Low-cost, point-of-care screening and diagnosis of preeclampsia/eclampsia: novel biomarkers in a lateral-flow test

Organization: 
PATH
Organization Location: 
Seattle, WA, USA

The World Health Organization estimates that PE/E accounts for at least 16% of maternal deaths in low-resources settings. The risk of dying from PE/E is approximately 300 times higher for a woman in a developing country than for a woman in a developed country. Automated diagnostic systems for detection of blood biomarkers with higher accuracy and better predictive values (e.g., Alere Triage® PlGF test; 96% sensitivity, 98% negative predictive value) are commercially available. Unfortunately, these systems are feasible only in resource-rich settings; no low-cost solution currently exists for diagnosis of PE/E. Instead, blood pressure and proteinuria screening serve as surrogate markers of risk for developing PE/E. We have identified three promising urine-based biomarkers from published proteomic studies; our first project activity will be to develop these three urine-based biomarkers into three respective ELISA for proof-of-concept validation and technology transfer to lateral-flow assays. Also, we have engaged with two developers who have novel blood-based biomarkers in developed ELISA; they have conducted small, pilot clinical validations, and the resulting data shows promising sensitivity, specificity, and correlation to PE/E outcomes. Our second project activity will be to transfer the developers’ assays into lateral-flow assays. Our third activity will be to evaluate the analytical performance of all the assays, the results of which will be a decision point for further work. Our fourth project activity will be to continue and/or initiate discussions with manufacturers and clinical investigators regarding potential clinical and commercialization activities.

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