title: Evaluation of clinical methods for diagnosing bacterial vaginosis.
abstract: OBJECTIVE
  To determine whether the current clinical criteria for diagnosing bacterial vaginosis can be simplified by using 2 clinical criteria rather than the standard 3 of 4 criteria (Amsel's criteria).
  
  
  METHODS
  This was a prospective observational study of 269 women undergoing a vaginal examination in the Women's Primary Care Center, Division of Research, or Colposcopy Clinic at Women & Infants Hospital. All 4 clinical criteria for diagnosing bacterial vaginosis were collected, and Gram stain was used as the gold standard. Sensitivity and specificity were calculated for each individual criterion, combinations of criteria, and a colorimetric pH and amine card. Receiver operating characteristic curve was generated to estimate the preferred pH and percentage of clue cells for diagnosing bacterial vaginosis.
  
  
  RESULTS
  The prevalence of bacterial vaginosis in our study population was 38.7%. Vaginal pH was the most sensitive of all the criteria, at 89%, and a positive amine odor was the individual criteria with the highest specificity, at 93%. Similar specificity was seen with combinations of 2 criteria and Amsel's criteria. Receiver operating characteristic curve analysis yielded a preferred pH and percentage of clue cells of 5.0 and 20%, respectively. However, a pH of 4.5 or greater improves sensitivity with minimal loss of specificity.
  
  
  CONCLUSIONS
  The clinical criteria for diagnosing bacterial vaginosis can be simplified to 2 clinical criteria without loss of sensitivity and specificity.
authors.affiliation: Division of Research, Department of Obstetrics and Gynecology, Women & Infants Hospital, and the Center for Statistical Sciences, Brown University, Medical School, Providence, Rhode Island, USA. rgutman1@jhmi.edu
authors.forename: Robert E
authors.initials: RE
authors.lastname: Gutman
authors.forename: Jeffrey F
authors.initials: JF
authors.lastname: Peipert
authors.forename: Sherry
authors.initials: S
authors.lastname: Weitzen
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Blume
mesh_terms: D000328:Adult; D003124:Colorimetry; D003581:Cytodiagnosis; D005260:Female; D005840:Gentian Violet; D006801:Humans; D006863:Hydrogen-Ion Concentration; D009812:Odorants; D010619:Phenazines; D012372:ROC Curve; D012680:Sensitivity and Specificity; D014621:Vagina / Q000737:chemistry / Q000166:cytology; D019522:Vaginal Discharge; D016585:Vaginosis, Bacterial / Q000175:diagnosis*
chemical_list: C035863:Gram's stain; D010619:Phenazines; D005840:Gentian Violet