Laboratory test-comparable mobile assessments of hemoglobin for anemia detection

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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.