Innovations

Improving Screening for Pre-Eclampsia and Eclampsia: A Low-Cost Solution for a Persistent Global Health Challenge
Device Features: Versatile device platform to include other screening tests for maternal health conditions One device contains over 1,000 tests Easy-to-interpret color change in the presence of proteinuria Requires no laboratory infrastructure and very little training Appropriate for community setting Extremely affordable Collaborators and Supporters: Johns Hopkins University Center for Bioengineering Innovation and Design, the United States Agency for International Development, GlaxoSmithKline, and the Morton K. and Jane Blaustein Foundation Contact: For more information on this project, contact Brinnon Mandel at bmandel@jhpiego.net

Global Health Need

Pre-eclampsia is a pregnancy complication characterized by raised blood pressure, proteinuria, and sometimes edema, which if undetected and unmanaged, can progress to eclampsia and present serious risks to the mother and baby. Early diagnosis of pre-eclampsia and eclampsia (PE/E) depends on the detection of proteinuria and elevated blood pressure during pregnancy. PE/E are among the top causes of maternal mortality and morbidity worldwide,1 contributing to 12% of all maternal deaths (> 60,000 deaths annually),2 and disproportionately affect women in low-resource countries. Despite the diagnostic importance of detecting protein in the urine, it continues to be an underutilized clinical test due to limitations related to cost, time, training, and laboratory infrastructure. All of these limitations amount to low coverage of critical detection and management of PE/E.

Low-Cost Technology Solution

Jhpiego and the Johns Hopkins Center for Bioengineering Innovation and Design have developed a protein device test that contains a reagent that detects protein in the urine and employs a novel platform to make proteinuria detection intuitive, extremely affordable, and a reliable point-of-care screening tool that can lead to earlier and more widespread detection of PE/E. The test uses a simple color change that is easy for individuals with little to no training to interpret. This feature enables community health workers and volunteers to distribute this test to pregnant women outside of facilities and has the potential to dramatically increase the coverage and quality of pre-eclampsia screening. A device platform for dispensing a simple, colorchanging solution will facilitate increased proteinuria tests and can eventually be adapted for the detection of other maternal conditions easily detected through the use of urine tests.

Current Status and Future of the Protein Device

Early prototypes have undergone rigorous laboratory testing in Baltimore and have undergone sensitivity and specificity testing in Baltimore and Nepal. Additional testing has been done in antenatal care clinics and in the community in Nepal to determine feasibility and acceptability among community health workers and pregnant women in preparation for industrialization and additional field studies.

1 2

Khan KS, Wojdyla D, Say L, et al. WHO analysis of causes of maternal death: A systematic review. Lancet 2006; 367: 10661074. World Health Organization. 1994. Mother-Baby Package: Implementing Safe Motherhood in Countries. Geneva.
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