Field Validation of a New Protein-To-Creatinine (PrCr) Strip Test: An Impactful New Tool to Improve Diagnosis of Preeclampsia at the Front Lines of Antenatal Care in Low-Resource Settings

Organization: 
PATH
Organization Location: 
Seattle, Washington, USA

The WHO estimates that preeclampsia (PE) accounts for at least 16 percent of maternal deaths in low-resource settings (LRS). Due to its high cost and complexity, the reference standard for proteinuria diagnosis, 24-hour urine collection, is largely unavailable in antenatal care (ANC) in LRS. Instead, the standard of care for proteinuria detection for the majority of pregnant women in routine ANC is the low-cost, but inaccurate protein-only dipstick test. PATH seeks to improve access to improved preeclampsia screening in routine ANC by addressing the need for a low-cost, accurate proteinuria screening tool to replace the protein-only dipstick as the standard used in routine ANC in LRS. PATH is working in collaboration with LifeAssay Diagnostics, Ltd. (SouthAfrica) to develop and support validation of a simple, low-cost protein-to-creatinine ratiometric urine dipstick test and is seeking to demonstrate the feasibility for implementation and use of the test within routine ANC. This proposal will support a field evaluation of the new test in Ghana, in partnership with Kintampo Health Research Centre, and an in-country stakeholder analysis by PATH to understand the considerations for implementation of thetest. Anticipated outcomes of this project are the generation of evidence demonstrating the field performance of the PrCr test as well as building awareness among ANC stakeholders and improving understanding of the needs to help ensure success in future transition to scale activities.

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