MiCRIA: Two-minute rapid assay platform for point-of-care diagnosis

PROJECT SUMMARY Point-of-care testing has become one of the most rapidly growing fields in medicine, stimulated in recent years by the COVID-19 pandemic, but driven by the fundamental benefit that enabling healthcare workers to obtain actionable diagnostic results in the patient's presence provides. Current point-of-care testing to detect the presence of antibodies or antigens as biomarkers of disease is dominated by lateral flow assay technology, which relies on methods established several decades ago. While simple to perform, lateral flow assays are the end product of a complex development process relying on sophisticated and costly instrumentation and the precise assembly of multiple material components. Scaling up lateral flow tests to commercial volumes requires specialty equipment and infrastructure, and is a bottleneck constraining the ability of many smaller assay developers to bring new point-of-care tests to commercial launch, hindering useful applications in public health. We have developed a novel point-of-care assay technology termed Magnetic Capture Rapid Immunoassay (MiCRIA™) that relies on principles that differ from those of lateral flow, and offers a sample-to-answer turnaround time of 2 minutes, significantly faster than most currently available methods. Sensitivity is greater than lateral flow and approaching ELISA. MiCRIA™ utilizes a microfluidic approach that simplifies the assay development process as well as scale up for production. Development of a new assay requires modification of only one reagent, while the basic assay component is a generic device that can be produced inexpensively in volume. Assay reagent production is a bulk process that can be scaled up to millions of units without requiring any specialized equipment, and that can be done on a benchtop in a matter of days by a skilled technician. A compact, low-cost reader reads the result and transmits it to a smartphone or other device for interpretation and data handling. Assay components can be made available to third party developers to create a new point-of-care ecosystem free of the constraints of lateral flow scale up, opening up the point-of-care diagnostics market to a broader global community of assay developers and users. Applications of the new assay technology include infectious and non-infectious disease testing, and any assay aimed at detection of antibodies, antigens, or nucleic acids. In this Phase I project, we will develop and establish the feasibility of the MiCRIA™ technology by demonstrating its application to the rapid detection of Chagas disease antibodies in a point-of-care diagnostic test. The MiCRIA™ Chagas test will address the need for more accessible testing for Chagas, which is the most prevalent parasitic disease in the western hemisphere, but with only 10% of cases currently diagnosed. Sensitivity and specificity of detection using the MiCRIA™ Chagas test will be compared with FDA-approved ELISA assays for Chagas disease. Establishment of feasibility through this project will pave the way for further development of the MiCRIA™ Chagas test and for MiCRIA™ as an open point-of-care platform with broad applications.