Urogenital disease caused by Chlamydia trachomatis (Ct) is a major public health problem affecting 3-4 million people in the U.S. and over 100 million worldwide annually. Sequelae include urethritis, cervicitis, salpingitis (which can lead to infertility in women), pelvic inflammatory disease, adverse pregnancy outcomes (e.g. abortion, still birth or premature birth), and epididymitis (which can lead to infertility in men), as well as being a risk factor for HIV infection. Chlamydial infections are asymptomatic in up to 70% of women and 50% of men, thus delaying treatment and facilitating transmission. This asymptomatic feature coupled with the ease and efficacy of treatment (e.g. a single dose of azithromycin) places the burden for disease management on diagnosis. Furthermore, a persistent and unmet need exists for rapid, accurate, cost effective and simple (RACES format) diagnostic tests for Ct due to patient noncompliance with treatment and delays in providing treatment to infected patients. Currently marketed point-of-care (POC) Ct tests are rapid, but less sensitive than the more complex, slow and expensive laboratory methods such as cell culture and nucleic acid amplification tests (NAAT). To improve sensitivity without sacrificing specificity, the key challenge, we propose novel and proprietary methods that will provide enhanced sensitivity and reduced background signal, therefore maintaining specificity. The sensitivity enhancement will be assessed by comparison to gold standard tests including cell culture and a NAAT. We hypothesize that the proposed test system will increase testing accuracy while adding the speed and simplicity necessary for widespread POC clinical utilization. The resulting enhanced accuracy Ct POC test is directly relevant to the goal of improving diagnosis of infectious diseases stated by organizations such as the National Institute of Allergy and Infectious Diseases, the Bill and Melinda Gates Foundation and the World Health Organization. Furthermore the novel aspects of the test system are expected to result in significant intellectual property rights for the company.
