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: 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
• 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

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）：该提案支持将新的床旁STD（衣原体）诊断检测转化为社区诊所检测计划，以实现在受影响不成比例的人群中增加衣原体感染的早期识别的目标。我们提议Wave 80 Biosciences、旧金山弗朗西斯科总医院紧急护理中心和加州大学旧金山分校OPTIONS项目HIV研究计划合作，评估一种新的即时（POC）衣原体RNA快速检测，并在一次访问中对高危和健康差异人群进行基于社区的检测和治疗。这项计划将特别有利于受衣原体影响不成比例的患者，否则他们将多年未被诊断出来。少数群体受性传播疾病（STD）影响最大，最常见的是沙眼衣原体（CT）感染。在每年300万例新感染中，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比白人高8倍、3倍和5倍;据报道，非洲裔美国妇女的CT感染率比白色妇女高7倍。尽管有促进筛查和治疗的计划，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检查。通过早期诊断和CT治疗可以大大减少性病传播;然而，目前的CT控制策略需要患者接触初级保健提供者和OB/GYN。对于健康差异人群，获得医疗保健有相当大的障碍，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得到检测结果，并且最有风险的患者（青少年、无家可归者）不会返回进行后续治疗。对于这些有风险的患者群体，诊断和护理需要通过“检测和治疗”模式进行协调，其中诊断和治疗可以在单次就诊中进行。在社区卫生诊所、性病护理中心和移动的诊所进行的即时衣原体检测将极大地促进衣原体的诊断。EOSCAPE CT Assay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外展检测来克服CT治疗的耻辱和障碍。EOSCAPE CT平台集成了三项关键创新技术：通过单线态氧催化发光对靶核酸进行高灵敏度检测;稳健、均匀的检测化学;以及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、即时患者检测的长期障碍，并将实现社区卫生的关键外展和干预。