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 Monagle
Product development engineer/Jhpiego

Global Newborn Health conference, Johannesburg, South Africa

Massive unmet need for early detection of PE Source DHS

Country
Bangladesh Bolivia DRC India Indonesia Kenya Malawi Mozambique Nepal Zimbabwe

% Unmet need for BP Check

53.1% 24.5% 38.8% 52.5% 13.9% 22.8% 28.6% 48.7% 43.8% 14.0%

% Unmet need for Proteinuria Check

70.5% 50.9% 57.8% 56.8% 63.0% 38.9% 81.3% 73.9% 77.7% 39.8%
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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 women

Clear Result
Dichotomous (positive/negative) test result Less Chance for observer error

Development Teams
Peter Truskey, Maxim Budyansky, Sean Monagle, James Waring, Matthew Means, Sherri Hall, Mary OGrady, Shishira Nagesh

2010-11 2010-11

2009-10

Benjamin Yoo, Thembi Mdluli, Millie Shah, Sean Monagle, Stephen Dria, Ezra Taylor,Elisa No, Elaine Yang, Britni Crocker, Jackie Birkness

Validation of POC test in ANC Clients, Rural Nepal

Compared to Esbach (>.30 vs. <.30)

Sensitivity Specificity PPV NPV

POC (N=578) Point Estimate and 95% CI 93.9 (79.8, 99.3)

76.0 (72.1, 79.5) 19.1 (13.4, 26.0) 99.5 (98.3, 99.9)

Dipstick (N=578)
48.5 89.5 21.9 96.6

Esbach test is the qualitative standard, Dipstick test is the standard of care (trace or 1+ vs. negative); Point of Care (POC) self-test is new

Sanghvi, Monagle, Sharma 2011

Field Studies: nepal

Continued reagent optimization and closing in on design freeze

Key Features
Cap prevents leakage and protects reagent from environment

Material Compatible with chemical reagent

Metered Tip delivers consistent dose

Chemical Reagent Simple Dichotomous Color Change for Easy results

ASK Project Trajectory

2012/2013: Beta Prototype development based on Field Study feedback

Summer 2010: 1st Field Study, Kathmandu, Nepal Fall 2008: Initial Concept Development , Jhpiego and JHU-CBID

Summer 2014: CE cleared. Pilot Studies and Introduction of device

Summer/Fall 2011: 2nd, 3rd Field Studies. Usability and Accuracy of Alpha Prototype

Summer 2013: 4th Field Study (Nepal). Form Regulatory, Implementation Plans

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 community use

A Day of Birth Alliance product