Economic Health Care Technology for Developing Countries Portable Paper Diagnostic Test Dispenser Marlene Shi May 17, 2010 Marlene Shi 1 Current Problem Marlene Shi 2 Global Need in Developing Countries Case 1: Malaria in tribal belt of Central India Several hours/days to reach nearest Primary Health Centre Diagnosis based on clinical symptoms only 50% accuracy False positives Blood smears examined by 1 or 2 trained microscopists NEED: Early diagnosis and prompt treatment Bharti, PK, N Silawat, PP Singh, MP Singh, and M Shukla. 2008. The Usefulness of a New Rapid Diagnostic Test, the First Response(R) Malaria Combo (pLDH/HRP2) Card Test, for Malaria Diagnosis in the Forested Belt of Central India. Malaria Journal. 7, no. 126: [20]. Marlene Shi 3 Global Need in Developing Countries Case #2: Tuberculosis Gold standard techniques in infectious disease diagnostics: microscopy enzyme-linked immunosorbent assays (ELISA). tissue culture lateral flow immunoassays Problem: poor detection threshold expensive slow skilled technicians limited differentiation between multiple pathogens Hauck, Tanya, Supratim Giri, Yali Gao, and Warren C.W Chan. 2010. Nanotechnology Diagnostics for Infectious Diseases Prevalent in Developing Countries. Advanced Drug Delivery Reviews. 62, no. 4/5: 438-448. Marlene Shi 4 Global Need in Developing Countries Case #3: HIV 40 million worldwide 96% in developing countries 90% are unaware of having HIV Transmission of HIV U.S. Global Health Policy fact sheet. April 2009. http://www.kff.org/hivaids/upload/3030-13.pdf Marlene Shi 5 Global Need in Developing Countries Case #3 WHO Guidelines for diagnostic tools for infectious diseases 1) Affordable 2) Sensitive 3) Specific 4) User-friendly 5) Rapid and robust 6) Equipment free 7) Delivery to patients A S S U R E D Lee, Won Gu, Yun-Gon Kim, Bong Geun Chung, Utkan Demirci, and Ali Khademhosseini. 2010. Nano/Microfluidics for Diagnosis of Infectious Diseases in Developing Countries. Advanced Drug Delivery Reviews. 62, no. 4/5: 449-457. Marlene Shi 6 Marlene Shi 7 Global Need in Developing Countries Case #4 Gates Foundation Less than 5% of deaths from infectious diseases in developed countries Over 50% upwards to 95% of deaths in developing countries Syphilis detection diagnosis prevent 215,000 stillbirths Malaria test save over 2 million lives prevent 450 unnecessary treatment Huston, Stu. 2010. To Save Lives, Initiative Pushes for Standardized Diagnosti Tools. Nature Medicine. 16, no. 1:11.) Marlene Shi 8 Proposed Solution Marlene Shi 9 Proposed Solution Paper diagnostic dispenser Packaging Transport Equipment free Delivery to patients Easy reference Marlene Shi 10 Paper Diagnostic Technology behind paper… George Whitesides, Harvard • Natural spread of fluid • Hydrophobic polymer • Reagents in wells • Color key Citation: Healthcare Professionals Network http://medgadget.com/archives/2008/05/pap erbased_diagnostic_microfluidic_devices.html Marlene Shi 3-branced tree with 2 testing wells . Glucose and protein assays. 11 Paper Diagnostic Conventional microfluidic device • Expensive sensors and analyzers • External pumps, power sources • Etched channels Citation: Healthcare Professionals Network http://medgadget.com/archives/2008/ 05/paperbased_diagnostic_microfluidic _devices.html Whitesides • Chemical reactions (color) • Paper natural capillary action of liquid absorption • Inherent channels in paper • Hydrophobic polymer seals off channels • Cost of materials: $0.03 • Mass production using newspaper print technology Design Schematics Marlene Shi 13 Design Schematics Marlene Shi 14 Design Schematics Marlene Shi 15 Design Marlene Shi 16 Alternative Designs Marlene Shi 17 Final Solution Implementation Marlene Shi 18 Solution Implementation Marlene Shi 19 Funding Considerations Gates Foundation: • “Need common platform for point-of-care diagnostic devices for use in the developing world.” • $30 million in grants (Huston, Stu. 2010. To Save Lives, Initiative Pushes for Standardized Diagnosti Tools. Nature Medicine. 16, no. 1:11.) Diagnostics for All (Whitesides Group) Marlene Shi 20 Validation “ Improving diagnostic methods, including rapid diagnostic tests, can reduce costs and enhance the benefits of effective antimalarial drugs, but only if the consistency of response to test results is also improved. Investing in methods to improve rational response to tests is essential.” - Lubell, Y, H Reyburn, H Mbakilwa, R Mwangi, and S Chonya. 2008. The Impact of Response to the Results of Diagnostic Tests for Malaria: Costbenefit Analysis. BMJ. British Medical Journal. 336, no. 7637: 202-205. Marlene Shi 21 Validation “ A health care worker of the future is not a doctor, but an 18 year-old otherwise unemployed who has two things: a backpack full of these tests and a lancet to occasionally take a blood sample – and an AK-47.” - George Whitesides Marlene Shi 22 Acknowledgements Heather Benz Rahul Kaliki Sameer Manek Qing Xiang Yee Nitish Thakor Marlene Shi 23