-stage LD infection.

A data-driven diagnostic algorithm is then used to infer a LD diagnosis from the panel of measurements, enabling sensitive and specific testing of suspected early-stage Lyme patients across a diverse population with varying immune responses. An initial peer-reviewed clinical study of the prototype assay and diagnostic algorithm reported sensitivity and specificity of 87.5% and 96.7%, respectively, when compared to a rigorous clinical gold standard using all early-stage LD samples.

These initial technical results show potential for effective early-stage LD diagnosis at the point-of-care, enabling faster and more effective treatment that could mitigate debilitating late-stage symptoms and associated costs to the healthcare system.

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.