Office laboratory diagnosis of vaginitis. Clinician-performed tests compared with a rapid nucleic acid hybridization test.
BACKGROUND
The traditional diagnosis of vaginitis incorporates patient symptoms, clinical findings observed during vaginal examination, and laboratory analysis of vaginal fluid. The purpose of this study was to evaluate routine clinician-performed office laboratory diagnostic techniques for women with abnormal vaginal symptoms, and to compare these results with those obtained by a DNA hybridization test for Trichomonas vaginalis, Gardnerella vaginalis, and Candida species.


METHODS
The study included 501 symptomatic women who were between the ages of 14 and 67 years. Three vaginal specimens were obtained for saline wet mount, potassium hydroxide (KOH) prep, amine "sniff", pH, and nucleic acid hybridization (T vaginalis, G vaginalis, and Candida sp) tests. Clinicians and medical technicians independently evaluated the wet mount, KOH prep, amine, and pH tests. A medical technician processed the DNA tests according to manufacturer's protocol.


RESULTS
Of 499 subjects for whom complete data were available, vulvovaginal candidiasis was diagnosed in 20.0%, vaginal trichomoniasis in 7.4%, and bacterial vaginosis in 52.1%. Fourteen percent of subjects had multiple vaginal infections. The sensitivity and specificity of clinician microscopically diagnosed vulvovaginal candidiasis, vaginal trichomoniasis, and bacterial vaginosis were 39.6% and 90.4%, 75.0% and 96.6%, and 76.5% and 70.8%, respectively. The sensitivity and specificity of the DNA probe diagnosis of the same types of vaginitis were 75.0% and 95.7%, 86.5% and 98.5%, and 95.4% and 60.7%, respectively. When only women with multiple vaginal infections were considered, the percentages of correct clinician diagnoses for vulvovaginal candidiasis, vaginal trichomoniasis, and bacterial vaginosis were 49.3%, 83.6%, and 59.7%, respectively. For the DNA probe test, the percentages of correct diagnoses were 72.9%, 92.9%, and 90.0%, respectively.


CONCLUSIONS
Primary care clinicians demonstrated a high specificity but low sensitivity when identifying vaginal trichomoniasis and vulvovaginal candidiasis by microscopic techniques. Correct microscopic diagnosis of bacterial vaginosis was even more difficult for clinicians, as was the diagnosis of multiple vaginal infections. Clinicians were not as accurate as the DNA probe test in diagnosing vaginal infections. Clinicians need more education in the laboratory diagnosis of vaginitis. Clinicians should carefully scrutinize each microscopic slide, systematically examine the slide for each type of vaginitis, and consider specimen pH and the presence of leukocytes, Lactobacillus organisms, or amine odor as additional clues to infection.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D002175:Candida / Q000302:isolation & purification; D019411:Clinical Laboratory Techniques; D015342:DNA Probes; D005260:Female; D006194:Gardnerella vaginalis / Q000302:isolation & purification; D006801:Humans; D007778:Lactobacillus / Q000302:isolation & purification; D008875:Middle Aged; D009693:Nucleic Acid Hybridization; D014246:Trichomonas vaginalis / Q000302:isolation & purification; D014627:Vaginitis / Q000175:diagnosis* / Q000382:microbiology
D015342:DNA Probes