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

摘要--总体 艾滋病毒/艾滋病和新发传染病护理点技术创新中心 西北大学的疾病(C-Than)建议继续作为医疗保健点技术的成员 研究网络(POCTRN)作为技术研究和开发中心(TRDC)。C-Than Will 通过增强优势互补的模式促进诊断技术创新 在技术平台、临床、监管和商业化方面建立多学科合作伙伴关系 特别侧重于艾滋病毒/艾滋病和中低收入者新发传染病的领域 国家(LMIC)。C-Than结构将在开发过程中结合临床和用户需求 同时提供专业知识和资源，以解决技术开发、验证和 商业化。工作范围包括：1)评估POC测试中未满足的临床需求 艾滋病毒/艾滋病、其并存疾病和新出现的传染病；2)制定相关的征集主题，以 解决未得到满足的临床需求；3)奖励和管理C-Than制定的分奖项目；4)与 相关科学家、医生、研究人员和工程师；5)开发必要的技术、临床、工业 和监管伙伴关系；6)进行临床研究和/或提供用于验证的样本 原型设备的测试；以及7)为技术开发人员和其他人员创造培训机会 与PoC和家用设备开发相关的利益相关者。一系列技术将 包括用于检测感染和监测艾滋病毒/艾滋病及其常见潜在致命疾病的POC设备 疾病包括结核病、非结核分枝杆菌、乙肝、丙型肝炎 (丙型肝炎病毒)和艾滋病毒相关的恶性肿瘤。此外，新出现和再次出现的传染病将是 通过应用我们的战略来解决对SARS-CoV-2 POC检测的紧急诊断需求 以及其他新出现的感染，如MPOX病毒、埃博拉病毒、拉沙热和裂谷热等。 联合国艾滋病毒和艾滋病规划署(艾滋病规划署)制定了雄心勃勃的目标，即实现95%的 艾滋病毒的检测率，让95%的人接受治疗，并实现95%的病毒抑制 那些接受治疗的人。这项延期提案的主要前提是，如果没有这些目标，这些目标将无法实现 加强现有的艾滋病毒及其共病和新发传染病的诊断平台 经济实惠、快速且易于在LMIC中使用的POC，只需最少的技能和维护。一个 将重点放在具体的技术领域，在#年建立四个工作组(WG) 分子、横向流动、合成生物学和产品工程。我们将利用动态和 西北大学在非洲尼日利亚、马里、 塞内加尔、坦桑尼亚和南非。

SUMMARY - OVERALL The Center for Innovation in Point-of-Care Technologies for HIV/AIDS and Emerging Infectious Diseases at Northwestern (C-THAN) proposes to remain a member in the Point-of-Care Technologies Research Network (POCTRN) as a Technology Research and Development Center (TRDC). C-THAN will catalyze innovation in diagnostic technologies through a model that enhances complementary strengths to build multidisciplinary partnerships across technology platforms, clinical, regulatory and commercialization domains with a specific focus on HIV/AIDS and emerging infectious diseases in low- and middle-income countries (LMICs). The C-THAN structure will incorporate clinical, and user needs in the development process while providing expertise and resources to address early barriers to technologic development, validation, and commercialization. The scope of work entails: 1) assessment of unmet clinical needs in POC testing for HIV/AIDS, its co-morbidities, and emerging infectious diseases; 2) develop relevant solicitation topics to address unmet clinical needs; 3) award and manage sub-award projects made by C-THAN; 4) collaborate with relevant scientists, physicians, researchers and engineers; 5) develop essential technical, clinical, industrial and regulatory partnerships; 6) conduct clinical studies and/or provide access to specimens for validation testing of prototype devices; and 7) create training opportunities for technical developers and other stakeholders related to the development of POC and home-based devices. The range of technologies will include POC devices for detection of infection and monitoring of HIV/AIDS and its common potentially fatal co- morbidities including tuberculosis (TB), non-tuberculous mycobacterium (NTM), hepatitis B (HBV), hepatitis C (HCV) and HIV-associated malignancies. Furthermore, emerging, and re-emerging infectious diseases will be addressed by applying our strategy of addressing the urgent diagnostic need of POC testing for SARS-CoV-2 and other emerging infections such as mpox virus, Ebola, Lassa Fever, and Rift Valley Fever, among others. The United Nations Program on HIV and AIDS (UNAIDS) has set the ambitious goal of achieving a 95% detection rate for HIV, placing 95% of those individuals on treatment, and achieving 95% viral suppression in those that are treated. The major premise of this renewal proposal is that these goals will not be met without augmenting the current diagnostic platforms for HIV, its co-morbidities, and emerging infectious diseases with POCs that are affordable, rapid, and easy to use in LMICs requiring minimal skill and maintenance. An emphasis will be directed to specific technologic domains by establishing four working groups (WG) in molecular, lateral flow, synthetic biology, and product engineering. We will leverage the dynamic and productive collaborations established by Northwestern in Africa at nine academic centers in Nigeria, Mali, Senegal, Tanzania, and South Africa.