Glycosylated fibronectin point‐of‐care test for diagnosis of pre‐eclampsia in a low‐resource setting: a prospective Southeast Asian population study

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 p...

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Published in:	BJOG : an international journal of obstetrics and gynaecology Vol. 127; no. 13; pp. 1687 - 1694
Main Authors:	Nagalla, SR, Janaki, V, Vijayalakshmi, AR, Chayadevi, K, Pratibha, D, Rao, PV, Sage, KM, Nair‐Schaef, D, Bean, E, Roberts, CT, Gravett, MG
Format:	Journal Article
Language:	English
Published:	England Wiley Subscription Services, Inc 01-12-2020 John Wiley and Sons Inc
Subjects:	Adult Biomarkers Case-Control Studies Cohort Studies Creatinine Diagnosis Eclampsia Female Fibronectin Fibronectins - blood Gestation Gestational hypertension Glycation End Products, Advanced glycosylated fibronectin Health Resources Humans Hypertension India Maternal Medicine Medical diagnosis Placenta Point-of-Care Systems point‐of‐care test Population studies Poverty Pre-Eclampsia - blood Pre-Eclampsia - diagnosis Preeclampsia Pregnancy pre‐eclampsia Prospective Studies Protein-tyrosine kinase Proteins Young Adult India pre-eclampsia Gestational hypertension point-of-care test glycosylated fibronectin
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Summary:	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 The Lumella™ point‐of‐care test had excellent performance in diagnosing PE in a large Southeast Asian cohort. Tweetable The Lumella™ point‐of‐care test had excellent performance in diagnosing PE in a large Southeast Asian cohort.
Bibliography:	https://doi.org/10.1111/1471-0528.16405 This article is commented on by I Herraiz, p. 1695 in this issue. To view this mini commentary visit Linked article ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Linked article: This article is commented on by I Herraiz, p. 1695 in this issue. To view this mini commentary visit https://doi.org/10.1111/1471-0528.16405
ISSN:	1470-0328 1471-0528
DOI:	10.1111/1471-0528.16323