A Clinical Performance Evaluation Case-Control Study for Point-of-Care Preeclampsia Screening Kit in Pregnant Women

Preeclampsia (PE) is a multisystemic pregnancy-specific disease characterized by endothelial dysfunction. This condition develops in 2% to 8% of all pregnant women and remains a major cause of maternal and perinatal morbidity and mortality worldwide. It is estimated that approximately 4 million women are diagnosed with PE each year, resulting in >70,000 deaths in women and 500,000 babies. Currently PE can be detected only after the 20th week of pregnancy on clinical manifestation of symptoms or using biomarker based tests. There is an unmet clinical need for early and point of care diagnostic tests. Early diagnosis (before 20 weeks of gestation), with the help of effective screening tests, can help the clinicians to manage PE effectively. In order to address this need, we have developed a sensitive, visual, LFA for PE screening. The purpose of this study is to evaluate the efficacy of Preeclampsia Screening Kit to reliably identify patients in early pregnancy that are at risk of developing PE. It is a comparatively economical, point-of-care, rapid test that can predict the risk of developing preeclampsia.