Disposable platform provides visual and color-based point-of-care anemia self-testing

Tyburski, Erika A.; Gillespie, Scott; Stoy, William; Mannino, Robert G.; Weiss, Alexander J.; Siu, Alexa F.; Bulloch, Rayford H.; Thota, Karthik; Cardenas, Anyela; Session, Wilena; Khoury, H. Jean; O’Connor, Siobhán; Bunting, Silvia T.; Boudreaux, J. Philip; Forest, Craig R.; Gaddh, Manila; Leong, Traci; Lyon, L. Andrew; Lam, Wilbur A.

doi:10.1172/jci76666

Cited by 49 publications

(64 citation statements)

References 27 publications

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“…colorimetrically (both by eye and a smartphone app) using a redox reaction, 53 4) paper-based devices, 58 5) the hematocrit estimate method, 59 and 6) the WHO Hemoglobin Color Scale.…”

Section: Discussionmentioning

confidence: 99%

Diagnosis of iron deficiency anemia using density-based fractionation of red blood cells

et al. 2016

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Iron deficiency anemia (IDA) is a nutritional disorder that impacts over one billion people worldwide, it causes permanent cognitive impairment in children, fatigue in adults, and suboptimal outcomes in pregnancy. IDA can be diagnosed by detection of red blood cells (RBCs) that are characteristically small (microcytic) and deficient in hemoglobin (hypochromic), typically by examining the results of a complete blood count performed by a hematology analyzer. These instruments are expensive, not portable, and require trained personnel; they are therefore, unavailable in many low-resource settings. This paper describes a low-cost and rapid method to diagnose IDA using aqueous multiphase systems (AMPS)-thermodynamically stable mixtures of biocompatible polymers and salt that spontaneously form discrete layers having sharp steps in density. AMPS are preloaded into a microhematocrit tube and used with a drop of blood from a fingerstick. After only two minutes in a low-cost centrifuge, the tests (n = 152) were read by eye with a sensitivity of 84% (72-93%) and a specificity of 78% (68-86%), corresponding to an area under the curve (AUC) of 0.89. The AMPS test outperforms diagnosis by hemoglobin alone (AUC = 0.73) and is comparable to methods used in clinics like reticulocyte hemoglobin concentration (AUC = 0.91). Standard machine learning tools were used to analyze images of the resulting tests captured by a standard desktop scanner to 1) slightly improve diagnosis of IDA-sensitivity of 90% (83-96%) and a specificity of 77% (64-87%), and 2) predict several important red blood cell parameters, such as mean corpuscular hemoglobin concentration. These results suggest that the use of AMPS combined with machine learning provides an approach to developing point-of-care hematology.

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“…colorimetrically (both by eye and a smartphone app) using a redox reaction, 53 4) paper-based devices, 58 5) the hematocrit estimate method, 59 and 6) the WHO Hemoglobin Color Scale.…”

Section: Discussionmentioning

confidence: 99%

Diagnosis of iron deficiency anemia using density-based fractionation of red blood cells

et al. 2016

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“…RGB peak values were then converted to CIE L*a*b* color space values corresponding to Hgb concentrations via calibration, using the MATLAB mathematic model. 37 The CIE L*a*b* color space is a color representation model which maps a three-dimensional integer space for device-independent digital representation of color. 37 …”

Section: Smartphone Output and Readoutmentioning

confidence: 99%

“…37 The CIE L*a*b* color space is a color representation model which maps a three-dimensional integer space for device-independent digital representation of color. 37 …”

Section: Smartphone Output and Readoutmentioning

confidence: 99%

“…53 However, few of these tools are well-suited for transferring to low-resource areas, due to their costs and sophisticated designs that require professional operation. Simple and disposable platforms have recently been developed to test blood Hgb levels, 37,54,55 including the WHO Hb color scale (HbCS) test, 56 but these platforms require fabrication facilities in scientific laboratories or skilled technicians for mass production and technology transfer, thereby offering limited adaptability for establishing study capacity in rural areas or low-income countries. We developed a color-scale assay combined with smartphone to ascertain Hgb blood levels using only $5 ll blood from a finger prick.…”

Section: Rapid Poc Diagnosis Of Anemiamentioning

confidence: 99%

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3D printed auto-mixing chip enables rapid smartphone diagnosis of anemia

et al. 2016

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Clinical diagnosis requiring central facilities and site visits can be burdensome for patients in resource-limited or rural areas. Therefore, development of a lowcost test that utilizes smartphone data collection and transmission would beneficially enable disease self-management and point-of-care (POC) diagnosis. In this paper, we introduce a low-cost iPOC 3D diagnostic strategy which integrates 3D design and printing of microfluidic POC device with smartphone-based disease diagnosis in one process as a stand-alone system, offering strong adaptability for establishing diagnostic capacity in resource-limited areas and low-income countries. We employ smartphone output (AutoCAD 360 app) and readout (color-scale analytical app written in-house) functionalities for rapid 3D printing of microfluidic auto-mixers and colorimetric detection of blood hemoglobin levels. The automixing of reagents with blood via capillary force has been demonstrated in 1 second without the requirement of external pumps. We employed this iPOC 3D system for point-of-care diagnosis of anemia using a training set of patients (n anemia ¼ 16 and n healthy ¼ 6), which showed consistent measurements of blood hemoglobin levels (a.u.c. ¼ 0.97) and comparable diagnostic sensitivity and specificity, compared with standard clinical hematology analyzer. Capable of 3D fabrication flexibility and smartphone compatibility, this work presents a novel diagnostic strategy for advancing personalized medicine and mobile healthcare. Published by AIP Publishing. [http://dx

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“…A new POC visual method that can also be interpreted via smartphone has been recently tested and has given some promising results [11].…”

Section: Hematologymentioning

confidence: 99%

Point of Care Testing and Transfusion Safety in Resource Limited Settings: A Review

Musi¹

2015

J Blood Disord Transfus

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Worldwide, one of the fastest growing aspects of clinical laboratory testing is point of care testing (POCT). Decentralized patient care and access to testing in under-served areas are key elements in the evolving expansion of POCT. Several available POCT devices can potentially contribute to safer transfusion practices in resourcelimited settings. Only "rapid diagnostic tests" and some simple hemoglobinometers are normally encountered in the peripheral hospitals of low income countries. Strengths, weaknesses and barriers of large scale utilization of POCT in transfusion medicine are discussed.

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Disposable platform provides visual and color-based point-of-care anemia self-testing

Cited by 49 publications

References 27 publications

Diagnosis of iron deficiency anemia using density-based fractionation of red blood cells

Diagnosis of iron deficiency anemia using density-based fractionation of red blood cells

3D printed auto-mixing chip enables rapid smartphone diagnosis of anemia

Point of Care Testing and Transfusion Safety in Resource Limited Settings: A Review

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