Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases

性传播疾病护理点技术研究中心

• 批准号: 10159902
• 负责人: Yukari C Manabe
• 金额: $ 151.53万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-30 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10159902
• 关键词: Address; Algorithms; Anxiety; Back; Behavioral; Biological Assay; Centers for Disease Control and Prevention (U.S.); Chlamydia; Clinical; Clinical assessments; Communicable Diseases; Congenital Syphilis; Counseling; Country; Data; Development; Diagnosis; Diagnostic; Direct Costs; Disease; Education; Emerging Technologies; Engineering; Ensure; Epidemic; Facilities and Administrative Costs; Funding; Goals; Gonorrhea; HIV; Healthcare; Healthcare Systems; Home; Income; Individual; Infection; Lead; Medical Device; Mental Depression; Modeling; Needs Assessment; Newborn Infant; Patients; Personal Satisfaction; Point of Care Technology; Prevention; Privacy; Public Health; Reporting; Research; Resources; Rest; Sampling; Scientist; Self Care; Sexual Health; Sexually Transmitted Diseases; Structure; Syphilis; System; Technology; Testing; Training; Translations; United States; Universities; Validation; Woman; Work; World Health Organization; accurate diagnosis; behavior change; clinical translation; commercialization; design; health disparity; health inequalities; improved; indicated prevention; member; new technology; point of care; point of care testing; prevent; prototype; rapid diagnosis; self testing; social stigma; success; targeted treatment; technological innovation; transmission process

Project Summary The long-term goals of our center include addressing the epidemics of STDs/HIV in the U.S. and in resource-poor settings by development and better use of Point-of-Care (POC) tests, so as to address health inequity and improve the sexual health of individuals. Our specific aims are: 1. To develop a “Center of Excellence for the Development and Testing of Point of Care Tests (POCT) for Sexually Transmitted Diseases (STDs)” with cores that can: drive the development and application of point-of-care technologies via collaborative efforts that merge scientific and technological capabilities with clinical need and training of developers, as well as end users of POCT. 2. To use clinical drivers of technology progression for developing and expanding existing POC STD technologies, by providing assistance and feed back in an iterative fashion to developers in a “go-no go” manner, such that we insure that deliverables for each project are met. 3. To implement functioning core components that work smoothly together in a collaborative fashion and with other members of the Point-of-Care Technologies Research Network (POCTRN), which can work with our administrative component to implement a smooth transition along a pipeline from developmental prototype assays through early in- house, clinical translation and validation testing, In this coordinated manner, we can assist with the logical development of POC assays, which prove to have qualifications of sufficient scientific merit and can progress towards eventual FDA submission and commercialization. These goals and aims will be accomplished by an effective administrative component, ascertaining needs of users of POC, training of scientists, funding scientists and engineers for development of prototype and mature POC technologies, and pilot testing and implementation of POC tests in diverse clinical settings, which will lead to the commercialization and use of POC tests for diagnosing STDs in order to improve the sexual health of individuals in the United States and the rest of the world.

项目概要 我们中心的长期目标包括解决美国性传播疾病/艾滋病毒的流行问题。 在资源匮乏的环境中，通过开发和更好地使用即时护理 (POC) 测试， 解决健康不平等问题并改善个人的性健康。我们的具体目标 是： 1. 建立“护理点开发和测试卓越中心” 性传播疾病 (STD) 检测 (POCT)”的核心可以： 通过协作努力开发和应用现场护理技术 符合临床需求的科技能力和开发人员的培训，以及 作为 POCT 的最终用户。 2. 利用技术进步的临床驱动力来开发和 通过提供帮助和反馈来扩展现有的 POC STD 技术 以“走-不走”的方式向开发人员迭代，这样我们就可以确保交付成果 每个项目都满足。 3. 实现能够顺利协同工作的功能核心组件 以协作方式并与即时护理技术研究的其他成员合作 网络（POCTRN），它可以与我们的管理组件一起实施 从开发原型检测到早期试验的流程顺利过渡 内部、临床翻译和验证测试，以这种协调的方式，我们可以协助 随着 POC 检测的合理发展，这些检测被证明具有足够的资格 具有科学价值，并且可以朝着最终向 FDA 提交和商业化的方向发展。 这些目标和目标将通过有效的行政部门来实现， 确定 POC 用户的需求、培训科学家、资助科学家和工程师 原型和成熟的POC技术开发、试点测试和实施 在不同的临床环境中进行 POC 测试，这将导致其商业化和使用 用于诊断 STD 的 POC 测试，以改善美国个人的性健康 各国和世界其他地区。