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：
8692558
负责人：
Amy Droitcour
金额：
$ 17.94万
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/8692558
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 STD（衣原体）诊断测试转化为社区诊所测试计划，以期提高受影响人群中衣原体感染的早期识别率。我们建议 Wave 80 Biosciences、旧金山总医院紧急护理中心和 UCSF 的 OPTIONS Project HIV 研究项目合作，评估一种新的护理点 (POC) 衣原体 RNA 快速检测，并为社区试行一项计划——在单次就诊中对高危人群和健康差异人群进行基于检测和治疗的治疗。该计划将特别有利于那些受衣原体影响尤为严重的患者，否则他们可能会多年得不到诊断。少数族裔受性传播疾病 (STD) 的影响最大，最常见的是沙眼衣原体 (CT) 感染。在每年300万新增感染者中，非裔美国人、西班牙裔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，非洲裔美国女性的 CT 率是白人女性的 7 倍。尽管制定了促进筛查和治疗的计划，但从 2000 年到 2004 年，非洲裔美国人的感染率仍增加了近 20%，而且 2006 年只有 42% 拥有医疗保健计划的妇女接受了 CT 检查。通过早期诊断和早期诊断，可以大大减少性传播疾病的传播。 CT治疗；然而，当前的 CT 控制策略需要患者接触初级保健提供者和妇产科医生。对于健康差异人群来说，获得医疗保健存在相当大的障碍，包括缺乏医疗保险、持续的医疗保健来源、与 CT 相关的耻辱以及高质量服务的经济负担。目前，患者必须等待数天才能获得检测结果，而高危患者（青少年、无家可归者）不会返回接受后续治疗。对于这些高危患者群体，诊断和护理需要通过“检测-和治疗”范例，其中诊断和治疗可以在单次就诊中进行。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等待衣原体检测将大大促进衣原体的诊断。 EOSCAPE CT 检测将提供快速、准确和匿名的结果，使分散的诊所能够通过扩大检测范围来克服 CT 治疗的耻辱和障碍。 EOSCAPE CT 平台融入了三项关键创新技术：通过单线态氧催化光发射对目标核酸进行高灵敏检测；稳定、均质的分析化学；和狭缝毛细管阵列流体致动器（SCAFA）微芯片。这些创新将克服低成本、即时护理患者检测的长期障碍，并将实现社区健康的关键外展和干预。