Laboratory test-comparable mobile assessments of hemoglobin for anemia detection

用于贫血检测的血红蛋白实验室测试可比移动评估

• 批准号: 9341800
• 负责人: Young L Kim
• 金额: $ 20.41万
• 依托单位: PURDUE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-18 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9341800
• 关键词: Adult; Affect; Africa; Age; Agreement; Algorithmic Analysis; Algorithms; Anemia; Attention; Blood; Blood Tests; Blood Transfusion; Care Technology Points; Catchment Area; Cellular Phone; Characteristics; Child; Clinical; Cognitive; Color; Communities; Consent; Data; Detection; Developing Countries; Device or Instrument Development; Diagnosis; Digital Photography; Early Diagnosis; Electronic Health Record; Evaluation; Eyelid structure; Fatigue; Foundations; Goals; Gold; Guidelines; HIV Infections; Health; Health care facility; Heart failure; Hematology; Hemoglobin; Hemoglobin concentration result; Image; Image Analysis; Individual; International; Kenya; Laboratories; Liver Function Tests; Location; Malnutrition; Mathematics; Measurement; Measures; Medical; Medical Device; Methods; Modality; Modeling; Monitor; Mucous Membrane; Nursery Schools; Output; Pallor; Patients; Performance; Population; Pregnant Women; Prevalence; Procedures; Public Health; Reading; Recruitment Activity; Research; Resolution; Resources; Sensitivity and Specificity; Serum; Site; Standardization; Surface; System; Technology; Testing; Thinness; Time; Tissue imaging; Tissues; Woman; Work; accurate diagnosis; base; clinical diagnostics; clinical translation; computer science; conjunctiva; health care availability; low and middle-income countries; mHealth; malaria infection; mobile application; patient population; point of care; portability; pregnancy disorder; programs; reconstruction; sensor; standard of care; study population; tool; transmission process; user-friendly; virtual

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.

项目概要/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 非洲贫血患病率极高，影响了三分之二的学龄前儿童和一半的儿童 女性。如果不及时发现和治疗贫血，可能会导致严重的健康问题 后果，包括疲劳、心力衰竭、妊娠障碍和身体/认知状况不佳。 早期准确诊断贫血可以减少复杂治疗的需要。 尽管目前可以使用便携式（内部）或即时血液分析仪，但这些分析仪仍然存在 在低收入和中等收入国家环境中难以负担且不足。临床检查，数字化 摄影和基于智能手机的无创测量也受到了关注，但这些仍然 贫血诊断缺乏敏感性和特异性。考虑到开发中迫切的临床需求 对于各国而言，“正确”的技术是准确且灵敏的无创血红蛋白测量 可以轻松嵌入到传统移动智能手机中的技术。 我们将开发基于移动智能手机的无创无光谱仪血红蛋白分析仪 (mHema) 并通过提供医疗保健的学术模型 (AMPATH) 计划进行研究 肯尼亚。我们的方法利用虚拟高光谱（每个像素都有详细的颜色信息） 与基于实验室的血红蛋白测试（金标准）相比，成像具有相似的结果。这 该平台将作为传统移动智能手机中用户友好的应用程序实施。我们建议 以下三个具体目标： i) 开发准确且灵敏的血红蛋白的两步算法 量化，ii) 在电子健康记录系统中实施血红蛋白检测算法- 集成智能手机应用程序，以及 iii) 评估 mHema 在现实世界中的性能特征 肯尼亚的临床环境。 由于拟议的研究处于医疗设备开发、临床实验室测试的交叉点， 和计算机科学，我们的跨学科团队已做好准备开展这项拟议的工作，作为 AMPATH。鉴于检测技术完全无创且快速，我们将搭载患者 正在进行常规血液检查。计划研究的成功完成将促进临床转化 该移动应用程序工具的功能并最大限度地提高当前可用护理标准的质量。这项工作将 为综合评价mHema对较大患者的准确性和精密度提供基础 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。