Early Stage Diagnosis of Kaposi's Sarcoma in Limited Resource Settings using KS-Detect

 描述（由申请人提供）：在该项目中，我们将在有限的资源环境中对用于诊断卡波西肉瘤 (KS) 的快速护理点平台进行现场测试和临床验证。我们的“KS-Detect”诊断平台采用太阳能和智能手机技术，使其能够在不依赖任何外部基础设施的情况下运行，同时保持高度的可用性和较低的单位成本。提供 KS 快速确认诊断的能力有望促进社区在临床阶段更早地检测 KS，此时对治疗更敏感。 KS 的特异性诊断还可以防止对 KS 临床模仿者进行不适当的治疗。到项目结束时，我们将展示该诊断技术的现场功效，并量化评估其对促进 KS 早期检测的效果。为了实现这一目标，我们聚集了来自康奈尔大学、加州大学旧金山分校和乌干达坎帕拉传染病研究所的工程师、当地医生、临床流行病学家、商人、翻译合作伙伴和企业家团队。来自康奈尔大学的工程师和企业家 David Erickson 教授（康奈尔大学联系人 PI）是 KS-Detect 技术的原始开发者，将领导工程和产品开发工作，而 KS 流行病学家 Jeff Martin 教授（加州大学旧金山分校 PI）和临床医生 Toby Maurer 教授（UCSF）将与我们在乌干达的合作伙伴一起领导临床和部署工作。 Ethel Cesarman 博士（威尔·康奈尔饰）是导致 KS 的病毒的最初发现者之一，他将领导当地的分子病理学工作。与我们的翻译合作伙伴 A'As inc. 合作， 我们将开发一个双用途平台，可以通过直接太阳能加热、太阳能电池板或传统电源插座供电，以便在不改变分析方法的情况下实现现场和实验室操作。在该项目的第一阶段，我们将 (1) 从我们的乌干达合作伙伴网站收集 500 个样本并验证基于 PCR 的检测； (2) 构建一套现场加固两用KS-Detect系统和耗材； (3) 与当地卫生技术人员一起部署 5 个单位，为期 3 个月。如果成功，在第二阶段，我们将进行广泛的现场研究，在乌干达部署 17 个 KS-Detect 装置，由当地经过培训的临床医生操作和服务，并证明该系统能够比现有诊断程序更早期地检测 KS。

 DESCRIPTION (provided by applicant): In this project, we will field-test and clinically validate a rapid, point-of-care platform for the diagnosis of Kaposi's sarcoma (KS) in limited resource settings. Our "KS-Detect" diagnostic platform uses solar- power and smartphone technology enabling it to be operated without reliance on any external infrastructure, while maintaining a high degree of usability with low per-unit cost. The ability to provide rapid confirmatory diagnosi of KS promises to facilitate earlier detection of KS in the community at a clinical stage when it i more responsive to therapy. Specific diagnosis of KS also prevents inappropriate therapy of clinical mimickers of KS. By the end of the project, we will have demonstrated both the field efficacy of the diagnostic technology as well as quantifiably evaluated its effect on promoting earlier detection of KS. To achieve this, we have brought together a team of engineers, local physicians, clinical epidemiologists, business people, translation partners, and entrepreneurs from Cornell, UC-San Francisco and the Infectious Diseases Institute in Kampala, Uganda. Prof. David Erickson (Contact- PI, Cornell), an engineer and entrepreneur from Cornell University, is the original developer of the KS- Detect technology and will lead the engineering and product development efforts while Prof. Jeff Martin (PI, UCSF), a KS epidemiologist and Prof. Toby Maurer (UCSF), a clinician, will lead the clinical and deployment efforts along with our partners in Uganda. Dr. Ethel Cesarman (Weill Cornell) as one of the original discoverers of the virus that causes KS, will lead the local molecular pathology effort. With our translation partner, A'As inc., we will develop a dual-use platform that can be powered by either direct solar heating, solar panels, or conventional electrical outlet to enable both field and lab operation without changing the analysis method. In Phase I of this project, we will (1) collect 500 samples from our Ugandan partner site and validate the PCR based assay; (2) construct a set of field ruggedized dual use KS-Detect systems and consumables; and (3) deploy 5 units for 3 months with local health technicians. If successful, in Phase II we will perform an extensive field study deploying 17 KS-Detect units in Uganda, operated and serviced by locally trained clinicians, and demonstrate the ability of the system to enable earlier stage detection of KS than existing diagnostic procedures.