Genital Chlamydia trachomatis (CT) infection is the most common Sexually Transmitted Disease in the United States. Although it is frequently asymptomatic in women and causes serious sequelae, it is readily treatable when diagnosed. Therefore, cervical CT is an ideal target for widespread screening. However, currently available diagnostic methodologies are prohibitively expensive, time consuming, cumbersome and labor intensive. They require refrigeration of selected components, instrumentation, and multiple timed steps and components. As a result, they are not widely utilized for on-site testing. LCI proposes to demonstrate the technical feasibility of developing a point-of-care, colorimetric, presumptive screening test for cervical Chlamydia infection. The LCI cervical CT test will be the approximate size and shape of a credit card with built-in, specimen activated, positive and negative control elements. To perform the test, a clinician will apply an unprocessed cervical specimen directly from a swab to the test area. No developing solution is required. A vivid color change within five minutes indicates a positive test result. The device will be stable at room temperature. Its ease of use will enable the LCI CT test to be used in a variety of clinical settings in both industrialized and Resource Limited Settings.
