Microfluidics-Enabled Automated Immunoassay Devices for Rapid Point-of-Care Diagnostics
Open Access DepositedThe evolution of point-of-care (POC) diagnostics, aimed at delivering rapid and accurate results directly at the site of patient care, represents a paradigm shift in medical diagnostics. Immunoassays are biochemical tests that rely on the reaction between an antibody and an antigen to detect and quantify specific substances, including proteins, hormones, and pathogens. With the objective of providing timely and precise diagnostics and treatment for patients, immunoassays are employed for the detection of a broad spectrum of diseases. This includes chronic diseases such as diabetes and heart diseases, as well as infectious diseases like HIV and hepatitis C. While 96-well plate-based assays are dominant in clinical settings for their sensitivity and high throughput capabilities, they often require substantial equipment and processing time, limiting their POC applicability. Conversely, Lateral flow immunoassays (LFIA), characterized by their simplicity, cost-effectiveness, and rapid results, fall short in sensitivity and quantification, particularly for early-stage disease detection.This dissertation addresses some of the foremost challenges faced by current immunoassays in POC settings, including their complexity, extensive duration, substantial equipment requirements, high costs, and inefficiencies in antigen capture. By developing and evaluating two devices – a cartridge-based handheld automated microfluidic immunoassay system and a microfluidic cover designed for integration with standard 96-well plates – this research facilitates the timely and accurate diagnosis, marking a step forward in the field of point-of-care diagnostics. Additionally, this work presents a mathematical model and simulation method, validated with experimental data, to offer a framework for immunoassay design and performance prediction. This model enhances the predictability and optimization of immunoassay designs, broadening the scope of POC testing across various biomedical applications. The significance of this research lies in its potential to overcome the existing limitations of POC immunoassays by leveraging microfluidic technology, numerical modeling, and advanced fabrication technologies. By addressing the challenges of complexity, cost, and low antigen capture efficiency inherent in current POC settings, this dissertation proposes a path toward developing high-sensitive, low-cost, and user-friendly immunoassay systems that could elevate POC testing to new levels of sensitivity, accuracy, and accessibility.
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