STTR Phase I:Low-Cost Quantitative Lateral Flow Assay for Cytokine Release Syndrome Detection in Point-of-Care/Point-of-Need Settings

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is a biosensing technology that may enable highly sensitive, quantitative, point-of-care diagnostics. Once validated, the proposed biosensor, disposable sensor chips/cartridges, and electronic readout modules can be readily mass-produced using existing medical device manufacturing capacities. The technology may have an impact on the health and welfare of patients. The immediate goal is to examine interleukin protein monitoring for early detection of cytokine release syndrome, a potentially life-threatening health complication that develops in patients undergoing immunotherapy treatment, organ transplant, infectious disease, sepsis, etc. Additional applications include early detection of cancers or cancer recurrence, dry eye disease, existing and emerging infectious disease, biothreats, etc.This Small Business Technology Transfer (STTR) Phase I project is a proof-of-concept demonstration of a low-cost, magnetic biosensor technology that may enable analytical laboratory capabilities for reliable biomarker detection and quantitation at the point of care. The proposed biosensor will be adapted for quantitative detection of interleukin proteins in blood for early diagnostics of cytokine release syndrome. The technology integrates magnetic sensing into the ubiquitous lateral flow assay (LFA) format (used in pregnancy tests) utilizing magnetic nanoparticles as reporters of biomolecular interactions. The tests are well-suited for point-of-care applications where rapid and convenient access to low-cost diagnostic tools helps improve patient care. The rationale for this project is that the proposed biosensors can provide clinically-relevant quantitative data rivaling those of state-of-the-art laboratories while preserving the advantages of LFA tests in terms of low cost and ease of use. The disposable chip with its clam-shell design builds upon the usual LFA cassette design. The disposable chip will be produced and assembled from low-cost printed circuit board (PCB) manufacturing and is expected to add only cents to the cost of an LFA test. A low-cost portable reader capable of ultrahigh sensitivity quantitative readings will be built from conventional off-the-shelve electronic components.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.