Performance of the Affirm VP-III using residual vaginal discharge collected from the speculum to characterize vaginitis in symptomatic women.
OBJECTIVE
To evaluate the ability of collecting the Affirm VP-III test sample using the residual vaginal discharge found on the speculum.


METHODS
One hundred nine symptomatic women (≥18 y) participated in this study. During pelvic examination, vaginal fluid was collected onto 3 swabs for office-based diagnostic tests and Affirm (referred to as Affirm-R). A fourth swab was used to collect residual vaginal discharge from the speculum, followed by Affirm testing (referred to as Affirm-RVD). Sensitivity, specificity, and Cohen κ agreement for office-based diagnostic tests and Affirm-RVD were determined against Affirm-R.


RESULTS
Complete results were available for 99 samples. Cohen κ agreement between Affirm-RVD and Affirm-R was 0.66 (p<.0001) for Gardnerella vaginalis, 0.81 (p<.0001) for Candida species, and 1.0 (p<.0001) for Trichomonas vaginalis. Affirm-RVD sensitivity, specificity, and positive and negative predictive values were 73.8%, 91.2%, 86.1%, and 82.5% for G. vaginalis; 84.2%, 96.3%, 84.2%, and 96.3% for Candida species; and 100%, 100%, 100%, and 100% for T. vaginalis, respectively. Cohen κ agreement between office-based diagnostic tests and Affirm-R was 0.16 (p=.141) for G. vaginalis, 0.46 (p<.0001) for Candida species, and 0.55 (p<.0001) for T. vaginalis.


CONCLUSIONS
The Affirm VP-III sample collected from the residual vaginal discharge found on the speculum after performing office-based diagnostic tests can produce comparable results to traditionally collected sample.
1Department of Family Medicine, Beaumont Health System, Troy; 2Oakland University William Beaumont School of Medicine, Rochester; and 3Department of Clinical Pathology, Beaumont Health System, Royal Oak, MI.
Elie
E
Mulhem
Bobby L
BL
Boyanton
Barbara
B
Robinson-Dunn
Carolyn
C
Ebert
Ruzica
R
Dzebo
D000293:Adolescent; D000328:Adult; D000368:Aged; D002175:Candida / Q000302:isolation & purification; D002181:Candidiasis, Vulvovaginal / Q000175:diagnosis* / Q000382:microbiology; D005260:Female; D006194:Gardnerella vaginalis / Q000302:isolation & purification; D006801:Humans; D008828:Microbiological Techniques / Q000379:methods*; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D019095:Point-of-Care Systems; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D014247:Trichomonas Vaginitis / Q000175:diagnosis* / Q000469:parasitology; D014246:Trichomonas vaginalis / Q000302:isolation & purification; D019522:Vaginal Discharge / Q000382:microbiology* / Q000469:parasitology*; D016585:Vaginosis, Bacterial / Q000175:diagnosis* / Q000382:microbiology; D055815:Young Adult