Performance of the Affirm VP-III using residual vaginal discharge collected from the speculum to characterize vaginitis in symptomatic women.

Abstract

OBJECTIVE:

To evaluate the ability of collecting the Affirm VP-III test sample using the residual vaginal discharge found on the speculum.

METHODS AND 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.

• Authors: Elie Mulhem, Bobby L Boyanton Jr, Barbara Robinson-Dunn, Carolyn Ebert, Ruzica Dzebo
• Journal: Journal of lower genital tract disease (J Low Genit Tract Dis) Vol. 18 Issue 4 Pg. 344-6 (Oct 2014) ISSN: 1526-0976 [Electronic] United States
• PMID: 24832170 (Publication Type: Evaluation Study, Journal Article)

Topics

• Adolescent
• Adult
• Aged
• Candida (isolation & purification)
• Candidiasis, Vulvovaginal (diagnosis, microbiology)
• Female
• Gardnerella vaginalis (isolation & purification)
• Humans
• Microbiological Techniques (methods)
• Middle Aged
• Molecular Diagnostic Techniques (methods)
• Point-of-Care Systems
• Predictive Value of Tests
• Sensitivity and Specificity
• Trichomonas Vaginitis (diagnosis, parasitology)
• Trichomonas vaginalis (isolation & purification)
• Vaginal Discharge (microbiology, parasitology)
• Vaginosis, Bacterial (diagnosis, microbiology)
• Young Adult