Döbert Moritz, Varouxaki Anna-Nektaria, Mu An Chi, Syngelaki Argyro, Nicolaides Kypros H
Harris Birthright Research Centre for Fetal Medicine, King's College Hospital, London, UK.
J Matern Fetal Neonatal Med. 2022 Dec;35(25):5686-5690. doi: 10.1080/14767058.2021.1888924. Epub 2021 Jun 28.
Several cross-sectional studies have investigated the incidence of urinary Congo-red dye positivity in women with preeclampsia (PE), compared to unaffected pregnancies, and reported very high sensitivity and low false positive rate in the diagnosis of PE.
To determine the performance of the urinary Congo-red dot paper test at 35-37 weeks' gestation in the prediction of delivery with PE at ≤2 and >2 weeks after assessment.
This was a prospective observational study in women attending for a routine hospital visit at 35 to 36 weeks' gestation in a maternity hospital in England. Urine samples were collected and the Congo-red dot paper test was used to assess the degree of Congo-red dye positivity. The test uses a scoring system from 1 to 8 and the higher the score the greater the degree of Congo-red dye positivity. We examined and compared the degree of Congo-red dye positivity in the groups that delivered with PE at ≤2 and >2 weeks with those that remained normotensive. Reproducibility was assessed by examining the inter- and intra-observer reliability of scoring on stored images with the researchers blinded to previous results.
The study population of 2140 women included 46 (2.1%) that subsequently developed PE (2.1%). The urinary Congo-red dot test was positive in 8.3% (1/12) and 2.9% (1/34) that delivered with PE at ≤2 and >2 weeks from assessment and in 0.2% (4/2094) of the unaffected pregnancies when the cutoff for Congo-red dye positivity was ≥5. The respective values when the cutoff used was ≥3 were 66.7%, 23.5%, and 16.5%, respectively. The intraclass correlation coefficient for the inter-observer reliability was 0.926 (95% CI 0.890-0.953, <.0001) and Cohen's kappa coefficient for the intra-observer reliability was 0.904, <.0001.
The performance of the urinary Congo-red dot paper test at 35-37 weeks' gestation in the prediction of PE is very poor.
多项横断面研究调查了子痫前期（PE）女性与未受影响妊娠女性相比尿刚果红染料阳性的发生率，并报告了其在PE诊断中具有非常高的敏感性和低假阳性率。
确定妊娠35 - 37周时尿刚果红点试纸试验在评估后≤2周和>2周时预测PE分娩的性能。
这是一项对在英国一家妇产医院进行妊娠35至36周常规医院检查的女性进行的前瞻性观察研究。收集尿液样本，使用刚果红点试纸试验评估刚果红染料阳性程度。该试验使用1至8分的评分系统，分数越高，刚果红染料阳性程度越高。我们检查并比较了在≤2周和>2周时发生PE分娩的组与血压正常组的刚果红染料阳性程度。通过检查研究人员对先前结果不知情的存储图像评分的观察者间和观察者内可靠性来评估可重复性。
2140名女性的研究人群中，有46名（2.1%）随后发生了PE（2.1%）。当刚果红染料阳性临界值≥5时，在评估后≤2周和>2周时发生PE分娩的孕妇中，尿刚果红点试验阳性率分别为8.3%（1/12）和2.9%（1/34），在未受影响的妊娠中为0.2%（4/2094）。当使用的临界值≥3时，相应的值分别为66.7%、23.5%和16.5%。观察者间可靠性的组内相关系数为0.926（95%CI 0.890 - 0.953，<.0001），观察者内可靠性的Cohen's kappa系数为0.904，<.0001。
妊娠35 - 37周时尿刚果红点试纸试验在预测PE方面的性能非常差。
