Hillary Bracken1, Irina A Buhimschi2, Anisur Rahman3, Patricio R Sanhueza Smith4, Jesmin Pervin3, Salma Rouf5, Manuel Bousieguez1, Lourdes García López6, Catalin S Buhimschi2, Thomas Easterling7, Beverly Winikoff1. 1. Gynuity Health Projects, 220 East 42nd Street, Suite #710, New York, NY 10017, USA. 2. Department of Obstetrics and Gynecology, University of Illinois at Chicago, College of Medicine, Chicago, IL 60612, USA. 3. Maternal and Child Health Division, icddr,b, Dhaka, Bangladesh. 4. Mnistry of Health, Mexico City, Altadena 23, Nápoles, 03810 Ciudad de México, CDMX. 5. Department of Obstetrics and Gynecology, Dhaka Medical College and Hospital, Dhaka, Bangladesh. 6. Hospital Materno-Infantil Inguarán, Ministry of Health, Mexico City, Mexico. 7. University of Washington, Seattle, WA 98195, USA.
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: Prospective diagnostic case-control study conducted in 409 pregnant women (n = 204 preeclampsia; n = 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: The GV-005 was positive in 85% of clinical cases (83/98) and negative in 81% of clinical controls (79/98) in the Bangladesh cohort. In the Mexico cohort, the GV-005 test was positive in 48% of clinical cases (51/106) and negative in 77% of clinical controls (82/107). Adjudication confirmed preeclampsia in 92% of Bangladesh clinical cases (90/98) and 61% of Mexico clinical cases (65/106). The odds ratio of a urine congophilia in adjudicated cases versus controls in the Bangladesh cohort was 34.5 (14.7 - 81.1) (p<0.001) compared to 4.2 (2.1 - 8.4; p<0.001) 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.
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: Prospective diagnostic case-control study conducted in 409 pregnant women (n = 204 preeclampsia; n = 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: The GV-005 was positive in 85% of clinical cases (83/98) and negative in 81% of clinical controls (79/98) in the Bangladesh cohort. In the Mexico cohort, the GV-005 test was positive in 48% of clinical cases (51/106) and negative in 77% of clinical controls (82/107). Adjudication confirmed preeclampsia in 92% of Bangladesh clinical cases (90/98) and 61% of Mexico clinical cases (65/106). The odds ratio of a urine congophilia in adjudicated cases versus controls in the Bangladesh cohort was 34.5 (14.7 - 81.1) (p<0.001) compared to 4.2 (2.1 - 8.4; p<0.001) 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.
Authors: Anne W S Rutjes; Johannes B Reitsma; Jan P Vandenbroucke; Afina S Glas; Patrick M M Bossuyt Journal: Clin Chem Date: 2005-06-16 Impact factor: 8.327
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Authors: Liona C Poon; Andrew Shennan; Jonathan A Hyett; Anil Kapur; Eran Hadar; Hema Divakar; Fionnuala McAuliffe; Fabricio da Silva Costa; Peter von Dadelszen; Harold David McIntyre; Anne B Kihara; Gian Carlo Di Renzo; Roberto Romero; Mary D'Alton; Vincenzo Berghella; Kypros H Nicolaides; Moshe Hod Journal: Int J Gynaecol Obstet Date: 2019-05 Impact factor: 3.561