title: Relative performance of three methods for diagnosing bacterial vaginosis during pregnancy.
abstract: OBJECTIVE
  This study measures the relative performance of three methods for diagnosing bacterial vaginosis (BV) during pregnancy and assesses the implications of measurement for clinical practice and surveillance.
  
  
  METHODS
  A sample (n = 1,780) of English or Spanish speaking women, with a singleton intrauterine pregnancy and receiving prenatal care at a consortium of public health centers in Philadelphia were consecutively enrolled. Gram stain, clinician's diagnosis, and a commercial test were the three diagnostic methods used to assess BV. Sensitivity, specificity, and the positive and negative predictive values of clinical diagnosis and the commercial test were assessed using the gram stain/Nugent score as a gold standard.
  
  
  RESULTS
  The prevalence of BV, measured on the same population, differed considerably depending on the diagnostic test used. The measured prevalences were 55% (Gram stain), 28.5% (clinician's diagnosis), and 12.6% (commercial test). The prevalence of BV (diagnosed by gram stain) was twice as high among African American women compared to White women. Only 69% BV-positive high-risk women were treated for BV.
  
  
  CONCLUSIONS
  Inaccurate diagnosis of BV leads to missed cases. The identification of true cases is critical for assigning treatment and for assessing treatment effectiveness. Clinician's routine diagnosis fell short of recommended procedures and performed poorly compared to gold standard in case ascertainment. This inability to ascertain cases may have an impact on our ability to prevent preterm birth.
authors.affiliation: Department of Maternal and Child Health, School of Public Health, University of North Carolina, CB# 7445, Chapel Hill, NC 27599-7445, USA. vijaya_hogan@unc.edu
authors.forename: Vijaya K
authors.initials: VK
authors.lastname: Hogan
authors.forename: Jennifer F
authors.initials: JF
authors.lastname: Culhane
authors.forename: Jane
authors.initials: J
authors.lastname: Hitti
authors.forename: Virginia A
authors.initials: VA
authors.lastname: Rauh
authors.forename: Kelly F
authors.initials: KF
authors.lastname: McCollum
authors.forename: Kathy J
authors.initials: KJ
authors.lastname: Agnew
mesh_terms: D000328:Adult; D001741:Black or African American; D000554:Ambulatory Care Facilities; D002983:Clinical Competence; D003430:Cross-Sectional Studies; D003951:Diagnostic Errors / Q000379:methods*; D005260:Female; D005840:Gentian Violet; D006801:Humans; D008853:Microscopy; D016017:Odds Ratio; D010619:Phenazines; D015143:Philadelphia; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000175:diagnosis* / Q000188:drug therapy / Q000453:epidemiology; D011296:Prenatal Diagnosis / Q000379:methods*; D015995:Prevalence; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014626:Vaginal Smears / Q000379:methods*; D016585:Vaginosis, Bacterial / Q000175:diagnosis* / Q000188:drug therapy / Q000453:epidemiology; D044465:White People
chemical_list: C035863:Gram's stain; D010619:Phenazines; D011933:Reagent Kits, Diagnostic; D005840:Gentian Violet