1. Congo Red Dot Paper Test for Antenatal Triage and Rapid Identification of Preeclampsia
- Author
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Guomao Zhao, Theresa Dible, Philip Samuels, Shaylyn Webster, Catalin S. Buhimschi, Irina A. Buhimschi, and Kara M. Rood
- Subjects
medicine.medical_specialty ,Urine ,01 natural sciences ,Misfolded proteins ,Preeclampsia ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Congophilia ,Interquartile range ,Medicine ,030212 general & internal medicine ,0101 mathematics ,Prospective cohort study ,lcsh:R5-920 ,business.industry ,Obstetrics ,010102 general mathematics ,General Medicine ,medicine.disease ,Triage ,3. Good health ,Congo red ,Test (assessment) ,chemistry ,Point-of-care ,business ,lcsh:Medicine (General) ,Cohort study ,Research Paper - Abstract
Background: Proteins in the urine of women with preeclampsia (PE) bind Congo Red dye (urine congophilia). We sought to determine the diagnostic performance of a paper-based point-of-care test detecting urine congophilia for rapid triage and diagnosis of PE. Methods: Prospective cohort study conducted in 346 consecutive pregnant women evaluated for PE in the Labour and Delivery triage unit at our institution. The Congo Red Dot (CRD) Paper Test (index test) was performed on fresh urine samples. The CRD Paper Test results were compared to an expert adjudicated diagnosis in each case. The accuracy of the CRD Paper Test was also compared to urine and serum analytes (placental growth factor and soluble fms-like tyrosine kinase-1) previously proposed as diagnostic aids for PE. Findings: During the first triage visit, 32% (112/346) of women received a clinical diagnosis of PE. Yet, 63% (217/346) were admitted for in-patient diagnostic work-up or delivery. The CRD Paper Test was positive in 25% (86/346) of the cases. Adjudication confirmed PE in 28% (96/346) of all cases. The CRD Paper Test outperformed measured serum and urine markers (80·2% sensitivity, 89·2% specificity, 92·1% negative predictive value, 86·7% accuracy). The pre-test, positive and negative post-test probabilities were 27·7%, 74·0%, and 8·0%, respectively. Of women who were discharged undelivered, 38% (133/346) had at least one additional triage visit and the interval between the last negative and first positive CRD Paper Test was 12 (interquartile range, [5–34]) days. Interpretation: The CRD Paper Test is a simple, non-invasive, “sample-in/answer-out” point-of-care clinical tool for rapid identification of PE. Funding: Saving Lives at Birth Program and NICHD. Keywords: Preeclampsia, Cohort study, Congophilia, Misfolded proteins, Point-of-care
- Published
- 2019