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The  eyeHeme : A Novel Approach to Anemia Diagnosis

The  eyeHeme : A Novel Approach to Anemia Diagnosis. Team Dx, D-lab Health Arianne Jong Seema Kacker Kristin Kuhn Spring 2010. Motivation Background Strategy Design Parameters Proposal Progress Demonstration! Future directions Prototype development Product development Pricing

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The  eyeHeme : A Novel Approach to Anemia Diagnosis

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  1. The eyeHeme: A Novel Approach to Anemia Diagnosis Team Dx, D-lab Health Arianne Jong Seema Kacker Kristin Kuhn Spring 2010

  2. Motivation • Background • Strategy • Design Parameters • Proposal • Progress • Demonstration! • Future directions • Prototype development • Product development • Pricing • Manufacturing • Regulatory pathway • Potential impact Overview

  3. Anemia is a primary contributor to the global burden of disease • 2 billion people worldwide • impaired development, reduced productivity • increased infection risk • more rapid disease progression • 42% of all pregnant women • 20% of maternal deaths (>120,000 per year) • birth complications, infant mortality (>134,000 per year) • 40-50% of preschool children in the developing world are anemic • $50 Billion in GDP lost each year Motivation – Impact of Anemia Global Health Risks Report: Mortality and burden of disease attributable to selected major risks.  WHO, 2009. Prevalence estimates from WHO Global Database on Anaemia, 2008.

  4. Nine out of 10 anemics live in the developing world, but anemia affects all countries and demographics Motivation

  5. Anemia • Definition: inability of red blood cells to carry enough oxygen to the tissues of the body • measured by hemoglobin concentration • Causes: nutritional and due to infection • Iron-deficiency: >50% of cases • Infection (malaria, hookworms, etc.) • Other nutritional deficiencies • Challenge • Treatment is known, but anemia is under-diagnosed and undertreated Background

  6. Diagnostic Methods: Invasive Methods Limitations Painful Risk of infection Training required Costly Result may not be immediately available • Complete blood count • [Hb] • Hematocrit - volume occupied by RBCs in plasma • Mean Corpuscular Volume: average size of RBCs • Alternative in-vitro methods • HemoCue www.hubpages.com

  7. Diagnostic Methods: Non-Invasive Methods • Few widely available devices • Mostly qualitative analysis of obvious clinical signs • Eyelid, tongue, palmar and nailbed observation, patient interview • Sensitive only to severe anemia • Subjective • Requires training/experience Karnath, 2004

  8. Subcutaneous Absorbance: Modified Pulse-Oximeter Concept Challenges • Sensitivity • Impure sample (multiple species of Hb, blood, tissue, etc.) • Beer-Lambert Law: • Attenuation: • Measure variation in path length with sonomicrometer Aldrich et al., 2002

  9. Occlusion Spectroscopy - OrSense Concept Concept • Occlusion of blood flow causes low signal-noise ratio • Measures transmittance using multiple wavelengths • Cost issues • Appropriate? Challenges Amir et al., 2007

  10. Reflectance Spectroscopy Nadeau et al., 2001 http://www.nrc-cnrc.gc.ca/eng/projects/ibd/diffuse-reflectance.html

  11. Orthogonal Polarization Spectral Imaging Concept Most polarized light retains polarization Deep-penetrating light (to blood vessels) becomes depolarized • Sublingual mucosa • Hemoscan, Cytoscan Nadeau et al., 2001

  12. Optical Diagnosis via the Eye Method • Reflectance obtained from blood vessels in the eye • Fundus, Conjunctiva • Obtain/view reflected signal • Modified ophthalmoscope? Jay et al., 2007

  13. Strategy: Goals for Appropriate Design • Safety • Accuracy • Sensitivity • Specificity • Robustness • Cost-effectiveness • Ease of maintenance • Portability • Results available quickly • User-friendly -> Initial screening device -> Quantitative, but specific numeric output not required

  14. - Use: palpebral conjunctiva         -Why?              -Clinical signs             -Mucosal tissue - Via: reflectance         - How?             -filter with photodiode Proposal

  15. 7.3 g/dL (Anemic) 12.7 g/dL (Mildly Anemic) Proposal 14.0 g/dL (Non-Anemic) 14.5 g/dL (Non-Anemic)

  16. The Concept: Reflectance

  17. Anemic and Non-Anemic Blood The Concept: Reflectance

  18. Tissue and Hemoglobin The Concept: Reflectance

  19. Proposal: Working Prototype

  20. Progress

  21. Future Directions

  22. Prototype Development Increase sensitivity and precision • multiple wavelengths  • alternative surfaces (mouth, nostril, e.g.) • multimodal (combine absorbance, reflectance, fluorescence) Nathan Cooke, 2010

  23. Prototype Development • Determine best light source  • Test using Intralipid, blood

  24. Product Development • Patient testing • Pilot study: small NGO, health care provider • Comparison to blood tests • Deployment • Integration into health system • Two-tiered pricing system Sensor Light Nathan Cooke, 2010

  25. 510(k) Predicate Devices Orsense's absorbance-based hemoglobin sensor Ophthalmoscope SPO Medical's reflectance-based pulse oximeter

  26. Innovation Compass

  27. Impact on Global Health Better statistics More awareness More funding (fortified rice, iron supplements, etc.)

  28. Questions?

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