Development of a Point of Care Multiplexed Diagnostic Platform to Target Anemia and Micronutrient Deficiencies

项目摘要 贫血是最普遍的临床病症之一，影响全球超过16亿人， 孕妇和幼儿的负担最重。贫血与增加的风险有关 不利的健康后果，包括孕产妇和婴儿死亡率，以及儿童认知功能受损 成人的工作能力。印度的贫血负担是世界上最高的，在那里它需要一个 产妇和婴儿死亡率、残疾率和生产力损失等方面的重大损失。贫血影响估计 56%的育龄妇女、59%的孕妇、63%的哺乳期妇女和70%的年轻人 印度的孩子们。缺铁是世界范围内贫血的主要原因，而铁补充是 预防和治疗贫血的护理标准。然而，据估计， 50%的贫血是由于缺铁。其他营养因素，特别是维生素B12和叶酸， 非营养因素如炎症，也有助于贫血的病因和影响人类 健康用不正确的微量营养素治疗贫血可能会加剧病情或掩盖真正的症状。 缺陷准确确定贫血的多因素原因是实施成功的关键 然而，现有的贫血诊断方法通常耗时，昂贵， 需要冷链，在资源有限的环境中不易获得。在本申请中，我们提出 开发和验证AnemiaPhone，这是一个基于智能手机的低成本即时护理平台， B族维生素（维生素B12和叶酸）以及铁的多重定量评估 状态和炎症，贫血的主要原因。这项技术包括一个一次性的测试条 含有多重夹心ELISA所需的试剂，可重复使用的低成本智能手机配件， 其在手指针刺血液样品已经被引入之后接受测试条并将其附着到 智能手机，以及提取由智能手机捕获的测试条的图像的智能手机应用程序 相机，解释图像数据以提供定量测试结果，以及通信和编目数据。 此应用程序直接响应在资金机会公告中的呼吁， 现有的医疗设备，通过提供负担得起的 以及在资源有限的环境中获得医疗保健。它汇集了来自圣约翰的专家团队 印度的研究所和美国的康奈尔大学在不同领域， 医学、围产期健康、传染病、纳米技术、微流体技术和工程， 针对贫血症，这是印度和其他资源有限环境中一个紧迫的公共卫生问题。可用性 AnemiaPhone在未来两年内将使人们有可能可靠和准确地诊断贫血， 即使是印度最偏远的地区，也不需要什么培训。此外，鉴于广泛流行的 这项技术将使全球低资源环境受益。这种转化研究的影响 以及开发一种基于智能手机的低成本即时护理平台，以减少对健康的不利影响， 在资源有限的环境中，贫血对发展的影响怎么强调都不过分。

Project Summary Anemia is one of the most widespread clinical conditions, affecting over 1.6 billion individuals globally, with the greatest burden among pregnant women and young children. Anemia has been associated with increased risk of adverse health outcomes, including maternal and infant mortality, and impaired cognitive function in children and work capacity in adults. The burden of anemia in India is among the highest in the world, where it exacts a heavy toll in terms of maternal and infant mortality, disability, and lost productivity. Anemia affects an estimated 56% of women of reproductive age, 59% of pregnant women, 63% of lactating women, and 70% of young children in India. Iron deficiency is the leading cause of anemia worldwide, and iron supplementation is the standard of care for prevention and treatment of anemia. However, it is estimated that only approximately 50% of anemia is due to iron deficiency. Other nutritional factors, particularly vitamins B12 and folate, and non-nutritional factors such as inflammation, also contribute to the etiology of anemia and impact human health. Treating anemia with the incorrect micronutrient may exacerbate the condition or mask the true deficiency. Accurate determination of the multifactorial causes of anemia is critical to implement successful interventions; however, existing diagnostic methods for anemia are typically time consuming, expensive, require cold chain, and are not easily accessible in resource-limited settings. In this application, we propose to develop and validate AnemiaPhone, a point-of-care, low-cost, smartphone-based platform for a multiplexed, quantitative assessment of B-vitamin status (vitamin B12 and folate), in addition to iron status, and inflammation, the leading causes of anemia. The technology consists of a disposable test-strip containing reagents required for a multiplex sandwich ELISA, a reusable low-cost smartphone accessory, which accepts the test strip after the finger stick blood sample has been introduced and attaches it to the smartphone, and a smartphone application that extracts images of the test strip captured by the smartphone camera, interprets image data to provide quantitative test results, and communicates and catalogues data. This application directly responds to the call in the funding opportunity announcement for re-engineering of existing medical devices to significantly improve conditions of the poorest populations by providing affordable and accessible healthcare in resource-limited settings. It brings together a team of experts from St. John's Research Institute in India and Cornell University in the United States in diverse areas including nutrition, medicine, perinatal health, infectious disease, nanotechnology, microfluidic technologies, and engineering to target anemia, an urgent public health problem in India and other resource-limited settings. Availability of AnemiaPhone within the next two years will make it possible to reliably and accurately diagnose anemia in even the most remote parts of India with little training required. Furthermore, given the widespread prevalence of anemia, this technology will benefit low-resource settings globally. The impact of this translational research and the development of a point-of-care, low-cost, smartphone-based platform to reduce the adverse health and development consequences associated with anemia in resource-limited settings cannot be overemphasized.