Urinary misfolded proteins detected by a novel point-of-care device and integrated into multivariate models for short-term prediction of preeclampsia

Preeclampsia (PE) remains a major cause of maternal and fetal morbidity, necessitating accurate prediction tools. This prospective study evaluated urinary misfolded proteins (MPs), detected by the point-of-care CercaTest RED device, for short-term PE prediction in 365 women with suspected PE at ≥ 20 weeks with 1207 longitudinal urine samples. MPs alone showed predictive value (AUC 0.770) for PE within one week. A multivariate model integrating MPs with clinical parameters (mean arterial pressure, antihypertensive treatment, prior PE history, and gestational age-adjusted BMI change [ΔBMI/GA]) further improved performance (AUC 0.937). The mean gestational age at PE diagnosis was 36.7 ± 2.5 weeks. The model offered high negative predictive value (97.7%) to rule out imminent PE and a positive predictive value of 54.0% to support rule-in decisions, and maintained robustness across gestational age groups (< 34 vs. ≥34 weeks). The integration of urinary MPs with clinical data provides a practical, non-invasive tool for short-term PE risk stratification, with potential for convenient monitoring in low-resource settings. Trial registration : ChiCTR2300074878. https//www.chictr.org.cn/showproj.html?proj=202096.