Laboratory test-comparable mobile assessments of hemoglobin for anemia detection

项目摘要/摘要 在发展中国家，贫血是一个主要的公共卫生问题，包括儿童和孕妇。在……里面 在非洲，贫血率极高，影响三分之二的学龄前儿童和一半的学龄前儿童 女人。如果贫血得不到及时发现和处理，可能会导致严重的健康问题 后果，包括疲劳、心力衰竭、妊娠障碍和不良的身体/认知状况。 及早准确地诊断贫血可以减少复杂治疗的需要。 尽管目前已有便携式(内部)或护理点式血液分析仪，但它们仍然存在 在低收入和中等收入国家环境中负担不起和不足。临床检查，数字化 摄影和基于智能手机的非侵入性测量也受到了关注，但这些仍然 对贫血的诊断缺乏敏感性和特异性。考虑到发展中的迫切临床需要 在许多国家，正确的技术将是准确和灵敏的非侵入性血红蛋白测量 可以轻松嵌入到传统移动智能手机中的技术。 我们将开发一种基于移动智能手机的无创无创血红蛋白分析仪 (MHEMA)，并与学术模型进行研究，以提供获得医疗保健(AMPATH)计划 肯尼亚。我们的方法利用了虚拟高光谱(每个像素都有详细的颜色信息) 与实验室的血红蛋白检测(黄金标准)相比，成像具有相似的结果。这 平台将在传统移动智能手机中作为用户友好的应用程序实施。我们建议 以下三个具体目标：i)开发准确和灵敏的血红蛋白的两步算法 量化，ii)在电子健康记录系统内实施血红蛋白检测算法- 集成的智能手机应用程序，以及iii)在真实世界中评估MHEMA的性能特征 肯尼亚的临床环境。 由于拟议的研究处于医疗器械开发、临床实验室测试、 和计算机科学，我们的跨学科团队已经做好准备，将这项拟议的工作作为 AMPATH。鉴于检测技术是完全无创和快速的，我们将搭载患者 正在接受常规的血液测试。成功完成计划中的研究将促进临床翻译 并最大限度地提高当前可用的护理标准的质量。这项工作将 为更大患者综合评价MHEMA的准确性和精密度提供了依据 具有更广泛条件的人群，进一步作为定制我们的技术的模范临床环境 用于其他资源有限的设置。

PROJECT SUMMARY/ABSTRACT In developing countries, anemia is a major public health problem including children and pregnant women. In Africa, the prevalence of anemia is extremely high, affecting two thirds of preschool-age children and a half of women. When anemia is not detected and managed in a timely manner, it can result in major health consequences, including fatigue, heart failure, pregnancy disorders and poor physical/cognitive conditions. Early and accurate diagnosis of anemia can reduce a need for complicated treatments. Although portable (in-house) or point-of-care blood analyzers are currently available, these still remain unaffordable and inadequate in low- and middle-income country settings. Clinical examinations, digital photography, and smartphone-based noninvasive measurements have also received attention, but these still lack sensitivity and specificity for anemia diagnosis. Considering the imperative clinical need in developing countries, the `right' technology would be an accurate and sensitive noninvasive hemoglobin measuring technology that can easily be embedded into conventional mobile smartphones. We will develop a mobile smartphone-based noninvasive spectrometer-less hemoglobin analyzer (mHema) and to conduct studies with Academic Model Providing Access to Healthcare (AMPATH) program in Kenya. Our approach takes advantage of virtual hyperspectral (each pixel has detailed color information) imaging to have similar results compared with laboratory-based hemoglobin tests (gold standard). This platform will be implemented as a user-friendly application in conventional mobile smartphones. We propose the following three specific aims: i) develop a two-step algorithm for accurate and sensitive hemoglobin quantification, ii) implement the hemoglobin detection algorithm within an electronic health record system- integrated smartphone application, and iii) evaluate the performance characteristics of mHema in a real-world clinical setting in Kenya. As the proposed study is at the intersection of medical device development, clinical laboratory testing, and computer science, our interdisciplinary team is well poised to carry out this proposed work as a part of AMPATH. Given that the detection technology is completely noninvasive and rapid, we will piggyback patients undergoing routine blood tests. Successful completion of the planned studies will facilitate clinical translation of this mobile application tool and maximize the quality of current available standard of care. This work will provide a foundation to comprehensively evaluate the accuracy and precision of mHema for a larger patient population with a broader set of conditions, further serving as a model clinical setting to tailor our technology for other resource-limited settings.