A Hand-Held, Fast, Small Volume Blood Diagnostics Device for MethylGlyoxal, a Biomarker for Alzheimer's Disease's Mild Cognitive Impairment Stage

Around 44 million people worldwide suffer from Alzheimer's Disease (AD). AD is a progressive, neurodegenerative disease that destroys critical brain functions. AD is the 6th leading cause of US deaths and one of the most expensive conditions to care for, at about $0.3 B/year. Diagnosing AD early and monitoring its progression are key for potential treatments to be effective. Early detection of the Mild Cognitive Impairment (MCI) stage, the clinical stage preceding early AD, is critical for drugs and cognitive therapy to be impactful. AD diagnostics are presently limited. Most commonly, self-reporting or reporting by those close to the patient is often inefficient and delays treatment past the critical phase of MCI. AD can be confirmed by spinal tap and advanced brain imaging, which are invasive and expensive, respectively. In 2019, methylglyoxal (MGO) levels in blood serum were found to correlate significantly with MCI preceding AD, making MGO a potential biomarker for the diagnosis of MCI when it is a precursor to AD. The present work prototypes a novel, hand-held, fast, inexpensive, and accurate Small Volume Blood Diagnostics (SVBD) device-akin to glucometers- called Alz-BioSs™, to measure MGO levels when MCI is present and also potentially help monitor the effect 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 with a greater chance for early and 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. The resulting 0.2-0.3 mL of plasma then reacts with 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.