Congo red test for identification of preeclampsia: Results of a prospective diagnostic case-control study in Bangladesh and Mexico
Hillary Bracken, Irina A. Buhimschi, Anisur Rahman, Patricio R. Sanhueza Smith, Jesmin Pervin, Salma Rouf, Manuel Bousiéguez, Lourdes García López, Catalin S. Buhimschi, Thomas R. Easterling, Beverly Winikoff
Abstract
BACKGROUND: Misfolded proteins in the urine of women with preeclampsia bind to Congo Red dye (urine congophilia). We evaluated a beta prototype of a point-of-care test for the identification of urine congophilia in preeclamptic women. METHODS: = 205 uncomplicated pregnancies) presenting for delivery in two tertiary level hospitals located in Bangladesh and Mexico. The GV-005, a beta prototype of a point-of-care test for detecting congophilia, was performed on fresh and refrigerated urine samples. The primary outcome was the prevalence of urine congophilia in each of the two groups. Secondary outcome was the likelihood of the GV-005 (index test) to confirm and rule-out preeclampsia based on an adjudicated diagnosis (reference standard). FINDINGS: 001) in the Mexico cohort. INTERPRETATION: The GV-005, a beta prototype of a point-of-care test for detection of urine congophilia, is a promising tool for rapid identification of preeclampsia. FUNDING: Saving Lives at Birth.