Objective To determine the performance of a glycosylated fibronectin (GlyFn) point‐of‐care (POC) test for pre‐eclampsia (PE) in a large Southeast Asian cohort (India) in comparison to previously described biomarkers. Design A total of 798 pregnant women at ≥20 weeks of gestation were enrolled in a prospective case‐control study. Study participants included 469 normotensive women with urinary mg protein/mmol creatinine ratio <0.3, 135 with PE (hypertension with urinary mg protein/mmol creatinine ratio ≥0.3) and 194 with gestational hypertension (hypertension with urinary mg protein/mmol creatinine ratio <0.3). Methods GlyFn levels were determined using a POC device and PIGF, sFlt‐1 and PAPPA2 levels were determined by immunoassay. Performance was assessed using logistic regression modelling and receiver‐operating characteristic (ROC) curves. Classification performance and positive and negative predictive values are reported at specific thresholds. Results Increased levels of GlyFn, soluble fms‐like tyrosine kinase‐1 (sFlt‐1) and pregnancy‐associated placental protein A2 (PAPPA2), and decreased levels of placental growth factor (PlGF) were significantly associated (P < 0.01) with clinically defined PE. Area under the ROC (AUROC) values with 95% confidence intervals were: GlyFn, 0.99 (0.98–0.99); PlGF, 0.96 (0.94–0.98); sFlt‐1, 0.86 (0.83–0.89); and PAPPA2, 0.96 (0.94–0.97). Of subjects with GH, 48% were positive for more than two PE biomarkers, and 70% of these delivered preterm. Conclusions The Lumella™ GlyFn POC test has been validated in a low/middle‐income country setting for PE diagnosis and may be a useful adjunctive tool for early identification, appropriate triage, and improved outcomes. Tweetable abstract The Lumella™ point‐of‐care test had excellent performance in diagnosing PE in a large Southeast Asian cohort.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.