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

基本信息

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
项目类别：
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

项目摘要

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）：该提案支持将新的护理点性性病（衣原体）诊断测试转化为社区诊所测试计划，目的是增加对受影响不成比例的人群中衣原体感染的早期鉴定。我们建议在UCSF的80 Wave Wave Biosciences，San Francisco General Hospart Care Center和在UCSF的期权项目HIV研究计划之间进行合作，以评估新的护理点（POC）Chlamydia RNA快速测试，并试行社区 - 单访问中处于风险和健康状况的基础测试和治疗。该计划特别会受益于因衣原体影响不成比例的患者，否则这些衣原体会被诊断多年。少数群体受到性传播疾病（STD）的影响最大，最常见的是沙眼衣原体感染（CT）。在每年300万个新感染中，非裔美国人，西班牙裔和美国印第安人的率分别比白人高出8倍，3倍和5倍。据报道，非洲裔美国妇女的CT发生率比白人妇女高7倍。尽管有促进筛查和治疗的计划，但从2000 - 2004年开始，非洲裔美国人的感染率近20％，只有42％的卫生保健计划的女性在2006年进行了CT的测试。随着早期诊断和早期诊断和CT的处理；但是，当前的CT控制策略需要患者进入初级保健提供者和OB/Gyns。对于健康差异人群，获得医疗保健的障碍，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，患者必须等待几天的测试结果，而高危患者（青春期，无家可归）则不得返回这些高危患者人群的后续治疗，需要通过“测试 - 和治疗”范式，可以在一次访问中进行诊断和治疗。可以在社区健康诊所，性病护理中心和移动诊所实施的服务点，而您的等待衣原体测试可以极大地促进衣原体的诊断。 Eoscape CT测定法将通过扩大外展测试来使分散的诊所提供快速，准确和匿名的结果，以使分散的诊所能够克服CT治疗的污名和障碍。 Eoscape CT平台纳入了三种关键的创新技术：通过单线氧催化的光发射对靶向核酸的高度敏感性检测；强大的均质测定化学；和缝隙毛细管阵列液体执行器（SCAFA）微芯片。这些创新将克服长期以来的低成本障碍，护理点的患者测试，并能够对社区健康进行关键的外展和干预。