Project Description: 

Chlamydia is the second most sexually transmitted infection in the US. In 2018, 1.8 million people tested positive for chlamydia. Most people with chlamydia are asymptomatic causing the incidence to be drastically underreported. If left untreated, chlamydia can cause infertility, ectopic pregnancy, and chronic pelvic pain. Current testing methods are found in a clinical setting or an at-home test that requires shipping of samples to a lab. Each of these present different barriers to potential users such as scheduling, cost, type of sample needed, or wait time for results. Based on these gaps in the market and critical needs presented by interviews with potential users and clinical professionals, it was decided that the final device and packaging must be non-stigmatic, gender neutral, ergonomic, handheld, affordable and provide clear instructions. Our solution to the problem is a rapid at-home chlamydia screening device. Our device consists of a hand-held sample collection container with an integrated funnel and leukocyte esterase (LE) dipstick test. The device uses immunochromatography to identify LE and provide users results in under one minute. The packaging was specifically designed according to color psychology to ensure gender neutrality and avoid stigmatization of STI testing. These design choices were assessed by over 100 potential users using a 5-point Likert scale survey. The functionality of the device was determined by testing the sensitivity of the LE test and color dissipation of the immunochromatography within our design. The target users are sexually active people aged 15-24 which is ~25.8M in the United states. This device would be classified as a FDA Class II, cost approximately $3 to manufacture, and require a de novo application to further specify regulatory requirements. Putting this device to market would have the potential to minimize the testing gap and lower the overall incidence rate of chlamydia.