Glycosylated fibronectin - Point-of-care test for diagnosis of preeclampsia

The present study aims to evaluate and compare the diagnostic performance of soluble fms-like tyrosine kinase-1/placental growth factor (sFlt-1/PlGF) ratio and glycosylated fibronectin (GlyFn) in women with suspected PE, with a particular focus on their potential for improving risk stratification and guiding timely clinical management In this prospective cohort study, 124 pregnant women with clinical suspicion of PE were recruited at the University Clinic of Gynecology and Obstetrics in Skopje between May 2024 and May 2025.GlyFn was measured by a point-of-care test (Lumella PE), and sFlt-1/PlGF was determined by automated electrochemiluminescence immunoassay.Diagnostic performance was evaluated using sensitivity, specificity, predictive values, and receiver-operating characteristic (ROC) analysis.Of 124 women, 70 were diagnosed with PE and 54 with gestational hypertension (GH).Median biomarker levels were significantly higher in PE versus GH: sFlt-1/PlGF ratio 180 (IQR 111-477) vs. 17 (IQR 9-48), and GlyFn 454 g/mL (IQR 385-601) vs. 252 g/mL (IQR 220-298) (both p<0.001).At thresholds of 85 for sFlt-1/PlGF and 350 g/mL for GlyFn, sensitivity was 84.3% and 80%, and specificity was 85.2% and 88.9%, respectively.Negative predictive values at 5% prevalence exceeded 98% for both markers.ROC analysis demonstrated excellent discrimination: AUC 0.946 (95% CI 0.905-0.978)for sFlt-1/PlGF and 0.906 (95% CI 0.844-0.958)for GlyFn.Both sFlt-1/PlGF and GlyFn reliably differentiate preeclampsia from gestational hypertension, with high diagnostic accuracy and excellent negative predictive value.While sFlt-1/PlGF remains the benchmark biomarker, GlyFn offers comparable performance and the advantage of rapid point-of-care testing, supporting its complementary role in diverse clinical settings