FeverPhone: Point of Care Diagnosis of Acute Febrile Illness using a Mobile Device

 描述(申请人提供)：在这项工作中，我们将开发和现场验证“FeverPhone”技术，用于对急性发热性疾病(即：登革热、疟疾、基孔肯雅热、钩端螺旋体病、伤寒和恰加斯)的六种常见原因的医疗点式鉴别诊断。“FeverPhone”系统建立在我们团队在基于智能手机的诊断、传染病和全球健康开发方面的广泛背景之上。该计划的技术努力包括开发：利用我们之前在移动设备上的颜色识别分析工作的专用6路比色分析试剂盒，相关的基于iPad的硬件，允许在我们的现场技术人员已经使用的平台上快速解释试剂盒结果，以及将区分分子诊断与操作员使用的确认性症状界面相结合的软件。最终的系统将在大约15分钟内实现可行的诊断。在技术开发的同时，我们将在厄瓜多尔马查拉的现有传染病监测点进行一项分阶段的现场验证研究。除了临床和工程方面的专业知识外，我们还在该计划中引入了一名翻译合作伙伴，以确保我们的系统在工作结束时得到充分验证并准备好接受FDA的批准。

 DESCRIPTION (provided by applicant): In this work we will develop and field validate "FeverPhone" technology for point-of-care differential diagnosis of six common causes of acute febrile illness (namely: Dengue, Malaria, Chikungunya, Leptospirosis, Typhoid fever, and Chagas). The "FeverPhone" system builds on our team's extensive background on the development of smartphone based diagnostics, infectious disease, and global health. The technical effort of this program comprises of the development of: a specialized 6-plexed colorimetric IgM/IgG assay cartridge that exploits our previous work on color discrimination assays on mobile devices, associated iPad based hardware that allows rapid interpretation of the cartridge results on a platform already used by our field technicians, and software that will combine differential molecular diagnosis with a confirmatory symptomatic interface used by the operator. The final system will enable actionable diagnosis in around 15 minutes. In parallel with technical development, we will perform a staged field validation study at our existing infectious diseases monitoring site in Machala, Ecuador. In addition to clinical and engineering expertise, we have incorporated a translation partner into the program that will ensure that our system is fully validated and ready for FDA approval by the end of the effort.