Point-of-Care Rapid Test for Early Diagnosis of Preeclampsia via sFlt1

Javan Esfandiari of Chembio Diagnostics, Inc. in the U.S. will develop an affordable point-of-care diagnostic platform for prediction and detection of preeclampsia early in pregnancy. The diagnostic test is a semi-quantitative lateral flow immunoassay to monitor the level of the key preeclampsia biomarker protein sFlt1 in whole blood from a finger prick. The test will discriminate between two levels of the biomarker, identifying patients at either low, medium, or high risk of developing preeclampsia, and it will be integrated into a low-cost, portable reader device. Through local collaboration, the prototype device will be tested in France, Nigeria, and Benin. In each country, 100 women with identified risk of preeclampsia will participate. For comparison with the diagnostic test results and predicted preeclampsia risk, patient clinical outcomes will be recorded, and serum samples will be tested at a central laboratory, using existing tests to measure sFlt1 and the sFlt1/PIGF biomarker ratio.