BME PhD Preliminary Exam announcement for Luke Brennan (J. Linnes and N. Rodriguez, co-advisors) Everyone is invited to attend the public presentation beginning at 11:00am. Title: HPV RAPID DIAGNOSTIC TEST DEVELOPMENT THROUGH HUMAN-CENTERED DESIGN Date: January 25, 2023 Time: 11:00am Location: MJIS 2001 or https://iu.zoom.us/j/5867035107 Advisory Committee: Jacqueline Linnes Ph.D., Co-Chair Natalia Rodriguez Ph.D., Co-Chair Aaron Ermel M.D. Monica Kasting Ph.D. Mohit Verma Ph.D. Abstract: Almost every case of cervical cancer in the United States is medically preventable with proper screening, yet many Americans are insufficiently screened. Over 12 thousand American women suffered from cervical cancer in 2018 causing 4 thousand deaths, with over a third in women who had never received a routine screening test. New, sensitive testing techniques have started to facilitate self-sampling at outpatient clinics and mail-in testing, which ameliorate some barriers to screening. Screening with a rapid diagnostic test (RDT), which can be performed in a variety of settings to deliver results in minutes, could further increasing screening uptake and follow-up care delivery. The goal of this project is to create a sample-to-answer RDT for cervical cancer screening. In the first aim we use interviews and a survey to explore clinician perspectives on current and newly proposed cervical screening methods such as self-sampling, RDTs, and home-based screening. This will result in a user-informed set of technical specifications for device design. The second aim augments a recombinase polymerase assay that isothermally amplifies any of 13 high-risk human papillomavirus (hrHPV) strains with an endogenous *-globin sample control and a simple colorimetric lateral flow assay (LFA) readout. The third aim incorporates this assay onto a paper-based device with a simple resistive heater, lysis buffer, and timers. The resulting test will accept vaginal fluid samples, buffer and lyse the samples, copy any hrHPV DNA present, and report copied DNA through a colorimetric LFA.