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

S. R. Nagalla, V. Janaki, A. R. Vijayalakshmi, K. Chayadevi, D. Pratibha, P. V. Rao, K. M. Sage, D. Nair-Schaef, E. Bean, C. T. Roberts, M. G. Gravett

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1687-1694
Number of pages8
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Volume127
Issue number13
DOIs
StatePublished - Dec 2020
Externally publishedYes

Keywords

  • Gestational hypertension
  • glycosylated fibronectin
  • point-of-care test
  • pre-eclampsia

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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