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

护理点衣原体核酸检测，确保及时治疗

• 批准号: 8549657
• 负责人: Amy Droitcour
• 金额: $ 19.3万
• 依托单位: WAVE 80 BIOSCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-01 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8549657
• 关键词: Address; Adolescent; Affect; African American; Alaska Native; American Indians; Archives; Asian Americans; Bacterial Sexually Transmitted Diseases; Biological Assay; Blindness; Blood capillaries; Burn injury; Caring; Centers for Disease Control and Prevention (U.S.); Cervix Uteri; Chemistry; Chlamydia; Chlamydia Infections; Chlamydia trachomatis; Clinic; Clinical; Clinical Research; Clinical Sensitivity; Clinical assessments; Code; Collaborations; Communities; Community Health; Community Health Centers; Counseling; Detection; Development; Diagnosis; Diagnostic; Diagnostic tests; Early Diagnosis; Early identification; Early treatment; Economic Burden; Ensure; Esthesia; Evaluation; General Hospitals; Goals; HIV; Hawaiian population; Health; Health Personnel; Health Services Accessibility; Health care facility; Healthcare; High Prevalence; Hispanics; Homelessness; Infection; Infertility; Institutional Review Boards; Insurance; Intervention; Laboratories; Lead; Link; Mammalian Oviducts; Medical; Minority; Minority Groups; NASBA Analysis; Needs Assessment; Newborn Infant; Nucleic Acid Amplification Tests; Nucleic Acids; Pacific Island Americans; Pain; Patient Recruitments; Patients; Pelvic Inflammatory Disease; Performance; Phase; Pilot Projects; Population; Pre-Eclampsia; Pregnant Women; Preparation; Prevalence; Primary Health Care; Process; Protocols documentation; Provider; RNA; Reporting; Research; Research Design; Ribosomal RNA; Risk; Sampling; San Francisco; Sensitivity and Specificity; Services; Sexually Transmitted Diseases; Singlet Oxygen; Source; Specimen; Specimen Handling; Structure; System; Test Result; Testing; Text; Time; Translations; Transportation; Urethra; Validation; Visit; Woman; base; capillary; commercialization; cost; demographics; design; disease transmission; evaluation/testing; follow-up; health care quality; health disparity; inhibitor/antagonist; innovation; innovative technologies; light emission; men; microchip; outreach; patient population; point of care; point-of-care diagnostics; preference; programs; prototype; public health relevance; racial and ethnic; sample collection; screening; sexually active; social; social stigma; socioeconomics; success; urgent care

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.

描述(由申请人提供)：该提案支持将一种新的保健点性传播疾病(衣原体)诊断测试转化为社区诊所测试计划，以期在受不成比例影响的人群中增加衣原体感染的早期识别。我们建议Wave 80 Biosciences、旧金山总医院紧急护理中心和加州大学旧金山分校的Options Project HIV研究计划合作，评估一种新的护理点(POC)衣原体RNA快速检测，并在一次就诊中试行一项针对高危人群和健康差距人群的社区检测和治疗计划。这项计划将特别有利于受衣原体影响不成比例的患者，否则他们将多年没有得到诊断。少数群体受性传播疾病(STD)的影响最大，最常见的感染是沙眼衣原体(CT)。在每年300万新感染病例中，非洲裔美国人、西班牙裔美国人和美国印第安人的感染率分别比白人高8倍、3倍和5倍；据报道，非洲裔美国女性的CT发病率是白人女性的7倍。尽管实施了促进筛查和治疗的计划，非裔美国人的感染率从2000年到2004年增长了近20%，2006年，只有42%的有医疗保健计划的女性接受了CT检测。通过早期诊断和治疗CT可以显著减少性病的传播；然而，目前的CT控制策略要求患者能够接触到初级保健提供者和妇产科医生。对于健康差距人群来说，获得医疗保健具有相当大的障碍，包括缺乏医疗保险、始终如一的医疗保健来源、与CT相关的耻辱以及高质量服务的财政负担。目前，患者必须等待数天才能得到检测结果，而且风险最高的患者(青少年、无家可归者)不会回来为这些风险患者群体进行后续治疗，诊断和护理需要通过“测试和治疗”模式进行协调，在这种模式下，诊断和治疗可以在一次访问中进行。可以在社区卫生诊所、性病护理中心和流动诊所实施的即时衣原体检测将极大地方便衣原体的诊断。EOSCAPE CT检测将提供快速、准确和匿名的结果，通过扩大外展检测，使分散的诊所能够克服治疗CT的耻辱和障碍。EOSCAPE CT平台融合了三项关键创新技术：通过单重态氧催化发光对目标核酸的高灵敏度检测；稳健、均匀的分析化学；以及狭缝毛细管阵列射流致动器(SCAFA)微芯片。这些创新将克服长期存在的低成本、就诊点患者检测的障碍，并将使社区卫生方面的关键推广和干预成为可能。