A Point of Care, Nucleic Acid Test for Chlamydia to Ensure Prompt Treatment of He

描述（由申请人提供）：本提案支持将一种新的即时性病（衣原体）诊断测试转化为社区诊所测试项目，以提高对衣原体感染人群的早期识别。我们建议Wave 80生物科学公司、旧金山总医院紧急护理中心和加州大学旧金山分校的OPTIONS项目艾滋病毒研究项目合作，评估一种新的护理点（POC）衣原体RNA快速检测，并试点一项以社区为基础的检测和治疗项目，在一次访问中对高危人群和健康差异人群进行检测和治疗。这个项目将特别有利于受衣原体影响的患者，否则他们将多年未被诊断出来。少数群体最容易受到性传播疾病的影响，最常见的是沙眼衣原体感染。在每年新增的300万感染者中，非洲裔美国人、西班牙裔美国人和美洲印第安人的感染率分别是白人的8倍、3倍和5倍；据报道，非裔美国妇女的CT率比白人妇女高7倍。尽管有促进筛查和治疗的项目，非洲裔美国人的感染率从2000年到2004年增加了近20%，2006年只有42%的有医疗保健计划的妇女接受了CT检测。通过CT的早期诊断和治疗，可以大大减少性病的传播；然而，目前的CT控制策略要求患者获得初级保健提供者和妇产科医生的帮助。对于健康差距较大的人群，获得医疗保健存在相当大的障碍，包括缺乏医疗保险、一致的医疗保健来源、与CT相关的污名以及高质量服务的经济负担。目前，患者必须等待数天才能得到检测结果，而且最危险的患者（青少年、无家可归者）不会返回接受后续治疗。对于这些高危患者人群，需要通过“检测和治疗”模式协调诊断和护理，即在一次就诊中即可进行诊断和治疗。衣原体的诊断将通过在社区卫生诊所、性传播疾病护理中心和流动诊所实施的即时衣原体检测得到极大的便利。EOSCAPE CT检测将提供快速、准确和匿名的结果，通过扩大检测范围，使分散的诊所能够克服耻辱感和治疗CT的障碍。三项关键创新技术被纳入EOSCAPE CT平台：通过单线态氧催化光发射高灵敏度检测靶向核酸；稳健、均匀的分析化学；狭缝毛细管阵列流体执行器（SCAFA）微芯片。这些创新将克服长期存在的低成本、即时患者检测障碍，并将使社区卫生方面的重要推广和干预成为可能。

DESCRIPTION (provided by applicant): 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.