Advancing a Protein-to-Creatinine Rapid Test for Determining Proteinuria Status as an Onset Indicator of Preeclampsia/Eclampsia

Louis Roux from LifeAssay Diagnostics (Pty) Ltd. in South Africa, in collaboration with PATH, will develop an easy-to-use, low-cost, strip test for pregnant women in developing countries to detect the onset of proteinuria, which indicates a highly increased risk of preeclampsia/eclampsia. Preeclampsia/eclampsia is a major cause of maternal death, particularly in developing countries. Onset is rapid, and so early diagnosis is crucial, particularly in remote communities where health care is not immediately available. The test measures the ratio of protein to creatinine, which is more accurate than the current protein-only version, and they will produce a low-cost version that can be locally manufactured. They will evaluate the test's performance in comparison to three similar tools on a minimum of 1100 urine samples collected from the CAP trial in South Africa. The study also includes usability and stability evaluations to inform further prototype improvements and product insert development for downstream validation studies.