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  • Title: Performance of the Affirm VP-III using residual vaginal discharge collected from the speculum to characterize vaginitis in symptomatic women.
    Author: Mulhem E, Boyanton BL, Robinson-Dunn B, Ebert C, Dzebo R.
    Journal: J Low Genit Tract Dis; 2014 Oct; 18(4):344-6. PubMed ID: 24832170.
    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.
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