title: Maternal serum glycosylated fibronectin as a point-of-care biomarker for assessment of preeclampsia.
abstract: OBJECTIVE
  We assessed the association of glycosylated fibronectin (GlyFn) with preeclampsia and its performance in a point-of-care (POC) test.
  
  
  METHODS
  GlyFn, placental growth factor (PlGF), and soluble vascular endothelial growth factor receptor 1 (sFlt1) levels were determined in serum samples from 107 pregnant women. In all, 45 were normotensive and 62 were diagnosed with preeclampsia. The ability of GlyFn to assess preeclampsia status and relationships between GlyFn and maternal characteristics and pregnancy outcomes were analyzed.
  
  
  RESULTS
  GlyFn serum levels in the first trimester were significantly higher in women with preeclampsia (P < .01) and remained higher throughout pregnancy (P < .01). GlyFn, sFlt1, PlGF, and the sFlt1/PlGF ratio were significantly associated (P < .01) with preeclampsia status, and the classification performance of these analytes represented by area under the receiver operating characteristic curve was 0.99, 0.96, 0.94, and 0.98, respectively, with 95% confidence intervals of 0.98-1.00, 0.89-1.00, 0.86-1.00, and 0.94-1.00, respectively. Increased GlyFn levels were significantly associated with gestational age at delivery (P < .01), blood pressure (P = .04), and small-for-gestational-age neonates. Repeated-measures analysis of the difference in weekly GlyFn change in the third trimester demonstrated that mild preeclampsia was associated with a weekly change of 81.7 μg/mL (SE 94.1) vs 195.2 μg/mL (SE 88.2) for severe preeclampsia. The GlyFn POC demonstrated similar performance to a plate assay with an area under the receiver operating characteristic curve of 0.93 and 95% confidence interval of 0.85-1.00.
  
  
  CONCLUSIONS
  GlyFn is a robust biomarker for monitoring of preeclampsia in both a standard and POC format, which supports its utility in diverse settings.
authors.affiliation: Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR; Department of Obstetrics and Gynecology, Oulu University Hospital, Oulu, and Kuopio University Hospital and University of Eastern Finland, Kuopio, Finland.
authors.forename: Juha
authors.initials: J
authors.lastname: Rasanen
authors.affiliation: DiabetOmics Inc, Hillsboro, OR.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Quinn
authors.affiliation: DiabetOmics Inc, Hillsboro, OR.
authors.forename: Amber
authors.initials: A
authors.lastname: Laurie
authors.affiliation: DiabetOmics Inc, Hillsboro, OR.
authors.forename: Eric
authors.initials: E
authors.lastname: Bean
authors.affiliation: DiabetOmics Inc, Hillsboro, OR.
authors.forename: Charles T
authors.initials: CT
authors.lastname: Roberts
authors.affiliation: DiabetOmics Inc, Hillsboro, OR.
authors.forename: Srinivasa R
authors.initials: SR
authors.lastname: Nagalla
authors.affiliation: Department of Obstetrics and Gynecology, University of Washington School of Medicine, Seattle, WA. Electronic address: gravettm@u.washington.edu.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Gravett
mesh_terms: D000293:Adolescent; D000328:Adult; D015415:Biomarkers / Q000097:blood; D005260:Female; D005353:Fibronectins / Q000097:blood*; D017127:Glycation End Products, Advanced; D006801:Humans; D000072483:Placenta Growth Factor; D019095:Point-of-Care Systems; D011225:Pre-Eclampsia / Q000097:blood* / Q000175:diagnosis*; D011247:Pregnancy; D011257:Pregnancy Proteins; D055815:Young Adult; D000093844:Glycated Proteins
chemical_list: D015415:Biomarkers; D005353:Fibronectins; D017127:Glycation End Products, Advanced; D000072483:Placenta Growth Factor; D011257:Pregnancy Proteins; C000608036:PGF protein, human; C045099:glycated fibronectin; D000093844:Glycated Proteins
keywords: biomarker; glycosylated fibronectin; point-of-care; preeclampsia