Advancing a Simple, Low-Cost Rapid Diagnostic Test for Urinary Adipsin: A Promising New Biomarker-Based Test for Improving Pre-Eclampsia Screening in Low-Resource Settings

Organization Location: 
Seattle, Washington, USA

Preeclampsia (PE) remains one of the leading global causes of maternal death and disability. Early and accurate identification of women at high risk for developing PE is key to linking women to appropriate interventions to improve clinical outcomes and reduce morbidity and mortality due to PE. New biomarker-based tests for PE have shown great potential to allow for more timely and accurate diagnosis, as compared to current tools used throughout low-resource settings including the protein-only dipstick. Under a recently completed SL@B Round 4 Seed Award, PATH developed a new prototype lateral flow rapid diagnostic test (RDT) for the promising PE biomarker, urinary adipsin (UA). Under the round seven proposal, PATH seeks to incorporate a new, innovative design feature to this prototype that will further improve its usability by enabling midstream urine collection and thus align the test process to that of a common one-step, at-home pregnancy test. No current PE diagnostic test allows for such a simple test process, which could improve test accuracy by limiting end-user errors. The project’s development goal is a new PE diagnostic that will meet the target characteristics of the World Health Organization ASSURED criteria (Affordable, Sensitive, Specific, User-friendly, Rapid and Robust, Equipment-free, and Deliverable) to ensure optimal alignment with the needs for access and use across low-resource settings. SL@B Validation Award funding would support early R&D activities, laboratory validation with a large, diverse sample set to generate proof-of-prototype evidence, and ultimately inform the advancement of the UA RDT prototype to downstream development phases including transfer to a commercial manufacturing partner. If successful, this new diagnostic has potential to enable access to improved PE diagnosis across low-resource settings including in peripheral settings where the majority of pregnant women receive routine antenatal care.

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