The Center for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern University (C-THAN)

总体摘要 西北大学艾滋病毒/艾滋病护理点技术创新中心(C- Than)将开发一系列基于需求的护理点技术，这对改善 低收入和中等收入国家的艾滋病毒/艾滋病感染者。C-Than将利用我们现有的 专业知识和我们的研究和临床网络，拥有17年的动态和生产力历史 合作解决撒哈拉以南非洲的传染病问题。西北大学也加入了 拉各斯大学、伊巴丹大学和乔斯大学(尼日利亚)、开普敦大学和斯特伦博斯大学(南非)、 科学、技术和技术巴马科(马里)和穆亨比利健康与联合科学大学 (坦桑尼亚)。 联合国艾滋病规划署(艾滋病规划署)制定了雄心勃勃的90-90-90目标 检测90%的艾滋病毒病例，90%的病例进行治疗，90%的病例进行病毒抑制 治疗，到2020年。如果不改进目前的诊断途径，这在LMIC中是不可能实现的 使用价格实惠、快速、易于使用且几乎不需要维护的PoC诊断测试。 C-Than将作为支持研究项目的平台，以开发满足以下要求的PoC技术 这一未得到满足的需求涉及多个技术就绪级别，这些级别受 发展中世界。支持的项目范围从需求评估到商业化，以期 确保转化为临床影响。我们的总体目标是支持PoC技术的发展，以 促进国立卫生研究院艾滋病毒/艾滋病研究的高度优先主题，包括：通过改善 与艾滋病毒、艾滋病毒耐药性和抗逆转录病毒药物有关的筛查、检测和治疗监测 水平；诊断艾滋病毒相关的合并症，包括结核病、非结核病 分枝杆菌(NTM)、乙肝(乙肝)和丙型肝炎(丙型肝炎)；通过发展 测试能够在服务不足的社区环境中发挥作用的技术；以及培训能够 将PoC技术从研发转化为实施。 C-Than结构将在项目开发中纳入临床和用户需求，同时提供专业知识 和资源，以解决商业化和实施的早期障碍。其核心组件将 以综合方式运作，以交付需要的工作范围：1)评估未满足的临床需求 艾滋病毒/艾滋病及其合并症的POC检测；2)与相关科学家、医生、 研究人员和工程师；3)基本技术、临床、工业和监管的发展 伙伴关系；4)现场POC设备原型的临床测试；5)创造培训机会 面向技术开发人员、评估人员和其他利益相关者。C-Than将对 在小岛屿发展中国家和全球预防和临床管理艾滋病毒/艾滋病，并将为 持续发展概念验证技术，超越其生命周期。 1

Summary Overall The Center for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern University (C- THAN) will develop a pipeline of needs-based point-of-care technologies critical for improved management of HIV/AIDS infected individuals in low-and-middle-income countries (LMICs). C-THAN will harness our existing expertise and our research and clinical network which has a 17-year history of dynamic and productive collaboration on addressing infectious diseases in sub-Saharan Africa. Northwestern University is joined by the Universities of Lagos, Ibadan and Jos (Nigeria), Cape Town and Stellenbosch (South Africa), University of Sciences, Techniques and Technologies Bamako (Mali) and Muhimbili University of Health and Allied Sciences (Tanzania). The United Nations' Program on HIV and AIDS (UNAIDS) has set the ambitious 90-90-90 goals to achieve detection of 90% of HIV cases, treatment for 90% of those cases, and viral suppression for 90% of those treated, by 2020. This will not be achieved in LMICs without improvement of the current diagnostic pathway with POC diagnostic tests that are affordable, rapid, easy to use, and require little maintenance. C-THAN will serve as a platform for the support of research projects to develop POC technologies that address this unmet need across multiple levels of technology readiness which are amenable to the conditions of the developing world. Projects supported will range from needs assessment to commercialization, with a view to ensuring translation into clinical impact. Our overall goal is to support the development of POC technologies to promote high priority topics of NIH HIV/AIDS research, including: Reducing HIV incidence by improving screening, detection and treatment monitoring related to HIV, HIV drug resistance, and antiretroviral drug levels; Diagnosing HIV-associated comorbidities which include tuberculosis (TB), non-tuberculosis mycobacteria (NTM), hepatitis B (HBV), and hepatitis C (HCV); Reducing health disparities by developing testing technology that can function in underserved community settings; and Training of the workforce able to translate POC technologies from Reseach & Development to implementation. The C-THAN structure will incorporate clinical and user needs in project development while providing expertise and resources to address early barriers to commercialization and implementation. Its Core components will operate in an integrated manner to deliver a scope of work entailing: 1) assessment of unmet clinical needs in POC testing for HIV/AIDS and its comorbidities; 2) collaboration with relevant scientists, physicians, researchers and engineers; 3) development of essential technical, clinical, industrial and regulatory partnerships; 4) clinical testing of prototype POC devices in the field; and 5) creation of training opportunities for technology developers, evaluators, and other stakeholders. C-THAN will have major impact on the prevention and clinical management of HIV/AIDS in LMICs and globally, and will lay a knowledge foundation to sustain POC technology development beyond its lifespan. 1