Laboratory test-comparable mobile assessments of hemoglobin for anemia detection

项目概要/摘要 在发展中国家，贫血是包括儿童和孕妇在内的主要公共卫生问题。在 在非洲，贫血的患病率极高，影响到三分之二的学龄前儿童和一半的儿童。 妇女当贫血没有及时发现和管理，它可能会导致重大健康问题。 这些疾病的后果包括疲劳、心力衰竭、妊娠障碍和身体/认知状况差。 贫血的早期和准确诊断可以减少复杂治疗的需要。 虽然便携式（内部）或即时血液分析仪目前可用，但这些仍然存在 低收入和中等收入国家负担不起和不足。临床检查，数字 摄影和基于智能手机的非侵入性测量也受到了关注，但这些仍然存在。 贫血诊断缺乏敏感性和特异性。考虑到迫切的临床需要， 在一些国家，"正确的"技术将是准确和敏感的非侵入性血红蛋白测量 这种技术可以很容易地嵌入到传统的移动的智能手机中。 我们将开发一种基于移动的智能手机的无创无光谱血红蛋白分析仪 （mHema），并与提供医疗保健机会的学术模式（AMPATH）计划一起进行研究， 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） 与实验室血红蛋白检测（金标准）相比，成像具有相似的结果。这 平台将被实现为传统移动的智能电话中的用户友好应用。我们提出 以下三个具体目标：i）开发用于准确和灵敏的血红蛋白的两步算法 ii）在电子健康记录系统内实现血红蛋白检测算法; 集成的智能手机应用程序，以及iii）评估mHema在现实世界中的性能特征 在肯尼亚的诊所 由于拟定研究处于医疗器械开发、临床实验室检测， 和计算机科学，我们的跨学科团队已经准备好开展这项拟议的工作，作为 AMPATH。鉴于检测技术是完全无创和快速的，我们将搭载病人 进行常规血液检查。成功完成计划的研究将促进临床翻译 这一移动的应用工具，并最大限度地提高目前可用的护理标准的质量。这项工作将 为全面评价mHema在较大患者中的准确性和精密度提供了基础 具有更广泛条件的人群，进一步作为模型临床环境来定制我们的技术 对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.