Comparative Performance of the SavvyCheck Vaginal Yeast Test Versus Culture
Uniformed Services University of the Health Sciences
Summary
The purpose of this study is to establish lay user performance criteria for the SavvyCheck Vaginal Yeast Test in comparison to standard vaginal yeast culture and identification method for Candida (the Reference Method). Polymerase chain reaction (PCR) and sequencing of fungi will be used as an aid to explain the nature of the discrepancy in the case of discordant results between the lay user-performed SavvyCheck Vaginal Yeast Test and standard vaginal yeast culture and identification method for Candida.
Description
The purpose of this study is to establish lay user performance criteria for the SavvyCheck Vaginal Yeast Test in comparison to standard vaginal yeast culture and identification method for Candida (the Reference Method). Polymerase chain reaction (PCR) and sequencing of fungi will be used as an aid to explain the nature of the discrepancy in the case of discordant results between the lay user-performed SavvyCheck Vaginal Yeast Test and standard vaginal yeast culture and identification method for Candida. Primary Objective: The primary objective is to establish lay user performance criteria (s…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: Symptomatic Women Symptomatic women include those women who present with a complaint consistent with symptoms of vaginitis (e.g., increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination). Enrollment will continue at each clinical site until our target number of 216 Reference Method (vaginal Candida yeast culture) positives have been collected. We estimate up to 600 symptomatic women will be enrolled to meet our target. Inclusion Criteria for Symptomatic Women 1. DoD Military He…
Interventions
- DeviceSavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test)
The SavvyCheck Vaginal Yeast Test is a lateral flow immunochromatographic qualitative test for detection of Candida antigen in vaginal secretions, sampled by a swab as an aid for identification of vulvovaginal candidiasis (VVC), as a primary cause of vaginal yeast infections. The SavvyCheck Vaginal Yeast Test is designed for use by women experiencing vaginal symptoms, including: increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination. The SavvyCheck Vaginal Yeast Test is indicated for OTC use.
Locations (3)
- Womack Army Medical CenterFort Bragg, North Carolina
- Brooke Army Medical CenterFort Sam Houston, Texas
- Landstuhl Regional Medical CenterLandstuhl