Rood Kara M, Buhimschi Catalin S, Dible Theresa, Webster Shaylyn, Zhao Guomao, Samuels Philip, Buhimschi Irina A
Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH 43210, USA.
Department of Obstetrics & Gynecology, University of Illinois at Chicago College of Medicine, Chicago, Illinois, 60612, USA.
EClinicalMedicine. 2019 Mar 1;8:47-56. doi: 10.1016/j.eclinm.2019.02.004. eCollection 2019 Feb.
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.
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.
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.
The CRD Paper Test is a simple, non-invasive, "sample-in/answer-out" point-of-care clinical tool for rapid identification of PE.
Saving Lives at Birth Program and NICHD.
子痫前期（PE）女性尿液中的蛋白质可结合刚果红染料（尿液嗜刚果红性）。我们旨在确定一种基于纸张的即时检验检测尿液嗜刚果红性对PE进行快速分诊和诊断的诊断性能。
在我们机构的分娩和分娩分诊单元对346名连续接受PE评估的孕妇进行前瞻性队列研究。对新鲜尿液样本进行刚果红点（CRD）纸试验（指标试验）。将CRD纸试验结果与每例病例的专家判定诊断进行比较。CRD纸试验的准确性还与先前提议作为PE诊断辅助手段的尿液和血清分析物（胎盘生长因子和可溶性fms样酪氨酸激酶-1）进行了比较。
在首次分诊就诊时，32%（112/346）的女性被临床诊断为PE。然而，63%（217/346）的患者因住院诊断检查或分娩而入院。CRD纸试验在25%（86/346）的病例中呈阳性。判定在所有病例的28%（96/346）中确诊为PE。CRD纸试验优于测定的血清和尿液标志物（灵敏度80·2%，特异性89·2%，阴性预测值92·1%，准确性86·7%）。检验前、阳性和阴性检验后概率分别为27·7%、74·0%和8·0%。在未分娩出院的女性中，38%（133/346）至少有一次额外的分诊就诊，最后一次阴性CRD纸试验与第一次阳性CRD纸试验之间的间隔为12（四分位间距，[5-34]）天。
CRD纸试验是一种简单、非侵入性的“样本进/结果出”即时临床工具，用于快速识别PE。
出生时拯救生命计划和美国国立儿童健康与人类发展研究所。
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