title: A comparison of the diagnostic utility of the sFlt-1/PlGF ratio versus PlGF alone for the detection of preeclampsia/HELLP syndrome.
abstract: OBJECTIVE
  The Elecsys(®) immunoassay sFlt-1/PlGF ratio and the Triage(®) PlGF assay were compared (in a prospective, multicenter, case-control study) for diagnosis of preeclampsia/hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome.
  
  
  METHODS
  Women in European perinatal care centers with singleton pregnancies were enrolled: 178 cases had confirmed preeclampsia and 391 controls had normal outcome. Patients in the preeclampsia/HELLP syndrome group were matched pairwise by gestational week to healthy controls (1:2). Maternal blood samples were analyzed using (a) fully automated Elecsys PlGF and Elecsys sFlt-1 immunoassays with two cutoffs (early-onset [<34 weeks] ≤33, ≥85; late-onset [≥34 weeks] ≤33, ≥110), and (b) Triage PlGF immunoassay (single cutoff). Diagnostic performance and utility were assessed.
  
  
  RESULTS
  Respectively, 83 and 95 women had early-onset or late-onset preeclampsia/HELLP syndrome. The overall diagnostic performance of the Elecsys immunoassay sFlt-1/PlGF ratio (area under the curve [AUC] 0.941) was higher than for Triage PlGF (AUC 0.917). The Elecsys immunoassay sFlt-1/PlGF ratio sensitivity and specificity was: 94.0% (95% confidence interval [CI] 86.5-98.0) and 99.4% (95% CI: 96.8-99.9) for early-onset preeclampsia; and 89.5% (95% CI: 81.5-94.8) and 95.4% (95% CI: 91.7-97.8) for late-onset preeclampsia. The Triage assay sensitivity and specificity was: 96.4% (95% CI: 89.8-99.3) and 88.5% (95% CI: 82.8-92.8) (early-onset); and 90.5% (95% CI: 83-96) and 64.5% (95% CI: 57.8-70.9) (late onset).
  
  
  CONCLUSIONS
  The fully automated Elecsys immunoassay sFlt-1/PlGF ratio provides improved diagnostic utility over the Triage PlGF assay with improved specificity for the clinical management of pregnant women with suspected preeclampsia/HELLP syndrome.
authors.affiliation: a Department of Obstetrics , Leipzig University , Leipzig , Germany.
authors.forename: H
authors.initials: H
authors.lastname: Stepan
authors.affiliation: b Roche Diagnostics International , Medical and Scientific Affairs , Rotkreuz , Switzerland.
authors.forename: M
authors.initials: M
authors.lastname: Hund
authors.affiliation: b Roche Diagnostics International , Medical and Scientific Affairs , Rotkreuz , Switzerland.
authors.forename: M
authors.initials: M
authors.lastname: Gencay
authors.affiliation: c Roche Diagnostics GmbH , Penzberg , Germany.
authors.forename: B
authors.initials: B
authors.lastname: Denk
authors.affiliation: c Roche Diagnostics GmbH , Penzberg , Germany.
authors.forename: C
authors.initials: C
authors.lastname: Dinkel
authors.affiliation: d Bioscientia, Institute for Medical Diagnostics GmbH , Ingelheim , Germany.
authors.forename: W E
authors.initials: WE
authors.lastname: Kaminski
authors.affiliation: d Bioscientia, Institute for Medical Diagnostics GmbH , Ingelheim , Germany.
authors.forename: P
authors.initials: P
authors.lastname: Wieloch
authors.affiliation: d Bioscientia, Institute for Medical Diagnostics GmbH , Ingelheim , Germany.
authors.forename: B
authors.initials: B
authors.lastname: Semus
authors.affiliation: d Bioscientia, Institute for Medical Diagnostics GmbH , Ingelheim , Germany.
authors.forename: T
authors.initials: T
authors.lastname: Meloth
authors.affiliation: e Charité Campus Virchow-Klinikum , Berlin , Germany.
authors.forename: L-A
authors.initials: LA
authors.lastname: Dröge
authors.affiliation: e Charité Campus Virchow-Klinikum , Berlin , Germany.
authors.forename: S
authors.initials: S
authors.lastname: Verlohren
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood; D016022:Case-Control Studies; D005260:Female; D017359:HELLP Syndrome / Q000097:blood / Q000175:diagnosis*; D006801:Humans; D000072483:Placenta Growth Factor / Q000097:blood*; D011225:Pre-Eclampsia / Q000097:blood / Q000175:diagnosis*; D011247:Pregnancy; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D040281:Vascular Endothelial Growth Factor Receptor-1 / Q000097:blood*; D055815:Young Adult
chemical_list: D015415:Biomarkers; D000072483:Placenta Growth Factor; C501162:FLT1 protein, human; D040281:Vascular Endothelial Growth Factor Receptor-1
keywords: Diagnosis; HELLP syndrome; placental growth factor (PlGF); preeclampsia; soluble fms-like tyrosine kinase-1 (sFlt-1)