Simple and Rapid Diagnosis of Preeclampsia

Organization: 
Becton, Dickinson and Company
Organization Location: 
Research Triangle Park, NC, USA

Preeclampsia is a pregnancy-related hypertensive disorder affecting 2 to 8% of all pregnancies and a major cause of maternal and antenatal mortality in the developing world. Key pathophysiological processes are initiated by impaired early trophoblastic invasion and overproduction of angiogenic factors. A panel of predictive biomarkers reflecting different aspects of the disease offers the potential to diagnose preeclampsia at an early stage in gestation. Early stage detection will be based on the Surface Enhanced Raman Scattering (SERS)–Homogenous No-Wash (HNW) platform enabling detection of clinically validated biomarkers without pre-processing or washing from a complex sample in a point-of-care setting. Clinical performance will be assessed using non-invasive urine specimens and optimized assay algorithms to improve specificity for interventions recommended by the World Health Organization (WHO). SERS HNW is an innovative multiplex, low-cost, point-of-care SERS HNW test for prediction of preeclampsia risk. Most of the WHO ASSURED criteria are met using the Surface Enhanced Raman Scattering (SERS)–Homogenous No-Wash (HNW) platform. SERS HNW provides ELISA-like analytical sensitivity, is low-cost (< $1.00 per test), semi-quantitative, requires minimal training, and has the ability to multiplex pathophysiological biomarkers. Multiplex capabilities in the platform provide the potential to detect maternal/antenatal disease beyond preeclampsia. Preeclampsia is one of many maternal and neonatal diseases challenging the developing world. An expanded pan pregnancy-associated risk test that includes premature rupture of the membrane and premature birth as well as infectious diseases like HIV and syphilis may provide a better solution for the milieu of challenges faced in the developing world.

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