title: Accuracy of the clinical diagnosis of vaginitis compared with a DNA probe laboratory standard.
abstract: OBJECTIVE
  To estimate the accuracy of the clinical diagnosis of the three most common causes of acute vulvovaginal symptoms (bacterial vaginosis, candidiasis vaginitis, and trichomoniasis vaginalis) using a traditional, standardized clinical diagnostic protocol compared with a DNA probe laboratory standard.
  
  
  METHODS
  This prospective clinical comparative study had a sample of 535 active-duty United States military women presenting with vulvovaginal symptoms. Clinical diagnoses were made by research staff using a standardized protocol of history, physical examination including pelvic examination, determination of vaginal pH, vaginal fluid amines test, and wet-prep microscopy. Vaginal fluid samples were obtained for DNA analysis. The research clinicians were blinded to the DNA results.
  
  
  RESULTS
  The participants described a presenting symptom of abnormal discharge (50%), itching/irritation (33%), malodor (10%), burning (4%), or others such as vulvar pain and vaginal discomfort. According to laboratory standard, there were 225 cases (42%) of bacterial vaginosis, 76 cases (14%) of candidiasis vaginitis, 8 cases (1.5%) of trichomoniasis vaginalis, 87 cases of mixed infections (16%), and 139 negative cases (26%). For each single infection, the clinical diagnosis had a sensitivity and specificity of 80.8% and 70.0% for bacterial vaginosis, 83.8% and 84.8% for candidiasis vaginitis, and 84.6% and 99.6% for trichomoniasis vaginalis when compared with the DNA probe standard.
  
  
  CONCLUSIONS
  Compared with a DNA probe standard, clinical diagnosis is 81-85% sensitive and 70-99% specific for bacterial vaginosis, Candida vaginitis, and trichomoniasis. Even under research conditions that provided clinicians with sufficient time and materials to conduct a thorough and standardized clinical evaluation, the diagnosis and, therefore, subsequent treatment of these common vaginal problems remains difficult.
  
  
  METHODS
  II.
authors.affiliation: From the Division of Women, Children and Family Health, University of Colorado Denver College of Nursing, Aurora, Colorado; and Ohio State University College of Nursing, Columbus, Ohio.
authors.forename: Nancy K
authors.initials: NK
authors.lastname: Lowe
authors.forename: Jeremy L
authors.initials: JL
authors.lastname: Neal
authors.forename: Nancy A
authors.initials: NA
authors.lastname: Ryan-Wenger
mesh_terms: D000328:Adult; D000818:Animals; D002175:Candida / Q000145:classification; D002181:Candidiasis, Vulvovaginal / Q000175:diagnosis* / Q000382:microbiology; D015342:DNA Probes; D005260:Female; D006194:Gardnerella vaginalis / Q000145:classification; D006801:Humans; D008875:Middle Aged; D008889:Military Personnel; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D014247:Trichomonas Vaginitis / Q000175:diagnosis* / Q000382:microbiology; D014246:Trichomonas vaginalis / Q000145:classification; D016585:Vaginosis, Bacterial / Q000175:diagnosis* / Q000382:microbiology; D055815:Young Adult
chemical_list: D015342:DNA Probes