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Congo red test for identification of preeclampsia: Results of a prospective diagnostic case-control study in Bangladesh and Mexico
- Source :
- EClinicalMedicine, Vol 31, Iss, Pp 100678-(2021), EClinicalMedicine
- Publication Year :
- 2021
- Publisher :
- Elsevier, 2021.
-
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
- Subjects :
- medicine.medical_specialty
lcsh:R5-920
Research paper
Obstetrics
business.industry
010102 general mathematics
Case-control study
General Medicine
Urine
Odds ratio
medicine.disease
01 natural sciences
Test (assessment)
Preeclampsia
03 medical and health sciences
0302 clinical medicine
Primary outcome
Cohort
medicine
030212 general & internal medicine
0101 mathematics
Tertiary level
business
lcsh:Medicine (General)
Subjects
Details
- Language :
- English
- ISSN :
- 25895370
- Volume :
- 31
- Database :
- OpenAIRE
- Journal :
- EClinicalMedicine
- Accession number :
- edsair.doi.dedup.....177f89b60c6a8e9a4557b59cd68fa023