7/28/2019 Sanghvi: Protein Self Test

1/11

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

7/28/2019 Sanghvi: Protein Self Test

2/11

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

7/28/2019 Sanghvi: Protein Self Test

3/11

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

7/28/2019 Sanghvi: Protein Self Test

4/11

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

7/28/2019 Sanghvi: Protein Self Test

5/11

Validation of POC test in ANC Clients,Rural Nepal

5

Compared to Esbach (>.30 vs.

7/28/2019 Sanghvi: Protein Self Test

6/11

7/28/2019 Sanghvi: Protein Self Test

7/11

Field Studies: nepal

Continued reagent optimization and closing in on

design freeze

7/28/2019 Sanghvi: Protein Self Test

8/11

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

7/28/2019 Sanghvi: Protein Self Test

9/11

9

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

7/28/2019 Sanghvi: Protein Self Test

10/11

HemoGlobe

Low cost non-invasive anemia screening and surveillance

What the health worker sees What the health official sees

10

7/28/2019 Sanghvi: Protein Self Test

11/11

Simplifying the technology for communityuse

A Day of Birth Alliance product