title: Fetal fibronectin detection in preterm labor: evaluation of a prototype bedside dipstick technique and cervical assessment.
abstract: OBJECTIVE
  The aims of this study were to evaluate a prototype bedside test for fetal fibronectin detection in women with symptoms of preterm labor, to compare the efficacy of obtaining fetal fibronectin swabs with and without a speculum, and to assess the value of combining the fetal fibronectin test with cervical dilatation for predicting delivery within 10 days.
  
  
  METHODS
  This investigation prospectively studied a cohort of women with symptoms of preterm labor (n = 121), gestational age between 24 and 33 6/7 weeks, and cervical dilatation </=3 cm. Vaginal swabs for fibronectin testing with the bedside dipstick Fetal Fibronectin Membrane Immunoassay test (Adeza Biomedical, Sunnyvale, Calif) were obtained with and without a speculum. Results were not available to the clinicians.
  
  
  RESULTS
  Twenty-two percent of the fetal fibronectin samples collected with a speculum (27/121) yielded positive results. The incidence of delivery within 10 days of testing was 14% (17/121). Fetal fibronectin detection predicted delivery within 10 days with sensitivity, specificity, and positive and negative predictive values of 65%, 85%, 41%, and 94%, respectively. The positive and negative likelihood ratios were 4.3 and 0.41, respectively. There was substantial association between samples obtained with and without a speculum (Cohen kappa statistic 0.65, 95% confidence interval 0.44-0.87). Cervical dilatation >/=1 cm predicted delivery within 10 days with sensitivity, specificity, and positive and negative predictive values of 71%, 87%, 46%, and 95%, respectively, with positive and negative likelihood ratios of 5.5 and 0.33, respectively. Combination of fetal fibronectin testing with cervical dilatation >/=1 cm did not significantly improve the fetal fibronectin test characteristics. After exclusion of women with slight vaginal bleeding, cervical dilatation >/=1 cm and fetal fibronectin status remained the only independent variables associated with delivery within 10 days.
  
  
  CONCLUSIONS
  Fetal fibronectin testing according to this prototype may have a limited role in clinical decision analysis. In this study a cervical dilatation >/=1 cm had predictive values equivalent to those of the fetal fibronectin test, and it should be evaluated further in a clinical setting.
authors.affiliation: Departments of Obstetrics and Gynaecology and Pharmacology and Clinical Pharmacology, National Women's Hospital, Auckland, New Zealand.
authors.forename: M A
authors.initials: MA
authors.lastname: Coleman
authors.forename: L M
authors.initials: LM
authors.lastname: McCowan
authors.forename: N S
authors.initials: NS
authors.lastname: Pattison
authors.forename: M
authors.initials: M
authors.lastname: Mitchell
mesh_terms: D000328:Adult; D002582:Cervix Mucus / Q000737:chemistry*; D005260:Female; D005353:Fibronectins / Q000032:analysis*; D005865:Gestational Age; D006801:Humans; D007118:Immunoassay; D007752:Obstetric Labor, Premature / Q000175:diagnosis*; D019095:Point-of-Care Systems; D011237:Predictive Value of Tests; D011247:Pregnancy; D011446:Prospective Studies; D011934:Reagent Strips; D012680:Sensitivity and Specificity; D013525:Surgical Instruments
chemical_list: D005353:Fibronectins; D011934:Reagent Strips