Congo red test for identification of preeclampsia: Results of a prospective diagnostic case-control study in Bangladesh and Mexico.

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 (

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

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.

Informations de copyright

© 2020 The Authors.

Déclaration de conflit d'intérêts

Dr. Irina Buhimschi reports grants from Saving Lives at Birth (SLaB) partners including USAID, Bill & Melinda Gates Foundation, Goverments of Canada, Norway and UK DFID, during the conduct of the study; other from GestVision Inc. In addition, Dr. Irina Buhimschi has a patent US Patent Number 8263,342 with royalties paid by GestVision Inc, a patent US Patent Number 9229,009 with royalties paid by GestVision Inc and by Shuwen Biotech, a patent U.S. Patent Number 10,324,094 with royalties paid by GestVision Inc, and a patent European patent No 3,129,779 with royalties paid by GestVision Inc. These royalties are paid to Yale University who disburses a percentage to inventors and co-inventors. The Congo Red devices used in this study were purchased from GestVision Inc who had no input in data interpretation or decision to submit for publication. Dr. Catalin Buhimschi reports grants from Saving Lives at Birth (SLaB) partners including USAID, Bill & Melinda Gates Foundation, Goverments of Canada, Norway and UK DFID, during the conduct of the study; other from GestVision Inc. In addition, Dr. Catalin Buhimschi has a patent US Patent Number 8263,342 with royalties paid by GestVision Inc, a patent US Patent Number 9229,009 with royalties paid by GestVision Inc and by Shuwen Biotech, a patent U.S. Patent Number 10,324,094 with royalties paid by GestVision Inc, and a patent European patent No 3,129,779 with royalties paid by GestVision Inc. These royalties are paid to Yale University who disburses a percentage to inventors and co-inventors. The Congo Red devices used in this study were purchased from GestVision Inc who had no input in data interpretation or decision to submit for publication. Dr. Easterling reports personal fees from DiabetOmics, Inc., outside the submitted work. The other authors have no conflicts to declare.