This proposal supports the translation of a new point-of-care STD (chlamydia) diagnostic test into a community clinic testing program, toward the goal of increasing early identification of chlamydia infections in populations that are disproportionately affected. We propose collaboration between Wave 80 Biosciences, the San Francisco General Hospital Urgent Care Center, and the OPTIONS Project HIV research program at UCSF to evaluate a new point-of-care (POC) Chlamydia RNA rapid test and to pilot a program for community-based testing and treatment for at-risk and health-disparity populations within a single-visit. This program would particularly benefit patients disproportionately impacted by Chlamydia who would otherwise go undiagnosed for years. Minority populations are the most impacted by sexually transmitted diseases (STDs), most commonly infections by Chlamydia trachomatis (CT). Of the 3 million new infections each year, African Americans, Hispanics, and American Indians have rates that are 8-fold, 3-fold, and 5-fold higher than that of whites, respectively;rates of CT in African American women have been reported to be 7-fold higher that in white women. Despite programs to promote screening and treatment, the infection rates in African Americans increased nearly 20% from 2000-2004, and only 42% of women with health care plans were tested for CT in 2006. STD transmission can be drastically reduced with early diagnosis and treatment of CT;however, current CT control strategies require patient access to primary care providers and OB/GYNs. For health disparity populations, access to healthcare has considerable barriers, including lack of medical insurance, a consistent healthcare source, stigma associated with CT, and financial burden for high-quality service. Currently, patients must wait days for test results, and the most at-risk patients (adolescent, homeless) do not return for follow-up treatment For these at-risk patient populations, diagnosis and care need to be coordinated through a "test- and-treat" paradigm, where diagnosis and treatment can be performed within a single visit. The diagnosis of chlamydia would be greatly facilitated by a point-of-care, while-you-wait chlamydia test that could be implemented at community health clinics, STD care centers, and mobile clinics. The EOSCAPE CT Assay will provide rapid, accurate, and anonymous results to enable decentralized clinics to overcome stigma and barriers to treatment of CT, by broadening outreach testing. Three key innovative technologies are incorporated into the EOSCAPE CT platform: Highly sensitive detection of targeted nucleic acids by singlet oxygen-catalyzed light emission;robust, homogeneous assay chemistry;and slit capillary array fluidic actuator (SCAFA) microchips. These innovations will overcome longstanding barriers to low cost, point-of-care patient testing, and will enable critical outreach and intervention in community health.

Public Health Relevance

The US CDC estimates that 19 million new STD infections occur each year with an economic burden of more than $6 billion. The most common STD is Chlamydia trachomatis (CT), with nearly 3 million new infections each year. Untreated CT infections can lead to pelvic inflammatory disease, infertility, and blindness in newborns. African Americans, Hispanics, and American Indians have infection rates 8-fold, 3-fold, and 5-fold higher than whites, respectively. To alleviate this health disparity, we aim to develop a point-of-care diagnostic that will increase CT intervention by enabling access to low-cost testing within minority communities.

National Institute of Health (NIH)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZEB1-OSR-B (M1))
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Lash, Tiffani Bailey
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Wave 80 Biosciences, Inc.
San Francisco
United States
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