Microfluidic Serologic Assay for Point of Care Detection

Human papillomavirus (HPV) infection has a large burden on society. It is a causal agent of 99.7% of all cervical cancer cases. The prevalence of HPV infection worldwide is high, but the burden of HPV infections lies on less developed regions. Cervical cancer is not associated with immediate symptoms, screening methods are needed to detect HPV disease presence before lesions progress to cervical cancer. Protein biomarkers are a growing area of diagnostic medicine and facilitate the detection of disease at an early and treatable stage. Technologies for healthcare diagnostics often require laboratory space or expensive instrumentation, which are not feasible for point of care applications. In order for clinical diagnostics to advance in developing countries, low cost, rapid, portable, and easy to use point of care diagnostic tests are needed. The project adapts the Enzyme Linked Immunosorbent Assays (ELISA) and Nucleic Acid-Programmable Protein Array (NAPPA) to a proof of concept assay for use in magnetic bead based microfluidics. The biomarker used for analyte detection was E7, as a strong correlation has been found between presence of E7 antibodies and development of advanced cervical cancer. It is demonstrated that magnetic microfluidic assay design for rapid detection of antibodies is amenable to fluorescence detection in point of care settings. The data demonstrates that the microfluidic assay is rapid, low-cost, specific, and relevant to serology detection. The assay detects antibody responses to analytes with the point of care reader system and is realized in an on chip capacity. With the integration of anti-GST capture antibodies conjugated to the magnetic beads in the microfluidic system, many analytes can be detected without large changes to the existing assay structure, which gives the ability to adapt the system to analytes of interest rapidly.