title: Assessment of the diagnostic accuracy of the TDx-FLM II to predict fetal lung maturity.
abstract: BACKGROUND
  Because respiratory distress syndrome (RDS) affects 1% of live births, accurate and rapid assessment of markers of fetal lung maturity is critical to clinicians in deciding whether to deliver a preterm infant. Our objective was to determine the optimal diagnostic cutoff value for the TDx-FLM II assay (Abbott Laboratories) for predicting clinically significant RDS.
  
  
  METHODS
  Amniotic fluid TDx-FLM II data were collected retrospectively over 4 years. Women were included in the study if they had delivered within 72 h of TDx-FLM II testing and both the mother and infant charts could be reviewed. Women who had been treated with steroids and delivered unaffected infants were excluded from the analysis. The diagnosis of RDS was defined as infants who either were treated with surfactant and/or were placed on a ventilator and/or required continuous positive airway pressure for >1 day.
  
  
  RESULTS
  A total of 185 women met all entry criteria (15 RDS, 170 non-RDS). A cutoff value for a mature result of >or=45 mg/g gave a sensitivity of 100% (95% confidence interval, 82-100%) and a specificity of 90% (95% confidence interval, 78-89%).
  
  
  CONCLUSIONS
  The TDx-FLM II appears to predict clinically significant RDS when a cutoff of >or=45 mg/g is used for mature results. Further studies will be required to confirm these findings.
authors.affiliation: Department of Pathology and Immunology, Division of Laboratory Medicine, Washington University School of Medicine, 660 South Euclid Ave., Box 8118, St. Louis, MO 63110, USA.
authors.forename: Corinne R
authors.initials: CR
authors.lastname: Fantz
authors.forename: Cynthia
authors.initials: C
authors.lastname: Powell
authors.forename: Brad
authors.initials: B
authors.lastname: Karon
authors.forename: Curtis A
authors.initials: CA
authors.lastname: Parvin
authors.forename: Kelly
authors.initials: K
authors.lastname: Hankins
authors.forename: Molina
authors.initials: M
authors.lastname: Dayal
authors.forename: Yoel
authors.initials: Y
authors.lastname: Sadovsky
authors.forename: Vandita
authors.initials: V
authors.lastname: Johari
authors.forename: Fred S
authors.initials: FS
authors.lastname: Apple
authors.forename: Ann M
authors.initials: AM
authors.lastname: Gronowski
mesh_terms: D000653:Amniotic Fluid / Q000737:chemistry; D015415:Biomarkers / Q000032:analysis; D005260:Female; D005325:Fetal Organ Maturity; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D008168:Lung / Q000196:embryology*; D011247:Pregnancy; D011296:Prenatal Diagnosis / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012016:Reference Values; D012127:Respiratory Distress Syndrome, Newborn / Q000175:diagnosis*; D012189:Retrospective Studies; D012680:Sensitivity and Specificity
chemical_list: D015415:Biomarkers; D011933:Reagent Kits, Diagnostic