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Protein self test
Harshad Sanghvi, M.D.
Vice President and Medical Director, Jhpiego
Senior Advisor, Accelovate/USAID
Senior Associate, Bloomberg School of Public Health Johns Hopkins
University
Seam MonagleProduct development engineer/Jhpiego
Global Newborn Health conference, Johannesburg, South Africa
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Massive unmet need for early detection ofPE Source DHS
Country % Unmet need for BP
Check
% Unmet need for
Proteinuria Check
Bangladesh 53.1% 70.5%
Bolivia 24.5% 50.9%
DRC 38.8% 57.8%
India 52.5% 56.8%
Indonesia 13.9% 63.0%
Kenya 22.8% 38.9%
Malawi 28.6% 81.3%Mozambique 48.7% 73.9%
Nepal 43.8% 77.7%
Zimbabwe 14.0% 39.8%
2
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Value Proposition
Low Cost Estimated 0.5 1 Cent (US) Facilitate wide-spread distribution in rural regions
Simple Design Easy for nurses and minimally trained CHWs to learn and create test strips Easy to Use by pregnant womenClear Result Dichotomous (positive/negative) test result Less Chance for observer error
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Benjamin Yoo, Thembi Mdluli, Millie Shah,
Sean Monagle, Stephen Dria, Ezra
Taylor,Elisa No, Elaine Yang, Britni Crocker,
Jackie Birkness
Peter Truskey, Maxim Budyansky, Sean
Monagle, James Waring, Matthew Means, Sherri
Hall, Mary OGrady, Shishira Nagesh
2010-11
Development Teams
2009-10
2010-11
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Validation of POC test in ANC Clients,Rural Nepal
5
Compared to Esbach (>.30 vs.
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Field Studies: nepal
Continued reagent optimization and closing in on
design freeze
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Key Features
Metered Tip deliversconsistent dose
Material Compatible withchemical reagent
Cap prevents leakage and protectsreagent from environment
Chemical Reagent Simple DichotomousColor Change for Easy results
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ASK Project Trajectory
Fall 2008:
Initial
Concept
Development, Jhpiego and
JHU-CBID
Summer 2010:
1st Field Study,
Kathmandu,
Nepal
Summer/Fall 2011:
2nd, 3rd Field
Studies. Usability
and Accuracy ofAlpha Prototype
2012/2013:
Beta Prototype
development
based on Field
Study feedback
Summer 2013:
4th Field Study
(Nepal). Form
Regulatory,
Implementation
Plans
Summer 2014: CE
cleared. Pilot Studies
and Introduction of
device
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HemoGlobe
Low cost non-invasive anemia screening and surveillance
What the health worker sees What the health official sees
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Simplifying the technology for communityuse
A Day of Birth Alliance product