RecruitingNCT05079711

Comparative Performance of a Vaginal Yeast Test

Comparative Performance of the SavvyCheck Vaginal Yeast Test Versus Culture

Sponsor

Uniformed Services University of the Health Sciences

Enrollment

1,200 participants

Start Date

Mar 18, 2022

Study Type

OBSERVATIONAL

Conditions

Vulvovaginal candidiasis

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria15

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.
DoD Military Health System beneficiary
Have a healthcare appointment at a recruitment clinic
18 years of age or older
Must speak and understand English
Able to provide informed consent
Women experiencing vaginal symptoms, including: increased discharge, itching, soreness and irritation, rash on the labia, and genital burning that may worsen during urination
Must determine the test is applicable to her based on her symptoms after she has read the outside device labeling (box label)
Asymptomatic Women Asymptomatic women include those women who do not present with a complaint consistent with vaginitis. Enrollment will continue at each clinical site until our target number of 170 Reference Method (vaginal Candida yeast culture) negatives have been collected. We estimate up to 320 asymptomatic women will be enrolled to meet our target.
DoD Military Health System beneficiary
Have a healthcare appointment at a recruitment clinic
18 years of age or older
Must speak and understand English
Able to provide informed consent
Healthy women appearing for routine care without symptoms of vaginal yeast infection

Exclusion Criteria6

If any of the following criteria are met, a potential subject will be excluded from the study:
Currently menstruating
History of any clinical therapies and/or interventions related to gender confirmation (transgender person)
Use of any vaginal medication, taken by mouth or vaginally, within the last 7 days
Use of any vaginal product within 24 hours, including contraception (cream, gel, or foam), or douching solutions
NOTE: Women who currently have an intrauterine device (IUD) placed are eligible to participate

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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.