Accuracy of the clinical diagnosis of vaginitis compared with a DNA probe laboratory standard.
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.
Lowe
Nancy K
NK
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.
Neal
Jeremy L
JL
Ryan-Wenger
Nancy A
NA
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
D015342:DNA Probes