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疾病之一，全球有超过16亿人受到影响， 孕妇和幼儿的负担最大。贫血与增加风险有关。 不良健康后果，包括孕产妇和婴儿死亡率以及儿童认知功能受损 以及成年人的工作能力。印度的贫血症负担是世界上最高的之一，在那里它需要 在孕产妇和婴儿死亡率、残疾和生产力丧失方面造成了沉重的损失。贫血影响了估计的 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。缺铁是世界范围内导致贫血的主要原因，而补铁是最主要的 预防和治疗贫血的护理标准。然而，据估计，只有大约 50%的贫血是由缺铁引起的。其他营养因素，特别是维生素B12和叶酸，以及 非营养因素，如炎症，也是导致贫血的原因，并影响人类 健康。用错误的微量营养素治疗贫血可能会加剧病情或掩盖真相 缺乏症。准确确定贫血的多因素原因是成功实施的关键 干预；然而，现有的贫血诊断方法通常耗时、昂贵、 需要冷链，在资源有限的情况下不容易访问。在此应用程序中，我们建议 为了开发和验证AnymaPhone，这是一个基于智能手机的低成本看护点平台，用于 除了铁之外，对维生素B状态(维生素B12和叶酸)的多重定量评估 地位和炎症是贫血的主要原因。这项技术由一次性试纸组成 含有多重夹心ELISA所需的试剂，这是一种可重复使用的低成本智能手机配件， 在引入指棒血样后接受测试条，并将其附着到 智能手机和智能手机应用程序，该智能手机应用程序提取由智能手机捕获的测试条的图像 相机，解释图像数据以提供定量测试结果，并交流和编目数据。 此应用程序直接响应了资金机会公告中的号召，以重新设计 现有医疗设备，通过提供负担得起的医疗设备，显著改善最贫困人口的条件 以及在资源有限的环境中获得医疗保健。它汇集了圣约翰医院的一组专家 印度研究所和美国康奈尔大学在不同领域的研究，包括营养， 医学、围产期健康、传染病、纳米技术、微流体技术和工程学 以贫血为目标，这是印度和其他资源有限的一个紧迫的公共卫生问题。的可用性 未来两年内的贫血电话将使可靠和准确地诊断贫血成为可能 即使是印度最偏远的地区，也几乎不需要培训。此外，鉴于普遍存在的 在贫血症方面，这项技术将使全球资源匮乏的环境受益。这项翻译研究的影响 以及开发基于智能手机的低成本护理点平台，以减少不良健康和 在资源有限的情况下，与贫血有关的发展后果怎么强调都不为过。

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.