A Novel, Hand-Held, Fast, Small Volume Blood Diagnotstics Device to Correlate Biomarkers with Mild Cognitive Impairment and Alzheimer's Disease

Nearly 44 million people worldwide suffer from Alzheimer’s Disease (AD), a progressive, neurodegenerative disease that destroys critical brain functions. AD has become the 6^th leading cause of US deaths and is one of the most expensive conditions to care for, costing ~ $300 M/year. Diagnosing AD early on and monitoring is key to slow AD’s progression. Early detection during the Mild Cognitive Impairment (MCI) phase is critical as drug treatments and cognitive therapy are then more effective. AD diagnostic methods are limited. They include first self-reporting or reporting by those close to the patient. This is often inefficient and delays treatment past the critical phase of MCI. AD can be confirmed by spinal tap and complex brain imaging. Recently, blood methylglyoxal (MGO) levels were found to correlate significantly with AD¹ and in patients who develop MCI leading to AD². This makes MGO a potential biomarker for early diagnosis of MCI when it is a precursor to AD. Hence, the present work aims to prototype a novel, hand-held, fast, inexpensive, and accurate Small Volume Blood Diagnostics (SVBD) device, Alz-BioSs™, to test for the presence MCI via MGO levels and help monitor the impact of treatments on a regular basis. Alz-BioSs™ aims to help diagnose and then monitor MCI and AD during the MCI precursor phase to provide patients a greater chance for effective treatments. Alz-BioSs™ measures MGO in blood plasma by collecting a 0.5 mL blood drop into a single-use microfluidic chip for rapid, passive separation of plasma from blood. Extracted 0.2-0.3 mL plasma reacts then into an adjacent chip coated with bio-reagent o-phenylenediamine (OPD) and gold nanoparticles (AuNP). The resulting colorimetric reaction is detected via a miniature optical cage system (OCS) using LEDs and photodetectors to quantify MGO levels via photo-absorption, akin to some handheld blood glucose monitor used for diabetes monitoring.